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D I G I T A L Use Zenopa to progress your career We will guide you through every stage We have two decades of experience placing sales, marketing and executive personnel in the Heathcare Supplier Industries Zenopa will always contact you before sending you forward for a job, and we will help you prepare your CV accordingly Our client relationships are built on years of service, it’s in our interest to find you a job you will excel in Before every assessment we will find out the format and interview style of your assessor, and ensure you are ready Think of where you want your career to go and call one of our consultants Pharmaceutical Sales Medical Communications Pharmaceutical Executive Testimonial "I just wanted to express my thanks and gratitude for the really good service Zenopa has provided since my CV was forwarded. The process has been very slick, you have always been amenable and knowledgeable about every process along each stage of interviewing, and that has made this career move that much easier! The medical team have always been helpful and I would recommend Zenopa to all colleagues and acquaintances who are in the health care and medical job market.” Sam - Theatre Sales Specialist Pharmaceutical Field Editor Chris Ross [email protected] Assistant Editor Iain Bate INTRODUCTION FROM THE EDITOR [email protected] Web Editor Diana Spencer [email protected] Designer Stephen Fisher [email protected] Sales Manager Jagdeep Oubhie [email protected] Finance Manager Sandra Workman [email protected] Administrator Lisa Maylin [email protected] General Manager Heidi Sharland [email protected] Pf Awards Melanie Hamer [email protected] Publisher Dr Philip Brown NHS ADVISORY BOARD Omar Ali Surrey & Sussex NHS Trust Paul Denny General Practice Michael Sobanja NHS Alliance INDUSTRY ADVISORY BOARD Anne Chandler Vybrant Organisation Niall Barry GEM Resourcing Kristin Darlison IHS Susan Glenn The Portland Partnership Steven Passmore Teva UK Lucy O’Neill STAR Medical Mike Stowe SpePharm UK Colin Watson Ashfield In2Focus READERSHIP ADVISORY BOARD Brian Bambrick-Sattar Chiesi Rachel Dixon Eli Lilly & Co Kim Hollis Pfizer Shazad Khilji Schering Plough Neeru Lorimer Merck Serono Trisha McGarry Eli Lilly Adrian McIlwrath Eli Lilly Rosie Sheppard Pfizer Sue Thomson Allergan Gareth Williams Janssen-Cilag IMPORTANT NOTICE The content of and information contained in this magazine are the opinions of the contributors and/ or the authors of such content and/or information. Health Sector Publishing Ltd accepts no responsibility or liability for any loss, cost, claim or expense arising from any reliance on such content or information. Users should independently verify such content or information before relying on it. The Publisher (Health Sector Publishing Ltd) and its Directors shall not be responsible for any errors, omissions or inaccuracies within the publication, or within other sources that are referred to within the magazine. The Publisher provides the features and advertisements on an ‘as is’ basis, without warranties of any kind, either express or implied, including but not limited to implied warranties of merchantability or fitness for a particular purpose, other than those warranties that are implied by and capable of exclusion, restriction, or modification under the laws applicable to this agreement. No copying, distribution, adaptation, extraction, reutilisation or other exploitation (whether in electronic or other format and whether for commercial or noncommercial purposes) may take place except with the express permission of the Publisher and the copyright owner (if other than the Publisher). The information contained in this magazine and/or any accompanying brochure is intended for sales and marketing professionals within the healthcare industry, and not the medical profession or the general public. Pharmaceutical Field is published monthly. For subscription details, telephone 0121 633 0044 or fax 0121 633 0055. 2010: a year of change? Welcome to the 2010 Pf Digital Yearbook – Health Sector Publishing’s first step into the world of digital publishing, providing our loyal audience of UK-based medical sales professionals with a new and exciting way to access market intelligence. The Yearbook, available for viewing in pageturning PDF format on your laptop or as an ‘eBook’ on iPad or equivalent, looks back at the developments that shaped the pharmaceutical industry in 2010, the repercussions of which will be felt throughout 2011 and beyond. It would be easy to define 2010 as a year of change for the pharmaceutical sector, but, in truth, the industry – and the customerbase it serves – rarely stands still. Certainly the selling environment for UK medical sales professionals continues to evolve at a rapid pace. Following years of steady (yet seemingly relentless) health reforms, 2010 began with an almost eerie silence in terms of NHS policy. It would prove to be the calm before the storm. The May General Election, which had driven the slowdown in policy development, was followed by the unveiling of what have been described as the most radical set of reforms to hit the NHS since its inception. The White Paper for health in July 2010 laid out a blueprint for wholesale change to the way healthcare will be delivered in the UK. The Health and Social Care Bill, which was presented to Parliament in January 2011, formalises the aspirations of the White Paper following a series of consultations and will, it seems, face some formidable opposition as it works its way towards legislation. For the UK pharmaceutical industry, which has spent the past decade responding to the evolution of New Labour’s 2000 NHS Plan, the Health and Social Care Bill will once again dictate a shift in customer-base. The onset of GP Commissioning will give budgetary power back to a familiar customer-group, but the imperatives of demonstrating both clinical and costeffectiveness mean that the rules of engagement with GPs will be very different. The industry has, for the past few years, made a serious attempt to redesign its sales and marketing model. For sales professionals this has meant a dramatic reduction in the size of the field-force and, for those that have remained, an evolution towards Key Account Management. Alongside this, the clamour for NHS/industry partnership, with sales professionals tipped to be facilitators in the process, has reached fever pitch – not least because the demands of the QIPP agenda has meant that NHS professionals are now looking to industry for a different kind of support. The mantra from within has been that the new and emerging role of the ‘rep’ dictates new skill-sets. But the allegation from outside is that many Key Account Managers are simply old-school reps with a different job title. In a year of change, did anything really change at all? The 2010 Pf Digital Yearbook charts the progress of the industry and, with links back to additional features online at pharmafield.co.uk, provides clear evidence of the narrative outlined above: the political reform, the ensuing uncertainty, the industry’s operational response, and the implications for the future. In truth, 2010 was not so much a year of change, it merely paved the way for one: 2011. In twelve months’ time, things really will look different. Chris Ross Editor JANUARY 2010 DH moves towards generic substitution The DH has promoted the use of generic medicines in primary care as part of proposals that it is hoped will bring about long-term savings for the NHS. The proposals are now open to a 12-week consultation. The ABPI has welcomed the opportunity for all stakeholders to express their views, as well as the emphasis given to patient safety in the DH report. Pharmaceutical Field The gateway to a commercial career in pharma Is the NHS facing Armageddon? p18 Becoming a mastermind p20 January 2010 Management is child’s play p26 DH moves towards generic substitution The DH has promoted the use of generic medicines in primary care as part of proposals that it is hoped will bring about long-term savings for the NHS. The proposals are now open to a 12-week consultation. The ABPI has welcomed the opportunity for all stakeholders to express their views, as well as the emphasis given to patient safety in the DH report. Various options for replacing branded medicines with generics were outlined, including a scheme whereby a list of products are exempt from substitution or where only certain products can be replaced with a generic version. Under these options, health professionals would be able to stipulate on a prescription form where they do not think it appropriate for medicines to be substituted. Patients would also continue to receive a specific manufacturer’s product where their treating clinician judges that this is necessary to meet clinical need. Pharmacists will be able to dispense generic medicines instead of branded products unless otherwise stated on the prescription form. The ABPI has responded that patient safety should prevail and prescribers should retain the right to prescribe a particular branded generic. During PFJAN10 - NEWS.indd 1 PPRS discussions, the ABPI argued that certain groups of products should be exempt from substitution based on patient welfare and international best practice, including modified or sustained release preparations, medicines with a narrow therapeutic index, vaccines, biosimilars, devices and routes of administration, and controlled drugs. The publication of the proposals coincided with an independent piece of market research, which indicated that 83% of Europeans believe generics are as effective as the original product. Health Minister Mike O’Brien said: “We want to make sure that patients and taxpayers are getting the best medicines at the best price. Where clinically appropriate, it is Mike O’Brien only sensible to allow more expensive branded products to be substituted with the same generic medicines, which are just as effective as the branded version. “Patient safety is always our top priority. (Continued on p2) NICE reverses Yondelis decision A new treatment which could extend the lives of a specific group of cancer patients will be available on the NHS following a U-turn by NICE. Final draft guidance has recommended trabectedin (Yondelis) as a treatment for certain patients with advanced soft tissue sarcoma. NICE reversed its original decision not to recommend the drug after the manufacturer, PharmaMar, agreed to meet the costs of trabectedin if it is needed beyond the fifth cycle of treatment. The independent appraisal committee also applied NICE’s criteria for evaluating life-extending end of life treatments. The draft guidance is now with consultees who have the opportunity to appeal against the proposed recommendation. Final guidance will be published next year. Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “We are delighted the Independent Appraisal Committee has been able to recommend trabectedin in its draft guidance. It has certainly not been an easy decision to make; soft tissue sarcoma is a rare cancer and the evidence was limited. “However, treatment options for this type of cancer are limited and in the last 20 years there have been no major developments to treat the advanced stages of this disease. Being able to recommend trabectedin for use on the NHS represents a step forward in the care of this group of patients who may have very few treatment options left.” NICE recommends the use of trabectedin as a treatment for people with advanced soft tissue sarcoma if treatment with anthracyclines and ifosfamide has failed, or if they are intolerant of or have contraindications for treatment with anthracyclines and ifosfamide. Research shows the drug can extend life by at least three months more than other treatments currently available on the NHS. NHS in England ‘more efficient’ The UK has dropped to the bottom of the official league table comparing the prices of medicines across Europe, a Government report has revealed. For the first time, the UK lags behind Austria, Belgium, Finland, France, Germany, Ireland, Italy, Netherlands, Spain and Sweden. The NHS in England is more efficient than elsewhere in the UK, a new study has revealed. A unique analysis of the performance of the NHS across the four countries of the UK has found striking differences in performance, funding and staff levels. NICE decision NICE rejects ‘another step dronedarone backwards’ for To read the full story, click on the headline Saflutan approved in Scotland A new treatment which could extend the lives of a specific group of cancer patients will be available on the NHS following a U-turn by NICE. Final draft guidance has recommended Yondelis (trabectedin) as a treatment for certain patients with advanced soft tissue sarcoma. The SMC has accepted Saflutan (tafluprost) for the treatment of glaucoma, the first preservativefree ophthalmic prostaglandin to be recommended for use in Scotland. Saflutan is recommended for the reduction of elevated intraocular pressure (IOP) in open angle glaucoma and ocular hypertension – as monotherapy in patients who would benefit from preservativefree eye-drops or are insufficiently responsive or intolerant to the first-line therapy, or as adjunctive therapy to beta blockers. 21/01/2010 16:41 Prices of medicines hits all-time low The National Institute for Health and Clinical Excellence (NICE) has decided against RoActemra (tocilizumab) for patients with rheumatoid arthritis (RA) for the second time. The Institute has issued new preliminary guidance which recommends that RoActemra is not used in patients who do not respond to DMARDs (disease modifying anti-rheumatic drugs), and has issued a ‘minded not to recommend’ decision for RoActemra’s use in patients who cannot tolerate anti-TNF treatments. NICE reverses Yondelis decision NICE has issued draft guidance advising against NHS funding for Multaq (dronedarone) to treat atrial fibrillation. The evidence provided to the independent appraisal committee indicates that dronedarone is less effective and costs considerably more than existing treatments for controlling atrial fibrillation. Industry and NHS invest in innovation GSK is to join other private sector companies in partnering with the NHS and higher education bodies to provide health education and training. The new Health Innovation and Education Clusters (HIECs) are crosssector partnerships between NHS organisations, higher education and private sector companies. SMC decision ‘encouraging news’ for CLL Scotland has become the first country in the UK to make MabThera (rituximab) available to all patients with the most common form of leukaemia. The Scottish Medicines Consortium (SMC) has extended its recommendation on the use of MabThera to include people with relapsed and difficult-to-treat (refractory) chronic lymphocytic leukaemia (CLL) in combination with any suitable chemotherapy. NICE ‘unable’ to recommend Alimta NICE has revealed that, due to data uncertainties, it is unable to recommend Alimta (pemetrexed) for the maintenance treatment of non-small-cell lung cancer. The draft guidance has been issued for consultation and the manufacturer, Eli Lilly, now has an opportunity to consider and respond to comments made by the independent Appraisal Committee. Pharmaceutical Field YEARBOOK 2010 Shape our success in 2011 At Ashfield In2Focus, we rely on the drive and dedication of talented people to help deliver exceptional results to our clients. As market leaders, our experience in building specialist secondary care, primary care and nurse teams is unparalleled. Our continued growth means we can offer unrivalled opportunities to develop your career. Great people are the key to our success. That’s why we’re always looking for outstanding individuals to take us further. If you’re passionate, ambitious and looking to be part of our 2011 success story, visit our website or call us on 01530 562405. www.ashfieldin2focuscareers.com Ref: PF/J2011 A United Drug Company www.advancerecruitment.net Aspire to Advance Advance Recruitment specialises in medical sales and marketing recruitment for leading healthcare, pharmaceutical, dental and veterinary companies throughout the UK. Freephone : 0800 783 0920 Tel: 0161 969 9700 www.advancerecruitment.net Fax: 0161 969 9766 email: [email protected] Advance Recruitment, Stafford Court, 145 Washway Road, Sale, Cheshire. M33 7PE JANUARY 2010 Tories promise Sir Liam a decentralised Donaldson health service to retire The Conservative Party has pledged to scrap NHS process targets, open up the NHS further to independent sector providers, and enable patients to choose their own providers at all levels of healthcare. The Conservative ‘Reform Plan for the NHS’, published as the first chapter of the party’s Draft Manifesto 2010, places emphasis on decentralisation. It consolidates a number of policy statements made in late 2009 – and echoes a number of Labour commitments, including the conversion of all hospital trusts to Foundation Trusts. England’s Chief Medical Officer, Sir Liam Donaldson, has decided to step down in May 2010 after 12 years of service. Appointed in 1998, Sir Liam is the longest-serving Chief Medical Officer of modern times. M&A has contributed 63% of ‘big pharma’ sales growth over 1995–2014, recent analysis by Datamonitor has revealed. The industry analysts also predict that large-scale M&A activity will remain an integral strategy of big pharma and will continue to contribute nearly two-thirds of peer set sales growth in the year up to 2014. EC approves intravenous PAH therapy Sir Liam Donaldson Six new Business Ambassadors for CHMP update UK life sciences The December meeting of the CHMP Prime Minister Gordon Brown has appointed six new Business Ambassadors – business and academic leaders chosen to support the Government in promoting the UK’s excellence internationally. The new Business Ambassadors include Chris Brinsmead, Chairman of AstraZeneca UK, and Lord Ara Darzi, Professor at Imperial College and former Health Minister, representing the UK life sciences industry. saw the recommendation of marketing authorisations for six new drugs and a review of swine flu vaccines. The Committee reviewed further data on the pandemic flu vaccines Celvapan, Focetria and Pandemrix and the antiviral Tamiflu. In the EU at least 26 million people have been vaccinated so far, and worldwide 13 million patients have taken Tamiflu from 1 May 2009 to 31 October 2009. The European Medicines Agency has reaffirmed the positive balance of benefits and risks in the context of the current H1N1 pandemic. Patent box to boost UK investment Alcon shareholders challenge The ABPI has welcomed the proposal for a ‘patent box’ outlined by Chancellor Alastair Darling in his Pre-Budget Report. The patent box is being introduced to encourage research and development within the UK from the pharmaceutical and biotech industries. In his speech, Mr Darling said he would bring in a 10% corporation tax rate on income that stems from patents in the UK. Alcon’s minority shareholders have filed a class action against Novartis for offering two groups of Alcon shareholders different prices for the same stock. Law firm Labaton Sucharow LLP is advising the shareholders on the prevention of the $39 billion merger proposed by Novartis in which, it argues, Alcon’s minority public shareholders will be “squeezed out at an unfair price”. Pharmaceutical Field YEARBOOK 2010 M&A strategy to continue Revatio (sildenafil) has become the first pulmonary arterial hypertension (PAH) treatment in its class to be approved as an intravenous (IV) formulation, allowing access to patients who are unable to use oral therapy. The European Commission has approved Pfizer’s treatment in an IV formulation for patients with PAH who are prescribed oral Revatio but are temporarily unable to take it. NICE launches new guide NICE has launched How to use NICE guidance to commission high quality services, a guide that explains how NICE guidance supports the commissioning of high quality services and describes how the guidance can be used throughout the commissioning cycle. The guide is aimed at everyone involved in commissioning health and social care services. Follow Pf on Twitter @PharmaField Clough secures new ABPI role Alison Clough has been promoted to Commercial and Communications Director at the ABPI. Alison will be responsible for both the commercial and communications functions at the ABPI, and for coordinating the work of the ABPI’s four work streams around Value, Innovation, Trust and Access (VITA). Alison Clough Pharma sends relief to Haiti Pharmaceutical companies are leading the way in providing support and donations of supplies to aid workers and victims of the Haiti earthquake. Major companies, including Pfizer, GSK, AstraZeneca and Novartis, have responded to the call for aid following the tragic events in early January. Donations, including the provision of pharmaceuticals and nutritional products, have also been made by Merck Serono, BMS, Eisai, Eli Lilly, Amgen and Abbott. AZ enters into Novexel AstraZeneca has entered into an agreement to purchase Novexel, a private infection research company based in France, for $350 million. The company is also to collaborate with Forest Laboratories on the future co-development of two late-stage antibiotic development programmes that utilise Novexel’s novel investigational beta-lactamase inhibitor. CUSTOMER FOCUS Is the NHS facing Is the NHS facing Armageddon from 2011? ARMAGEDDON from 2011? Mike Sobanja, Chief Executive, NHS Alliance and Andy Etheridge, Commercial Director, Cegedim Dendrite, assess the outlook for 2010 and beyond. Pharmaceutical Field January 2010 P olitical uncertainty and the ongoing impact of the swine flu pandemic are major concerns for NHS senior managers. But it is the possible financial meltdown that is the number one issue to consider in 2010. With projected deficits for this year alone already coming in at £50 million from individual Trusts, the big question is just how senior managers plan to manage the financial pressures. Will they revert to the 1980s style of slash and burn, drastically cutting down the number of outpatient appointments, removing beds and reducing surgery? Or will a positive response to the Quality, Innovation, Productivity and Prevention (QIPP) agenda be enough to increase efficiency and achieve more effective management of resources? Crisis point Senior managers are warning that the NHS faces the greatest financial pressure since its inception. Indeed, a study by the King’s Fund and the Institute for Fiscal Studies forecasts a funding gap of between £20bn and £40bn by 2017, if funding for the NHS receives no increase or gets a real term freeze which only keeps pace with inflation. NHS Trusts have been asked by the Secretary of State not to second guess the Government on financial projections. With the next round of funding plans due for 2011, organisations are currently planning on the basis of 0.7% gain – which is estimated by the Institute of Fiscal Studies, as a decline of 2.3% in real terms. It is little surprise that, working on this basis, a number of Trusts are already predicting multi-million pound deficits. The issue is just how are these organisations planning to address the shortfall? It is clear that after years of investment, the NHS must now retrench alongside other public services. But the response and strategies put in place this Pharmaceutical Field January 2010 year will have long term implications on the level and quality of care. Jobs and services cut this year to meet budgets are unlikely to be reintroduced in subsequent years until financial pressures ease – creating very real implications for the quality and timeliness of patient care. Yet given the scenario planning released by some PCTs, it would appear that drastic cuts are under consideration, including a massive reduction in outpatient appointments. The potential outcome of such strategies has been termed by some an NHS ‘Armageddon’. QIPP agenda But it is questionable whether this ‘slash and burn’ approach to cost reduction can be delivered in today’s NHS. The world has moved on significantly since the early 1980s, with a strong focus on quality targets, a reduction in waiting lists and the introduction of patient rights under the NHS constitution. It is unlikely that the electorate would stand for a wholesale reduction in the quality and depth of NHS services – therefore an alternative approach is required. Executive David Nicholson wrote of QIPP: “..meeting the challenges is central to the role of every NHS leader and every NHS board. In short this is your day job.” CEs are now beginning to review ongoing strategy, and budgets, with quality, efficiency, improved productivity and prevention in mind. And this will affect every aspect of service delivery and budgetary spend. For example, prescribing decisions will now take into account additional factors such as long-term effectiveness and outcomes, including the ability of a drug to reduce hospital admissions and improve day-to-day management of a condition in the community, and to reduce the cost to care per patient. Political change Of course, the timing of this financial crisis is unfortunate: in the run up to the general election the political uncertainty is certainly not helping the planning process or enabling CEs to embark on innovative strategies with confidence. Furthermore, whilst many in the NHS have been working towards the need to meet a NHS Chief Executive David Nicholson wrote of QIPP: “..meeting the challenges is central to the role of every NHS leader and every NHS board. In short this is your day job” Indeed, the belief behind the Quality, Innovation, Prevention and Productivity (QIPP) agenda is that the NHS can only survive in this financial climate, with greater demands being placed on it every day, if it innovates and improves. And the Government is putting strong faith in this strategy: with central funding and leadership in place and a clear planning focus. There is also an expectation of personal responsibility to adhere to the QIPP recommendations. In a letter to the CEOs of each PCT, NHS Chief Conservative agenda, the latest polls are suggesting the possibility of a hung parliament, which would bring Liberal Democrat NHS policies into play for the first time, and the prospect of an unpredictable mixed bag of policy. Certainly the NHS looks set for further change – with a Conservative Government planning to ring fence the public health budget, create an independent NHS board and make practice-based commissioning budgets real. And should the Conservative Party come to power, it will bring further divergence between national strategy, with the Scottish and Welsh health policies following a very different political agenda that will continue to avoid any form of market exposure. But whichever party comes to power in 2010, the demands facing the NHS will be the same: costs must be reduced and there will be an increasing focus on improving efficiency and productivity. Conclusion By this time next year, the implications of this financial crisis on the NHS will be clear. A new government could be in place and PCTs will have completed the 2011 round of budget planning. It is also likely that a programme for consolidating PCTs will be underway, with an expectation that numbers will be reduced by up to one third over the next few years. The implications for prescribing practices will also have become clearer, as organisations increasingly combine the recommendations of QIPP with the expected renewed drive for the adoption of generics wherever possible. And the growing differences across England, Wales, Scotland and Northern Ireland, especially in key strategies such as commissioning, will be even more apparent. 2010 looks set to be a year of further, very significant change; with PCTs juggling extremely tough financial targets with the need to drive up efficiency and innovation. Will it be Armageddon? Too soon to say. But there is no doubt that it is during this year that the target will come sharply into focus: the pharmaceutical industry will know exactly what it has got to hit if it is to avoid simply being a victim of the financial squeeze. Andy Etheridge is Commercial Director for Direct Marketing at Cegedim Dendrite. Cegedim Dendrite provides value added information, CRM and Marketing solutions to the pharmaceutical industry. Mike Sobanja is Chief Executive of the NHS Alliance the only organisation that brings together PCTs with GP practices, clinicians with managers and board members, and NHS primary care with its patients. Becoming a Mastermind Your specialist subject is…? Pharmaceutical sales professionals need to brush up on their specialist and general knowledge if they are to make the most of the opportunities provided by world class commissioning. Andy Lee puts the field force in the big black chair. Do you have the answers? Pharmaceutical Field January 2010 I f, as a pharmaceutical sales professional, you have only one new year’s resolution as you begin 2010, it should be to become a Mastermind. Your specialist subject? Well, that needs to be a composite of your disease area, your product (and the services it can sit within), your customers and your marketplace. Knowledge is power – the key question is: do you have enough knowledge to ensure your product is a success in 2010? If you’re planning to rely on the traditional, sequential sales approach that has previously served the industry so well, the answer will undoubtedly be ‘no’. Aside from the industry’s need to improve efficiencies within the field force in an endeavour to contain costs, another major driver for a change in sales methodology is the continued emergence of a customergroup at the centre of a changing NHS – the commissioning function. Whilst this is not a new customer for pharma, its role is becoming increasingly more influential – and the need to understand and engage with it has become imperative. The era of solely targeting clinicians is over – the need to influence customers responsible for implementing services across the NHS is now paramount – and that means commissioners. The opportunity for pharma to support the world class commissioning agenda is real – but the stakes are high, not only for the industry, but also for the NHS. The UK health service is facing a funding gap of potentially gargantuan proportions – NHS Chief Executive David Nicholson says it could be as high as £20 billion over the first three years of the next spending round. Nicholson is, of course, the driving force behind the health service’s QIPP agenda, which promises a focus on Quality, Innovation, Productivity and Prevention across the NHS. The overriding challenge for a health service driving for quality is unequivocal: achieve more, but spend less. Improving patient care against a backdrop of fiscal turbulence will hinge upon the effective commissioning of services. Commissioners have a huge role to play. Last autumn, Nicholson explained how commissioning would play a pivotal role in addressing the many challenges facing the NHS. World Pharmaceutical Field January 2010 For medical sales professionals, success really does depend on becoming a Mastermind. You need to know your specialist subject inside out, and also to demonstrate a good general knowledge of your market and your customers. The traditional sales representative’s training has always begun with clinical product knowledge. class commissioning would, he said, help identify and develop strategy and put systems and processes in place to deliver quality. But he warned that achieving success would require a redoubling of effort and a change in mindset to move the service forward. “This really is the time when commissioning needs to deliver,” he said. “Both commissioners and commissioning now need to make sure we can take forward these great visions and strategies and make them a reality for our patients and communities.” The scale of the challenge for the NHS is colossal – but with it comes an opportunity for pharma to help deliver improvements and transform services. Gary Belfield, the DH’s Acting Director General for Commissioning & System Management Directorate, says that WCC and PCTs need to ‘step up’ and be ‘brave and bold’ if they are going transform healthcare. The commissioning function therefore needs to raise the bar to drive health outcomes and improve patient experiences. Commissioners need to embrace and advance radical change to succeed. They are grappling with the challenge to be fit for purpose. To support them, the pharmaceutical industry must do exactly the same. Specialist subject So are you fit for purpose? Last November, the first article in this twopart series provided a simple guide to the commissioning function, showing how the industry can engage with these important customers and, in the process, help meet the ambitions of world class commissioning. The article outlined the most likely scenarios for interaction with commissioners. But having identified the doors on which you need to knock, and when best to knock on them, as sales professionals, what do you do once you’ve been invited into the room? How competent are you and your organisation in developing dialogue with these key customers? And how do you move from simple dialogue to real action? If you’re to become a Mastermind in 2010, you’re going to need to make the following competencies part of your specialist subject. 1 Sophistication NHS commissioning is desperately short of capacity and capability. The commissioning community is small and, at present, the number of capable commissioners is low. The ones that do exist are incredibly over-burdened. So if you are going to help the NHS, you will need to be offering solutions that address these deficiencies. Sales professionals need to do their homework – detailed preparation will put you in pole position. But clinical product knowledge will not be enough – you need to be more sophisticated. Ahead of your approach, you’ll need to understand where your offerings align with commissioners’ priorities – whether from a single product or a portfolio perspective. Which of the common commissioning scenarios is most appropriate for your brand? Is it service redesign, or is it PBC? Is it several of them? You need to understand where you can make that engagement, and make sure you can get your messaging right so that when you push on the door, it opens. Being more sophisticated depends as much on improving your communications internally as it does externally. The industry is beginning to encourage a more integrated approach to sales and marketing. The two departments – which have traditionally operated in ‘silos’ – are now working more closely together. This is vitally important. Marketing messages must be built from a shared understanding of all customer groups, and tailored accordingly – and as a company’s biggest customerfacing body, the sales force has a significant role to play in identifying and communicating customers’ needs. Between you, the solutions you prepare need to demonstrate how your product, or portfolio, can support the commissioner’s challenges of capacity and capability. What can you do to support your product that will help support them? In fact, pharma companies are well-placed to provide valuable information for commissioners – much of which will help address their lack of capacity. Through their meticulous research processes, drug companies generate huge amounts of disease expertise when developing their products – this information can easily become additional capacity that can be offered to commissioners. For example, where appropriate, budget impact models or adaptable service specifications that support the redesign of a service will undoubtedly provide value to a commissioner. The industry can also help address capability issues. This might be the provision of additional skilled human resource – such as a capable project manager to drive through a commissioning work stream. Alternatively, pharma companies may be able to provide a KOL who can talk to non-clinical commissioners about a specific disease area and what the issues are for payers. In therapy areas where commissioners have prioritised a major service redesign, such additional capability is of real value. The DH has identified increasing the engagement between clinicians and commissioners as a major priority in its objective to develop more ‘informed’ commissioners. Pharma is wellpositioned to facilitate this. To do so, sales and marketing professionals must become more proactive, more communicative and more sophisticated in their methodologies. 2 Empowerment Pharma is now adopting an account management model – deploying a reduced number of sales professionals, but promising the chosen few more responsibility and greater accountability. The role of the account manager is largely seen as being a more specialist position with a much broader customer-base that includes influencers from across their entire local health economies. As we have seen, to succeed, dialogue needs to be more sophisticated. But has the model moved beyond rhetoric? As an account manager, are you empowered to be able to build on the sophisticated discussions you are having? You may be able to talk the talk, does your brand team empower you enough to walk the walk? Lack of empowerment in the field force is, sadly, not uncommon. But to capitalise on the opportunity of WCC, this cannot remain the case. A sales professional who is only able to talk about the product, but is not allowed to discuss the wider disease agenda, will not be able to develop the kind of dialogue that will interest commissioners. An empowered field-based person will not only be able to ask the right questions, but will be able to act upon the answers they are given. Too often, account managers ask questions and gather answers, only to exit the discussion armed with a ‘wish list’ and fail to return with a solution. This is because too few of them are actually empowered or understand what it is that they can put forward. As a sales professional, being passive is not enough: it is your responsibility to push for this empowerment. The challenge for fieldbased personnel is to identify commissioners’ capacity and capability needs, and to enter into a negotiation/discussion about the level of help they may be able to A sales professionals who is only able to talk about product, but is not allowed to discuss the wider disease agenda, will not be able to develop the kind of dialogue that will interest commissioners. An empowered field-based person will not only be able to ask the right questions, but will be able to act upon the answers. It is your responsibility to push for this empowerment. provide. Identifying needs is about framing the question in the right way: why does the commissioner feel the need to redesign the service? Where is the current service falling short? What level of care are current patients are getting? Where are the variations in care? Are there particular groups of patients that are missing out? And if you are empowered enough to ask the question, you need to be similarly empowered to be able to build on the answer. Negotiating the solution is about knowing what can be put on the table – in advance. For example, if your account manager gets into a negotiation where the commissioner is revealing that he needs a half dozen trained data analysts, there is no harm in responding that it’s not possible and offering an alternative solution. The industry should not be afraid to have the discussion. But do you know your terms of engagement? Once again, preparation is key. Ongoing communication between sales and marketing departments is essential to drive it. Marketers need to have agreed the options ahead of any customer engagement. If together you can agree what your areas of strength are, and the limits of what you can do, as a sales professional you should be able to turn discussions around to areas where you can really help – rather than having wide-ranging discussions about problems, creating long wishlists and then running scared. The industry can provide a number of solutions for commissioners. These include: • • • • • • • • disease expertise project management facilitation of clinical engagement data – both clinical and patient experience patient education access to KOLs market development strategy outcomes-based evidence. All of these solutions are readily available and can be shared. At present, the channels to share them aren’t being created in an optimal way. Much of this boils down to a lack of empowerment. 3 Matching local agendas where you need to match agendas. A commissioner needs a good service specification and a plan to implement it – and, if you understand their priorities and are operating in a disease area that aligns with them, you should be well-positioned to help. Faced with a shortfall in both capacity and capability, most commissioners should be very open to partnering with pharma companies that can help design plans that fit their local needs and, equally, can help deliver them. This builds naturally from the first two competencies. If you are sophisticated in your approach and understand how your product or portfolio fits with what the NHS is looking for, and you are empowered to negotiate the solution you can provide, your ability to match agendas successfully will be crucial. It lies at the very core of the account management model. 4 Flexibility Having matched agendas, to progress further you will need adaptable offerings. To do this, you’ll need high quality generic templates, processes and frameworks that can be customised to suit individual customers. Through dialogue with a commissioner, your shared objective should be to co-develop a blueprint that will deliver the capacity and capability required. These will normally be developed with marketing, and will be heavily dependent upon customer information garnered in the field. Offerings could include: Whether in sales or marketing, being able to match your agenda with that of the commissioner is imperative. To succeed you will need a level of understanding and a high degree of influencing skills. If, in proposing a solution that matches your agenda, you can show how it helps provide something that a commissioner is looking for, your power to influence will increase. As identified in the first article, the role of the commissioner is divided into two basic areas: specification and implementation. These are the areas • • • • • • a best-practice patient pathway generic service specifications case studies, including clinical models, examples of market development and procurement options good data sets and access to data that can be interrogated at a local level models for stakeholder engagement project management process including frameworks for communications and mobilisation plans. Pharmaceutical Field January 2010 MARKET ACCESS 5 Matching the national agenda The national agenda is, perhaps, the most important one to match – and that is the drive for quality. The industry needs to equip for QIPP. Responsibility for driving the QIPP agenda belongs to Jim Easton, National Director of Improvement and Efficiency, who has pinpointed commissioning as a central component in achieving success. Describing commissioning as ‘driving clinical change’, Easton says its purpose includes reshaping the pattern of demand to focus more on upstream care and prevention, and away from the expensive ‘rescue end’ of care. Commissioning, he says, includes redesigning at scale, and at pace, clinical pathways for chronic disease management and for urgent care in a way that will unlock the experience of patients and unlock cost and quality together. For pharma, focusing on quality care for patients is critical. If your approach is built around delivering that, it will be very difficult for today’s NHS to argue against it. By keeping the patient at the centre of your plans, and at the heart of your messages, your chances of success increase dramatically. The health service is changing, and world class commissioning is at the centre of that change. The NHS is having to alter its mindset and behave differently. The pharma industry must follow suit. The era of joint working between NHS and industry is here. As Jim Easton says, to solve its problems the health service needs co-operation, collaboration and people finding ways of solving problems together. “We need innovation on how we deliver. We need the sort of innovation which is innovating in how you take great ideas and put them on the ground in a way that’s really going to make a difference.” For medical sales professionals, success really does depend on becoming a Mastermind. You need to know your specialist subject inside out, and also to demonstrate a good general knowledge of your market and your customers. The traditional sales representative’s training has always begun with clinical product knowledge. For many, it largely ended there too. In today’s marketplace, product knowledge is only the beginning. Success requires so much more. The chances are, you’re probably already half way there. So in true Mastermind fashion, you’ve started, now you must finish. Andy Lee is Commissioning and NHS Partnerships Director, WG Consulting. Tel: 01494 470760 or email: [email protected]. ow N e liv For a clearer picture of the pharma job market, visit the Pharmajobs website Providing improved job search capabilities and more ways to secure your perfect pharma sales position than ever before! www.pharmajobs.co.uk The gateway to a commercial career in pharma Pharmaceutical Field January 2010 FEBRUARY 2010 Pharma giants make further job cuts Pharmaceutical Field AstraZeneca and GSK have revealed plans to cut thousands more jobs as part of restructuring plans from 2010 onwards. AZ has announced expected cuts of 8,000 over the next five years, in addition to the 12,600 positions that have already been cut. GSK will cut 4,000 more jobs from its global workforce of 99,000. The gateway to a commercial career in pharma The FISH! school of management Pharma giants make further job cuts AstraZeneca and GSK have revealed plans to cut thousands more jobs as part of restructuring plans from 2010 onwards. AZ has announced expected cuts of 8,000 over the next five years, in addition to the 12,600 positions that have already been cut. GSK will cut 4,000 more jobs from its global workforce of 99,000. Whereas AZ will be making general cuts worldwide, GSK is making reductions from its US and EU operations in order to target emerging David Brennan markets. Both companies have revealed that sales and marketing departments will be cut as part of the cost-saving efforts, but neither has specified to what extent the UK sales force will be affected. In publishing its financial report for 2009 and outlook for the next few years, AZ predicted a difficult year ahead for pharma. Despite reporting a net profit increase of 23% for 2009, the company admitted that the year’s revenue was boosted by factors such as the swine flu outbreak that are unlikely to have a positive impact in 2010. AZ CEO David Brennan, however, remained positive: “In 2009 we delivered a strong financial performance, exceeding the targets we set at the beginning of the year,” he said. “In addition, good progress was made on the pipeline; we now have five products awaiting regulatory approval, and have added four significant late stage development projects through our externalisation efforts. “Our plans for the next five years confirm our commitment to researchbased, innovative biopharmaceuticals. I believe successful execution of this strategy will benefit patients and generate the cash-flow necessary to provide for the investment needs of the business and shareholder returns.” GSK has yet to release its financial reports and details of the job cuts, though analysts are optimistic about the company’s pipeline, which contains more than 30 products in advanced development. The company also has launches planned for its products Menhibrix, a vaccine to combat meningitis, and Benlysta, a treatment for lupus. US sales forces on the chopping board (p8) February 2010 Hard times ahead for the NHS Aligning with the QIPP agenda Collaboration the key in Pharma 3.0 Pharma companies are increasingly looking for innovative ways to collaborate with new players to improve patient services, a new Ernst & Young report has found. Despite agreement among industry executives that companies such as IT, retail and telecommunications firms will help reshape the healthcare marketplace, most feel unprepared to address the challenges these new creative alliances will bring. The Progressions, Pharma 3.0 report identifies several industry trends driving this collaborative working, including health reform, health IT, comparative effectiveness and the rising confidence in consumer power. These factors and others are prompting pharmaceutical companies to broaden their focus from simply producing new medicines to delivering ‘healthy outcomes’ – a shift that will be driven through creative partnerships and the adoption of new business models. (Continued on p2) pro-active resourcing precision placement visit www.medicasearch.co.uk MEDICA visit or call 0844 3571016 Search & Selection Medica Banner Advert - Feb10.indd 3 PFFEB10 - NEWS.indd 1 Local rates 17/02/2010 11:50 14:47 18/02/2010 Osteoporosis guidance stands Duo not recommended by NICE NICE’s original recommendations on the prevention of osteoporotic fractures remain unchanged, despite a legal challenge to the process used to produce the guidance. Merck’s Fosamax (alendronate) remains the recommended treatment option for both primary and secondary prevention of fractures. NICE has updated its draft guidance on the use of Bristol Myers-Squibb’s dasatinib (Sprycel) and Novartis’ nilotinib (Tasigna) for chronic myeloid leukaemia. Following a public consultation, both NICE and the Appraisal Committee have agreed to split the appraisal of dasatinib and nilotinib in this indication into two separate appraisals. Pfizer reveals Collaboration R&D outlook the key in Pharma 3.0 Pfizer has launched a portfolio of generic medicines for its pharmacy and dispensing customers in the UK. The six products have been introduced into Pfizer’s Established Products Business Unit portfolio of over 80 of patent medicines, following agreements between Pfizer and generic medicine manufacturers Aurobindo Pharma Ltd and Claris Lifesciences last year. Pharma companies are increasingly looking for innovative ways to collaborate with new players to improve patient services, a new Ernst & Young report has found. Despite agreement among industry executives that companies such as IT, retail and telecommunications firms will help reshape the healthcare marketplace, most feel unprepared to address the challenges these new creative alliances will bring. EMA pledges to improve access to medicines Steve Poulton Sanofi vaccines included in top 10 breakthroughs Two of Sanofi Pasteur’s vaccines have made it into Time magazine’s list of the 10 most important medical breakthroughs of 2009. The firm’s HIV vaccine came in second place. The magazine highlighted that trials of its effectiveness yielded “reasonable” results, with an infection prevention rate of 31%. The European Medicines Agency (EMA) has pledged to improve access to medicines in its new publication Road Map to 2015. The Agency has admitted that its model for analysing the benefit/risk ratio of products needs to be improved and that it cannot continue to operate in the same was as it has done for the past 20 years. HAPPY IN THE WORKPLACE? HAVE YOUR SAY PF COMPANY PERCEPTION, MOTIVATION & SATISFACTION SURVEY 2011 - OUT JANUARY Alliance buys Cambridge Labs Protelos No NICE decision for Iressa NICE has ruled that it is unable to assess Iressa (gefitinib) in non-small-cell lung cancer and has requested more information from the manufacturer. In draft guidance, NICE has asked AstraZeneca to provide more data on the effectiveness of its product as a treatment for locally advanced or metastatic non-small-cell lung cancer. Speciality pharmaceutical company Alliance Pharma has agreed a deal to purchase Cambridge Laboratories in the UK and Ireland for between £14.3m and £16.4m. Included in the acquisition are 18 prescription products across a range of therapeutic areas, including: ImmuCyst, an immunotherapy for superficial bladder cancer; gelclair, an oral gel for the management of oral mucositis caused by chemotherapy and radiotherapy; and procarbazine, a treatment of Hodgkin’s Lymphoma as part of chemotherapy treatment. To read the full story, click on the headline Pioneering access scheme recommendation Cimzia has become the first RA treatment to receive positive guidance from NICE in more than two years due to an innovative patient access scheme. Certolizumab pegol, or Cimzia, has been recommended for approval for the treatment of adults with severe active RA, on the condition that the patient access scheme is implemented and the drug is prescribed in accordance with NICE’s specifications. Pharmaceutical Field YEARBOOK 2010 Making people healthier all over the world – it’s the most rewarding work you can do. In this era of profound change we call the New Health, Quintiles is helping pharma companies bring new medicines to patients faster. What role will you play? Quintiles recruit talented individuals from the NHS and Pharma to become part of their commercial teams in a wide range of roles and therapy areas including: Oncology Hospital Specialists Healthcare Development Managers Medical Devices Representatives e.g. Orthopaedics; diabetes devices Key Account Managers Medical Sales Representatives – primary and secondary care Sales Management Find us on: Dental Sales Nurse Advisors and Nurse Managers Quintiles* Voted No. 1 CSO for 9 consecutive years Voted Best Places to work 2008, 2009 and 2010 Winner of the Pharmatimes Sales Recruiter of the Year 2008/2009 and 2010/2011. Quintiles – the global pioneer in pharmaceutical services has worked with biopharma companies in the development or commercialisation of the top 30 drugs and 9 of the top 10 products on the market today. We have worked with over 300 pharma and biotech companies, covering 550 products in 150 therapy indications through our 23,000 employees in more than 50 countries. To find out more about Quintiles and how to become one of our talented and highly sought after employees, who make a difference, visit www.quintiles.com or contact our Talent Management Team on 01344 601550. *Quintiles, formerly Innovex. Corporate identity remains Quintiles. Royce - Experience the Difference Are you looking for a new challenge or a different role in 2011? Do you want access to the best jobs in the sector; the highest chance of success and first rate support? At Royce, we have over 30 years’ experience matching the best candidates to the best opportunities. We have consistently been the Agency of Choice and have won Recruiter of the Year 2008/2009 and 2010/2011. So if you are looking for your next career move or to find new talent for your organisation, you can be sure that we will find the opportunity and skills that suit you perfectly. Hospital Specialists, Healthcare Development Managers, Diagnostic Sales, Medical Devices, Nurse Advisor Roles, Territory Sales Managers, Sales Management To find out more about how our award winning pharmaceutical and healthcare recruitment specialists can support you and benefit from our local knowledge and longstanding experience within the industry, please contact our Talent Management team: 01344 601144 www.roycejobs.com Healthcare and Pharmaceutical Recruitment Specialists Follow us on @roycejobs FEBRUARY 2010 Elonva secures EU approval The European Commission (EC) has approved Merck, Sharpe and Dohme’s Elonva (corifollitropin alfa injection) for controlled ovarian stimulation (COS). Elonva, the first sustained follicle stimulant, is indicated in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program. NICE rules Afinitor ‘too expensive’ NICE has ruled that it is unable to recommend Novartis’ everolimus (Afinitor) for the second-line treatment of advanced renal cell carcinoma, due to doubts about its ability to extend life. The Appraisal Committee decided that, although the drug is clinically effective, more evidence is needed to judge whether it is a reasonable use of NHS resources. Patients set to benefit from Procoralan The European Medicines Agency (EMA) has approved a new indication for Servier’s Procoralan (ivabradine). The drug is now the first and only rate-limiting anti-anginal licensed for use in combination with betablockers for chronic stable angina patients for whom an optimal dose of beta-blockers is insufficient, and whose heart rate is above 60 beats per minute. Herceptin approved in Europe New guideline could save EC approves lives BPH treatment Pharmaceutical Field YEARBOOK 2010 Mepact (mifamurtide), the first new treatment in 20 years to improve survival in patients with osteosarcoma (malignant bone cancer), is now available in the European Union. The treatment will be available via a paid named-patient programme in countries where it is not initially reimbursed. Recordati’s Urorec and Silodyx (silodosin) have been approved for launch in Europe for the treatment of benign prostatic hyperplasia (BPH). The launch of the products is expected by the end of 2010 or beginning of 2011. The MHRA has questioned the safety of the DH proposal for Automatic Generic Substitution in relation to immunosuppressants. The regulatory agency has advised that all products that contain ciclosporin, one of four classes of immunosuppressants, must be prescribed and dispensed by brand name to minimise the risk of inadvertent switching between brands. Orencia approved for GSK’s Jose to pJIA in the EU be new ABPI President Bristol-Myers Squibb’s Orencia (abatacept) has secured marketing approval in the EU to treat paediatric patients. The drug has been authorised by the European Commission in combination with methotrexate for children with moderate to severe polyarticular juvenile idiopathic arthritis (pJIA). Roche’s Herceptin has been approved in the EU for patients with HER2positive advanced stomach cancer. The European Commission approval is based on results from the international ToGA trial, which showed that treatment with Herceptin significantly prolongs the lives of patients with this aggressive cancer. A new NICE guideline on treating blood clots in hospital patients could mark a significant advance in the prevention of an estimated 25,000 avoidable deaths. The guideline sets out simple steps to help prevent venous thromboembolism (VTE), which covers both deep vein thrombosis (DVT) and its possible consequence pulmonary embolism (PE). Mepact ‘brings MHRA doubts hope’ to patients generic safety Simon Jose, Senior Vice President and General Manager of GlaxoSmithKline, has been named as President Designate of the ABPI. Simon will take over from the current ABPI President, Chris Brinsmead of AstraZeneca (UK), on 28 April this year. He will serve for a one-year term, with the option of re-election for a further 12 months. BMA against NHS New position commercialisation The BMA is urging the public to join its ‘Look After our NHS’ campaign against commercial companies providing NHS care in England. Government policies have created a healthcare market where commerciallyrun firms can compete with existing NHS trusts and GP practices to provide NHS care. The BMA claims that this is having an adverse impact on many parts of the NHS in England. Hamish Meldrum at ABPI The ABPI has appointed a new Head of Government Affairs to spearhead its work with politicians and those in Government in both the UK and Europe. Amanda Stuart, who is currently Associate Director at Insight Public Affairs, will take up her new role this week. Amanda will play a key role in communicating industry-wide messages to politicians at Westminster and in Europe, as well as to civil servants and others connected with forming and implementing government policy. Follow Pf on Twitter @PharmaField CUSTOMER FOCUS Can pharma respond to the QIPP agenda? Mike Sobanja, Chief Executive, NHS Alliance and Andy Etheridge, Commercial Director, Cegedim Dendrite, outline the challenges facing pharma in adapting to the recommendations of QIPP, the expected rationalisation of PCTs and the predicted emergence of GP consortialed practice-based commissioning. C an pharmaceutical companies find any positive opportunities in a cash strapped NHS that is going to be torn between slash and burn tactics and the objectives of Quality, Innovation, Productivity and Prevention (QIPP) to meet challenging financial targets in 2010? Political uncertainty notwithstanding, the NHS looks set for serious change in the coming years as senior managers wrestle the budgeting challenges that must be imposed in response to the global economic problems. At a most basic, organisational level, there is little doubt that the number of Primary Care Trusts (PCT) will be cut over the next few years in a bid to reduce administrative costs and achieve greater consistency in policy making. The current number of 31 trusts in London looks set to be consolidated to eight, whilst smaller PCTs are also likely to disappear. Realistically, the number of PCTs is likely to reduce by up to one third. There is also going to be a stronger divergence in health policy between England and the rest of the United Kingdom; with Wales and Scotland, in particular, following very different political agendas. While PCT consolidation has already occurred in Northern Ireland, where four trusts have been replaced by one single body, policies for commissioning will be very different nationally, with politicians in Wales and Scotland extremely against any type of market exposure within the NHS. In England, by contrast, if the Conservative Party gains power, it is likely to follow through on its pledge to make practice-based commissioning a reality. This will place budgetary control in the hands of increasingly powerful GP consortia, a move that will have very real implications for the pharmaceutical industry. But this shift will also raise questions about the long-term future of Strategic Health Authorities (SHA). With budgetary control shifted to the GP, the PCT will be left with the role of ensuring sound performance management and enforcing accountability. This will be a clear duplication of role with SHAs, a duplication that is unlikely to be tolerated in what must become an administratively leaner health service. Understanding QIPP But for pharma companies, changes in the NHS will have far greater implications than the need to identify a new set of Key Opinion Leaders (KOLs). Politicians of every party are increasingly committed to a quality agenda and David Nicholson is taking personal responsibility in ensuring every PCT is defining its new budgetary planning with the recommendations of Quality, Innovation, Productivity and Prevention (QIPP) in mind. Pharmaceutical Field February 2010 Speed of response For NHS senior management, QIPP is seen as the only way of achieving the real term budgetary cuts that must be put in place for the next few years, without drastically compromising the quality of patient care. No politician wants a repeat of the 1980s style of slash and burn, which saw beds, appointments and staff numbers radically reduced. There will undoubtedly be another wave of pressure on spending, including pharma spending, across the NHS and pressure to increase the use of generics even further. But for pharma companies, QIPP represents a shift away from traditional prescribing decision making and must have a profound impact on the way medicines are presented to the NHS. Critically, companies will have to express the value propositions for each drug in line with the QIPP agenda; the messaging must include information about a drug’s ability to improve productivity by, for example, preventing hospital admissions and enabling patients to more effectively manage their conditions in the community. Pharmaceutical Field February 2010 Consistent messaging In some ways, the huge emphasis on the QIPP recommendations is beneficial for pharma; organisations can focus on this one, critical challenge, as opposed to managing the multiple challenges and objectives that have characterised the NHS in the past. But pharma will also have to deal with a far wider range of customers within the NHS and greater market fragmentation, especially if the Conservative Party policy of pushing budgets away from PCTs and towards clinical groups is adopted. Each PCT will have its own QIPP interpretation and implementation policies. Pharma companies will have to understand a far wider range of customers, assess their interpretation of QIPP and align the messaging accordingly. Furthermore, the move to QIPP based messaging will be a challenge for many companies. Realistically, how many products can be described as having a real quality, efficiency and productivity outcome? The pharmaceutical industry has been notoriously slow to respond to changes in the NHS. And although companies now admit that the traditional rep role has been dramatically changed by the shift towards a more team-focused approach, where key account management is the new aim, it has taken the industry 15 years to recognise the need for a new model. Companies cannot wait another 15 years before adapting and introducing the skills that will be needed in this marketplace. Successful pharma operations now require individuals with competencies that include analytics, the ability to identify alignment opportunities, negotiating skills and partnership skills. These are very different from the traditional competencies and will require investment and training. Organisations must also address the challenges posed by very different national NHS strategies. With pressures on cost and resources within each pharma company, the objective is to create national, even global, marketing strategies but deliver them in a way that can be implemented successfully at a local level. In the politically fragmented UK marketplace, this will be achieved by creating the right competencies across the work force, but also restructuring around regional units and the reorganisation of company departments within these regional set ups. The move to QIPP based messaging will be a challenge for many companies. Realistically, how many products can be described as having a real quality, efficiency and productivity outcome? Conclusion The pressures posed by the NHS in 2010 and onwards will undoubtedly pose even greater challenges to pharma companies, companies that are already struggling in an extremely tough global marketplace. Consolidation will continue, whilst many international companies are likely to retrench their UK operations. But while NHS structural change and market fragmentation will be key issues to address, if pharma companies fail to express their value propositions in a way that reflects the QIPP agenda, the chances for success and market growth will be minimised. Andy Etheridge is Commercial Director for Direct Marketing at Cegedim Dendrite. Cegedim Dendrite provides value added information, CRM and Marketing solutions to the pharmaceutical industry. Mike Sobanja is Chief Executive of the NHS Alliance the only organisation that brings together PCTs with GP practices, clinicians with managers and board members, and NHS primary care with its patients. CUSTOMER FOCUS Think big The benefit of unrealistic expectations Are you on track to meet your targets for the first quarter of 2010? Maybe you need to set yourself a bigger goal. Motivational speaker Dave Hyner explains. The early part of a new year is the perfect time to be setting goals, both personal and professional. What do you want to achieve? Although losing weight, getting healthier and spending more time with friends and family are all popular resolutions, ‘exceed my sales targets’ should also feature among many Pf reader’s goals for 2010. As the weeks progress, how far have you come? Have you made the impact you were hoping to make? It is not uncommon to start the year full of enthusiasm, but lose all motivation amidst the cold and dark of the winter months. Could it be that you are not setting the right targets? It’s time to refresh those good intentions with a whole new approach. Aspiring to mediocrity The common mantra when setting any goal, like a sales target, is to come up with something ‘realistic’ and ‘achievable’. Conventional wisdom suggests this is better, because it means the goals are easier to hit. It also says the alternative – setting a massive, amazing goal – can be demoralising when people realise it’s out of their reach. In reality, while that may be true for some, it just sets the majority of people up for mediocrity – at best. How could anyone be truly inspired and motivated by something that is within their reach? And don’t be fooled into thinking realistic, achievable targets can’t be equally demoralising. The lack of inspiration can be just as de-motivating – imagine how it would feel to set a realistic goal and then not achieve it! So if realistic goals can be demoralising, is there really any point in setting them? Pharmaceutical sales is no different. In fact, the need for a massive goal in such a pressurised, competitive environment could not be greater. The rewards of a successful sales career within the pharmaceutical sales industry can be huge, but this means there are more people willing to aim for them – and to do what they have to to get there. But there is a way to be number one, without being completely ruthless. I base this assertion on years of speaking to top achievers, from various fields including sport, business Setting a realistic goal just sets the majority of people up for mediocrity – at best. How could anyone be truly inspired and motivated by something that is within their reach? and academia. They all have one thing in common – they set themselves a massive goal and refused to give up until they reach it. And then they set themselves another one. Case studies: leading by example One example is sales professional Geoff Cox, who had set up a networking group called Network2Connect. He implemented this goal-setting technique – despite being sceptical about it – and transformed his fledgling business into an international company, with a global reach through the website (www.network2connect.com). He had quadrupled his business in one year alone. As a young man, Poundland founder Steve Smith was told to get a job and a haircut or leave home. He set up a market stall selling items for £1, to the ridicule of friends and fellow traders. He experienced more ridicule when he opened the first Poundland store in Burton-upon-Trent in 1990 – they said costs would be too high and the prices would give the goods a poor image. Today Poundland has over 70 stores around the country, employs over 2800 people and has turnover of more than £160 million. Sport is a field where goal-setting has a major role to play. The late Emlyn Hughes OBE is a fine example Pharmaceutical Field February 2010 of this. As a child, he set himself the goal of playing football for England. However, he was considered too small to play football, so he lied about his age to get into teams of older players, which made him stronger than those in his own age group. It also made him a fierce tackler, and earned him the nickname ‘Crazy Horse’. His determination and drive took him into the Liverpool and England sides of the late 1970s and early 1980s, becoming captain of both and the most successful English footballer of all time before his retirement in 1981. By that time he had played for England 62 times and won 14 trophies, despite being ‘too small’ to play football. Yet another example is author Andy Cope, who is now a best-selling children’s writer after applying the Massive Goals Principle. He was a college lecturer, with the dream of writing a children’s book about his pet dog, Lara. His first novel Spy Dog was published in 2005, and this has since developed into a hugely successful series of books, beating JK Rowling to win the Red House Children’s Book Award in 2006. Andy is now an author, trainer, accomplished professional speaker and positive psychologist. Pharmaceutical Field February 2010 While these are truly remarkable individuals, there is no reason why we can’t all emulate their success. Five steps to success 1. The first thing is to decide what the goal is. What does it look like? How will it feel to get there? Some people choose an expensive sports car, or a mansion, or an exotic holiday. Others choose security for their family, or a better worklife balance. The important thing is to make it specific, tangible, and quantifiable. If you need help with this, think about people you admire – particularly those who have succeeded in pharmaceutical sales. How did they get to the top? Can you take anything from their experience and apply it to your own goal-setting? What about Asa Candler, the man who brought Coca-Cola to a global audience, who started out as a pharmaceutical salesman and manufacturer? Or perhaps there is someone a bit closer to home? 2. Secondly, think about the process. The best approach with a massive goal is to break it down into bitesize chunks. Once the building blocks have been created, commit to doing something each month to help you hit the ultimate target. 3. You must hold yourself accountable to your commitments. Without accountability your massive goal will soon fall by the wayside. This is why the minigoals have to be measurable. But they don’t necessarily have to be connected to sales – it could be something as simple as contacting former clients and prospects, or reading a book from an industry expert. In other words, they can be related to the personal developments which will help you reach your ultimate goal, or generate more leads. 4. Develop some landmarks to achieve along the way. This makes it easier to gauge progress and prove the goal is becoming closer. 5. And bring in some fun, incentives or rewards to help you. The journey may become difficult at times, but a reward, such as a gift for yourself, or a city break to somewhere you’ve always wanted to visit, will help to focus the mind and keep you on the path. Follow these five steps and I guarantee you will hit the heights – it really is that simple! Just be clear on what you want to achieve and what you need to do to get there. This is the only way you will become the number one pharmaceutical salesperson in your company or therapy area. If you continue to set achievable goals you will only ever get to mid-table, and you’ll never reach your full potential. Let’s make 2010 your most successful year ever! Dave Hyner is a Staffordshire-based motivational speaker and Managing Director of Stretch Development. He has travelled the world to deliver keynote addresses on his research into top achievers in sport, business and academia. A wide range of case studies and testimonials, along with a video of David in action, are available at the Stretch Development website: www.stretchdevelopment.com. - Voted No 1 Selection of the fittest! The evolution of CHASE from recruitment agency to a highly rated and widely recognised UK Contract Sales Organisation (CSO) has taken place over a 12 year period. “Evolution is a good word to use to describe our development,” says Chris Phillips, Managing Director of CHASE. “Like all successful life forms, we have adapted quickly to a changing business environment, aggressive competition and a fast-moving landscape. Throughout this journey, we like to think that our DNA has always remained the same – we believe our unique structure allows us to deliver quality in everything we do.” “Many members of our team have over 10 years’ service and all of us are experienced from within the pharmaceutical industry – we believe that a high level of consistency and applied experience is what our customers really value. Building long-term client relationships are an important element to our team of consultants. At CHASE we really understand and support our client strategies and have developed strong strategic partnerships.” The quality approach of CHASE permanent recruitment is well documented by their customers: “Following on from my CSO experience with Schering Plough through CHASE, I just wanted to drop a note of thanks for the excellent support CHASE has provided to date for my current campaign. Firstly, I have been sent a consistent list of good candidates; I have even turned some people down that on normal circumstances I would have been happy to progress. In particular, CHASE has excelled in the ‘service’ offered.” Tom Harrington – NSM “Having given a tight brief as to the specific qualities of the candidates I required, CHASE only delivered candidates who met this brief, which saved me enormously on screening unsuitable candidates and made it much easier to find the right people I was looking for.” Simon Davis – Southern Sales Manager Ability to Adapt Certainly the market landscape has changed beyond all recognition in this timeframe: the constantly developing NHS with its demands and formularies, the endless M&A activity, the reduction in headcount and focus shift to key accounts and secondary care. This competitive landscape is littered with the fossils and skeletons of evolutionary failure – those companies that did not change and attempted to carry on ‘business as usual’ were always going to be doomed to extinction. “Of course our adaptability is crucial, however, it is the our people and values that sets CHASE apart,” says Judy Phillips, Recruitment Director. Adapting to the times is critical; it’s also true that keeping some standards absolutely unchanged is equally important. Our candidate quality remains uncompromised over the last 12 years – we always interview every candidate and complete competency based interview notes. CHASE also remains unique in that we never, ever subcontract contract or permanent recruitment. We know from client and contractor feedback that these things really matter: “Having experienced working with Chase previously I didn’t hesitate when another opportunity came along to work with them again. As a medical sales representative I expect a CSO provider to offer complete & professional care. CHASE exceeds this expectation with an efficient and personable approach.” Dawn Hewitt CHASE/ MSD – Medical Representative. accolades from the industry – with an impressive list of awards and recognition: • Pharmaceutical Field – Recruiter of the year 2010 * • PharmaTimes – Recruiter of the Year 2007 / 2009 ** • PharmaTimes – Agency of the Year 2007, 2008 and 2009 *** • Pf Awards – Clinical Nursing Award Winner (CHASE / Abbott) 2009/10 * As voted for by respondents to the Pf Company Perception, Motivation and Satisfaction Survey 2010 ** PharmaTimes Sales Recruiter of the Year 2007/2009 *** PharmaTimes Most Nominated Recruiter of year 2007/2008/2009 - Sales Category Flexible Resourcing Evolution is about constant variation and, like all successful organisms, CHASE has adapted and diversified in order to satisfy customer requirements. Over the years, by listening closely to customers’ needs as they plan strategies, it became clear that flexibility in sales resourcing was becoming increasingly important. This led to the development of distinct divisions with specialised offerings CHASE VM, CHASE Flex and CHASE Graduates – all responsive developments to improve client competitiveness in tough environments. CHASE VM provides high quality vacancy management allowing client businesses to manage the challenges of short and long term territory vacancies. “Sticking to the brief is the key – we’ve used CHASE for vacancy management and recruitment for a number of years – I love the ‘no time wasting, right candidate, right job’ approach. The CHASE VM team understand precisely the skills and experience that we’re looking for here, and they have delivered every time.” Ken Shields – Head of Endocrinology and Gastroenterology Meanwhile, CHASE Flex offers that operational flexibility needed by so many sales teams as they maximise the opportunity of differential resourcing, whilst CHASE Graduate offers a real ‘try before you buy’ scheme for trainees and new entrants. “Speed is a crucial factor in managing our vacancies and I’ve been amazed, quite frankly, at how quickly CHASE VM has placed the right high-quality people for us. We treat CHASE VM as a true partner – and the relationship is important from both sides. There’s no doubt in my mind that having open communication with a senior director and team who understand our needs and respond with real urgency makes real difference.” Stuart Shotton – Sales Director Our Focus If you want to measure our evolution, then CHASE is reflecting the market with 80% of our contract and permanent activity in secondary care, key account work and Market Access. Additionally, we have seen our CSO business grow by 48% last year, which is unprecedented in the CSO sector. CHASE is providing clients with a real alternative choice in the CSO market and they appreciate the quality of our candidates and focus we can offer. There is doubt that CHASE has thrived and survived by getting involved and listening to our clients needs – it is only by working in close partnership that we can create tailored services. Consistent quality in service, in both permanent and contract offerings, remain the hallmark of our business. If you’d like to discuss how CHASE can help you with recruitment, specialist contract teams or vacancy management, then please call us on 0131 553 6644 or email us at [email protected]. For more information, visit: www.chasepharmajobs.com. COMMISSIONED PROFILE CHASE has also won a string of MARCH 2010 Report calls for review of NICE’s processes Pharmaceutical Field The gateway to a commercial career in pharma Around 16,000 patients have been denied access to important treatments that could have prolonged their lives, latest findings have revealed. A new report from the Rarer Cancers Forum has highlighted continuing problems for people with rarer cancer in accessing treatment. Preparing for stormy weather p14 March 2010 Oscars for outcomes p26 Playing the game p16 Report demands urgent review of NICE’s processes Around 16,000 patients have been denied access to important treatments that could have prolonged their lives, latest findings have revealed. A new report from the Rarer Cancers Forum has highlighted continuing problems for people with rarer cancer in accessing treatment. Exceptional Progress? Assessing the progress made in improving access to treatment for people with rarer cancers found that, though progress has been made, with many patients being given vital treatment, thousands are still being denied access to life-saving treatments. Since NICE promised to improve access to drugs for rarer cancers, four drugs that meet this criteria have been denied funding, while draft guidance recommends against NHS use of another six. Just five have been accepted. The report argues that NICE is taking too long to appraise new cancer drugs – 21 months, rather than the six months promised by ministers. Andrew Wilson, Chief Executive of the Rarer Cancers Forum, said: “Although progress has been made in improving access to cancer treatments since the publication of the top-ups review, there is still more to do. It is unacceptable that many thousands of patients are still missing out on the treatment they need, and which their doctors want to give them, because NICE has decided that their treatment However, patient groups have cited NICE’s recent rejection of everolimus, an effective new kidney cancer drug that met the ‘end of life’ criteria, as evidence against this statement. Rose Woodward, Head of Patient Support at The James Whale Fund, said: “What is the point of sons and daughters and friends and families running relays and holding coffee mornings to raise funds for cancer research if new drugs aren’t available to NHS cancer patients? It’s morally wrong that these new drugs can only be prescribed to rich patients or patients who have private health insurance.” does not meet some arbitrary criteria. The changes introduced by NICE should be benefitting more patients than they are doing at the moment. An urgent review of NICE’s processes is needed.” In cases where appeals were raised by individual patients to gain access to a drug, inequalities across the UK were revealed, as out of 62 PCTs, 11 approved all drugs, two approved none. In response, Sir Andrew Dillon, Chief Executive of NICE, said: “We have introduced significant additional latitude in our appraisal of treatments for cancer, particularly where they are designed to extend life, at the end of life.” ‘Disappointing’ progress on health inequalities Health inequalities between the poor and the wealthy are worsening, despite overall health improvements, a new Audit Commission report has shown. Healthy Balance revealed that although there has been progress, including cuts in infant mortality and increases in life expectancy, this has coincided with a widening gap between the poor and the better off. It recommends that PCTs comply with public health guidance from NICE to cost-effectively reduce health inequalities. The Commission estimates that in 2009/10, the NHS allocated £21 billion to PCTs to reflect differences in health inequalities. However, among its conclusions, the report suggests there may have been too much policy and guidance for PCTs and local authorities to keep up with. Andy McKeon, the Audit Commission’s Managing Director, Health, said: “We know the health of (Continued on p5) PF-MARCH NEWS.indd 1 Health briefing March 2010 Healthy balance A review of public health performance and spending The health of people in England has improved over the past ten years. Life expectancy has increased, infant mortality has fallen. Government targets to cut death from heart disease and stroke by 2010 have already been met. But if the big picture is positive, stark problems remain. Inequalities in the health of people from certain areas and social backgrounds has stubbornly resisted improvement, and has even increased in some cases. A potent measure is the gap between the worst areas and the England average. This is captured in the difference between the England average and performance in the spearhead local strategic partnerships (LSPs), the one-fifth of areas with the worst rates of deprivation and early death. On that measure, the gap in death rates for both men and women rose between 1998 and 2007 – from 16.1 per cent to 18.6 per cent and from 13.9 to 15.2 per cent respectively. For infant mortality, the gap at first narrowed and had been on course to meet the government’s target – a 10 per cent reduction by 2010 from a 1998 starting line. But the latest figures show little improvement during the past four years (Ref. 1). 18/03/2010 12:27 Health inequalities increasing Marketing award for Schering-Plough Health inequalities between the poor and the wealthy are worsening, despite overall health improvements, a new Audit Commission report has shown. Healthy Balance revealed that although there has been progress, including cuts in infant mortality and increases in life expectancy, this has coincided with a widening gap between the poor and the better off. Schering-Plough has been named as Best Medical Supplier at this year’s UK Marketing Excellence Awards. The company fought off competition from 3M Drug Delivery Systems, Mediplus and Nutricia Advanced Medical Nutrition to win the award, which was partly judged by Natalie Uhlarz of Pharmaceutical Marketing. Health briefin g March 2010 e Healthy balanc A review of publi c health perfo rmance and spending d people in Englan The health of over the past has improved expectancy has ten years. Life mortality has increased, infant to ment targets fallen. Govern e heart diseas cut death from y 2010 have alread and stroke by is if the big picture been met. But . problems remain positive, stark of people health the in Inequalities areas and social from certain has stubbornly backgrounds has and , ement resisted improv in some cases. even increased the worst is the gap between A potent measure This is captured England average. areas and the England average between the in the difference d local strategic nce in the spearhea areas with and performa of (LSPs), the one-fifth On partnerships and early death. of deprivation men the worst rates rates for both the gap in death that measure, and 2007 – from 1998 between to and women rose and from 13.9 to 18.6 per cent 16.1 per cent For infant mortality, respectively. course 15.2 per cent had been on narrowed and per cent the gap at first target – a 10 nt’s to meet the governme a 1998 starting line. But 2010 from ent during reduction by show little improvem the latest figures years (Ref. 1). the past four EMA and FDA agree annual report The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have agreed to accept a single annual report for orphan drugs for use in both the EU and the US. The announcement coincides with World Rare Disease Day (28th February), which seeks to call attention to rare diseases as a public health issue, and to reinforce the increased need for access to information, research and treatment. Pharma and biotech top R&D The pharmaceuticals and biotechnology sector dominated UK R&D spending in 2008, the latest R&D scoreboard has revealed. Around 80% of UK R&D was conducted by just one hundred of the top R&D investing companies, many of which operate in the pharmaceuticals and biotechnology sector. To read the full story, click on the headline Abbott completes Solvay deal NICE should retire old drugs, says article Abbott has completed its EUR 4.5 billion acquisition of Belgium-based Solvay Pharmaceuticals. The takeover provides Abbott with a large and complementary portfolio of pharmaceutical products and expands its presence in key global emerging markets. The methods for abandoning old drugs in favour of new ones must be improved, experts have warned. Writing for the BMJ, health academics Dyfrig Hughes and Robin Ferner said that decisions about which drugs to abandon to fund new treatments recommended by NICE are inconsistent and may be contributing to the postcode lottery – one of the key issues that NICE was set up to tackle. Forbes reveals the world’s most expensive Miles D. White AZ cuts UK R&D Up to 1,000 workers will lose their jobs at AstraZeneca as the company closes two of its research facilities and ends development in various disease areas. AZ’s R&D site at Charnwood in Leicestershire is to close, as well as a smaller facility in Cambridge. The company also intends to end R&D work at its Avlon facility near Bristol. Some workers will move to AZ’s largest R&D site, Alderley Park in Cheshire. Specialty drugs for rare diseases have been shown to be the most costly, according to market and analysts’ data gathered by Forbes magazine. Alexion Pharmaceuticals’ treatment for paroxysymal nocturnal haemoglobinuria (PNH), Soliris (eculizumab), came top of the Forbes’ list of the top nine priciest drugs on the current global market. HAPPY IN THE WORKPLACE? HAVE YOUR SAY PF COMPANY PERCEPTION, MOTIVATION & SATISFACTION SURVEY 2011 - OUT JANUARY NICE restricts RA options NICE has published three recommendations that could “drastically limit” the treatment options available to patients with severe rheumatoid arthritis (RA). NICE’s latest ruling against funding tocilizumab (RoActemra) came only a day after a negative decision on abatacept (Orencia) as a second-line treatment and restrictions were placed on the use of three other antiTNF drug therapies (adalimumab, etanercept and infliximab). Alisa Bosworth Pharmaceutical Field YEARBOOK 2010 MARCH 2010 Retacrit Diversity the Vidaza decision key for pharma, secures EU appealed recommendation report says Top pharmaceutical and biotech companies will face a major decline in sales growth up to 2014, according to a new report. However, those companies that have been able to diversify into biologics, niche products and generics will still enjoy positive growth, says business analyst Datamonitor. Retacrit is to become the first biosimilar of epoetin to achieve a subcutaneous licence in renal patients. The biosimilar, manufactured by Hospira, received a positive opinion from the CHMP for subcutaneous (SC) use in renal anaemia. Flu vaccine secures recommendation UCB partners NHS to provide Cimzia NICE has finalised its revised Cimzia (certolizumab pegol) guidance, recommending the treatment for some people in England and Wales suffering with rheumatoid arthritis. The recommendation is another example of a negative NICE decision being reversed due to a patient access scheme agreed with the manufacturer. The CHMP has recommended a conditional marketing authorisation for a fifth pandemic influenza vaccine – Humenza from Sanofi Pasteur. This is the second pandemic vaccine to be assessed by the Committee using an emergency procedure which fasttracks the evaluation of new vaccines developed during a pandemic. Government invests in cancer UK boost for campaigns Intercell The Government has pledged £8 million to help local NHS organisations fund campaigns that improve early diagnosis of cancer. The investment follows the Prime Minister’s pledge to ensure that all patients with cancer symptoms receive their results from diagnostic tests within one week. Charity calls to end scheme AML candidate recommended The MS Society is campaigning for an end to a scheme that gives multiple sclerosis patients access to drugs that are not recommended by NICE. The Risk Sharing Scheme, which was to run for ten years, was implemented by the DH in 2002 when NICE decided that certain disease-modifying drugs were not cost-effective. The drugs involved are Biogen Idec’s Avonex, Bayer Schering Pharma’s Betaferon, Teva/ sanofi-aventis’ Copaxone and Merck Serono’s Rebif. Pharmaceutical Field YEARBOOK 2010 Celgene UK has appealed NICE’s decision against the use of Vidaza (azacitidine) in patients with higher-risk myelodysplastic syndrome (MDS), a rare type of blood cancer. NICE has concluded that the drug does not represent a good use of NHS funds, though it is reimbursed in this indication in most other European countries. The European Medicines Agency (EMA) has recommended orphan drug status for an acute myeloid leukaemia (AML) treatment under development by Swedish biotech company Aprea. The drug is currently undergoing a Phase I clinical study and a final decision from the European Commission is expected in a few weeks. The Joint Committee on Vaccination and Immunization (JCVI) in the UK has recommended the use of Intercell’s Ixiaro to protect people at high risk of contracting Japanese Encephalitis. Ixiaro is recommended for individuals aged 18 years and older that are at high risk of exposure during travel or in the course of their occupation. BMS reveals new CEO Bristol-Myers Squibb has announced that Lamberto Andreotti will take over as the company’s Chief Executive Officer when current Chairman and CEO James M. Cornelius retires. Andreotti, who is currently President and Chief Operating Officer, has served with BristolMyers Squibb for 12 years in senior leadership roles, both internationally and in the US. Prior to joining Bristol-Myers Squibb, he held senior roles at KABI Pharmacia and then at Pharmacia & Upjohn. Forum to combat drug shortages The onus to ensure there is a sufficient supply of medicines to the NHS will be placed on manufacturers and wholesalers, health ministers have decided. A package of tough new actions was agreed at a summit to discuss current difficulties with the supply of medicines, hosted by Health Secretary Andy Burnham and Health Minister Mike O’Brien. Unique ITP treatment EU approved A new treatment for immune thrombocytopenic purpura (ITP) with a unique mode of action has been approved for marketing in the EU. The EMEA has granted a marketing authorisation for Revolade (eltrombopag), the first oral thrombopoietin receptor agonist (TRA) to be approved for this patient group. To read the full story, click on the headline Preparing for stormy weather The NHS Operating Framework 2010/11 Is the NHS now at a critical juncture in its history? How will it operate in the incoming financial storm? Alan Jones reports. T he NHS New Year has now started and the NHS modus operandi for the year ahead is now live. An important document at the moment is the Operating Framework for the NHS in England for 2010/11, published last December, which sets out the priorities for your NHS customers over the next 12 months – particularly for payers. These key priorities will have a significant impact on your business this year. The full document is 52 pages long, but this article will highlight some key areas, as well as provide some ‘takehome’ points. Planning for the tough financial climate ahead is at the heart of this year’s Operating Framework. There will be some growth in 2010/11 but a big freeze will follow, where up to £30bn of efficiency savings are required. The UK economy may be emerging from the recession, but the NHS is just about to enter one. So, although the national priorities largely remain the same, a number of shifts in national policies are set out. Hospital-based care particularly will be restructured (and even downsized) and management levels are to be reduced. Hard times ahead Implications for hospitals Earlier this year, Pf published a piece on the white paper NHS 2010-15; from good to great. This new five-year NHS Plan mapped out a slight change of direction by Government, who had to acknowledge the incoming cold financial winds. This year’s operating framework is year one of its implementation. There will be difficult times ahead for hospitals because big changes are planned to ‘payment by results’, the acute sector’s financial lifeblood. The more accurately titled ‘payment by activity’ has encouraged overheating in the hospital sector and driven up costs. And despite the focus on care closer to home, hospitals have expanded, with the numbers of consultants growing faster than GPs. So there are some hard hitting measures to cut the cost and number of hospital procedures. A new two-part NHS tariff capping system will be introduced, where a set level of emergency procedures will be paid for at full tariff price but over that volume hospitals will only get 30%. Tariff prices are also to be frozen and the only extra income (apart from increases in volume for elective care) will come through the Commissioning for Quality and Innovation (CQUIN) scheme. Hospital income will depend on improving the patient experience, and PCTs will be handed the power to withdraw payments where they judge that care is below par. ‘Best practice’ tariffs (probably at a lower price) are also being introduced to ensure the highest quality care. These changes to the tariff are designed to reward quality but also incentivise care outside hospitals. The net result of all of this may be that hospitals become trapped in a rather uncomfortable ‘pincer movement’ where they will have to drive down costs while their activity levels also fall. There are predictions that hospitals could run up deficits of around £7.5bn a year by 2015. To balance the books, cuts in ‘heads and beds’ might be necessary. The tariff moves are another attempt to shift the balance of power away from Acute Trusts towards PCTs as commissioners; while the marginal tariff is clearly an attempt to force a discussion about risk-sharing in relation to unplanned admissions and improving demand management. There is also something extraordinary about giving Foundation Trusts the opportunity to run community services. The focus is on vertical integration between acute and community services. There will be a new deadline for all hospitals that are not yet foundations to submit their timetable for achieving this Pharmaceutical Field March 2010 “The Operating Framework challenges all organisations to reduce overheads and management costs… it is now time to tackle those things we have known about in the system for a long time…” Sir David Nicholson, page 2, 2010/11 NHS Operating Framework for England, December 2009 status by 2013/14 – otherwise they risk takeover by another Trust. This all points towards some major ‘turbulence’ in this sector; we will see more mergers and possibly wholesale hospital closures. Implications for commissioners The NHS will face its biggest financial challenge in the next generation and the document suggests taking costs completely out of the system – including admin costs, commissioning costs and management costs. NHS managers will take a hit again, as there is a target for PCTs and SHAs to reduce their management costs by 30% over the next four years. Although it is not long since PCTs faced ‘the night of the long knives’ (in 2006/7, when the current number of 152 PCTs was created), this level of savings could result in management functions being merged with other organisations and up to 6,000 PCT and SHA jobs could go. And yet the DH wants commissioning to significantly improve. Other commentators are arguing that up to £1.5bn is wasted on ineffective interventions, so there will be a greater focus on the decommissioning of services and treatments that bring little benefit to patients. Pharmaceutical Field March 2010 The document also contains a renewed emphasis on prevention, integration of care, care closer to home and self care for long-term conditions, which are also seen as reducing costs. However, an Audit Commission report last year suggested that PCTs have made little inroad into transferring care from hospitals to the community and the annual 2009/10 report from the National Quality Board showed that high hospital admission rates in areas like COPD and diabetes are a measure of the (lack of) quality of primary care. So there is still a lot of work to be done. The Operating Framework points out that care closer to home would achieve better outcomes and save money – up to £2.7 billion a year. So there is likely to be new pressure on consultants and GPs to agree local care pathways and more consultants working in the community. In primary care, there will be major reforms to QOF from 2011 (less money and harder targets) with the ‘regulation’ of GPs by the CQC to follow. There is even a suggestion that the GMS contract might need to be renegotiated to return it to a 24/7 service. There will also be more focus on primary care resource usage, with tougher sanctions for those with unjustifiable spends and a particular focus on prescribing. Conclusions Thus concludes our quick tour of the NHS until April 2011. There may be an upcoming election, but whoever is in power this June will still have to deal with the impending NHS funding crisis and these plans are unlikely to substantially change over the shorter term. This Government is now saying that the urgent £15/20bn savings will no longer be ‘cashable’ savings, but a reinvestment in ‘front line’ services, to cope with rising demands. The key message is that after years of unprecedented growth, the NHS now faces a period of unprecedented austerity. Prepare for a bumpy ride. Alan Jones is an occasional contributor to Pf. He commentates and presents widely on the ongoing reform within the NHS and its implications for pharma and is a consultant to Wellards. An independent healthcare policy analyst, adviser and NHS trainer, he can be contacted at [email protected]. Ten key take-home points 1. Policy documents like this come out with great regularity. Have you been briefed internally as to its implications for you? How does this work in your company? Certainly this document is an organisational ‘must-read’ and a detailed analysis is required. Chapter 3 is the key section (pages 27-43). 2. Acute Trusts are likely to feel the icy cold winds of recession first. Significant reconfigurations are likely. Is it time for ‘real’ account management in hospitals, rather that just KAMs working a few selected (key) hospitals (accounts)? 3. Expect the numbers of PCTs to fall, but do not pull back on your payer liaison activities or hesitate to start them. For good account management reasons, perhaps even intensify them. 4. PCTs are highly unlikely to be able to afford all the treatments recommended by NICE, so new drugs will face stiffer market access challenges, even when they are NICE approved. Expect NICE to be tougher in its decision-making. 5. There could be significant change coming in primary and community care. There will be increased community delivery of specialist drugs and even tougher formularies. PCT prescribing budgets will be expected to make savings. 6. There is now a recognition that healthcare has become too fragmented. Integration is a key theme in the document, so expect both vertical and horizontal integration to occur – new accounts needing new account management strategies. 7. There is to be even more joint working with local authorities and even mergers, such as that in Herefordshire and some London boroughs. Most Director of Public Health posts are now joint ones. What do companies know about social services and elected councilors? 8. Perhaps for the first time ever, there is an explicit suggestion that the local NHS should ‘work in partnership with the life science industry’. How will you avail yourself of the major opportunities here? 9. There will need to be more focus on care pathways, with companies prepared to work across the purchaser/provider divide. How many companies are set up for this? Clinical networks in areas like CHD and diabetes are new accounts. NHS-alignment of sales and marketing strategies will be key. 10. Finally, there seems little confidence that the cushion of recent huge funding increases has put the NHS into any stronger position to weather the incoming financial ‘storm’. The only real way to save money is to spend less. That might not only mean fewer staff and but also less medicines use. Pf Awards 2010: Oscars for Outcomes Pharmaceutical sales’ equivalent of the Oscars, the Pf Awards 2010, recognised the brightest and best sales talent the sector has to offer. During a time of transition, and sometimes uncertainty, the Awards provide an opportunity to celebrate the achievements of a successful industry with patient outcomes at its core. T his year’s Pf Awards Dinner was once again a memorable night. Held at the sumptuous Lancaster London Hotel near Hyde Park in London (March 11th), the event was attended more than 550 sales and marketing professionals from across the industry. These included not only the sponsors and judges, but, most importantly, hundreds of nervous candidates and their excited colleagues, all looking as if they could have graced the red carpet of the previous week’s premier event, the Oscars. Much like the Oscars, emotions were high amongst the evening’s attendees, as they shared their experiences of the assessment day and caught up with old friends at the pre-awards champagne reception. Prior to the awards dinner and official ceremony, an award of a different kind was presented: the Pf Employer of Choice. Each year, Pf asks respondents to its Company Perception, Motivation and Satisfaction Survey to vote for their Employer of Choice – this is the company they view as the most desirable to work for, not including their current employer. The Winners Award Category Experienced Hospital Representative Ethical Leadership in Sales New Representative Account Manager Clinical Nursing Learning and Development Initiative IMS Business Simulation Cross-functional Partnership Nurse Manager New Hospital Representative Business Manager Partnership Leader Award Account Team Experienced Representative Outstanding Performer Winner Company Louise Finke Paul Sandhu Irene Harvey Charlene Ward Tracey-Anne Blanc Charlie Crabtree Laura Rosenthal Anthony Peers Caroline Gadd and Christian Rimmer Leigh Thomson Anthony Peers Ian Saunders Farrah Ahmad Elizabeth Albon and Allison May Alison Dixon Alison Dixon Shire Schering-Plough (a part of MSD) Janssen-Cilag Abbott Ashfield In2Focus on behalf of Takeda UK Ltd Chase / Abbott Schering-Plough (a part of MSD) Quintiles Schering-Plough (a part of MSD) National Services For Health Improvement Ltd Quintiles Pfizer Schering-Plough (a part of MSD) Chiesi Ltd Pfizer Pfizer “The Awards just get better every year. It was a superb evening, and James Cracknell was a great choice for cohost – his achievements stand as an excellent example to anyone hoping to go the extra mile. Congratulations must go to all our winners, who did just that, particularly our Outstanding Performer, Alison Dixon.” Melanie Hamer – Pf Awards Pharmaceutical Field March 2010 Forthe second year running, the Employer of Choice was Boehringer Ingelheim, and its National Operations Manager Dominic Timney gratefully received the award from Heidi Sharland, General Manager of Pf publisher, Health Sector Publishing. Dominic Timney said: “The Pf Awards evening is a tremendous event and this year was a night I will remember for a long time. Boehringer Ingelheim has won the Employer of Choice Award for the second year running. It’s an exceptional achievement and it was a privilege to receive the award on behalf of all my colleagues and friends at such a great company.” The official ceremony opened with a presentation by the guest host, Olympic gold medal winner and world record holder James Cracknell. An accomplished public speaker, he spoke on preparation and the build-up to an important challenge, as well Pharmaceutical Field March 2010 as entertaining the attendees with anecdotes from his experiences at the Beijing Olympics. Another winner to address the audience was former England footballer and 1966 World Cup hero Sir Geoff Hurst. In his capacity as the current President of Sparks, the children’s medical research charity and the Pf Awards’ nominated charity for 2010, Sir Geoff thanked the Pf Awards for their support via a pre-recorded video message. In total, £1000 was raised on the night for the charity. And the winners are... The awards were presented by Pf Awards Events Director Melanie Hamer and co-host James Cracknell, with the sponsor of each award announcing the winner. The top performing candidates represented a variety of companies and were deployed across a range of roles from within the pharmaceutical sales industry. In addition to the overall winners, commendations were announced for those candidates that achieved full marks in one part of their assessment. The Pf Awards’ main success story on the night was Schering-Plough, now a part of Merck, Sharpe and Dohme, which came away with four awards – the highest number won by one company. These included one of the night’s most desired awards, Experienced Hospital Representative, but also two newer categories, the Cross-functional Partnership and Partnership Leader awards, which recognise when candidates have engaged in a partnership with a customer that has made a significant difference to patients. Another big winner was pharma giant Pfizer, boasting this year’s Experienced Representative and Outstanding Performer Alison Dixon, two of the most coveted awards of the evening. Alison described her feelings on the night: “It was a really special evening, but I don’t think the enormity of winning really hit me until the next day, when I was inundated with calls from colleagues to congratulate me, even from people I didn’t know. In such a competitive environment, it was amazing to get that kind of recognition from colleagues that I admire.” “The whole experience was a really positive one from me, right through from the assessment day to the awards evening,” Alison added. “This was my first entry into the Pf Awards so I didn’t know what to expect, but it was a real compliment even to be nominated considering the calibre of the other candidates, even just those from Pfizer.” APRIL 2010 New NHS board to champion EU approval innovation for Duodart A new NHS Life Sciences Innovation Delivery Board (LSIDB) has been set up to champion innovation in drugs and medical technologies. The LSIDB aims to increase the use of cost effective treatments, improve relationships between the life sciences sector and the NHS and increase the attractiveness of the UK as a site for clinical trials and product development. Pharmaceutical Field The gateway to a commercial career in pharma Commercial skills for the NHS p12 April 2010 New title, same job? p22 US health reform p18 New NHS board will champion innovation A new NHS Life Sciences Innovation Delivery Board (LSIDB) has been set up to champion innovation in drugs and medical technologies. The LSIDB aims to increase the use of cost effective treatments, improve relationships between the life sciences sector and the NHS and increase the attractiveness of the UK as a site for clinical trials and product development. NHS leaders, regulators (NICE), senior policy makers and industry leaders from the life sciences sector will work in collaboration for the benefit of patients. The aim of the Board is to ensure the NHS and industry can work together to share information, which will ultimately lead to improved services. It is hoped that an effective partnership between the NHS and industry will help the NHS to increase quality and productivity and enable industry to develop new therapies that meet the needs of the NHS and patients. Mike Farrar, Chairman of the Life Sciences Innovation Delivery Board, said: “This is an exciting and important initiative for the NHS. It’s hard to think of a more significant, mutually reliant relationship that is conducted under such difficult circumstances. “The aim of this new Board is to Mike Farrar enable the life sciences industry and the NHS to work together in collaboration for the benefit of patients. This can only be good news for all parties concerned.” NHS plan to develop commercial skills New NHS Commercial Support Units will help local and regional decision-makers to support the quality and productivity agenda by building effective relationships with suppliers and independent health providers, a new DH publication explains. Commercial Skills for the NHS sets out a strategy for supporting NHS staff to develop their commercial skills, and for supporting local commissioners and providers with a new commercial infrastructure. The document makes it clear that the new infrastructure for NHS commissioning and procurement has the overarching goal of supporting a shift from hospital care to healthcare in the community. The role of the Commercial Support Units in helping PCTs and SHAs to relate more effectively to the range of product and service providers on the ground, as well as to the structures (such as NHS Supply Chain) that are seeking to rationalise procurement activity at national level, is explained. Commercial Skills for the NHS supersedes Necessity not Nicety – a new commercial operating model for the NHS (May 2009), clarifying the new infrastructure and indicating that the ‘preferred provider status’ of the NHS does not impede open competition for franchises in the redesign of service provision. The goal of Commercial Skills for the NHS is to clarify the role of the Commercial Support Units in supporting service redesign at local and regional level, driving changes in commissioning and procurement to support quality and productivity – and thereby opening doors for innovative suppliers and independent health providers. Looking around? GSK has secured European approval for Duodart (dutasteride and tamsulosin), the first fixed dose combination medicine for benign prostatic hyperplasia (BPH). Approval for the drug was given via the Decentralised Procedure, with Germany acting as Reference Member State. For the very latest vacancies in pharmaceutical sales and the news stories that matter most it’s wise to visit www.pharmajobs.co.uk PF-APRIL10-NEWS.indd 1 15/04/2010 14:36 Teva to become NHS to develop leading generics commercial company skills Teva has outbid Pfizer for ratiopharm, the sixth largest generic drug company worldwide. The deal is valued at EURO 3.625 billion and is expected to be completed by the end of the year, dependent upon certain conditions, including relevant regulatory approvals. Shlomo Yanai High Court success for Servier The High Court has ordered NICE to issue new guidance in relation to Protelos within three months, following an appeal by the drug’s manufacturer Servier Laboratories. It has been ruled that NICE should not have rejected Servier’s clinical data on the reduction of risk of hip fracture by its osteoporosis treatment and was therefore unlawful in its decision making. New NHS Commercial Support Units will help local and regional decision-makers to support the quality and productivity agenda by building effective relationships with suppliers and independent health providers, a new DH publication explains. Commercial Skills for the NHS sets out a strategy for supporting NHS staff to develop their commercial skills, and for supporting local commissioners and providers with a new commercial infrastructure. Pharma employees more loyal A quarter of employees in the pharmaceutical sector are more loyal to their employer as a direct result of the economic downturn, according to a recent survey. The research, by global workforce solutions leader Kelly Services, shows that the economic recession has generated a clear and powerful sense of engagement between workers and bosses. Follow Pf on Twitter @PharmaField EMA reviews 2009 The European Medicines Agency received 96 applications for marketing authorisations for medicines in 2009, 60% higher than the initial forecast. At its recent meeting, the EMA’s Management Board also reported that it consistently met regulatory timelines and delivered good results in 2009, despite resources being diverted to deal with the H1N1 pandemic. Novartis and Roche threaten to leave UK, report claims Eddie Gray Code complaints down in 2009 Last year saw the lowest number of complaints in relation to the Code of Practice since 2004, according to figures published by the PMCPA (Prescription Medicines Code of Practice Authority). There were just 92 complaints against companies in 2009, compared to 112 in 2008, 127 in 2007, 134 in 2006, 101 in 2005 and 119 in 2004. Novartis and Roche have reportedly threatened to remove their operations from the UK, due to NHS pricing and restrictions placed on UK clinical trials. The accusations, reported in the Guardian, were apparently made in private meetings between the companies and Government Ministers, including Health Minister Mike O’Brien. To read the full story, click on the headline Rare disease drugs available on NHS Patients with very rare conditions will be given access to drugs and services not previously available on the NHS, the DH has announced. A small number of drugs and treatments for very rare conditions that are not yet appropriate for the NICE appraisal process can now be considered for use in the NHS. Mike O’Brien Pharmaceutical Field YEARBOOK 2010 APRIL 2010 Patients to Resolor launched in UK benefit from Xeloda Movetis’ Resolor (prucalopride) is now available in the UK to treat the symptoms of chronic constipation in women who do not receive adequate relief from laxatives. Resolor is a novel enterokinetic agent that represents a new approach to the treatment of chronic constipation as it targets underlying impaired gut motility. NICE backs limited use of Multaq NICE has revised its original recommendation that dronedarone (Multaq) should not be used to treat atrial fibrillation (AF) – a disturbance of the heart’s rhythm. After considering comments on the previous draft guidance, the independent Appraisal Committee decided to recommend limited use of the drug as a second-line treatment in people with additional cardiovascular risk factors whose AF has not been controlled by first-line therapy (usually including beta-blockers). Roche’s Xeloda (capecitabine) has been approved by the European Commission for post-surgery treatment of patients with early colon cancer. The drug is indicated in combination with oxaliplatin – a combined treatment named XELOX. The XELOXA study, one of the largest studies of early colon cancer, showed that patients taking XELOX immediately after surgery lived diseasefree for longer compared to those treated with chemotherapy regimen 5-fluorouracil/leucovorin (5-FU/LV). NHS pledges to cut costs The NHS has committed to deliver £4.35bn of savings through measures such as energy efficiency and reducing staff sickness. This will be the department’s contribution towards the £11bn savings that are being made across Government by 2012–13, as reaffirmed in the Budget 2010. Novartis vaccine EU approved EC approved ACS treatment Novartis has received approval for Menveo, the first quadrivalent conjugate vaccine in the EU to help prevent meningococcal disease. Menveo is indicated for the active immunisation of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitides groups A, C, W135 and Y, to prevent invasive disease. The European Commission has approved Sanofi-aventis and BristolMyers Squibb’s dual antiplatelet combination tablet DuoPlavin/DuoCover (clopidogrel and acetylsalicylic acid). The combination treatment is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Pharmaceutical Field YEARBOOK 2010 NICE provides clarity on pain treatments RA costs UK £8bn each year NICE has published the first guideline on the most effective drugs to treat neuropathic pain in general and community settings. The new clinical guideline outlines which drugs should be prescribed in nonspecialist settings and in what order these treatments should be given. Rheumatoid arthritis (RA) costs the UK economy almost £8 billion per year, yet NHS spending on the condition is less than 9% of this figure. These are the findings of a new report, The Economic Burden of Rheumatoid Arthritis, published by the National Rheumatoid Arthritis Society (NRAS) with support from Roche Products. Positive FAD for Lilly’s Alimta Eli Lilly’s chemotherapy Alimta (pemetrexed for injection) has received a positive Final Appraisal Determination from NICE. The Institute recommends Alimta as an option for the maintenance treatment of people with locally advanced or metastatic non-smallcell lung cancer with other than predominantly squamous cell (nonsquamous) histology, if the disease has not progressed immediately following first-line chemotherapy. ABPI builds Scottish team The ABPI has appointed an Operations Director in Scotland for the first time. Sandra Auld joins the ABPI team in Edinburgh from the NHS Scottish Centre for Telehealth where she is Service Development Manager. Sandra Auld Ailsa Bosworth ‘Perverse’ Vidaza ruling appealed Patient groups have appealed against the negative recommendation by NICE for the use of Vidaza (azacitidine) in patients with higherrisk myelodysplastic syndrome (MDS). Appeals have been lodged by MDS UK, the Leukaemia Society and the Rarer Cancers Forum. Strong NHS Q3 results The NHS met a number of key commitments on healthcare priorities at the end of last year, the DH has announced. The Quarter 3 (October – December 2009) performance report highlights that, despite the adverse weather conditions, the NHS maintained its commitment to treat all patients within 18 weeks from referral to treatment. Commercial Skills for the NHS A definition of procurement in the context of commissioning healthcare has emerged through the publication of a new DH document, which encourages NHS staff to improve their commercial skills. Thoreya Swage reports. T he long awaited successor to Necessity not Nicety has finally been published after a troubled gestation. Things seemed to be progressing well until the Secretary of State for Health, Andy Burnham, mentioned in a speech to the King’s Fund in September 2009 that the NHS would be the ‘preferred provider’ in the provision of health care, leaving the independent sector apparently high and dry. This view may have been influenced by the health care unions, concerned at their members losing out to non-NHS providers, particularly in the current economic climate. The ‘preferred provider’ issue came to a head when a PCT in the Eastern region excluded non-NHS providers in a procurement to run its community services, triggering an investigation by the NHS Cooperation and Competition Panel. This, however, was stopped in February by the Department of Health, possibly indicating that this policy would not stand up to legal scrutiny. Furthemore, there were rumours that members of the cabinet did not share this view, leading to some shuffling behind the scenes to allow some flexibility in this approach. In December 2009, NHS 2010–2015: from good to great. Preventative, peoplecentred, productive was published, seeking to clarify the situation with regard to independent sector involvement in health care. However, the health economy had to wait for the publication of Commercial Skills for the NHS on 25th March 2010 to read the finer rules of engagement. The focus of the document is to improve the commercial skills of NHS staff and to support commissioners and providers through access to specialist commercial expertise at regional and national level. Among the specific aims such as using procurement to drive service transformation, e.g. shifting care for people with long-term conditions from acute to community settings, and developing the competence of commissioners and providers in undertaking clinical service reviews to address performance issues, is a key aspiration: “to continue to remove potential barriers to the participation of non-NHS providers”. Commercial Skills claims to clarify ambiguities in the predecessor document, Necessity not Nicety and states that it reflects the changing background in the NHS. What is procurement in the NHS? The document defines what procurement means in the context of commissioning health care within the NHS environment. It describes how, over the last ten years, the separation of commissioner/provider roles has become clearer, with the result that commercial processes have come increasingly to the fore. For services covered by existing contracts, contract management is a mechanism to drive improvements. In contrast, procurement can be used to create new contractual relationships, whether with current providers or new ones. The document goes on to say that procurement is a transparent process of securing services to meet specific commissioning needs, formally engaging providers, resulting in a contract. The matter of competition between providers is regarded as secondary. The revised Principles and rules of cooperation and competition guidance also published in March 2010, explicitly says that commissioner or patient choice should not be restricted by agreements between commissioners and providers. The NHS Constitution states that patients can expect choice of health care regardless of which type of provider delivers those services. Quality is the basis for change in health care and, to this end, the government is asking the NHS and its staff to lead this change together with partners from other organisations. Commercial Skills continues to repeat the policy of allowing current NHS providers to have two formal opportunities to improve if underperforming, whilst, at the same time, not ‘freezing out’ other possible providers. The emphasis continues to Pharmaceutical Field April 2010 be that of developing integrated care across various boundaries and, if new services are required, to look at what the independent sector can provide. Core principles have been set out for commissioners, NHS providers and the independent sector. For commissioners, first and foremost, it is essential that they secure the best value for patients and taxpayers. However, if services are to be improved or developed, NHS and other existing providers should be involved at an early stage. If further down the line the decision is made to go to competitive tender, all providers (NHS and non-NHS) should have a ‘fair and equal’ opportunity to bid. Underpinning such processes are fairness, transparency and a clear rationale for how the decisions are made with oversight and assurance through PCT Boards, the Department of Health (DH) assurance of Strategic Health Authorities (SHAs)and World Class Commissioning. For NHS providers, full involvement of their staff is essential when commissioners conduct service reviews, particularly if there are concerns about performance or addressing service improvements. If new or substantially redesigned services are needed, engagement of current providers and their staff is required at an early stage so that they can contribute to service specifications. If competition is used in the service redesign process then NHS providers should have an opportunity to bid. The document states that the independent sector continues to make a ‘valued contribution’ to health care, specifically in adding extra capacity, improving quality and patient choice and driving innovative practice. Where an independent sector organisation is subject to closer scrutiny on their performance, they, like the NHS provider, will have two opportunities to improve their performance prior to contract termination should no improvements be forthcoming. As for the NHS provider, if the route to improving services is competitive tender then the process is expected to be open, fair and non-discriminatory. All types of providers will have a chance to highlight concerns or complaints about competition and procurement practices with the commissioner, SHA and ultimately the Co-operation and Competition Panel. Pharmaceutical Field April 2010 In situations where providers are found to be failing, in addition to working with the provider to improve care, commissioners could enlist the support of other providers within the local health system. These ‘other providers’ could include the independent sector. Further details on procurement can be found in the updated Primary care trust procurement guide for health services, published at the same time to accompany Commercial Skills in the NHS. Developing commercial skills in the NHS The second aim of Commercial Skills in the NHS is to support commissioners and providers through access to specialist commercial expertise. This is a key area for struggling commissioners who have been through the World Class Commissioning assurance process and have been found lacking in three competences: effective stimulation of the market, developing secure procurement skills to manage contracts, and managing systems and working in partnership with providers. The support also includes the improvement of procurement skills of NHS provider staff, e.g. responding to tenders, costing and pricing and ensuring access to information on commissioning intentions and procurement activities for all providers. The specialist commercial expertise comes in the guise of regionally based commercial support units (CSUs) which will be supporting both commissioners and providers in their area. Nationally, the NHS will continue to strengthen its purchasing power by preserving the NHS Purchasing and Supply Agency’s (PASA) well regarded secondary care pharmaceutical sourcing activity long after the dissolution of PASA itself at the end of March 2010. Implications for pharma Superficially it looks as though the policy of engaging the independent sector has not changed much since the publication of the five year strategy NHS 2010–2015. However, perhaps the negative tone towards anything non-NHS has been modified. The way forward seems to be around working with the NHS in delivering and improving health care. The emphasis on NHS staff, particularly clinical professionals, leading service improvement and redesign together with partners is an important one, and pharma should ensure that relationships with these key personnel continue to be developed and maintained, especially if innovative ideas or evidence-based practice are required. This could be an opportunity to bring new initiatives or different pathways of care from the industry that have worked well in other countries or health care systems. The review of services as part of the performance management process will require clinical expertise which could be supported by evidence-based practice produced by pharma. In terms of bidding for new services, the fact that access to information on commissioning intentions and procurement activities will be universally available will enable all providers to have an equal opportunity to prepare for tenders. Removing the potential barrier of excluding the independent sector in tendering process through openness and transparency will make it more difficult for the NHS to award contracts to preferred NHS providers simply on the basis of their public sector background. A key role of the CSUs will be to develop various strategic relationships with non-NHS organisations in order to widen the market for commissioners. Here is an opportunity to raise the profile of the pharma industry in the area of new ideas and innovative practice through such contacts. Whatever the forthcoming election brings, it is clear that fair and open competition for health care services is here to stay and now is as good a time as any to take advantage of this climate. Dr Thoreya Swage has several years’ experience in the NHS, both as a clinician (psychiatry) and as a senior manager, including Executive Director for a Health Authority, in various NHS organisations covering acute and primary care. She has expertise in commissioning health services, most recently working with the independent sector as part of the Independent Sector Treatment Programme at the DH. She is currently working for a number of NHS organisations, including DH agencies, to develop a more commercial approach to the commissioning of healthcare. MORE PF 2010 features online at www.pharmafield.co.uk New title, same job? The psychology of KAM Delivering the promise of Key Account Management requires a brave, cultural shift for pharma. Letting go of the old approach is essential. Half measures will not suffice. Success will come from embracing the concept fully, rather than simply rebadging traditional reps as account managers. Adam Knights and Simon Toy assess the psychology of KAM. I f I place one foot in a bucket of boiling water and the other foot in a bucket of freezing water it doesn’t take very long to work out what a bad idea it was. It is certainly not the same as plunging both feet in a bucket at 50 degrees! What’s that got to do with Key Account Management? It means you cannot have a foot in both camps, one in KAM and the other in a traditional model. Real Key Account Management is your biggest opportunity and at the same time your biggest threat. If you approach your salesforce remodelling at the half way house you will end up in a world of pain, meaning that you will have to change radically the culture in the organisation in order to achieve success. Half hearted commitment can be explained when we consider how our thinking, in terms of our beliefs, determine our motivation. Real, sustained change only occurs when two conditions exist: approach, both of these conditions do not exist. Whilst the benefits of KAM (as outlined in this article) appear very appealing and the consequences of not making such a switch very dangerous to the business, there are the other, more personal considerations. 1. The consequences of not Firstly, what happens if the KAM embracing change outweigh the benefits of not making that change approach doesn’t work? If there is a move to a more output rather than an input focused reporting AND structure for KPIs, how will I know who is working and who is not? 2. The benefits of embracing the change outweigh the consequences How can I show that I am staying on top of my sales force? How of making the changes. can I show cause and effect? How can I manage under performance Unfortunately, for many senior without frequency and coverage executives considering the data? wholehearted switch to a true KAM Secondly, things are not all bad at the moment anyway; at least I have data to ‘prove’ who is currently performing; I don’t want to upset everybody by adding even more change to an already rapidly changing environment. Most of these issues are very personal to us as individuals, rather than to our organisations. The problem with the motivation to change to KAM is simple: 1. We are being asked to give up short-term benefits (it’s working OK at the moment) at the risk of long-term consequences (the NHS is changing and we might be left behind if we don’t change with it). Pharmaceutical Field April 2010 AND 2. We must accept short term pain (my salesforce will need reeducating, upskilling and in many cases, a radical mindset shift) with the potential of benefits in the future (we will succeed in the Brave New World, if it is, indeed, a reality. After all, it might not be!) Put in those terms it is hardly surprising so many organisations only half-heartedly embrace a true KAM approach; BOTH of these conditions must exist for committed change to last. The change to KAM is not easy though; you have to start measuring more outputs than inputs, assess your business metrics, adapt your marketing and throw away your coverage and frequency model. You can’t claim to have embraced KAM and then hit the key account manager over the head because of their low call rate. Look at the duration of the call as opposed to the number they have seen. What would you like? Two calls a day at an hour each or ten calls a day at two minutes each? One huge challenge with embracing the KAM approach was summed up recently by a senior pharmaceutical sales manager we were dealing with: “It’s not that our salesforce are not sure how KAM differs from a more traditional selling model, it’s that they don’t believe that they are capable of liaising at the more senior levels within PCOs. They are too conditioned into handing out pens and post-it pads, believing that this is key to influencing senior stakeholders. We need a serious mindset shift in our salespeople in order to really make KAM work. Most programmes designed at delivering KAM skills totally ignore this.” Type ‘Key Account Management’ into Wikipedia and there is no definition, which probably explains why so many companies have their own versions of it. Every time we interview someone we ask them for their individual definition. This can range from “targeting customers more effectively” to “understanding the gatekeepers.” These are not wrong; KAM however, does go a lot deeper. We believe that real KAM involves the process of proper customer segmentation, whilst linking in the current environment depending on the PCO / account you may be Pharmaceutical Field April 2010 working. Real KAM needs a bottomup approach and accepts that some areas are simply not worth working in; you must be prepared to walk away from difficult accounts that will drain your resource for little return. The single biggest contributor to an effective KAM model is culture. We can re-model saleforces as often as we like, but if the culture does behaviours, where wrong means behaviours that everyone recognises as not driving the business. How about recognising innovative patient projects and absolute growth for recognition and reward? You will change the focus in the company and the business will understand what you are looking for. A word of caution though, don’t confuse ‘best practice’ with ‘standard You can’t claim to have embraced KAM and then hit the key account manager over the head for their low call rate. Look at the duration of the call, not the number of calls. What would you like? Two calls a day at an hour each or ten calls at two minutes each? not change, it will not succeed. This often means buy-in and changes from the top to make this happen. Successful companies that have moved to KAM have included everyone in the organisation. To change, culture cannot simply be about the sales force; it includes all head office personnel. For example the Business Intelligence Team may have different requests from the field as the business starts to look at and study different metrics; this in turn puts more pressure in the system. Some sales people have been running their own region through a KAM model for years, it’s just the company didn’t see it. Many sales folk have been at an appraisal and missed out on an “A” because their call rate wasn’t high enough, despite capturing most new business with their “in market” performance and delivering on units and cash. We have all been sat in the audience at conference and seen the wrong people being pulled up on stage for recognition as they finished 120% of target and delivered no new business; all that tells us is that the target was wrong. Often underperformance gets recognised through a variety of incentive schemes that link tedious inputs to performance, the result being that the salesforce don’t “buy in” to the scheme and start to resent it throughout the year. The easiest way to de-motivate high performers is to reward mediocrity, or even worse, reward the wrong practice’, running a big speaker meeting that was ‘a great success’ is not best practice unless you can throw some dynamic metrics behind it. Some of you will be reading this article thinking to yourself “yes, this is the exactly what we need to do here”, but do nothing about it and that’s because the cultural mind shift to move to a KAM model is huge. It takes all aspects of the organisation to buy in and will mean people being pulled from their comfort zone. Even when we think something makes sense and we say we want to embrace change we often don’t. Why is that? Simply put it can be summed up in one word...fear. Fear can display itself in many forms; loss of sales, loss of control and fear of failure. Ultimately, commitment to change only occurs when we challenge the beliefs we have that stop us from taking action. Additionally, we need to truly understand how our beliefs motivate, or de-motivate us. This means everyone in the organisation not just acquiring the knowledge and skills necessary to change to a KAM approach, but also to develop the winning attitude essential to making that transition a successful one. If you decide to make the move to KAM, just go for it, don’t live in two worlds, otherwise failure looms. The process to make the full move is tough and resistance will be strong, it will also mean taking some casualties for those that refuse or can’t understand it. I met with a Sales Director friend recently; he explained that the company had made the successful move to Key Account Management over a year ago. That’s great, can you validate it? The answers were quite woolly and non specific. Asking him to go back retrospectively and study their promotional spend in the field the year before, they went to KAM and then studied spend for the following year. Interestingly enough the same promotional expenditure was being spent on the same things as the year before, by default they had not made the move to Key Account Management. All that had happened was a re-badging exercise, what was of concern is that the culture had not moved on. Like it or not, the current economic world of cold climate will make you change. There is no new money, new products are facing vast market access challenges and the NHS customer has changed into a more commercial and clinical animal. This is where the opportunity now lies to do something exceptional in pharma. Will you be brave enough to embrace the whole KAM concept or will you send your team on a ubiquitous, generic KAM course and just rebadge them? Adam Knights is Managing Director of 15Healthcare, which acts as a healthcare broker between the NHS and pharma through holistic and strategic key account management. Adam joined the pharmaceutical industry in 1998 after a successful career in the armed forces. He applied military strategy and tactics early on to develop an account model that challenged traditional thinking and planning. He went on to pilot successfully the regional account director (RAD) role in Takeda before becoming the first RAD in the UK and then sales director for the RAD team. Simon Toy is the Managing Director of Performance Associates, a mindset and behavioural change organisation that works with numerous UK blue –chip companies. Clients include AstraZeneca, GSK, Solvay, 3M, Meda Pharmaceuticals, Johnson & Johnson, Lundbeck, Securicor, Bristol-Myers Squibb, SkyePharma. MAY 2010 Pharma can exploit political uncertainty The political uncertainty surrounding the UK’s first coalition government since the second world war could become a catalyst for progress with NHS/ industry joint working, a leading health figure has said. Mike Farrar, Chief Executive of North West SHA, told a pre-election industry audience that if, together with its NHS partners, it could present politicians with carefully designed solutions rather than historic problems, the opportunity for the two sectors to work in partnership to regenerate the economy and deliver benefits to patients and taxpayers was real. Pharmaceutical Field May 2010 The gateway to a commercial career in pharma Do you need to be better eQIPPed? p14 Be prepared: The Bribery Act 2010 p22 A glimpse of coalition p18 Pharma can exploit political uncertainty The political uncertainty surrounding the UK’s first coalition government since the second world war could become a catalyst for progress with NHS/industry joint working, a leading health figure has said. Mike Farrar, Chief Executive of North West SHA, told a pre-election industry audience that if, together with its NHS partners, it could present politicians with carefully designed solutions rather than historic problems, the opportunity for the two sectors to work in partnership to regenerate the economy and deliver benefits to patients and taxpayers was real. Farrar said the industry needed to take advantage of the political uncertainty and to put itself in ‘a good place’ to drive joint working between pharma and the NHS, once the situation was calmer. “We need to put ourselves in a position where we have policy we can place in front of new health ministers to show that these two sectors can work together for the good of the country. We need a policy framework to support us and must be ready for when that landscape lands.” Andrew Lansley Andrew Lansley has been confirmed as Secretary of State for Health and is to form part of the new ConservativeLiberal Democrat coalition Cabinet Lansley, who has been Shadow Health Secretary since 2003, was one of the five Tory health ministers to retain their seats in the General Election, which saw four key Labour DH members lose their jobs. Health Secretary Andy Burnham was the only member of the Labour health team to keep his seat. Former Health Ministers Ann Keen, Mike O’Brien and Gillian Merron, as well as ex-Care Services Minister Phil Hope, all lost their seats to the Conservative Party. The Conservatives and the Liberal Democrats share some common ground on health issues, though it seems unlikely that there will be any clarification on health policies until the Queen’s Speech at the end of May. The BMA has urged Lansley to work with doctors in the formation of new policy. “There is intense pressure to make savings, but cutting clinical staff or frontline services would be not only shortsighted, but could also cause irreparable damage to the NHS,” said Dr Hamish Meldrum, Chairman of Council at the BMA. “Doctors will want to play a central role in shaping the delivery of healthcare and we would encourage the new government to work with us to ensure that this can happen.” Lansley has previously pledged to abolish ‘politically-motivated’ targets and Mike Farrar told an ABPI audience that political uncertainty was an opportunity for the NHS and the industry to drive joint working give greater autonomy to local clinicians. Indeed, both coalition parties pledged to cut bureaucracy and targets in their manifestos. However, there may be conflict over the Conservatives’ plans to establish an independent NHS board to run the health service, as the Lib Dems have advocated local health commissioning boards. The industry has reacted positively to the news of the appointment. ABPI Spokesperson Richard Ley told Pf: “We are very much looking forward to working with the new health team and hope to have a meeting with them as soon as possible.” Court rules NHS prescribing incentives legal The ABPI has lost its case that the NHS is acting illegally in providing incentives for doctors who prescribe cheaper medicines. The Association argued that such incentive schemes were an illegal inducement under European rules on drug promotion. However, the European Court of Justice ruled that the prohibition did not apply to national public health authorities that control public funds, despite the fact that individual doctors can profit from these incentives. The ABPI said: “The ABPI believes it is important that patients can have total confidence that when their doctor is making prescribing decisions those decisions are, and are seen to be, completely independent of personal financial considerations. The ECJ interpretation of the legislation risks this being put in doubt.” The British Generic Manufacturers Association (BGMA) has welcomed the ruling. BGMA Director Warwick Smith said: “We welcome the ECJ’s statement that there are no patient health concerns since all medicines are constantly reviewed by the regulators.” The ABPI will now consider the implications of this decision on its case, which is proceeding in the High Court. PF-MAY10-NEWS.indd 1 Dolenio launches in the UK Dolenio, the UK’s first licensed glucosamine sulphate product for the symptomatic treatment of mild to moderate osteoarthritis of the knee, has launched in the UK. Traditionally, NSAIDS and other analgesics have been the first-line treatment options for osteoarthritis chosen by doctors. Conditional OK for Arzerra Arzerra (ofatumumab) has received a conditional European marketing authorisation, providing a new option for chronic lymphocytic leukaemia (CLL) patients who have limited treatment options. The European Medicines Agency (EMA) has granted this conditional authorisation for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab. 13/05/2010 20:17 Crestor gains new EU indication Court rules incentives legal Priligy now available in UK AstraZeneca’s statin Crestor (rosuvastatin) has been approved in nineteen countries within the EU for the treatment of patients at high risk of a cardiovascular event. The drug is also indicated for the treatment of high LDL cholesterol (dyslipidaemia), total cholesterol (hypercholesterolaemia) and/or triglycerides (hypertriglyceridaemia). The ABPI has lost its case that the NHS is acting illegally in providing incentives for doctors who prescribe cheaper medicines. The Association argued that such incentive schemes were an illegal inducement under European rules on drug promotion. However, the European Court of Justice ruled that the prohibition did not apply to national public health authorities that control public funds, despite the fact that individual doctors can profit from these incentives. The first prescription treatment for premature ejaculation is now available to men in the UK through an online consultation service. Although not licensed in the UK, Priligy, manufactured by Janssen-Cilag, can be accessed online through a unique service provided by Lloydspharmacy. Counterfeits targeted by MEPs Pfizer cancels Sutent trials Pfizer has discontinued its Phase III study of Sutent (sunitinib malate) in advanced hepatocellular carcinoma (HCC), or liver cancer. Following a review by the independent Data Monitoring Committee (DMC), the study was discontinued based on a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm. Proposals to crack down on counterfeit medicines were approved by the Environment, Public Health and Food Safety Committee of the European Parliament this month. The recommendations, which include the covering of internet sales in draft EU legislation to prevent fake medicines from entering legal supply chains and measures to improve pharmacovigilance, were proposed by the European Commission in December 2008. To read the full story, click on the headline Humira to top charts The rheumatoid arthritis treatment Humira will replace Lipitor as the world’s biggest-selling drug in 2016, but Pfizer will still hold the highest medicine sales, latest industry predictions state. The World Preview 2016 report, published by EvaluatePharma, contradicts previous estimates that cancer treatment Avastin would emerge as the biggest blockbuster drug following Lipitor’s patent expiry. Due to some clinical setbacks for Avastin, EvaluatePharma now forecasts Humira to be the top drug with sales of $10.1bn in 2016. HAPPY IN THE WORKPLACE? HAVE YOUR SAY PF COMPANY PERCEPTION, MOTIVATION & SATISFACTION SURVEY 2011 - OUT JANUARY EC approves low-cost hepatitis C treatment Biopartners has secured an EU marketing authorisation for its biosimilar version of branded drug Rebetol. The European Commission has approved Ribavirin Biopartners 200mg film-coated tablets. Pharmaceutical Field YEARBOOK 2010 MAY 2010 Indication extension for Tarceva ‘Heartless’ New treatments SMC decision approved for on cancer NHS Scotland ABPI appoints Catchpole Tarceva (erlotinib) will soon be available to more EU patients with advanced non-small-cell lung cancer (NSCLC), following its approval as a first-line maintenance treatment in this setting. The European Commission has extended its indication to include monotherapy maintenance treatment in patients whose disease remains largely unchanged (stable disease) after platinum-based initial chemotherapy. The Scottish Medicines Consortium (SMC) has ruled against a drug that could be used as a second-line treatment against kidney cancer. The SMC did not accept Afinitor (everolimus) for the treatment of patients with advanced renal cell carcinoma whose disease has progressed in spite of vascular endothelial growth factor (VGEF)targeted therapy. The ABPI has appointed Paul Catchpole into the role of Director of Value and Access. In his new role, Paul will drive forward the ABPI’s work to demonstrate the value of the industry and its medicines, and to improve access for patients to innovative medicines. He will be based at the ABPI’s offices in Whitehall. Diovan approved for children The world’s number one selling high blood pressure medication is now available for children in the EU. The European Commission has granted Novartis’ Diovan (valsartan) a new paediatric indication for the treatment of hypertension in children and adolescents 6–18 years of age. New class of COPD treatment The only once-a-day oral tablet for the treatment of Chronic Obstructive Pulmonary Disease (COPD) has been recommended for use in the EU. If it is approved by the European Commision, Nycomed’s antiinflammatory therapy Daxas (roflumilast) will become the first new class of treatment for COPD in more than a decade. Epicept launches Drug offers leukaemia new approach treatment The first fixed-dose combination therapy for benign prostatic hyperplasia (enlarged prostate) has received a UK license. Combodart (dutasteride/tamsulosin hydrochloride) is a new, once-daily combined treatment that can relieve symptoms and prevent disease progression in this common condition. Pharmaceutical Field YEARBOOK 2010 EpiCept Corporation has launched its leukaemia drug Ceplene (histamine dihydrochloride) in the UK. The drug’s launch was timed to coincide with the British Society for Haematology 50th Annual Scientific Meeting in Edinburgh. Abraxane (paclitaxel albumin) will be available for restricted use within the NHS in Scotland, following a positive opinion from the SMC. The drug has been approved for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline-containing therapy is not indicated. Cephalon completes Mepha deal Swiss-based pharma company Mepha has become a wholly-owned subsidiary of Cephalon, following its acquisition by the larger company in a deal worth approximately US$615.4 million. Branded and non-branded generics manufacturer Mepha is the leading company in the Swiss generic market, with more than 120 products. NICE to consider Avastin NICE is considering recommending Avastin to treat wet age-related macular degeneration, even though it is not currently licensed in this indication. Lucentis is the drug currently recommended for use by NICE, but it is an expensive treatment and was originally derived from the cheaper cancer drug Avastin. Paul Catchpole New CEO for Bayer HealthCare Dr Jörg Reinhardt is to be the new head of Bayer’s HealthCare division, effective from August this year. The 54-year-old previously worked as Chief Operating Officer of Novartis AG. Sanofi-aventis executive leaves company Laurence Debroux, Senior Vice President, Chief Strategic Officer and member of the Executive Committee at sanofi-aventis, will be leaving the company as of July 2010. Debroux was appointed to her current role in February 2009. Sanofiaventis has announced that she will be moving to “pursue another professional challenge”, but has yet to announce her successor. Looking back and looking forward: ABPI launches Annual Report and plans for 2010 T he ABPI has promised that in 2010 the UK will start to move into a position of world leadership in creating, valuing and accessing healthcare innovation. Its recently launched 2010 Strategic Plan includes promises to boost trust in the industry, extend and improve joint working between companies and the NHS and build on the momentum started by the Office for Life Sciences. The ABPI has also published its 2009/10 Annual Report, which cites the Kennedy Report and its attempts to reform Healthcare Technology Assessments (HTA), as well the introduction of the OLS, as major achievements of the past 12 months. Looking back The Annual Report looks back on what is described as “an eventful and successful” year and is optimistic about the industry’s future, but points out that the “financial and NHS climate” must be “conducive to innovation”. The Report states: “The opportunities that lie ahead for the UK pharmaceutical and biotechnology industry in a globally dynamic environment are vast. The fast moving pace of science, if harnessed, will enable the UK to retain its position as a world leader in the life sciences industry.” Last year saw the launch of the ABPI’s four key imperatives: Value, Innovation, Trust and Access, or VITA, which have been the focus of its activities. Achievements are targeted within these areas and separated within the document to illustrate this structure. However, in terms of overall achievements, the document focuses mainly on the ABPI’s improved relationship with healthcare providers and regulatory authorities, in particular through the progress achieved by the launch of the Office for Life Sciences. A key achievement for the industry was the establishment of the Office for Life Sciences, which recognised that joined-up government action was required to protect the interests of the life sciences industry in the UK. As a result of collaboration between the ABPI and the Office for Life Sciences, the Life Sciences Blueprint was published in July 2009 and Life Sciences 2010: Delivering the Blueprint in January 2010. These encompassed vital initiatives, including the Patent Box, the Innovation Pass and the Life Sciences Super Cluster, each of which considerably improved conditions and incentives for life sciences companies operating in the UK. Other achievements for the ABPI over the last year include: • The Kennedy report including recommendations that will enable companies to have increased involvement in the Health Technology Assessment (HTA) process. • Continued collaboration between the ABPI and NHS Chief Executive David Nicholson on how the industry can support the QIPP agenda. ABPI objectives • • • • • • • To maintain the UK’s position as a leader in the global pharmaceutical industry To enable the pharma industry to be a trusted partner in the delivery of healthcare To make the ABPI the acknowledged authority on the pharmaceutical industry with key stakeholders A commitment to R&D being added to the Annual Operating Framework for the NHS. The NHS Constitution enshrining the right of patients to have access to NICE approved treatments. The success of industry-NHS joint working projects. The creation of a forum to allow industry to engage with Higher Education institutions to enhance the skills needed by the industry. Pharmaceutical Field May 2010 “The ABPI is a catalyst for a new era of innovation in pharmaceuticals, improving the health and wealth of the nation. In the next decade, the UK will move to a position of world leadership in creating, valuing and accessing healthcare innovation... We are looking forward to working even closer with all our stakeholders in the new political environment to achieve this” Beyond sponsorship One key theme of this year’s Annual Report is the potential for joint working between the health service and the pharma industry and the document focuses particularly on achievements in this area. These include the start of the ABPI’s NHS Partnership Programme to allow closer engagements between companies and the NHS, and launch of the Moving Beyond Sponsorship joint working toolkit in March 2008. “This commitment to a shared vision and a more mature relationship between pharmaceutical companies and NHS organisations has already proved it can deliver better patient care,” the Annual Report states. A new era The 2010 Strategic Plan begins by describing the ABPI as offering a “compelling single voice founded on a shared understanding”. It goes on to say: “The ABPI is a catalyst for a new era of innovation in pharmaceuticals, improving the health and wealth of the nation. In the next decade, the UK will move to a position of world leadership in creating, valuing and accessing healthcare innovation.” The Plan divides the ABPI’s key campaign objectives for the coming year in accordance with the four VITA imperatives. The campaign objectives will be: • Key messages for 2010 • • • The ABPI is the globally respected voice of the UK pharmaceutical industry, which is world leading in the discovery and development of vital new medicines. The UK pharmaceutical industry is one of the most valuable industries in the UK and is part of the solution for delivering better outcomes for patients, the NHS and the UK economy. The ABPI believes that UK patients should have access to appropriate, innovative medicines, ensuring that the right patient receives the right medicines at the right time Pharmaceutical Field May 2010 • • • • To ensure innovative medicines are valued in the UK as cost-effective solutions for preventing and treating diseases (Value). To restore the UK as a world class leader in innovation by fostering excellence through key stakeholder partnerships (Innovation). To create a new contract between industry and society based on integrity, honesty, knowledge, appropriate behavior, transparency, openness and trust (Trust). To get the right medicine to the right patient at the right time (Access). The document also contains the ABPI’s top level organisational objectives and how these will translate into activity for each of the imperatives. The first of these is to maintain the momentum started by the launch of the Office for Life Sciences, and is associated with activities such as implementing the Innovation Pass, leveraging the QIPP opportunity, expanding joint working to a national scale, launching the Super Cluster and creating a positive environment for early clinical research. The ABPI’s second objective is to secure commitment to HTA reform to ensure that the UK is an environment that champions innovation, which will include the publishing of guidance for companies on data collection for HTAs and the launch of a Blue Print document describing how the UK can become a global centre of excellence in this area. The Association has also committed to implementing various behavior changes to boost the trust between the ABPI and other bodies, including new proposals within the Code of Practice to promote transparency, an annual survey conducted with stakeholders to gauge the reputation of the industry and a position paper on best practice in research data sharing to be delivered to the EFPIA by the end of 2010. Further objectives for 2010 are to agree principles for future PPRS, improve smaller member engagement, resolve pension conflict and agree ABPI financing, modernise ABPI systems and facilities and to bring life science trade associations together. In conclusion The Annual Report concludes: “Great progress was made in working towards improved health outcomes for patients, working in collaboration with the NHS and creating a better investment environment for our industry. However, we still need to do more to ensure that all patients in the UK have access to new medicines and treatment with no geographical anomalies, delay or restrictions. We are looking forward to working even closer with all our stakeholders in the new political environment to achieve this.” The 2009/10 Annual Report and 2010 Strategic Plan are available at http://www.abpi.org.uk/recent.asp. MORE PF 2010 features online at www.pharmafield.co.uk A glimpse of coalition Pf Editor Chris Ross reports on an annual ABPI conference coloured by pre-election fever and driven by a determination for industry and NHS to work together for the good of the nation. But will the wider industry be able to build on its manifesto pledges? T he spectre of an imminent General Election loomed large over the 2010 ABPI Conference, which took place ten days prior to polling day. Proceedings became a strange portent for the post-election political discussions that would later emerge, centring as they did on the need for two parties to work together in partnership for the greater good. A full working coalition between the NHS and the pharmaceutical industry has, until now, appeared as likely as a Liberal Democrat sitting at the top table of government. But in this figurative time for change, joint working is now considered ‘in the national interest’ – and the ABPI conference addressed it with relish. Unlike political coalition, however, the collaboration between NHS and industry cannot be considered as a temporary measure. It must, the conference concluded, become a long-term commitment. Unlike the 2010 General Election, the ABPI Conference managed to deliver an overwhelming majority – with presenters and audience members alike united in the view that the old adversarial pharma/NHS relationship is ‘old politics’, and that joint working represents the future for both parties. Political rhetoric? It cannot afford to be. The experts claim partnership working is an obligation not an option. Me? Well, to use some recent political vernacular, “I agree with Nick.” ABPI Director-General, Richard Barker, told delegates that partnering with the NHS was the biggest issue facing industry at the moment. The agenda, he said, had been put together to help debate solutions to a range of challenges: • How can we partner to bring • • • new medicines to market via UK research and clinical trials? How can we evaluate them more broadly and more fairly across the UK? How can we provide patient access to the best available treatments? How can we work together with NHS management and NHS professionals to reduce the burden of disease? Within the auditorium, conformity with these principles and objectives was widespread – but as with many Pharmaceutical Field May 2010 such conferences, it is often the audience outside of the room that matters most. Persuading the nonbelievers of the need for change will remain the biggest challenge. Barker said the industry’s relationship with the NHS was now entering a third phase. The first phase has previously been described as ‘trench warfare’, whereby the industry sought to promote its products and the NHS sought somehow to avoid it. “The second phase, which I’m delighted to say is where we have been for a few years now, is in experiments in joint working,” said Barker. “We’ve got more than a dozen of these experiments going across the UK and some of them have got to the point in their lives where we’ve been able to demonstrate real impact in what they achieve on the burden of disease. But I’d like to see us move to a third phase of relationship with the NHS, which is partnering to address each other’s challenges.” The challenges facing the NHS are well-documented and have been further highlighted by the glare of publicity the General Election has provided. The UK’s desperate economic climate has driven an annual funding gap of between £15-20 billion by the end of the next planning period. To help achieve it, the QIPP agenda, is crucial – and joint working is seen as a significant component in delivering success. The financial drivers for progressing joint working were further outlined by Mike Farrar, Chief Executive, North West SHA. Farrar said that the business case for working together more effectively had never been more compelling in terms of the patient, the taxpayer and the economy. “If we can get our act together and add value to what we do, we can really help transform the state of the economy. It behoves us to find a better way to work together than perhaps we have done in the past. We can’t afford to do what we’ve always done,” he said. Pharma and QIPP The need to change behaviours was a resonant theme of the conference, but Farrar warned that old behaviours and perceptions are stubborn and difficult to shift. Progress, he said, would require both parties finding a common language. “The language we talk about constantly is the QIPP challenge – Quality, Innovation, Pharmaceutical Field May 2010 Productivity and Prevention. And the pharmaceutical industry can help us meet this challenge.” Outlining the four pillars of the agenda, Farrar pinpointed where the industry can play a part: • Quality – the pharmaceutical input into the quality of patient care is significant, not only in terms of new products, but also existing products. The challenge is to ensure patients get swifter access to them and are supported in terms of compliance to make sure we get the benefits. “We also need to make sure our services are aligned to them, so that we have a whole service offer not just a single product offer.” • Innovation – the creation of the Life Sciences Delivery Board is an opportunity to bring sectors together – NHS, industry, academia. “This makes sense in terms of aligning businesses, getting businessto-business relationships and adding value to the processes we share. Innovation will be a clear manifestation that we are getting this right. Waste often occurs in industry business processes because the health service hasn’t specified what it wants properly. By sharing the pipeline earlier, building business processes so that as the NHS goes through selection of those products it can actually be prepared for their entry, we will deliver value and get products used sooner.” • Productivity – executives across the industry will be sitting on information where they know that if the pharmaceutical inputs can be got right in terms of the care pathway, NHS and associated care staff would be much more productive. In the process, lengths of hospital stays will reduce, the number of operations will increase and more opportunities to care for people within the existing inputs that we’ve got will emerge. • Prevention – this is not only relevant to the NHS, but also to every single country whose health service costs have increased due to the extra demand driven by the ageing population and new technologies. The demand side of the equation has not yet been managed. Top left: Richard Barker, Top right: Mike Dixon, Bottom left: R Blackburn, Botton right: Patrick Hopkinson “In all these dimensions, the industry can help me achieve these challenges,” said Farrar. “In return, I can offer value back and allow you to avoid the waste and get higher returns. But if we know what we should be doing, the question we have to ask ourselves is why we are not translating that into action. This is a world that has been completely stubborn to a lot of senior leadership cajoling. It makes absolute business sense for us to try to work on this agenda. But if that’s the view from the top of the office, why are we not able to get it into place? We need to get this drilled down into our organisations so that at middle management level we’ve got the right behaviours, the right degree of honesty and trust, the right amount of confidence and courage to work with each other in a different way. That’s the journey.” Farrar said that the journey called for new skillsets and increased emphasis on training. “How do people making the decisions get trained? How do they understand the nature of the business when they look at it from the industry or on the NHS side? How do we understand and walk in each other’s shoes? That’s where we have got to put attention and energy.” Industry perspectives From an industry perspective, the view from the top was similarly positive. Senior figures from some of the industry’s largest companies presented examples of their experiences in joint working and, in the process, became powerful advocates of the opportunity to partner. Patrick Hopkinson, Director, Portfolio and Partnership Marketing, GSK said: “This is an incredible opportunity to bring together great people, resources and skills for the benefits of patients. Partnership working can transform the relationship the industry has with the NHS, but it needs to be more than a nice sentiment, it needs to be a strategic imperative.” Alan Barge, VP and Head of Oncology and Infection TA, AstraZeneca, said that all the ingredients for success were there, and that the industry could provide the glue to hold it all together. Using alcohol as a metaphor, he said: “Between us, in academia, the NHS and the industry, we have a full six-pack. We have everything we need to develop innovative, groundbreaking treatments for cancer, to deliver them to patients and to make them cost-effective. But somehow, it sometimes seems we are missing the plastic ‘thingemy’ that holds it all together. My vision is to be the plastic thingemy, so that ultimately we have a full six-pack that holds together. In the UK, we have all of the components. Our challenge is to make it happen.” Healing the relationship One of the biggest challenges, however, is to improve trust in the industry. Richard Blackburn, Managing Director, Pfizer UK, said that there are varying levels of trust between different parts of the NHS and the industry, but that improving this was a major objective. He presented a slide that included a sticker one of his colleagues had seen on the door of a medical school. The sticker encouraged students to ‘say no’ to drug reps. “This is the sort of thing you normally see associated with stopping smoking or internet predatory. Can it really be the view that our future prescribers have of the people they meet from our industry? I don’t think it is representative, but it does serve The ABPI should change its code of practice to bring an end to the practice of industry representatives giving gifts to doctors and their support staff. Acting on this single recommendation alone would do much to rebalance the relationship between medicine and industry.” Royal College of Physicians, 2009 to remind us that there is a problem that we cannot afford to ignore.” Blackburn highlighted a handful of initiatives designed to tackle the issue of trust, outputs from the ABPI Trust Imperative Board. Promotional items were cited as a negative force. “The ubiquitous pens, pads and other giveaways have become a stick that our industry critics beat us with. They represent the kind of relationship where we hope that the significant value that we bring to our customers will somehow be remembered as a result of the relatively cheap item we have left with them. The time has come for us to put an end to that practice. Until we do, it is just going to be something that gets in the way of us moving forward.” Blackburn drew attention to the words of the Royal College of Physicians to support the argument: “The ABPI should change its Code of Practice to bring an end to the practice of industry representatives giving gifts to doctors and their support staff. Acting on this single recommendation alone would do much to rebalance the relationship between medicine and industry.” In November, ABPI member companies will have the opportunity to vote on a proposal to do just that. Another vote will be taken on a proposal to declare publically all payments made by pharma companies to HCPs. The ABPI will also encourage further dialogue around the funding of medical education, meetings and training. This, said Blackburn, was a legitimate debate that encouraged divergent views. The overall aim, he said, was to improve what had become a dysfunctional relationship between NHS and pharma. “Industry is honestly trying to address that. My plea would be that our colleagues in the NHS see that and respond to it.” Clinical leadership One senior NHS figure, Mike Dixon, Chairman of the NHS Alliance, said that he was impressed by the ABPI’s desire to make joint working happen, rather than allow it to become a ‘hollow desire because it sounds like a good idea.’ Dixon apologised on behalf of fellow clinicians, who he said had been complicit in a plot that had led to a mistrust of pharma. But Dixon raised the concern that much of the dialogue promoting the benefits of joint working was taking place between industry and ‘NHS managers’. “This conference has talked about working with leaders, and all the leaders are managers. I hope in the new world that we will see clinical leadership take a more central role in how the health service is working,” he said. “It doesn’t make sense to have the managers managing and the clinicians spending their money. The two need to meet up just as the industry and NHS needs to. In this new world, the old world of SHAs, PCTs and practices are going to give way and clinical leadership will emerge as being more important. Localism will be important, and groups of practices forming to provide and commission will increasingly be clinically led and an important point of contact for the industry. I think you need to prepare for that.” The ABPI Conference took place in central London at the impressive conference venue, The Brewery. Dixon took Alan Barge’s alcohol metaphor to new levels, mischievously commenting that the venue selection had been designed to show that the ABPI could indeed produce a good piss-up in a brewery! The mood of the meeting was, of course, more serious as delegates consumed the challenges of the political and economic environment that faced them. But the conference dinner that followed proceedings did allow for some champagne celebration – not least for the two projects that were awarded the very first ABPI Joint Working Awards (see news on p3). Further information on these, and other, joint working projects will be published in HSP’s new publication, Partnership in Practice, later this year. The ABPI Conference 2010 was held at The Brewery, London a week before the general election. 20 Pharmaceutical Field May 2010 JUNE 2010 Patient-centric health policy branded ‘idiocy’ New Government proposals to penalise hospitals for readmissions have been branded as ‘idiocy’ by surgeons. The policy, outlined in Andrew Lansley’s first significant speech since becoming Health Secretary, will make hospitals responsible for patients for 30 days after they have been discharged, and deny them additional payment for treatment upon readmission. NICE recommends Xeloda NICE has recommended that a new convenient treatment for advanced gastric cancer be made available to NHS patients. Roche’s Xeloda (capecitabine) has been given the go-ahead in combination with a platinum-based regimen for the first-line treatment of inoperable advanced gastric cancer. Nexavar too costly for NICE NICE has said it is unable to recommend Nexavar (sorafenib) for treating advanced hepatocellular carcinoma (HCC) due to its high cost and limited benefit. NICE’s final guidance is that the drug should not be funded by the NHS, despite an appeal and proposals to implement a patient access scheme by the manufacturer, Bayer. Pharmaceutical Field The gateway to a commercial career in pharma Power to the people p16 Pharma market access: a midterm report p18 June 2010 KAM: How do you measure up? p23 Patient-centric health policy branded ‘idiocy’ New Government proposals to penalise hospitals for readmissions have been branded as ‘idiocy’ by surgeons. The policy, outlined in Andrew Lansley’s first significant speech since becoming Health Secretary, will make hospitals responsible for patients for 30 days after they have been discharged, and deny them additional payment for treatment upon readmission. Lansley says the policy encourages hospitals to focus on successful initial treatment. But the Association of Surgeons of Great Britain and Ireland said it would mean day surgery patients would be kept in overnight at extra cost and labelled it as ‘shortsighted and counter-productive’. Vice-president Professor John MacFie said: “It will encourage hospitals to keep patients in. The policy is idiocy.” Lansley said the NHS is not just paying for activity, but for ‘performance and results’: “The outcome for the patients is the only outcome that matters – and so we are sending a clear message to the NHS that patient care doesn’t end when they walk out of the hospital door. This will have the added benefit of driving the further integration of hospital and community services where it most matters. Patients don’t PF-JUNE10-NEWS.indd 1 talk about ‘primary’ and ‘secondary’ care, they see it simply as treatment and care for the problem they have, whether at home or in hospital.” Lansley’s plans to build a patientcentred NHS were presented at a health centre in East London. There would, he said, be no “tradeoff between safety and efficiency”. “Good care is safe care. Unsafe care costs more, in lives and cash. High levels of infection, CTE, emergency readmissions, falls, pressure sores – all lead to more suffering and more cost,” he said. “I will not countenance a ‘production line’ approach to healthcare which measures the volume but ignores the quality.” Lansley promised an information revolution across the NHS, saying that patients need to know who is providing quality, safe, effective and accessible services. “It’s not just about choice. The combination of information and choice will hold people to account and drive up standards.” Dr Anna Dixon, Director of Policy at The King’s Fund, backed the plans. But, despite Lansley’s insistence that “this isn’t about money, it’s about raising standards and quality”, Dixon said the real challenge was how to secure these gains while facing increasing financial constraints. “These proposals could offer an opportunity to drive quality in the Andrew Lansley NHS by ensuring that hospitals are incentivised to provide good-quality care, but the key to the success of this policy will be to ensure sufficient care can be provided in the community following a patient’s discharge,” she said. “This will require hospitals to work with primary care and community health care providers to ensure that services are in place for patients on discharge and that they are not kept in beds for longer than necessary.” NICE rejects Tyverb despite patient access scheme Government plans to review NICE and set up a cancer drugs fund have been brought into immediate focus following the watchdog’s latest rejection of a cancer treatment. Draft NICE guidance has concluded that GSK’s Tyverb (lapatinib) will not be recommended for use on the NHS for breast cancer. Tyverb was assessed in combination with capecitabine (Xeloda) for women with advanced or metastatic HER2positive breast cancer, but it was ruled that it should only be used in the context of clinical trials. GSK had set up a patient access scheme under which it would pay for the first 12 weeks of treatment, but despite this, NICE said the drug does not provide sufficient clinical benefit to justify its cost. GSK has responded by saying that there are no other licensed ErbB2 targeted treatment options available to suppress the advanced disease and that many receive Herceptin (trastuzumab) off-licence. Simon Jose, General Manager, GSK UK, said: “This again highlights the limitations of the NICE appraisal process when evaluating cancer treatments for patients facing a relatively short life expectancy. (Continued on p5) 16/06/2010 13:25 NICE rejects Tyverb Government plans to review NICE and set up a cancer drugs fund have been brought into immediate focus following the watchdog’s latest rejection of a cancer treatment. Draft NICE guidance has concluded that GSK’s Tyverb (lapatinib) will not be recommended for use on the NHS for breast cancer. WHO denies industry influence WHO’s Director-General has denied that the organisation’s decisions over swine flu were influenced by commercial considerations. Reports in the BMJ and elsewhere had accused WHO of being led by the pharma industry to exaggerate the potential impact of the pandemic. HAPPY IN THE WORKPLACE? HAVE YOUR SAY PF COMPANY PERCEPTION, MOTIVATION & SATISFACTION SURVEY 2011 - OUT JANUARY Multiple myeloma treatments Thalidomide and Velcade (bortezomib) improve the effectiveness of current treatments for multiple myeloma, NICE has concluded. The two medicines have been recommended in draft guidance, in combination with an alkylating agent and a corticosteroid, in patients for whom high-dose chemotherapy with stem cell transplantation is considered inappropriate. Prix Galien finalists revealed Medicines from some of the pharmaceutical industry’s leading players will compete for two prestigious UK Prix Galien medals at the House of Lords this October, after the shortlist of finalists was revealed. The 2010 awards, billed as the ‘Nobel Prize for drug discovery’ by head judge, Professor Sir Michael Rawlins – Chairman of NICE – will see treatments from across the therapeutic spectrum battle it out for Prix Galien recognition. UK launch for innovative treatment Lung cancer drug approved NICE has issued draft guidance recommending Iressa (gefitinib) as an option for the first-line treatment of people with locally advanced or metastatic non-small-cell lung cancer. Patients will qualify to receive the treatment if they test positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation. A first-in-class biological for the treatment of osteoporosis has been granted marketing authorisation in the UK. Prolia (denosumab), which is indicated to treat post-menopausal women, has been shown to reduce fractures by up to 68% and can be given as six-monthly injections in a GP surgery. Follow Pf on Twitter @PharmaField Specialists appeal over Vidaza Thirty-two international MDS Centres of Excellence have written to the National Cancer Director to support better access to Vidaza (azacitidine) for UK patients. International haematologists and cancer specialists from the hospitals expressed their concern at the NICE decision not to recommend Vidaza for the treatment of myelodysplastic syndromes (MDS), a group of debilitating bone marrow diseases. Campaigners outside No.10 Pharmaceutical Field YEARBOOK 2010 JUNE 2010 New draft Innovation Novartis staff Government awarded millions guidance on could impose cost leader joins arthritis drugs controls ABPI A jury found Novartis guilty of discriminating against 12 female representatives and entry-level managers over pay, promotions and maternity leave in a Manhattan federal court earlier this week. An initial $3.3 million was awarded to the women. The punitive damages to be paid by Novartis are higher than analysts predicted and represent 2.6% of the company’s $9.5 billion 2009 revenue. Three treatments for psoriatic arthritis have been recommended in final draft guidance by NICE. Etanercept (Enbrel), infliximab (Remicade) and adalimumab (Humira) were assessed for treating adults with active and progressive psoriatic arthritis when specified criteria are met. The Coalition Government’s plans to introduce ‘value-based pricing’ for medicines could mean that price controls will be imposed. Industry analysts predict that the UK could soon lose its position as one of the few markets in the world where pharma is free to set the price of its products. New options available for Crohn’s New guideline to benefit LUTS sufferers NICE has recommended two new treatment options for people with severe Crohn’s disease. The guidance approves the use of Remicade (infliximab) and Humira (adalimumab) for adults with a severe, active form of the disease. Infliximab is also recommended for adults with active, fistulising Crohn’s disease, and for children and young people aged 6–17 years old with severe, active Crohn’s disease. NICE has issued the first national guidance on the diagnosis and treatment of men with urine problems. The new guideline aims to set a national standard so that all patients receive the same quality of treatment wherever they go. Revolade rejected for ITP NICE has ruled that there is insufficient evidence to recommend GSK’s Revolade (eltrombopag) for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP). Preliminary guidance states that the drug is not recommended for ITP in splenectomised adults who do not respond to other treatments (for example, corticosteroids, immunoglobulins), or as second-line treatment for nonsplenectomised adults when surgery is not advised. Pharmaceutical Field YEARBOOK 2010 Xolair offers ‘limited benefits’ NICE has decided that Xolair (omalizumab) does not represent good value for money for the treatment of severe persistent allergic asthma in children aged 6-11 years. As a result, NICE has issued preliminary guidance recommending that the drug is not funded by the NHS for this patient group. The Institute also concluded that the drug would only be suitable for around 300 patients in the UK. Carol Blount New diabetes New chairman tablet launched at BGMA Michael Cann, Director Generics at Actavis, has taken over as Chairman of the British Generic Manufacturer’s Association (BGMA). Cann took over his new role at the Association’s AGM in London on 26 May. He replaces Kim Innes of Teva, who will serve as Vice Chair for a year. NICE recommends first biosimilar NICE has issued its first recommendation for a biosimilar product, advising that seven somatropin products should be funded by the NHS. The drug is recommended to treat child growth deficiencies. NICE has recommended that when more than one product is suitable, the least costly option should be chosen. Carol Blount has joined the ABPI as Head of Commercial Affairs, bringing more than 15 years’ senior level leadership experience within the UK pharma industry. Her experience includes leadership of strategic innovation and change, business development and brand marketing leading to increased sales and contribution. Michael Cann Janumet, a new oral treatment for type 2 diabetes, has been launched in the UK. The combination tablet combines metformin, a widely used diabetes medicine, and Januvia (sitagliptin), a new generation of medicine in the class of DPP-4 inhibitors. Oral palonosetron approved in EU The EMA has approved an oral formulation of palonosetron (Aloxi) for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy (MEC). This positive decision for the secondgeneration 5-HT3 receptor antagonist from Swiss pharmaceutical group Helsinn follows the approval obtained in August 2008 in the USA. Power to the people Power to the people Power to the people The coalition’s recently unveiled Programme for Government and proposals for a new Health Bill promise significant change for the NHS. Patient power, value-based pricing and clinical leadership will take centre stage. But what will it mean for pharma? Chris Ross examines the rhetoric. P lans to review NICE and introduce value-based pricing have received a cautious welcome from the UK pharmaceutical industry in the wake of the new coalition Government’s first announcements on health. The ABPI has said it supports an assessment of NICE’s remit and the way in which it assesses value, but warned that the move towards valuebased pricing faces some significant design issues. The two proposals formed part of a series of new initiatives unveiled by the new Government, design to facilitate a devolution of power and responsibility within the NHS and give patients and doctors more control in a clinically-led health service. The new approach, outlined by Cameron and Clegg in their Programme for Government and expanded upon within the subsequent Queen’s Speech, aims to bring an end to the “bureaucracy, top-down control and centralisation” it claims has “diminished the NHS”. Health Secretary Andrew Lansley said the new NHS will be one in which patients enjoy a prominent voice. “Decisions must be taken with patients, closer to patients and with clinical leadership to the fore,” he said. The BMA has welcomed the pledge to develop a clinically-led health service following an increase in NHS management in recent years, but urged the coalition to deliver beyond rhetoric. “Doctors want to work constructively with the new Government and we are pleased with plans to prioritise clinical engagement with the medical profession. But it is essential that this dialogue is meaningful and does not just pay lip service to the notion of involving clinicians in proposals for the health service,” said BMA Chairman, Dr Hamish Meldrum. Plans to introduce a Health Bill that cements the coalition vision for the health service were unveiled in last month’s Queen’s Speech. The Bill, which will be put before parliament in around 18 months’ time, will propose an NHS run by clinicians and free from political interference. A flagship component will be the creation of an independent NHS Board, which will be responsible for apportioning resources and providing commissioning guidance. It will also give GPs power to purchase services for their patients. Other measures include the establishment of a Cancer Drugs Fund to enable patients to access the cancer drugs “their doctors think will help them”, an increase in the responsibilities of the Care Quality Commission, and awarding new powers to Monitor to act as an economic regulator “to oversee aspects of access and competition in the NHS”. Further attempts to improve efficiencies within the service will see a reduction in the number of health quangos in a bid to cut administration costs in the NHS by a third. Programme for Government The Queen’s Speech followed hot on the heels of the coalition’s Programme for Government, which was unveiled by Prime Minister David Cameron and Deputy Prime Minister Nick Clegg shortly after the new Government was formed. The Programme guaranteed a ‘real term’ increase in health spending in each year of the parliament and an end to “top-down reorganisations of the NHS” that it said had “got in the way of patient care.” The Government pledged to stop the “centrally dictated closure of A&E and maternity wards” and give people better access to local health services. Key measures outlined in the Programme include: Pharmaceutical Field June 2010 Patient power was a central theme in the Health Secretary’s first major speech at the Bromley by Bow Centre in London, hosted by the Patients Association and National Voices • NICE reform and a move to valuebased pricing so that all patients can access the drugs and treatments their doctors think they need. • Establishing a Cancer Drugs Fund. • Strengthening the power of GPs as ‘patients’ expert guides’ through the health system by enabling them to commission care on their behalf. • Prioritising dementia research within the health R&D budget. • Setting health targets in key areas such as cancer and stroke survival rates and reducing hospital infections. • £10 million a year from 2011 to support children’s hospices. • A new per-patient funding system for all hospices and providers of palliative care. • An extension of best practice on improving discharge from hospital – maximising the number of day care operations, reducing delays prior to operations and enabling community access to care and treatments. • Helping elderly people live at home for longer through home adaptations and community support programmes. • The development of a 24/7 urgent care service throughout England. • Giving every patient the power to choose any healthcare provider that meets NHS standards, within NHS prices. This includes independent, voluntary and community sector providers. The Programme’s commitment to end an era of top-down NHS reconfigurations and instead give power back to local communities has been highlighted as a key component of change. Health Secretary Andrew Lansley said: “We are committed to Pharmaceutical Field June 2010 devolving power to local communities – to the people, patients, GPs and councils who are best placed to determine the nature of their local NHS services. Local decision-making is essential to improve outcomes for patients and drive up quality.” Lansley said he expects decisions on NHS service changes to: • • • • focus on improving patient outcomes consider patient choice have support from GP commissioners be based on sound clinical evidence. Local NHS organisations that have started to look at changing services will need to ensure their plans match these criteria. Lansley had said he was looking to NHS London, the biggest authority in the health service, to lead the way in working with GP commissioners in their reconfiguration of NHS services. However, the head of NHS London, former GSK Chairman and CEO Sir Richard Sykes, resigned from his position late last month following the new Government’s decision to halt a wave of hospital reorganisations. Sykes was said to be furious at the Health Secretary’s decision to scrap a review of healthcare in the capital. The review included the possible closures of some A&E and maternity units. Reaction Reaction to the recent announcements has been varied. The ABPI said that the UK is slow to allow patients access to innovative new medicines, despite having the lowest prices compared to other countries – and therefore was pleased to see the proposed review of NICE. A spokesperson told Pf: “We would welcome a review of NICE, its remit and the way it assesses value, so that British patients get better outcomes and access to medicines available to patients in other countries, and the NHS spends its total budget as wisely as possible.” Its views on value-based pricing, however, were more cautious – with its successful implementation being dependent upon collective responsibility between the industry, the Government and the NHS. “The ABPI strongly supports the principle that NHS patients should receive faster access to innovative new medicines. Industry needs to be accountable for demonstrating the full value of medicines, while NICE and the NHS must put in place systems commensurate with evaluating this full value,” it said. “Value-based pricing (VBP) is clearly a priority for the new coalition Government, but faces some significant design issues – and we look forward to a dialogue with Government on these issues. No other country has yet implemented a full VBP system and its design will be critical in order to avoid unintended consequences for patients, the Government, the NHS and industry alike. The current PPRS runs until 2014 and, under this scheme, the UK enjoys the lowest prices in Europe.” Anna Dixon, Director of Policy at think-tank The King’s Fund, said the proposals confirm that the NHS is embarking upon a period of significant change. “Strengthening the role of doctors and the voice of patients will create some difficult dilemmas,” she said. “In setting up an independent NHS board, careful thought will need to be given to the relationship between its responsibilities and those of ministers, who will remain accountable to parliament for NHS expenditure”. “We welcome the acknowledgement of the critical role played by GPs within the NHS and the clear signal that changes are needed to improve the quality of general practice. If, as expected, these changes include transferring budgets to GPs, it will be important to learn from the previous experiences of GP-led commissioning in the UK and other countries to ensure it delivers benefits for patients and efficiency savings across the health system while ensuring accountability for public expenditure.” The Health Bill – at a glance Purpose: • To build a sustainable national framework for the NHS. • To support a patient-led NHS focused on outcomes. • To reduce bureaucracy. Benefits • An NHS led by clinical decision-makers that is more responsive to patients. • A system which drives up standards of care, eliminates waste and achieves outcomes. • A service where patients have greater choice and control in decisions about their care. Policy • The establishment of an independent NHS Board to allocate resources, provide commissioning guidance and to allow GPs to commission services. • Strengthening the Care Quality Commission and developing Monitor into an economic regulator to oversee access and competition in the NHS. • A reduction in the number of health quangos, cutting the cost of NHS administration by a third. But analysts have warned of the dangers of giving financial accountability to clinicians. Dean Arnold, head of health care practice at Deloitte, said: “Putting patients first is always a positive thing to do, so too is empowering clinicians. However, this requires some caution as clinicians are not specialists in cost management – a skill that will become increasingly important. With power comes greater accountability. Patients should be able to hold clinicians to account. It can be argued that today health care managers and executives are far more accountable to patients than clinicians. It will be vital to get the right ‘checks and balances’ if we are to put the NHS in the hands of clinicians.” Could do better: a mid-term report on pharma market access Market access has for some years been one of pharma’s most widely used buzzphrases. But now it is one of its highest priorities. New data shows the industry knows it can no longer pay lip service to the notion of market access. It can, and must, do better. Chris Ross reports. A n overwhelming majority of pharmaceutical companies across Europe have conceded the need to make improvements to their market access strategies, a new report has shown. The Cegedim Dendrite Market Access Industry Report, based on a survey of almost 200 sales and marketing executives from across Europe, says that 88% of organisations acknowledge the need to change their approach to market access, and that 75% have earmarked resources to invest in its improvement in 2010/11. The vast majority of pharmaceutical companies have already moved to a Key Account Management (KAM) model as they seek to align sales and marketing methodologies with the demands of the modern marketplace. This is borne out by the Cegedim Dendrite survey, which shows that 83% of companies have taken the KAM approach. The poll, conducted last month, indicates that many companies believe the shift towards KAM will deliver the greatest benefit to market access strategies. But, faced with a future without blockbuster drugs and with a European-wide reduction in healthcare spending having a major impact on marketing budgets and sales operations, successful market access will require much more than a restructured field force. According to the research, the industry has a number of current concerns. The most fundamental fear is, of course, the global economy – with 24% of survey respondents citing it as the most significant challenge facing market access. The tough economic climate has, in turn, been the catalyst for a whole raft of other concerns for pharma. Primarily, companies are worried by the growing influence of HTA bodies and the increasing shift in influence from prescribers to payers. Likewise, the fragmentation of decision-making across regional bodies with increasing influence on pricing and reimbursement locally is a further cause for concern. The developing Figure 1 Response to market access challenges 83% Key Account Management Health outcome measurement 61% Leveraging physician peer networks 61% Promotion of health/well-being over treatment 43% Pay-for-performance strategies for new medicines 25% Web 2.0 strategies 24% Other 4% trend towards the globalisation of pharmaceutical strategies is another major worry for market access managers; while reinforcing brand image may work at a global level, the report says that successful market access cannot be achieved in an increasingly fragmented market if organisations do not take into account that local market differences will cause problems. A cross-functional responsibility So how is pharma responding? Well, companies are deploying a variety of approaches (see figure 1), as indicated by the Cegedim Dendrite survey. Examination of the respondent profile (see ‘Survey Methodology’) shows that market access responsibilities now extend across the pharmaceutical organisation. Historically, market access has been considered the preserve of roles in health outcome research, but as the concept has evolved, the involvement of sales and marketing executives has grown considerably. The fact that market research, business intelligence Pharmaceutical Field June 2010 primary care field force to educate and inform healthcare professionals,” says David Round, General Manager, UK, Cegedim Dendrite. “However, the current shift towards key account management teams will continue and these KAM teams will rely on specific and increasingly detailed knowledge of their local health economies, as they seek to influence the key market access stakeholders.” From left to right: Thibaut de Lataillade, Stefan Janssens and David Round and business development roles are also represented in the survey demonstrates the extent to which market access strategies are now a cross-organisational concern. The evolution mirrors progress within the industry’s customer-base. The vastly expanding range of stakeholders now involved in health provision and able to influence decision-making, which includes charities and patient bodies at national level, as well as pharmacists and nurse practitioners locally, has underlined the importance of market access strategies that span the entire product lifecycle. With the emphasis now so heavily focused on cost, it is becoming increasingly important to communicate with HTAs earlier in the product development lifecycle, to gain insight into a product’s marketing potential. At the other end of the product lifecycle, ongoing communication is essential, since the pricing and reimbursement rates can be reset at any time, while pressure from generic prescribing is ever present. Key Account Management Research demonstrates that companies are embarking upon health outcome measurement in development and postlaunch (61%), leveraging physician peer networks and interactions (61%) and the promotion of health and well-being over treatment of illness (43%). But the most common response has been the move to key account management. Across the industry, companies have responded to the shift from prescriber to payer and the declining influence of local clinicians by dramatically cutting their field forces and implementing smaller, more strategic sales teams. But, say Cegedim Dendrite, creating a new workforce is only the starting point. Market access teams need new skill sets and the ability to communicate with a range of individuals – from commissioners to formulary managers in regional authorities and directors of Pharmaceutical Field June 2010 local healthcare units, as well as hospital doctors and, in some regions, primary care physicians. “These individuals expect business-led discussions about a product’s efficacy, its ability to deliver a financial return and its role in the overall care pathway,” notes the report. “In addition to new communication skills and a very different cultural approach, KAMs must be supported with excellent information that identifies the relevant stakeholders in these regional and local authority organisations.” The most notable example of the growth of ‘payer influence’ in the UK is, of course, NICE – which has frequently led the way in European HTA. The disparate nature of European healthcare markets has so far prevented the development of a pan-European NICE, but despite regional differences, the wider market faces common health economic challenges that are driving the need for market access strategies. “The fundamental Market Access driver for all markets is the need to demonstrate real value to the Care Pathway,” says Thibaut de Lataillade, Global Marketing VP, Cegedim Dendrite. “Even though European markets are at different levels of maturity, all of them are implementing Health Technology Assessment bodies, with a similar key driver to ensure that the cost of new treatments delivers acceptable ROI to the local Health Service.” In the UK, the rapid increase in payer influence has propelled a steady decline in the number of sales representatives targeting traditional clinicians. The new coalition Government says it aims to design a ‘clinically-led NHS’ that will give power back to prescribers – but, in a marketplace constrained by considerable economic imperatives, it seems highly unlikely that the highvolume, high-frequency model of sales will ever return. Instead, the smarter, leaner KAM approach will establish itself as the norm. “Of course, there will always be a role for the ‘traditional’ Identifying stakeholders While pharmaceutical companies have undoubtedly identified many of the key changes required to address a new, complex healthcare environment, the question remains as to how effective their responses have been to date. The key to success is the effective identification of market access stakeholders. According to Cegedim Dendrite’s survey, while pharma companies appear fairly happy with their ability to identify key stakeholders, only 7% strongly agree that they can identify them. This raises questions about the type and quality of information the industry gathers about its key customers. Does it support the complex, multidimensional market access strategies that are now required? Critically, how much information do companies collect to determine stakeholder roles within the fragmented, multi-tier regional health environment? So what do pharma companies need to do to ensure they respond to market needs more effectively? “Based on our experience, and the detailed results of the survey, the most important thing that pharma can do is the implementation of an organisationwide key account management strategy, with a CRM tool which shares information effectively across the whole organisation,” says Stefan Janssens, President EMEA, Cegedim Dendrite. “This must be built on a detailed understanding of the key drivers of the market access stakeholders that pharma seeks to influence.” The future: KAMs at the centre Pharmaceutical companies face an even tougher marketplace across Europe in the future. A combination of the increasing influence of non-clinical stakeholders and the vagaries of the global economy means that companies face huge challenges to create and deliver effective market access strategies. Success will depend upon building strong Survey methodology The Cegedim Dendrite survey was based on online interviews with 194 individuals from countries across Europe. The respondent group worked for companies across the pharmaceutical sector, with 23% in organisations employing fewer than 100 people, 38% in companies with between 100-500 staff, 20% in the 500-2000 category and 19% in companies with more than 2000 employees. Respondents were executives from marketing, market access, market research and sales departments. relationships with every stakeholder across national and regional health organisations, as well as the growing number of associated stakeholders such as patient groups, charities and pharmacists. But, says Cegedim Dendrite, identification of these clinical and non-clinical stakeholders is just the beginning. Robust segmentation and targeting that reflects peer networks of influence and tailored messaging can only enable effective market access if backed up by strong communication across highly motivated and skilled KAM teams. Therefore, the role of the field force, as part of a cross-functional organisation-wide effort, remains ever crucial. The effective consolidation of market access activities across organisations is key to supporting a drug throughout its lifecycle, from initial pricing and reimbursement decisionmaking, to delivering access to regional markets. The Cegedim Dendrite report concludes: “It is those organisations that understand the new stakeholders and their networks of influence, that create the 360 degree customer view and then leverage that information to deliver innovative service that truly reflect the underlying drivers, that will create the most successful market access strategies.” Key account managers will sit at the centre of these strategies. At present, progress is being made as companies begin to prioritise market access. But for now, the industry, in the words of my fifth form geography teacher, “could do better.” Sadly, I couldn’t. But you must. For a copy of the full white paper, The Cegedim Dendrite Market Access Industry Report, visit www. cegedimdendrite.com/ma-report JULY 2010 ‘Compelling,’ but a ‘significant risk’ The Government’s White Paper for the NHS has been dismissed as a ‘political experiment’ that could destabilise the health service. Critics claim the proposals, which will see the abolition of PCTs and SHAs and the emergence of commissioning led by GP consortia, represent a significant U-turn from a coalition Government who only weeks ago promised there would be no topdown reorganisations of the NHS. Pharmaceutical Field July 2010 The gateway to a commercial career in pharma A question of balance p24 A statute of liberty p14 Tiers of influence p20 ‘Compelling,’ but a ‘significant risk’ Radical new blueprint for the NHS welcomed and criticised in equal measure. The Government’s White Paper for the NHS has been dismissed as a ‘political experiment’ that could destabilise the health service. Critics claim the proposals, which will see the abolition of PCTs and SHAs and the emergence of commissioning led by GP consortia, represent a significant U-turn from a coalition Government who only weeks ago promised there would be no topdown reorganisations of the NHS. But NHS Chief Executive, Sir David Nicholson, said the document – Liberating the NHS – set out a ‘compelling vision’ for an NHS configured to deliver increasing quality of services. “The ambition is high and the proposed timetable is rapid,” he said. “The vision needs to be realised through a period in which the NHS needs to achieve £15-20 billion of efficiency savings to reinvest in improving quality and outcomes. This represents a significant delivery challenge.” Shadow Health Secretary Andy Burnham labelled the changes a political experiment. “It is a huge gamble with an NHS that is working well for patients,” he said. Under the new proposals, GPs will be handed around £80 billion of the NHS budget to commission patient care, with vast swathes of NHS management positions being cut away. Tens of thousands of jobs in PCTs and SHAs will be shed in the next four years. SHAs will be “abolished as statutory bodies during 2012/13” and PCTs “from April 2013”. The reforms will NHS Chief Executive David Nicholson (right) and once again redraw the Health Minister Earl Howe, during the launch of the pharmaceutical industry’s health White Paper at 10 Downing Street, London. customer-base. It will undoubtedly impact the industry’s sales we have seen since the inception of the methodology – and may well facilitate a move back towards primary care field NHS in 1948”. It said the plans were “not without risk” and that some GPs forces, albeit on a much smaller scale. would not have the skills to manage the Andy Lee, Commissioning and budget. Sir David Nicholson agreed, NHS Partnerships Director at WG saying that the scale of change being Consulting said: “The White Paper proposed was “unprecedented and promises significant reform and a affects all parts of the service”. renewed focus on quality and patient “The lesson of past reorganisations outcomes. However, it appears to was that there is a ‘significant risk’ offer equal measures of increased during this transition, of a loss of focus opportunity and exposure to risk. The on quality, financial and performance devil will be in the details and the disciplines as organisations and negotiations to follow.” individuals go through change,” he The King’s Fund described the said. (Cont. on p12) programme as being unlike “anything For a clearer picture, follow PharmaField on Twitter PF-JULY10-NEWS.indd 1 GSK launches cancer drug Orencia approved in EU A new first-line treatment for advanced renal cell carcinoma (RCC) has been launched in Europe following a conditional EMA approval. GlaxoSmithKline’s Votrient (pazopanib) is now available for the first-line treatment of patients with advanced RCC and for patients who have previously received cytokine therapy for advanced disease. Orencia (abatacept) has been approved in the EU as the first choice biologic to treat active rheumatoid arthritis (RA) after the failure of disease-modifying anti-rheumatic drugs (DMARDs). The European Commission has approved the drug, in combination with methotrexate (MTX), for the treatment of adult patients who have not responded to previous therapy with one or more DMARDs including MTX or a TNF-alpha inhibitor. 15/07/2010 15:02 CannabisABPI to based MS drug remove launched promo gifts Sativex Oromucosal Spray has become the first medicine available in the UK to contain both delta9-tetrahydrocannabinol (THC) and cannabidiol (CBD) from the cannabis sativa plant. The drug has been licensed as an additional treatment for people with Multiple Sclerosis (MS) experiencing the debilitating symptoms of spasticity, such as painful spasms and cramps. It is indicated for patients with moderate to severe spasticity due to MS who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. Warnings over drugs’price cuts Cutting drug prices will severely reduce the number of new medications making it to market, according to a study from ESMT Competition Analysis (ESMT CA). New medications likely to be hit hardest under tough pricing regulation include antibiotics, as well as treatments for cardiovascular disease and immune system disorders such as multiple sclerosis and chronic meningitis, the research has shown. Many of the promotional items currently given to doctors will be outlawed if current proposals to amend the ABPI Code of Practice are approved. The recommendations, which have been agreed by the ABPI Board of Management, are currently available for comment on the PMCPA website. The consultation period will close on Friday 13 August 2010. EU pharma leading the way European pharma companies are still leading the way in making medicines available to people in developing countries, the second Access to Medicine Index has shown. Compared to 2008, when the first Index was published, pharma companies have given more insight into their policies to increase access to medicines, say the researchers. They identify more industry initiatives than two years ago, but also see room for improvement. To read the full story, click on the headline First new class of COPD treatment for a decade Chewable Lipitor now in Europe A new chewable form of Lipitor (atorvastatin calcium) suitable for use in children aged 10 or older has been approved by the European Commission. Pfizer could receive a further six months’ patent protection on Lipitor as a result of securing this paediatric indication. Nycomed’s anti-inflammatory therapy Daxas (roflumilast) has received a marketing authorisation in the EU for patients with COPD associated with chronic bronchitis. It represents the first new class of treatment for COPD in more than a decade. Daxas is indicated for the maintenance treatment of patients with a history of frequent exacerbations as an add-on to bronchodilator treatment. HAPPY IN THE WORKPLACE? HAVE YOUR SAY PF COMPANY PERCEPTION, MOTIVATION & SATISFACTION SURVEY 2011 - OUT JANUARY New indication for Tyverb The EMA has granted a new indication for GSK’s oral breast cancer treatment Tyverb (lapatinib). Approval was given for Tyverb, in combination with an aromatase inhibitor (AI), to treat postmenopausal women with hormone receptor (HR)positive, ErbB2 (HER2) over-expressing metastatic breast cancer, based on evidence that it can increase progressionfree survival (PFS) by more than five months in this indication. Pharmaceutical Field YEARBOOK 2010 JULY 2010 DH wants to GIST drug receives negative end targets draft guidance NICE has ruled that it is unable to recommend Novartis’ Glivec (imatinib) as an adjuvant treatment for people who have had a gastrointestinal stromal tumour (GIST), despite the provision of further information by the manufacturer. In March this year, the Appraisal Committee requested further data from Novartis to address uncertainties relating to the clinical effectiveness and cost-effectiveness of the treatment. U-turn on Alimta NICE has reversed its opinion of Eli Lilly’s Alimta (pemetrexed) as a maintenance treatment for patients with non-small-cell lung cancer. Despite issuing draft guidance opposing the drug in December 2009, NICE has now recommended Alimta in its final appraisal determination. Anger over Mepact decision Patient groups have responded angrily to NICE’s decision not to back Takeda’s bone cancer treatment Mepact (mifamurtide). NICE has ruled that it is unable to recommend the drug due to a lack of evidence that it significantly increases the overall survival of patients compared to current treatments. This is despite Takeda’s proposal to make the drug free of charge for a patient’s first seven doses. Pharmaceutical Field YEARBOOK 2010 Cutting management costs and freeing the NHS from bureaucracy will result in benefits for patients, Health Secretary Andrew Lansley said. A revision to the 2010/11 NHS Operating Framework sets out changes to key priorities for the NHS, including plans to reverse the rise in management costs seen in the last year and changes to the use of targets. NICE rejects Yondelis NICE rejects Herceptin Yondelis (trabectedin) has not been recommended for use on the NHS as the manufacturer PharmaMar did not supply enough evidence in its favour. This is the conclusion of NICE’s appraisal of the drug, which is indicated in combination with pegylated liposomal doxorubicin (PLDH) for the treatment of relapsed ovarian cancer that is sensitive to platinum-based therapies. NICE has failed to recommend Roche’s Herceptin (trastuzumab) for use in stomach cancer due to doubts over the extent to which it can extend life. In preliminary draft guidance, NICE said it is “unable” to recommend Herceptin in combination with cisplatin and capecitabine or 5 fluorouracil for the treatment of people with HER2positive metastatic gastric cancer. DH pilots new scheme Andrew Lansley NICE says no to Tarceva NICE says it is unable to recommend Tarceva (erlotinib) as a maintenance treatment for people with non-smallcell lung cancer. Despite a proposed patient access scheme by manufacturer Roche, in which the cost of Tarceva would be reduced by 14.5%, the appraisal committee concluded that the drug “would not be a good use of NHS money”. It was also ruled that the total population for whom Tarceva is licensed is not small enough to qualify for the end-of-life criteria. Good news for RA patients NICE has issued new recommendations on treatments for rheumatoid arthritis (RA), following the advice of clinical experts. Roche’s MabThera (rituximab), Abbott’s Humira (adalimumab), Wyeth and Pfizer’s Enbrel (etanercept), Schering-Plough’s Remicade (infliximab) and Bristol-Myers Squibb’s Orencia (abatacept) have all been recommended as possible treatments for rheumatoid arthritis after treatment with a TNF inhibitor has failed. The DH is piloting the first direct-topatients payment scheme, which it promises will offer patients more choice and control over their healthcare. Eight Primary Care Trusts will begin to road-test direct payments for personal health budgets. Under the scheme, Primary Care Trusts will give the money for someone’s care directly to them, allowing individuals to decide how, where and from whom they receive their healthcare. ‘Disappointing blow’ for patients NICE has decided that the benefits of Novartis’ Afinitor (everolimus) do not justify its high cost. In draft guidance, the Institute has not recommended the drug for NHS funding for the second line treatment of advanced renal cell carcinoma. New BMA president Sir Michael Marmot will be setting out to tackle health inequalities over the next year in his role as the new President of the British Medical Association. A world expert in the social determinants of health, Sir Marmot chaired the WHO Commission which produced its report in 2008 entitled Closing the gap in a generation: health equity through action on social determinants of health. PCTs rely on pharma for training PCTs have been warned not to rely too heavily on pharma companies to provide education for practice nurses. However, several NHS organisations recognise the value of working with industry and are in talks to set up more formal joint working arrangements, HSJ has reported. A statute of liberty Liberating the NHS, the Government’s blueprint for healthcare in the UK, proposes an unprecedented and radical reorganisation for the NHS. Still ‘free at the point of use’, the White Paper remains true to the core principles of the NHS. But its desire to provide patients with the freedom of choice and, crucially, GPs with the freedom to commission services, suggests some challenging times lie ahead. In these turbulent economic times, not all that is good can be free. Chris Ross takes an early glance at the White Paper. S trategic Health Authorities (SHAs) and Primary Care Trusts (PCTs) are to be scrapped and hospitals encouraged to move out of the NHS to create a ‘vibrant’ industry of social enterprises, as part of radical proposals to restructure the NHS in England. The new White Paper, Equity and Excellence: Liberating the NHS, outlines how power will be devolved from Whitehall to patients and professionals – and gives GPs freedom to take charge of much of the budget. GP consortia Consortia of GPs will be given the responsibility for buying care from local hospitals and other providers as the balance of purchasing power shifts from central management to the GP surgery. The consortia will control upwards of 70% of the NHS budget – approximately £80 billion. The majority of commissioning will be undertaken by GP-led consortia – with the rest being done by a new NHS Commissioning Board. The NHS Commissioning Board will be “a lean and expert organisation, free from day-to-day political interference, with a commissioning model that draws from best international practice”. The White Paper states that the Board will: “support GP consortia in their commissioning decisions and provide leadership for quality improvement through commissioning: through commissioning guidelines it will help standardise what is known good practice, for example improving discharge from hospital, maximising the number of day care operations, reducing delays prior to operations and enabling community access to care and treatments. It will not manage providers or be the NHS headquarters.” Subject to consultation, the Government’s indicative timetable for GP consortia is to be as follows: • A comprehensive system of GP consortia in place in shadow form during 2011/12, taking on increased delegated responsibility from PCTs. • Following passage of the Health Bill, consortia to take on responsibility for commissioning in 2012/13. • The NHS Commissioning Board to make allocations for 2013/14 directly to GP consortia in late 2012. • GP consortia to take full financial responsibility from April 2013. The abolition of PCTs, which will take place ‘from 2013’, is seen as a major policy u-turn for the new government, having ruled out topdown NHS reorganisations in the coalition Programme for Government back in May. However, Health Secretary Andrew Lansley said the about turn was simply because his other reforms had left nothing for PCTs to do. “If we don’t have a job for primary care trusts to do, it doesn’t make sense to be paying thousands of people to do it,” he said. The policy is expected to result in tens of thousands of redundancies, with the cost of NHS management aiming for a 45% reduction over the next four years. “Inevitably, as a result of the record debt, the NHS will employ fewer staff at the end of this Parliament,” said Lansley. “That’s a hard truth which any government would have to recognise.” The NHS is charged with finding efficiency savings of £20 billion during the same period in which it hopes to drive through the reforms. Pharmaceutical Field July 2010 Foundation trusts The White Paper says that all NHS Trusts will become Foundation Trusts within three years. This, it says, will create the largest and most vibrant social enterprise sector in the world. “The intention is to free foundation trusts from constraints they are under, in line with their original conception, so they can innovate to improve care for patients. It will not be an option for organisations to remain as an NHS Trust, rather than become or be part of a foundation trust.” The NHS Trust legislative model will be repealed in due course, while SHAs will be abolished by 2012 – and their responsibilities in relation to providers will be undertaken by a new unit within the Department of Health. From April 2013, responsibility for regulating all providers of NHS care will be passed to Monitor. evidence shows that involving patients in their care and treatments improves their health outcomes, boosts their satisfaction with services received, and increases not just their knowledge and understanding of their health status but also their adherence to a chosen treatment. It can also bring significant reductions in cost, as highlighted in the Wanless Report, and in evidence from various programmes to improve the management of long-term conditions.” Information generated by patients will be critical to the process, and will include much wider use of tools such as Patient-Reported Outcome Measures (PROMS), patient experience data and realtime feedback. The use of PROMS and other outcome measures will be expanded across the NHS, while the DH will extend national clinical audits to support clinicians across a wider range of treatments and conditions. David Cameron and Andrew Lansley speak with a group of nurses during a visit to The Royal Marsden hospital in London, on the same day that the White Paper was launched. role of NICE will also be expanded to develop quality standards for social care. The White Paper notes the absence of an effective payment system within the NHS which it says restricts the ability of commissioners and providers to improve outcomes, increase efficiency and deliver patient choice. Responsibility for the future structure Patient choice of payment systems will belong to the The Government aims to make the NHS more accountable to patients, NICE and quality standards NHS Commissioning Board and the economic regulator will be responsible who, it says, will be at the heart of The Government says the central aim everything it does. As such, the White of its programme of reform, and indeed for pricing. The DH plans to refine the basis of current tariffs and to accelerate Paper promises patients will have of the NHS, is the drive to improve more choice and control, which will health outcomes. Progress on outcomes the development of best-practice tariffs, introducing an increasing number be supported by easier access to the will, it says, be supported by quality each year so that providers are paid information they need about the best standards. These will be developed for according to the costs of ‘excellent GPs and hospitals. The ‘information the NHS Commissioning Board by care’ rather than average care. Bestrevolution’ promised by Lansley has NICE, who will develop authoritative practice tariffs for interventional spawned a new slogan to sum up the standards setting out each part of the radiology, day-case surgery for breast approach to patients: ‘no decisions patient pathway, and indicators for surgery, hernia repairs and some about me, without me.’ each step. NICE will rapidly expand orthopaedic surgery will be introduced To help deliver this, a new body, its existing work programme to create in 2011/12. Alongside this, the DH HealthWatch, will be set up to a comprehensive library of standards will also extend the scope and value compile data on performance, while for all the main pathways of care. The of the Commissioning for Quality GP boundaries will be abolished to first three on stroke, dementia and and Innovation (CQUIN) payment allow patients to register with any prevention of VTE were published in framework. doctor they want. June. NICE expects to produce 150 The Paper says: “We want the standards within the next five years principle of ‘shared decision-making’ and, to support quality standards, will Value-based pricing to become the norm: no decision advise the National Institute for Health Reforms to the way in which about me, without me. International Research on research priorities. The drug companies are paid for NHS medicines are also on the way, with proposals to move to a system of value-based pricing when the current scheme expires. “This will help ensure better access for patients to effective drugs and innovative treatments on the NHS, and secure value for money for NHS spending on medicines,” the White Paper states. As an interim measure, the DH is creating a new Cancer Drug Fund, which will operate from 2011. “This fund will help patients get the cancer drugs their The Prime Minister and Health Secretary with Professor Steve Field, Chairman of the Royal doctors recommend.” College of GPs, during the launch of a health White Paper at 10 Downing Street, London. Pharmaceutical Field July 2010 ABPI response The ABPI has welcomed the proposals, in particular the extended remit of NICE which, it says, will help it move beyond a narrow focus on the cost-effectiveness of medicines. Dr Richard Barker, Director-General at the ABPI, said: “We warmly welcome the Government placing outcomes at the heart of health policy, a move we have long advocated. We must ensure that the new era of commissioning builds in the intelligent prevention, early diagnosis and timely treatment necessary to halt the burden of chronic disease that threatens the financial future of the NHS. The NHS spends more on unplanned hospital admissions for chronic disease sufferers than it does on medicines that, if used appropriately, could prevent them.” The move towards a more clinically-led NHS is also supported. “We are also pleased that the White Paper signals a move towards greater doctor and patient influence over clinical decisions. We agree with Government that it is important to set quality standards for the new era of GP-led commissioning and we welcome the involvement of NICE in this process. The ABPI believes that this expansion of NICE’s remit to promote clinical best practice is a higher priority for the future of the NHS than the overly narrow costeffectiveness calculations on new medicines it currently conducts. The new Government also proposes to introduce a Cancer Drugs Fund and to review how better to reflect value in the pricing of NHS medicines. We look forward to working with the Government to develop these proposals further whilst maintaining the stability of the current PPRS agreement.” Tiers of Influence The NHS may be changing, but some challenges remain the same. The battle pharma companies face is not simply to identify Key Opinion Leaders at local, regional, national and even international level, but to understand the different roles these individuals play and how they interact to create a Market Access influence network. Richard Gray explains. T he complexity of introducing a new drug into the NHS with a view to open up prescribing at local level has changed quite drastically over the past few years. The shift in emphasis from clinicians to payers and the growing significance of national and regional bodies has fundamentally transformed, not only the stakeholders, but also the shape of teams within many pharmaceutical companies. Most notable has been the expansion of pharmaceutical sales people operating at a more senior level within their customer accounts. Companies now have to consider the key national organisations such as Health Technology Assessment (HTA) bodies and the influence of patient advocacy groups and charities, as well as the explosion in regional decision makers, from Medicines Management committees to regional procurement organisations. Furthermore, it is becoming increasingly clear that national boundaries are being blurred. While each European country will undoubtedly continue to make its own drug approval decisions for some time to come, there is growing communication and collaboration between national HTAs. There is also evidence that local clinicians in the UK are increasingly as likely to consider the recommendations of SMC and SIGN in Scotland, IQWIG in Germany and AIFA in Italy as those of NICE in England, or the All Wales Medicines Strategy Group (AWMSG) in Wales. This extension of the sphere of influence across national boundaries now creates the need to track the interaction of KOLs across Europe; to highlight specific disease areas in which collaboration and communication is greater; and to understand the extent of individual and HTA influence on clinicians. Pharmaceutical Field July 2010 Expanding remit One of the greatest shifts now facing pharmaceutical companies is the need to significantly ramp up activity at a strategic, national level. While historically, lobbying parliamentary groups and collaborating with charities was the role of a single Policy and Affairs Manager, today this role requires an entire team. There are now large numbers of national bodies, including HTAs to consider. Patient advocacy groups and charities also have huge influence, taking a key role in many HTA committees, influencing care pathways and, in many cases, leveraging significant financial resources to lobby parliament. Many of these individuals will have multiple other roles at regional and local level, offering many opportunities for pharmaceutical company interaction – creating the need for a strong Market Access team able to track interactions at every level and across these diverse spheres of influence. In fact, there is evidence to suggest that pharmaceutical companies who do not track and manage individual interactions at all levels of their organisation may actually be harming the reputation of their company at a regional or local level. A traditional pharmaceutical sales call made by an inexperienced representative on a GP may not immediately trigger alarm bells, but if that GP is the PCT Lead on a purchasing or prescribing committee, damage to the relationship may occur. Indeed, in addition to increasing the expertise and experience within Policy and Affairs, pharmaceutical companies are having to address the new regional tier for the first time. Whilst most organisations will have, in the past, made little attempt to build relationships with the Strategic Health Authorities (SHA), preferring to work with This extension of the sphere of influence across national boundaries now creates the need to track the interaction of KOLs across Europe; to highlight specific disease areas in which collaboration and communication is greater; and to understand the extent of individual and HTA influence on clinicians clinicians at Primary Care Trust (PCT) and GP level, the growth in regional procurement strategies is creating a new group of stakeholders. With the emphasis on cost containment, the remit of regional procurement has expanded from the traditional focus on disposables to incorporate drug acquisition. These stakeholders are primarily focused on finance and are looking for discounts and opportunities to collaborate with other regional bodies to further drive down the cost of drugs, which requires pharmaceutical companies to create and deliver individual messages. Clinical relevance In addition, there are a number of emerging disease specific groups, including cancer and cardiac networks, that are operating at a regional level. The UK Medicines Information Centre has 14 regional centres and has a huge influence on prescribing; as does the National Prescribing Centre, which works alongside NICE to distil and assess new drug evidence and provide advice to prescribers. Furthermore, many of these regional groups work together: decisions made by one Commercial Support Unit (previously Procurement Hub) or Medicines Management group are often repeated across the country. It is therefore essential, not only to identify these groups, but also to track decision making and assess which groups are leading the way in both procurement strategy and pharmaceutical decision making. It will also be important to reinforce the work done at national level with patient advocacy bodies and charities at both a regional and local level. Most of these organisations focus their attention on national bodies, and undertake local patient-centric communication. There is therefore a key role for pharmaceutical companies to ensure joint projects, messaging and disease specific developments are clearly disseminated to the new regional stakeholders. Political change Given the efficiency drive that must now be put in place in order to attain the estimated £20 billion savings required across the NHS, it is also clear that rationalisation at management level is likely. The Government’s new White Paper promises a major reorganisation of the NHS, with PCTs and SHAs facing a slow death. The long-term impact of this remains unclear and, with change likely to occur in steady phases, pharma’s customerbase and targeting strategies will not change overnight. The reforms, combined with a need to drive greater cost savings at every level of the NHS, will place further emphasis on the regional procurement bodies. Throughout this time it will be essential to track changes, assess the impact on KOLs and networks of influence and rapidly assimilate the implications of new strategy, such as a renewed emphasis on generics or a stronger adherence to the QIPP agenda. Irrespective of the speed of change and moves towards a clinicallyled health service, the influence of payers will continue. However, it is also important to recognise that this influence is inconsistent. Disease areas typically treated in primary care, such as hypertension, are highly influenced by both the HTA and PCT. In secondary care and some specialist areas, clinicians retain control. And there are also local drivers that reflect the health needs of local communities and, in some cases, the personal goals of that individual. In this complex, fragmented marketplace the goal is not just to identify the new breed of nonclinical stakeholders – although this is essential since the number of nontraditional stakeholders has increased significantly – but also to understand how these stakeholders interact at a national, regional and local level and to determine an accurate network that spans these tiers of influence. Richard Gray is Commercial Director (CCI) for Cegedim Dendrite, responsible for their segmentation and targeting services and KOL / stakeholder mapping. For a clearer picture, follow PharmaField on Twitter Pharmaceutical Field July 2010 19 A question of balance The Pf Survey measures the happiness of the pharma workforce, what motivates them and which companies are viewed as the best employers. The latest results reveal that many companies are not striking the right balance in meeting the needs of their employees. Pf ’s Diana Spencer provides an overview. T he Pf Company Perception, Motivation and Satisfaction Survey, now in its ninth year, provides an annual temperature check of workforce attitudes to their own and other companies within the industry. It also compares remuneration packages and use of technology such as ETMS systems. The latest research has shown that many respondents are worried about the future. It is evident that there is concern over the industry’s pipeline and lingering insecurity following recent company mergers Figure 1: Overview of respondents 2009 2008 2007 2006 2005 2004 2003 2002 Number of respondents 1,214 1,479 1,552 2,212 1,507 1,503 2,005 1,843 Most frequently represented age group 35-44 35-44 35-44 25-34 25–34 25–34 25–34 25–34 Male/Female (%) 47/53 44/56 45/55 47/53 47/53 46/54 48/52 47/53 Primary care and primary & secondary care representatives (%) 39 37 39 43 49 57 53 55 Hospital specialists (%) 24 27 32 30 29 22 22 20 1st line managers (%) 10 10 11 11 11 12 11 10 More than 2 years’ experience (%) 45 28 90 88 90 81 89 84 More than 8 years’ experience (%) 13 66 59 50 51 38 40 41 and redundancies amongst the sales force. On a positive note, however, the majority of respondents have great belief in the products they are currently promoting. The company with the best external perception as an employer has remained consistent, with Boehringer Ingelheim securing the top position as an employer of choice for the third year running. The respondents As usual, response to the survey was high, though the lowest in recent years, which could reflect lower numbers of people in the industry. Figure 1 provides an overview of the survey’s respondents. Data from the last eight years demonstrate that there has been an overall increase in the average age of respondents, which was 25-34 until 2006, and that there is a trend towards a decreasing number of people in representative roles. This is hardly Pharmaceutical Field July 2010 surprising given the large number of redundancies that have taken place and a lower rate of recruitment in the last few years. However, the table also shows there has been consistency since 2007 in the average age of respondents and the number of representatives that responded, which could reflect greater stability across the industry over the last three years. One striking difference in the demographic of respondents is the reduction in those with more than eight years’ experience within the industry. Despite a fairly steady increase in numbers between 2002 and 2008, the percentage of respondents with more than eight years in the industry dropped in 2009 from 66% to just 13%. The data also show a higher number of people with two years’ experience than last year, though this is still a significant drop on the previous seven years. There could be various reasons for this disparity. It could be due to job cuts among more experienced and therefore expensive members of staff as a result of company mergers, due to people leaving the industry or, more positively, that people with long service are securing promotions to other departments or new roles and feel they are either too busy or no longer qualify for the survey. Figure 2: Employer of choice rankings 2009 2008 2007 2006 2005 1 Boehringer Ingelheim Boehringer Ingelheim Boehringer Ingelheim Roche Roche 2 Roche Roche Roche Boehringer Ingelheim Boehringer Ingelheim 3 Novo Nordisk and Eli Lilly Novo Nordisk Schering-Plough and Eli Lilly Eli Lilly Sanofi-aventis and Eli Lilly 4 Eli Lilly Sanofi-aventis 5 Abbott Schering-Plough Sanofi-aventis Schering-Plough Schering-Plough 6 Napp Napp and Abbott Laboratories Procter & Gamble Janssen-Cilag Janssen-Cilag and Schering Healthcare 7 Novartis and BristolMyers Squibb Novartis and Novo Nordisk Schering Healthcare Novartis and Sanofiaventis 8 9 Leo 10 Bayer Schering Pharma, Janssen-Cilag and Sanofi-aventis Novartis Napp, Wyeth and BMS Bristol-Myers Squibb, Leo and Janssen-Cilag GSK and Procter & Gamble Wyeth Procter and Gamble Novartis Company perception The Employer of Choice section of the survey asks respondents to rank companies, with the exception of their own, on how desirable they feel they would be to work for. 2009 was another successful year for Boehringer Ingelheim, which keeps its crown as the most admired employer for the last three years. Indeed, both Roche and Boehringer Ingelheim have succeeded in securing the top two positions since 2005. A previous top employer, Eli Lilly has also performed well since the origins of the survey and has improved its position this year to reach third place. Bristol-Myers Squibb too has performed well in improving its ranking by three places. Recent large-scale company mergers have obviously had a significant impact on the survey results in the last few years. It is Pharmaceutical Field July 2010 notable that Schering-Plough has dropped out of the top ten following its merger with MSD. However, Bayer Schering Pharma’s ninth place position perhaps reflects a higher level of success in the management of this fairly large-scale acquisition. Newer additions to the top ten, Novo Nordisk and Leo have consolidated their positions, Novo Nordisk maintaining its third place after moving up four places last year and Leo improving its top ten ranking after its first appearance there in 2008. The most impressive rising through the ranks for 2009 were achieved by Ipsen, improving seven places to 29th, Eisai, up six to 27th, UCB, up five to 29th and Norgine, up five to 21st place. Motivation factors As part of the research, respondents are asked to rank 18 work factors in terms of how important they feel they are and how satisfied they are with these areas at their current company. Again there is consistency in the responses over the last two years, demonstrating that pharma employees’ priorities have not really changed since 2008. The most notable variation in terms of motivation is that the respondents of 2009 place greater significance on company culture than belief in products, making the top five priorities when seeking an employer: salary, relationship with direct manager, work-life balance, job security and company culture. After the honest admission that salary matters most, respondents have placed value on more quality of life and relationship factors, signifying that these ‘softer’ company benefits remain very important to employees. It is unsurprising that job securityis still a top priority for the workforce. Although there is more security throughout the industry, most respondents will have experienced redundancy, either themselves or through the eyes of a colleague, and have not forgotten the impact this can have. Satisfaction data for 2009 reveal that respondents are still most happy with the products that they are currently promoting, but their concern over the future pipeline is evident, revealing an awareness of the industry’s current pipeline worries due to patent expiries and low numbers of potential new blockbusters. Car policy is also a downside for many, although salary is still midway up the table, demonstrating that this is not an area of particularly low satisfaction. It reflects badly on companies that two of the top five work factors in terms of motivation feature very low down for satisfaction: work-life balance and job security, indicating that employers are not doing enough to improve working hours and reduce insecurity amongst their employees. (As the top motivation factor, Pf will expand on the area of salary in August – find out how your remuneration package compares to the rest of the industry.) Future plans The survey also asks respondents whether they are planning a move in the next 12 months, and Figure 4 breaks this down by the key roles. The fairly low numbers of respondents intending to remain in the current role over the next year could be due to the low levels of satisfaction with important work factors. However, this could also be attributed to a greater number of roles becoming available and people expecting to receive promotions. The industry professionals revealing greatest unhappiness in their current roles are hospital specialists, with a high 24% planning to move company in the next year and just 49% intending to remain where they are. These results could reflect an increased number of opportunities for these professionals across the industry. It is also significant that high numbers of healthcare development managers (HCDs) and key account managers (KAMs) are planning to move position, as many of these could be looking towards a role in sales management. Career development, improved benefits and job security were top reasons given for a move of role, indicating that most professionals have hopes of moving onto ‘better things’. Lifestyle, work recognition, relationship with manager and product quality also featured in the Figure 3: Motivation and satisfaction factors What motivates you? What are you most satisfied with? 2009 2008 2009 2008 1 Salary Salary Belief in products Belief in products 2 Relationship with manager Relationship with manager Relationship with manager Future pipeline 3 Work-life balance Work-life balance Accountability Relationship with manager 4 Job security Job security Autonomy Accountability 5 Company culture Belief in products Additional responsbilities Car policy 6 Belief in products Company culture Pension scheme Pension scheme 7 Bonus Recognition of success Company culture Additional responsibilities 8 Recognition of success Bonus Future pipeline Autonomy 9 Autonomy Personal development Personal development Share scheme 10 Personal development Autonomy Salary Salary 11 Pension scheme Future product pipeline Recognition Job security 12 Future product pipeline Pension scheme Car policy Company culture 13 Car policy Car policy Training Personal development 14 Accountability Additional responsibilities Appraisal system Recognition 15 Additional responsibilities Accountability Work-life balance Appraisal system 16 Training Training Job security Training 17 Share scheme Appraisal system Bonus Work-life balance 18 Appraisal system Share scheme Share scheme Bonus Figure 4: Future plans Position Move company Move position Remain 1st line managers 16% 23% 56% NHS liaison/HCD 15% 33% 46% Representatives 15% 25% 55% KAMs 15% 31% 50% Hospital specialists 24% 23% 49% The Pf Company Perception, Motivation and Satisfaction Survey has been conducted annually by HSP, publishers of Pf, since 2002. It provides a benchmark of field force remuneration, motivation, satisfaction, perception and recruitment. As the survey is managed by Dr B Payne of Conker Statistics (A fellow of the Royal Statistical Society) and respondents are anonymous, it is able to provide a unique and impartial snapshot of workforce attitudes at the time the research is conducted. These latest results were gathered in early 2010, but relate to 2009. Pharmaceutical Field July 2010 AUGUST 2010 US investigating bribery claims The US Department of Justice (DoJ) has launched an international investigation into corruption in the pharma sector. The probe, being conducted jointly with the Securities and Exchange Commission (SEC), is looking into payments made by pharma companies for hospitality, consultants, licensing agreements and charitable donations in markets outside the US. It follows allegations that certain companies may have violated US anti-bribery law, the Foreign Corrupt Practices Act. Cancer fund could save hundreds An extra £50 million is to be made available to help patients access innovative new cancer drugs, the Government has revealed. The fund, due from October, precedes the promised Cancer Drugs Fund due to commence in April next year. Doctors will be put in charge of deciding how the funding is spent based on the advice of cancer specialists. David Willets UK lags behind, says ABPI UK patients are not seeing the benefits of the country’s R&D efforts, says the ABPI. The DH report, Extent and Causes of International Variation in Drug Usage, says that the UK lags behind its European counterparts in providing access to medicines, particularly new cancer drugs. Pharmaceutical Field The gateway to a commercial career in pharma Boosting your confidence p24 Does money matter? p22 August 2010 Food for thought p26 US investigating pharma bribery claims The US Department of Justice (DoJ) has launched an international investigation into corruption in the pharma sector. The probe, being conducted jointly with the Securities and Exchange Commission (SEC), is looking into payments made by pharma companies for hospitality, consultants, licensing agreements and charitable donations in markets outside the US. It follows allegations that certain companies may have violated US anti-bribery law, the Foreign Corrupt Practices Act. A number of leading pharma companies, including some of the biggest players in the industry, have disclosed being contacted by the DoJ and SEC in connection with the investigation in recent months. Currently, at least 11 companies are co-operating with investigators. The probe is assessing whether corrupt payments may have influenced the reliability and integrity of clinical data from studies undertaken outside the US. The recruitment of physicians for clinical trials will also come under the microscope – in some countries, the same physicians may serve on the regulatory boards that approve drugs. Hospitality activities are also being scrutinised. Under the Foreign Corrupt Practices Act, companies may not offer items of value to foreign government officials for profit. US law considers doctors, clinicians and regulators in foreign markets to be ‘government officials’ because they are employed by state-owned facilities. Alexandra Wrage, President of Trace, a not-for-profit organisation that helps companies establish anti-corruption practices, told the Financial Times that alleged wrongdoing at pharma companies could centre on ‘inappropriate, lavish hospitality’ – such as wining and dining doctors. “What we hear is not that doctors are expecting cash. But that doctors are only going to give companies time in front of a meal or a training session,” she said. In the UK, ABPI regulations governing hospitality have been tightened significantly in recent years. The FT reports that legal experts believe the DoJ is examining ‘egregious behaviour that smells of bribery’. AstraZeneca makes Seroquel settlement AstraZeneca is to pay $520 million to resolve allegations that they illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the FDA. Such unapproved uses are also known as ‘off-label’ because they are not included in the drug’s FDA approved product label. “Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets,” said US Attorney General Eric Holder. ABPI Code set for more changes UK pharmaceutical companies will have to declare exactly how much money is spent on sponsoring and paying consultants if new proposals are agreed. The Prescription Medicines Code of Practice Authority (PMCPA) has published a public consultation on its second round of proposed amendments to the ABPI Code of Practice. Phase two of the changes covers the employment of healthcare professionals (HCPs) to act as consultants, such as to speak at meetings or attend advisory boards, and sponsoring HCPs to attend meetings. However, many pharmaceutical companies are already publishing such figures on a regular basis. The PMCPA suggests that companies should “make publicly available details of the fees paid to consultants in the UK”. Companies will be required to disclose how many consultants were employed and the total amount that was paid to them at the end of each year from 2012 onwards. It has not been deemed necessary for each consultant to be named. Phase two also includes a recommendation that Clause 18, which previously referred to “gifts and inducements”, be renamed: “Items for Patients, Promotional Aids, the Provision of Medical and Educational Goods and Services, Agreements to Benefit Patients such as Joint Working, Outcome Agreements and Patient Access Schemes.” PF-aug10-NEWS COMPLETE.indd 1 19/08/2010 13:20 Code set for more changes UK pharmaceutical companies will have to declare exactly how much money is spent on sponsoring and paying consultants if new proposals are agreed. The Prescription Medicines Code of Practice Authority (PMCPA) has published a public consultation on its second round of proposed amendments to the ABPI Code of Practice. Prolia withdrawn NICE has closed an appraisal of Prolia (denosumab) for therapy-induced bone loss in patients with nonmetastatic prostate cancer after Amgen declined to provide any clinical or cost effectiveness data. In a statement NICE said it had been informed in August 2009 that Amgen would not be making an evidence submission. “Amgen stated that there was a high volume of upcoming NICE technology appraisals of Amgen products and in order to ensure best overall use of resources, it has decided to focus its resources on other topics. NICE has therefore terminated this single technology appraisal,” it said. Follow PharmaField on Twitter GSK bonuses decided by customers European pharma braced for squeeze Customer feedback will play a central role in deciding the bonuses that sales representatives working at GSK’s US subsidiary will receive, as part of a new scheme to be implemented from 2011 onwards. The company is implementing a compensation system that will rely on the customer service provided by the sales professional, as well as adherence to the company’s values of transparency, integrity, respect and patient focus. It is part of a wider effort on the part of GSK to better target its sales staff based on the changing needs of healthcare professionals (HCPs). Pharma companies are bracing themselves for further reductions on drug prices across Europe. CEOs fear the austerity measures being introduced by governments across the region are likely to lead to increased pressure for lower-priced medicines. Shire to buy Movetis Specialist gastrointestinal (GI) pharmaceutical company Movetis has expanded its organisation into the UK. The move coincides with Movetis accepting an offer of €420 million from Shire to buy the company. Deirdre Connelly Novo rejects diabetes request Novo Nordisk has turned down a request to postpone the withdrawal date of its insulin drug Mixtard 30. Diabetes UK asked for a delayed withdrawal to ensure a co-ordinated response could be arranged and suitable alternative treatments for patients found. HAPPY IN THE WORKPLACE? HAVE YOUR SAY PF COMPANY PERCEPTION, MOTIVATION & SATISFACTION SURVEY 2011 - OUT JANUARY UK COPD treatment launched The first 24-hour long-acting beta agonist (LABA) for the treatment of COPD in adults has been launched in the UK by Novartis. Onbrez Breezhaler (indacaterol) is the first new COPD treatment available in the UK for eight years. Pharmaceutical Field YEARBOOK 2010 AUGUST 2010 GPs overprescribing GPs have been over-prescribing expensive treatments instead of following NICE cost-effective guidelines, a new National Prescribing Centre (NCP) report says. Findings show how GPs have issued expensive drugs instead of cheaper generic options, costing the NHS tens of millions of pounds each year. Reyataz indicated for HIV HIV treatment Reyataz (atazanavir sulfate) has been granted a paediatric indication in the EU. The European Commission has approved the boosted form of BristolMyers Squibbs’ drug to treat HIV-1 infection in paediatric patients aged six to eighteen years and greater than 15kg, as part of combination HIV therapy. PAS not working Onerous paperwork could end up costing the NHS millions of pounds in missed reimbursements from patient access schemes (PASs), a report has claimed. A study of 31 PCTs in England showed more than 50% of the costs had not been recovered on two of the first four PASs – bortezomib and sunitinib. Pharmaceutical Field YEARBOOK 2010 Experience NICE to NICE backs drives AF review Vidaza cancer drugs recommendation NICE has recommended two new cancer guidance A new treatment to reduce mortality rates in patients with atrial fibrillation (AF) has been recommended by NICE, despite it being less effective in preventing the condition than existing options. But sanofi-aventis’ Multaq (dronedarone) can only be considered as a treatment option for patients who have additional cardiovascular risk factors such as diabetes or high blood pressure. treatments in final guidance. Roche’s Xeloda (capecitabine) has been recommended in combination with a platinum-based regimen for the first-line treatment of inoperable advanced gastric cancer. Iressa (gefitinib) has also been given the go-ahead for first-line treatment of locally advanced or metastatic nonsmall-cell lung cancer. NICE is to re-appraise the use of Vidaza (azacitidine) in patients with higher-risk myelodysplastic syndrome (MDS) – a group of debilitating bone marrow diseases. The decision follows months of campaigning on the part of MDS charities and patient groups. NICE offers more options Hepatitis C patients are set to receive more treatment options after NICE updated part of its guidance on the use of peginterferon alfa and ribavirin. New draft guidance reflects the extension to the licensed indications for peginterferon alfa. NICE relief for Children denied asthma constipation treatment A “pioneering” asthma drug for children aged 6-11 has been rejected by NICE in draft guidance. The decision on Novartis’ Xolair (omalizumab) came after tests showed little benefit compared to existing treatments and the lack of value for money. A new treatment for chronic constipation for women could be on its way to the UK after a 25 year wait. Movetis’ Resolor (prucalopride) has been recommended by NICE following initial draft guidance. A treatment for the most common form of leukaemia in the UK has been recommended by NICE. MabThera (rituximab) will now be available in combination with chemotherapy drugs fludarabine and cyclophosphamide for the treatment of relapsed or refractory chronic lymphocytic leukaemia. Speers and Turley to head EMG High NICE pass rate NICE has released figures showing it has approved more than 80% of the treatments it has reviewed since its formation in 2000. But the ABPI says that NICE could do more to offer medicines “doctors wished to prescribe”. MabThera recommended To read the full story, click on the headline The European Medicines Group (EMG) has elected UCB Pharma’s Managing Director Matthew Speers as its new chair. Speers takes over from Nigel Brooksby (sanofi-aventis) and will be supported by the new vice-chair, Lundbeck Managing Director Steve Turley. Money matters Are the best things in life free? Not according to our recent survey amongst sales professionals in pharma. So who is enjoying the best remuneration package? And which roles secured the best pay increase over the last year? Diana Spencer reports. S alary was voted the most important work motivator out of 18 factors in the Pf Company, Perception, Motivation and Satisfaction Survey 2009. It was ranked more important than your working relationship with your manager, the culture of the company you work for, your work-life balance and job security. Given the economic climate, it is unsurprising that the average salary for many people in the industry decreased between 2008 and 2009 and that many pharma sales professionals are less happy with their remuneration than they were a year ago. But who has suffered most from the wage cuts? And do age and gender have an impact on the salary you receive? Let’s take a closer look. increase in both pay and bonus in 2009, implying that these roles are increasing in significance as account management becomes the dominant sales model for Show me the money the industry. The salary picture is quite varied across After a slight boost to remuneration different roles in the industry, but the in 2008, those in representative roles most notable feature of Figure 1 is the (either both primary and secondary drop in bonus rates across all job titles. care or just primary) have experienced a This decrease was especially significant return to 2007 bonus and salary rates. for healthcare development managers When asked if they feel their (HCD), after quite a dramatic boost to their bonus rates in 2008. People in these remuneration is appropriate, the majority have agreed that their wage is fair, though roles have enjoyed a slight, but unusual, increase in their basic salary, however, this still an average of around 40% feel they are not getting just rewards for the work could go some way to easing the pain of they do. lower bonus pay. First line managers are one of the The exception to the rule is key least happy roles, and are significantly account managers (KAM), who saw an less satisfied than they were last year, no doubt due to cuts to salary and bonus rates. HCD managers are also feeling under-appreciated, but their satisfaction with their remuneration rate is still a vast improvement on 2007. Hospital specialists remain one of the happiest roles in terms of the compensation they receive. Mind the gap No discussion of industry salaries would be complete without a quick look at that age-old issue the ‘gender pay gap’. High profile cases, such as the recent Novartis trial in the US, have drawn attention to discriminatory behavior in pharma, demonstrating that perhaps gender bias Figure 1: Remuneration by role Primary role Median salary Median bonus Remuneration appropriate? 2007 2008 2009 2007 2008 2009 2007 2008 2009 1st Line Sales Managers £55,007 £56,000 £55,000 £8,000 £7,000 £6,000 67% 67% 59% NHS Liaison/HCD £45,000 £47,000 £48,200 £3,000 £6,000 £3,225 52% 59% 59% Hospital Specialist £42,000 £44,000 £43,000 £4,000 £5,000 £4,000 72% 74% 69% Medical Representatives £32,000 £33,000 £32,000 £2,500 £3,330 £2,500 62% 64% 62% Key Account Manager £40,900 £43,000 £44,000 £5,187.50 £4,150 £5,000 70% 58% 60% 22 Pharmaceutical Field August 2010 Figure 2: The value of experience Age before beauty Job role Age group Median salary (£) Another topical area of discrimination is that based on a person’s age. Government intentions to remove the compulsory retirement age have been both welcomed and criticised, and the issue of ageism remains a pertinent one for many. The demographic of respondents to this year’s survey imply that the UK pharma sales industry is made up of a relatively young workforce with just 8% of respondents over 54 years of age. Perhaps the more pertinent age issues within the industry are around how your level of experience within the industry impacts your salary and whether you are discriminated against for wishing to continue in a representative role throughout your career, rather than moving into sales force management. An analysis of certain key roles by age and salary indicates that experience is certainly highly valued and rewarded within pharma. However, those wishing to stay within a representative role for eight years or more can only expect to earn an average of £36,000, while someone who has moved into first line management can expect a salary of around £56,000. Interestingly, every one of the first line managers who responded to the survey had more than four years experience in the industry, demonstrating that fast-track routes to management are extremely rare. Medical representative >25 23,500 Tough times Medical representative 25-34 29,600 Medical representative 35-44 34,000 Medical representative 45+ 36,000 KAM >25 N/A KAM 25-34 40,500 KAM 35-44 45,500 KAM 45+ 45,000 First line manager >25 N/A First line manager 25-34 50,400 First line manager 35-44 53,900 First line manager 45+ 59,050 Job role Years of experience Median salary (£) Medical representative 0 to 4 27,000 Medical representative 4 to 8 31,750 Medical representative 8 plus 36,000 KAM 0 to 4 28,000 KAM 4 to 8 40,000 KAM 8 plus 46,000 First line manager 0 to 4 N/A First line manager 4 to 8 45,000 First line manager 8 plus 56,000 isn’t as dead as some would like to believe. This is a complicated issue and many factors could influence pay scales for the different genders, however, analysis of responses from the Pf Survey does indicate a slightly higher average salary for men in certain key roles. For example, while the average salary for a female sales representative is £32,000, a man in a similar role is taking home £34,000. This same £2,000 disparity is also found in KAM roles and first line management. This is an interesting finding, however, it is only with further investigation into experience levels etc that any discrimination could be proved. The survey also revealed that of those working reduced or part-time hours, 92% were women, and so it could be that these reduced salaries are impacting on the final result. Figure 3: Salary in different age groups Pharmaceutical Field August 2010 With ever-increasing pressures on our finances, mounting bills and the cost of living soaring, how much you earn is becoming more important a question than ever. However, many people appreciate that these pressures are felt by businesses too, even in an industry as secure as the pharmaceutical industry. The boom times, for both the industry and its sales force, came crashing to an end Quick Read • Salary decreased between 2008-2009 • Bonus rates down • Only key account managers saw increase in pay and bonus • Majority agree wages are fair • Higher average salary for men in key roles • Experience highly valued and rewarded within pharma with the large-scale redundancies that took place at the start of this decade. Now, as the decade draws to a close, a new model for the pharmaceutical industry is emerging. With a shift in focus to account management and partnership with the NHS, every member of the pharma field force needs to know their stuff and know it well. It is hard to predict what impact the events of the coming year will have on the industry, but for those prepared to meet this challenge, the rewards could be great. About the survey The Pf Company Perception, Motivation Satisfaction Survey has been conducted annually by Health Sector Publishing, publishers of Pf, since 2002. It provides a benchmark of field force remuneration, motivation, satisfaction, perception and recruitment. As the survey is managed by Dr B Payne of Conker Statistics (a fellow of the Royal Statistical Society) and respondents are anonymous, it is able to provide a unique and impartial snapshot of workforce attitudes at the time the research is conducted. These latest results were gathered in early 2010, but relate to 2009. The Pf Company Perception, Motivation and Satisfaction Survey has been conducted annually by HSP, publishers of Pf, since 2002. It provides a benchmark of field force remuneration, motivation, satisfaction, perception and recruitment. As the survey is managed by Dr B Payne of Conker Statistics (A fellow of the Royal Statistical Society) and respondents are anonymous, it is able to provide a unique and impartial snapshot of workforce attitudes at the time the research is conducted. These latest results were gathered in early 2010, but relate to 2009. 23 Seven steps to boost your confidence In modern society where everybody is judged building or maintaining self-confidence levels can be an almost impossible task. Here, Dr R K Powar offers valuable ways to boost self-esteem at work. T he word confidence originates from the Latin word confidere, meaning to trust and to have faith in. The original meaning of the word is to have trust or faith in an object or person. Confidence has many meanings for different people, generally meaning certainty in one’s world. Here are some other ideas. • • • A state of mind where one feels sure about themselves and their environment The feeling of being secure and selfreliant The feeling of optimism about things in general Therefore, it follows that self-confidence means freedom from doubt and having the belief in yourself and your abilities. Whilst confidence is about feelings we all at times have seen it in friends, idols, managers, parents etc. At times we also feel it and see it in ourselves, and some of us more so than others. Also, it is worth stressing that despite us at times seeing a great deal of confidence in people they may not necessarily be feeling confident inside and, whilst confidence is not tangible, it is contagious. Developing self-confidence The self-fulfilling prophecy: This is a false definition of a situation in the beginning evoking a new behaviour which makes the original concept become true. If we start with the premise that we will be good at learning a new task, completing Pharmaceutical Field August 2010 a presentation or writing up a report, this is what happens and vice versa. There are times we have admired presenters or broadcasters for their confidence, but they admit afterwards to being very nervous prior to and during the presentation. However, they have succeeded in wearing the ‘selfconfidence outfit’. But what does this outfit consist of? Self-confidence is made up of components such as being sure about oneself. For example, being competent, having the strength to set goals and be disciplined to achieve them, using failures as learning opportunities and identifying your successes and using them to your advantage, to name but a few. Recognising and managing insecurities and ignoring what others think are also important components for building selfconfidence. Finally, one needs to make sure the outfit fits the part in terms of body language and speech. Practise on being competent: At a practical level it helps when doing something for the first time, or a task that might be difficult, to break it down into do-able segments. These will help us stretch significantly to develop but realistically enough so that we can succeed. Each time we have a success that will make us a little more confident. After having a few successes, the bar can be raised to the next level. Setting goals and using failures as learning opportunities: Setting goals helps to improve our confidence because it gives us direction. However, the goals must be realistic and achieved within a certain time framework. Each time a goal is achieved we will get motivated and can set the next target. In cases where we have failed, this will give us ample opportunity to learn and grow. (See article on The Learning Organisation: Is the Pharma Industry willing to Learn? April 2010) Identify your successes: If we reflect on the successes we have had, this makes us feel good about ourselves giving us positive energy. Assured thoughts will help our behaviour be positive giving us Pharmaceutical Field August 2010 our next ‘win’. In identifying our successes it may become apparent that the things we have had successes in are things we enjoy or are good at. Focusing on our strengths will ensure more successes, increasing our confidence further and so on. Recognising and managing your insecurities and limitations: None of us are perfect or good at everything; therefore we need to be realistic and also recognise our insecurities and limitations. It is also helpful to get the viewpoints of some trusted friends and work colleagues. Once we have a truthful and holistic picture of ourselves we can either decide to do something or not about our insecurities and limitations which promotes positive thinking and actions. Being competent, setting goals and achieving them, learning from failures and identifying successes are all components to build self-confidence Analyse your body language: When we see people being confident, the first thing we see is their body language; and as we know, first impressions have a major impact on how we perceive people and on how we are perceived. It is therefore a good idea to pay attention to our body language. If one carries themselves confidently that’s how they will feel, and in turn, this is the image that is projected to the outside world. Confident people tend to have a strong body language that exudes a non-verbal presence. Improve your image/speech: Our body language is better when we are dressed in attire that is suitable to the situation. When we are dressed smartly we feel good, our body language is better making us more confident. Speech also plays a part in how confidently we are perceived by others. A clear, well-paced and enthusiastic speech, opposed to a dull and monotone speech, makes us feel more confident and, subsequently, that’s how we are perceived by others. As a result, this makes us feel more confident demonstrating the principles of the Reinforcement Theory (Positive). Confidence at work An organisation’s success is determined in many ways. There is a plethora of methods in which an organisation’s success can be bettered. The employees of an organisation are its greatest asset. A positive, confident work force is of paramount importance especially in an organisation where the focus is more on a service provision rather than product provision. In the pharmaceutical industry a great deal of money and time is spent and hard work is done behind the scenes to get new drugs to the forefront. With the combined skills and expertise of various staff, the drugs finally reach the endpoints, i.e. the patients. When several functions such as product innovation, clinical trials, medical affairs, marketing/branding, training and sales team come together it is crucially important that each function has confidence in each. One way or another this will be apparent to customers. For employees such as the sales staff that have contact with external customers, being confident is of paramount importance. Initial introductions will determine the possibility of any future meetings with customers and the likelihood of their successes. If sales staff see themselves as confident people performing a very important job, that’s how they will be seen by the customers. If the sales staff value their time the customers will value the time of the sales staff too. If the sales staff have confidence in the products they are promoting the customers are more likely to perceive these in a positive light as well. Sales people in the pharmaceutical industry provide medical professionals and their colleagues with invaluable knowledge, Quick Read • Not all people are as confident as they suggest • Set goals and learn from mistakes to initially boost esteem levels • Increase targets after successful periods • Identify strengths and work on them • Decide whether to challenge or ignore weaknesses or insecurities • Promote positive body language • Speak confidently and dress to impress developments in specialised therapy areas and, whilst selling, are equally providing a service with their expertise. Sales teams that are confident are also likely to be better ambassadors for the industry too. Contrary to popular believe selfconfidence is not something people are born with. It is something that can be developed as shown in this article. There are no shortcuts to increase one’s self-confidence as it is a slow and steady process. Selfconfidence, similar to learning, is ongoing and each time a person has a positive experience their confidence is made stronger. Dr R K Powar has over ten years experience in the pharmaceutical industry and provides a range of tailored programmes to develop staff to help an organisation improve on their Softer S’s skill base. She can be contacted on [email protected] or 07962 342 140. For further information visit www.r11osyconsultants.co.uk SEPTEMBER 2010 Prepare for partnership, Chief Exec says The NHS must look to develop “genuine partnerships” if it is to maintain high quality care within current resources, the Chief Executive of the NHS has warned. Sir David Nicholson has said that the transition to the new system outlined in the Government’s proposed reforms should not be allowed to distract the NHS from its major operational challenges, but warned that the opportunities of the White Paper would only be achieved by working together more effectively. Roche unveils cost-cutting plans Roche has outlined cost-cutting plans to increase its efficiencies in the US and Europe. The Group-wide Operational Excellence initiative has been launched to “adapt cost structures and accelerate productivity” after recent developments in Roche’s pipeline. Severin Schwan Pharmaceutical Field The gateway to a commercial career in pharma This is a man’s world p24 September 2010 NHS reform: what it means for pharma p15 Embracing technology p22 Prepare for partnership, chief exec urges NHS The NHS must look to develop ‘genuine partnerships’ if it is to maintain high quality care within current resources, the Chief Executive of the NHS has warned. Sir David Nicholson has said that the transition to the new system outlined in the Government’s proposed reforms should not be allowed to distract the NHS from its major operational challenges, but warned that the opportunities of the White Paper would only be achieved by working together more effectively. In a letter to senior NHS management outlining how the service can manage the transition, Nicholson said NHS organisations must be prepared to work not only with the proposed new public health service, but also the independent sector. “It will mean seeking genuine partnerships rather than competing for leadership space,” he said. The communiqué acknowledged that Government proposals are at consultation stage and subject to change: “It is important that we do not take binding actions that prejudge the outcome of the process.” However, he said the NHS could not wait for all of the elements of the new system to be in place before proceeding. “We should make tangible progress towards realising the principles of Equity and Excellence as far as possible, whilst not pre-empting consultation or legislation.” The move towards GP consortia remains pivotal. Nicholson said GP practices should be given time and space to develop their plans to form commissioning consortia, and that PCTs should provide support to help consortia take on new responsibilities. But, he said, there was not a race to have the first or the most GP consortia established or to rush through unsustainable solutions. “For commissioning, this is not about dragooning GPs into administrative boundaries that they do not feel any allegiance with. It is certainly not about replicating current structures with some new players involved. The proposals represent a fundamental change, not just in structure, but in culture and ways of working.” The letter outlined how plans and the bridging function have been appointed. Nicholson said the radical proposals for changing the health and social care system in the UK represented a significant leadership challenge for the NHS. Maintaining a strong grip on current performance was, he said, central to the success of the transition process. Sir David Nicholson He identified four broad areas where the NHS needs to focus to maintain to establish national leads for control of quality and finance during the commissioning and provision, and to transition. These were; the QIPP agenda, split commissioning from provision rising emergency activity, preparation at national and regional level whilst maintaining a bridging function during for winter emergency activity, and commitment to maintain the maximum the transition, have progressed. Leads 18-week time between referral and at regional level for commissioning treatment. development, provider development Difficult month for UK pharma giants Two of UK pharma’s biggest players have endured a tough September. GSK and AstraZeneca have each received adverse press coverage, with GSK facing increased concerns over its diabetes blockbuster, Avandia, and AstraZeneca battling a staff revolt after employees at its site in Macclesfield voted to strike over changes to pension benefits. The MHRA has said that Avandia “no longer has a place on the UK market” while the BMJ has called for it to be suspended. But GSK is defending its data (p6). AZ said that only 165 of its UK employees – less than 2% – voted to strike. But the GMB says AZ’s proposals are “draconian” (p2). PF-SEPT-NEWS COMPLETE - Amends IB.indd 1 Novo Nordisk launches ‘app’ A UK charitable trust is taking Cimzia’s manufacturer UCB to court for promoting the drug in combination with methotrexate. The Mathilda and Terence Kennedy Institute of Rheumatology Trust filed the case against Belgian company UCB for infringing its 2001 patent on combining drugs like Cimzia with methotrexate. The first-ever mobile insulin dosing guide for use with the iPhone has been launched by Novo Nordisk in the US. NovoDose is available as an application on iTunes for US healthcare professionals and is specific to Novo Nordisk’s Levemir and NovoLog insulin products. 15/09/2010 12:15 AZ staff strike AstraZeneca staff (AZ) have gone on strike in protest over changes to pension benefits. Seven out of ten employees at AZ’s site in Macclesfield voted to take action over what the GMB called “draconian proposals to, in effect, end its final salary pension scheme for 2,500 staff”. Calls for Avandia withdrawal Experts have called for a complete withdrawal in the UK of GSK’s diabetes drug Avandia (rosiglitazone). The MHRA said “it no longer has a place on the UK market”, while the BMJ called for Avandia to be suspended and insisted it shouldn’t have been licensed at all. Pharma turning to hired help Pharmaceutical companies are turning to contractors instead of full-time employees, new data suggests. The Global Life Science Hiring Index shows that 15% of sales and marketing positions are now outsourced across Europe, the Middle East and Africa. UK charity sues UCB US pharma sales calls drop The number of sales calls made by the pharma industry to US health professionals dropped in the first half of 2010. Overall, in the US, sales calls to practitioners decreased 1% in the first half of 2010 compared with the previous six months, according to a study by SDI. Trio breach ABPI code Three pharma companies have breached the ABPI’s Code of Practice. The PMCPA ruled that ProStrakan Group plc, Cephalon UK and GlaxoSmithKline Consumer Healthcare had breached Clause 2 of the Code – bringing discredit upon and reducing confidence in the pharmaceutical industry. Study assesses rep quality Sales representatives from Wyeth, Novartis and Recordati have outperformed their European competitors in a recent international study of rep quality. The Rep Quality Survey, conducted by Cegedim Strategic Data (CSD), aimed to benchmark representatives’ performance in the emerging markets of Brazil, Russia, India and China against the top-five Eurpoean markets, the US and Japan. Gyllenhaal to play sales rep Follow PharmaField on Twitter A romantic comedy based on a 2005 autobiographical exposé of the pharmaceutical industry is to be released in UK cinemas this December. Love and Other Drugs, starring Jake Gyllenhaal and Anne Hathaway, is loosely based on Jamie Reidy’s ‘kiss and tell’ account of selling Viagra for Pfizer, published in March 2005, Hard Sell: The Evolution of a Viagra Salesman. Pharmaceutical Field YEARBOOK 2010 SEPTEMBER 2010 Innovative pain MDD spray approved treatment approved The European Commission has approved a new nasal spray treatment for breakthrough cancer pain (BTCP) that has been proven to provide relief within 10 minutes. Archimedes Pharma’s PecFent, an innovative fentanyl nasal spray, has been granted a marketing authorisation to treat BTCP in adults who are already receiving maintenance opioid therapy for their chronic cancer pain. AstraZeneca’s Seroquel XR has been given a positive decision by the EC for use in patients with major depressive disorder (MDD) who have not responded to antidepressant monotherapy. The decision from the EC follows a similar recommendation from the FDA in the US. Vaccine under review GSK’s swine flu vaccine Pandemrix is to be reviewed by the European Medicine Agency (EMA) on the request of the European Commission. The investigation will study whether there is a link between cases of narcolepsy and the vaccination after a number of reported instances, mainly in Sweden and Finland. Brinavess secures EU approval The first new medicine for recent onset atrial fibrillation (AF) in more than a decade has been approved for use in Europe. The intravenous (IV) formulation of Brinavess (vernakalant) has been given the green light in the EU, Iceland and Norway for the conversion of recent onset atrial fibrillation to sinus rhythm in adults. NICE reverse backed NICE under fire over Avastin Thousands of rheumatoid arthritis (RA) sufferers are set to benefit from two new pieces of guidance after NICE reversed an earlier appraisal. NICE has now recommended MabThera (rituximab), Humira (adalimumab), Enbrel (etanercept), Remicade (infliximab) and Orencia (abatacept) as treatment options for RA. In separate guidance, RoActemra (tocilizumab) was also given the green light. Pharmaceutical Field YEARBOOK 2010 NICE has come under attack following its decision not to recommend bowel cancer drug Avastin. The independent Appraisal Committee considered the treatment too expensive and questioned Roche’s calculations on a proposed Patient Access Scheme. Drug uptake reported NHS organisations will be named for the first time in a report by NICE on their uptake of positively appraised drugs in England. The report, set to focus on SHAs, PCTs or cancer network levels, will include data depending on the level of usage and healthcare settings. NICE unable to recommend Glivec NICE has said that a lack of clinical evidence has made it unable to recommend Novartis’ Glivec (imatinib) as a treatment for the recurrence of gastrointestinal stromal tumour (GIST). The Appraisal Committee said that whilst Glivec after surgery, as adjuvant therapy, could delay the recurrence of GIST, concerns over key aspects of the drug’s clinical effectiveness contributed to the decision. UNISON to take DH to court UNISON, the UK’s largest public service union, has started legal action against the Secretary of State for Health as part of a campaign to save the NHS. The union claims that the Government’s refusal to consult the public on the proposals in its White Paper, Equity and Excellence: Liberating the NHS, is unlawful and “lip service of the worst kind”. PBC costs millions Practice based commissioning (PBC) has cost hundreds of millions more than it has generated in savings, an investigation by Pulse has found. The analysis of PBC since its inception in 2005 found that GPs will take on budgets faced by a hugely uneven playing field, depending on whether GP commissioning has become established in the local health economy. Victoza secures BMA issues restricted commissioning recommendation guidance NICE has recommended Novo Nordisk’s diabetes treatment Victoza (liraglutide), but restricted its use. In draft guidance, NICE recommended Victoza 1.2mg daily dosage in combination with metformin or a sulphonylurea if treatment with metformin or a sulphonylurea, and thiazolidinediones and dipeptidyl peptidase-4 (DPP-4) inhibitors are unsuitable. The BMA’s GPs Committee has outlined what it believes should be the fundamental principles underlying the development of GP commissioning. The GPC’s first position statement on GP commissioning since the publication of the White Paper says that these principles should be used to “define policy, inform debate and negotiations, and ensure that good medical practice is enshrined within the changes proposed in Liberating the NHS”. To read the full story, click on the headline The proposed White Paper reforms offer pharma companies the perfect opportunity to evolve and introduce new commercial strategies. Calling upon his own experiences, Adam Knights explains how the role of Key Account Managers can help pharma change the record I had a smile like the Joker from Batman when I first read the White Paper. It is not every day that Government agenda falls in line with your business strategy but on July 12th that’s exactly what happened to us at 15 Healthcare. Since we started the company in 2009, my fellow directors and I have championed one fundamental maxim to enable success: the only way to manage NHS customers is by deploying key account management strategies that ensure company personnel are in front of the right person at the right time in order to broker business to business deals. The White Paper is not so easy for the pharmaceutical industry though. How much time, effort and money has the industry spent dealing with medicine management mandarins; whose agenda has been about limiting effective branded medicine on the basis of cost? This customer cohort will likely dissipate from PCTs to compete for roles within emerging GP consortia. The question is, as customers move around amidst organisational upheaval, where should the industry focus its efforts? Who will the market access team deal with in the future? Where exactly will decisions be made? Whilst the White Paper heralds radical reform and change for the NHS, will the industry be prepared to embark upon such disruption in order to align more effectively with its customers? A new era The NHS has undergone many changes over the years. However the White Papers signals perhaps the most radical in the last 25-years. Whilst we await further details we know that that GP consortia will form and will most likely become home to a number of functions hitherto provided by PCTs. Pharma will need to react and adapt to interact with these emerging customer groups. Imagine a consortium of 150,000 patients with the power to commission services, procure medicines and manage prescribing without any interference from a PCT? The idea of calling on individual GPs with a ‘sales aid’ and the ‘latest campaign’ will become redundant. The industry talks a lot about Key Account Management yet most companies only tinker at the edges. Sending someone on a two-day KAM course and giving them a new title will not give them the commercial/ clinical nous they will need in the new world. New skills, competencies and frameworks will have to be drawn up to deal with a variety of customers ranging from commissioning leads to finance directors. That doesn’t mean just retraining the sales force, it means every aspect of the business needs to understand the new world. Medical departments will have to find ways to support these functions and resist becoming totally risk averse. Key Account Management is about telling your teams what they can instead of what they cannot do. Internal training and development teams will need to raise their game too. No more cuddly marshmallow attendance courses with everyone ‘loving’ the trainer at the end. My guess is the new level of training will come externally initially until the bar is raised internally. I have seen lots of courses running that don’t resemble anything like the environment the sales force are facing. Keep it real and accept it will be painful for some. Working together For me the next phase of Key Account Management is alignment - both external and internal. Let's assume that your sales force has become an effective group of account managers. Now ask yourself the question: are we aligned? Does every department understand the overall strategy? Does the strategy allow a bottom up process and, most importantly, is the strategy aligned with that of the NHS (See Figure 1). Culture and processes is the single biggest challenge, companies that manage this well excel. Those who don’t struggle to succeed with any organisational change. Pharmaceutical Field September 2010 • I have heard mutterings from some individuals that the White Paper will allow them to go back to the old way of working and coverage and frequency models will come back into vogue. Please do not be so naive to think that this will accelerate your organisation to success Businesses can assess their commercial effectiveness through alignment. Not being aligned costs money. Some simple and effective measures will increase productivity. I have heard mutterings from some individuals that the White Paper will allow them to go back to the old way of working and coverage and frequency models will come back into vogue. Please do not be so naive to think that this will accelerate your organisation to success. Teams comprising of capable account managers will gain ground with customers as GP commissioners seek to secure value-based clinical and commercial deals. • Autonomy: people used to autonomy thrive in a KAM environment. With autonomy comes responsibility however, it also means making some mistakes – you cannot build a first class account team without making errors, its normal! Sales focused: all these competencies are fine but useless unless you can deliver on sales. Professional account managers like to be held responsible for sales. Are account teams working the same locality successful? In my experience, no. This is because the key to KAM is to deploy an individual who becomes the centre of every activity in a specific geography. This person ideally should be accountable for the profitability of Commercial acumen: can this the business and report at a board level. person deliver on a commercial Other support functions like medical deal and, more importantly, can liaison and marketing should satellite they recognise one when it is this individual and be deployed as an staring them in the face. Strategic planning: is the account appropriate resource when needed. Many companies fail to resist plan strategic? Does it align with the local NHS? Does the account the temptation to establish a team of account managers on the same manager fully understand the territory and then add insult to injury business planning process? by introducing a RBM to manage Compelling argumentation: them. Where is the accountability in when challenged by a customer this model? By default it is the RBM. can the account manager By adding a regional boss to the mix deal with the issue there and you immediately create a further then without having to refer management tier that clouds effective simple questions to a medical ‘line of sight’ on the business. I was an department? purpose. How should companies assess capability, skills and competencies? Some of the competencies 15 Healthcare look for include: • • • The case for Key Account Managers The KAM approach works provided the individuals in role are fit for Figure 1 Pharma internal challenge: KAM is both your biggest commercial opportunity and your biggest threat Most pharma companies failed in changing their business model from traditional to KAM Most pharma companies failed in successfully restructuring their sales force after ignoring drivers that will change their KAM behaviour in the field: culture and processes Evaluating KAM restructuring effort Key Success Factors Importance Company Rationale Structure 20% Key account Team per territory People 30% Same people in same territory supposed to do a different job post - restructure Culture and processes 50% ! Setting the right environment for the field force to work the way you want them to work Manage the culture and the culture will manage your people Pharmaceutical Field September 2010 Quick Read • • • • Pharma needs to react and adapt to interact with the new emerging customer groups Every department needs to understand the new NHS and be aligned in order to succeed KAMs need realistic training to be successful Pharma should opt for KAM model instead of account teams overseen by RBMs RBM at one point in my career and, in all honesty, I got in the way. I was so concerned with delivering inputs for the senior management team that the real business did not receive the time or exposure it needed and, as a consequence, did not grow. The RBM is one of the toughest roles in the industry. Managing the business, appeasing senior management and keeping a team happy whilst getting a knife in your back every 10-minutes is no fun. It is a role that many aspire to and often regret within six months of being appointed. The question that has to be asked by all companies is clear: amidst so many changes affecting our customer organisations, and where a move towards advanced account management seems a logical progression, are RBMs really needed? If the RBM is that capable – and many are – at business skills, coaching, mentoring, leadership and selling, why not make the RBM the Key Account Manager? After all, there is no written rule that states all sales models have to conform to traditional norms. Adam Knights is Managing Director of 15 Healthcare – a leading healthcare broker between the NHS and pharma through holistic and strategic key account management. Adam joined the pharmaceutical industry in 1998 after a successful career in the armed forces. He applied military strategy and tactics early on to develop an account model that challenged traditional thinking and planning. He went on to pilot successfully the regional account director (RAD) in Takeda before becoming the first RAD in the UK and then sales director for the RAD team. This is a man’s world Whether in the playground or the boardroom the question of gender supremacy always causes heated debate. Using Pf’s Company Perception, Motivation and Satisfaction Survey, Iain Bate highlights some interesting differences between the sexes. T he recent cases in the US against two of the pharma industry’s major players has seen the ugly issue of gender discrimination dragged through the courts once again. Since the 1970s when the Equal Pay Act and the Sex Discrimination Act were introduced in the UK great strides have been made towards equality. However the US court cases have clearly shown that despite all the laws in place both here and across the pond gender discrimination is still alive and kicking. In the pharmaceutical industry it’s clear that women are fighting back this trend. A growing number of women now hold presidential or vice-presidential positions in various capacities in many high profile organisations. In the age of equality, this should come as no surprise. However, two main issues continue to bedevil the battle for a level playing field; does sexual equality extend to company pay structures? And, the age-old debate – who makes the better boss: man or woman? Sex(ist) Machine A study by UK recruitment firm www. ukjobs.net showed that two-thirds of women agreed that men make “stereotyping happens almost from day one where girls are dressed in pink and boys in blue. There’s very deep seated assumptions and stereotyping which goes on.” better bosses. Female managers being hormonal, talking behind employees’ backs and an inability to leave personal issues at home were all main factors in the conclusion. Yet in America it’s the other way round for Carol Smith, Senior Vice President and Chief Brand Officer for the Elle Group. “Hands down women are better. There’s no contest,” she said in an interview with the New York Times. “In my experience, female bosses tend to be better managers, better advisers, mentors, rational thinkers.” This isn’t a view necessarily shared by Charlotte Rayner, Professor of Human Resource Management, Portsmouth Business School, who argues that both males and females boast attributes which contribute to the age-old argument. “There’s no reason why men or women should be better bosses,” said Professor Rayner. “This is an area of ordinary human skill and competence and both genders should be able to perform just as well as each other. A man making a better boss than a woman is a matter of perception. Throughout all of history it’s often been the case that men have been profiled as the major leaders and it could be that we still perceive men as the archetype for those sorts of roles. “This perception results very much from stereotyping which happens almost from day one where girls are dressed in pink and boys in blue. There’s very deep seated assumptions and stereotyping which goes on.” While it may seem obvious that gender stereotyping involves males and females the reality may be that women are hindering the progress of other women in the workplace due to these long standing judgements. “In the studies I’ve been involved in we continually look for gender differences,” Professor Raynor added. “We ask people what experiences they have had in the workplace. This includes gossip and rumour and we continually find no differences between males and females. But what might be happening, for example, is that when a woman boss talks behind somebody’s back it’s gossip, but when a man does the same thing it’s then rumour. From a male boss perceptive it could also be seen that he’s asserting his position and working through the politics. Whereas a woman might be seen to be undermining and gossiping and that all comes back to basic stereotyping. It’s exactly the same behaviour but what we do is label it differently.” Payback The main bone of gender contention relates to pay. The debate appears to plague every industry – and pharma is no exception. The Pf Company Perception, Motivation and Satisfaction Survey includes a detailed section on remuneration. As ever, the 2009/10 poll provides some interesting insights – not least to the gender debate. Completed by more than 1,200 employees from UK pharma sales, 53% of which were women, it Pharmaceutical Field September2010 Quick Read • • • • • • • • • Great strides made in equality since 1970s No reason why men or women make better bosses Long standing assumptions and stereotyping continues Men earn more than £1,500 on median average salaries Generally, pay gap is decreasing Pharma industry attractive to women employees Women more satisfied with pay than men Maternity and paternity leave causes problems Equality improving, but still long way to go Figure 1 2010 median salaries (full-time employees) Job title Male Female Medical representatives £34,500 £32,060 Hospital specialist £44,000 £42,400 NHS liaison £49,000 £46,885 1st line manager £55,000 £55,000 Figure 2 Combined median salaries* Year Male Female Difference 2006 £41,027 £39,125 £1,899 2007 £41,000 £40,150 £850 2008 £45,200 £44, 288 £912 2009 £46,500 £43,840 £2,660 2010 £45,625 £44,086 £1,539 *figures combine median salaries of medical representatives, hospital specialists, NHS liaison officers and 1st line managers. Pharmaceutical Field September 2010 revealed some interesting statistics when comparing individual (figure 1) and overall salaries (figure 2), and also motivational factors between men and women. When the median salaries are scrutinised by gender, and combined across all the standard sales roles, the Survey reveals that the average median salaries for men in 2009/10 was £1,539 more than women. Only four years earlier the difference in median salaries was just £850. The latest Survey figure does however show an improvement of more than £1,000 from 2008/09. Despite the existing gap Professor Raynor says salary divide could have more to do with men being more willing to ask their superiors for a wage increase rather than companies trying to scam females out of thousands of pounds each year. “It’s quite often that men are more assertive in this area by often asking for pay rises,” she said. “But sometimes women are not pushing their own pay claims as much as they might. My advice to women in terms of pay would be to think like a man! “Generally the pay gap is getting smaller. What has been very helpful around the country, and certainly in the private sector, is there are much better job descriptions being produced and better human resources processes. Companies are assessing what a job is worth and not what a person is. People are being much clearer that they’re paying for a job and not a person.” Get on the good foot The UK pharmaceutical industry remains an attractive one for women. Of the respondents in this year’s survey 70% who had less than six month’s experience in the industry were female. While this high number suggests a career in pharma is appealing to women, that fact that half of those with more than eight years of experience were also female confirms this. In fact, despite the salary gap in certain roles, results from the Survey indicate that women are more satisfied with their annual wage than their male counterparts. More than half of women revealed they were happy with their wage packet at the end of the month compared with 46% of men. This continues an annual trend with the Pf Survey. Papa’s got a brand new bag Across all industries, data suggests that women still feel uneasy about stepping Figure 3 Top-five 2010 motivational factors Men Women 1. Salary 1. Salary 2. Relationship with manager 2. Work-life balance 3. Work-life balance 3. Relationship with manager 4. Job security 4. Belief in products 5. Company culture 5. Company culture off the career ladder to start a family. But Professor Raynor says this unease at switching from a business woman with responsibilities to a housewife with children is not solely reserved for females. “We’re seeing more women deciding not to have children and taking the career route because they look around and see it’s difficult to combine career and children,” she continued. “Although I feel that men experience this as well. When children come along, their focus on why they’re at work starts to change. It’s very good to start to see paternity leave come in. In many ways what we’re talking about now could be an end to those stereotypes. Actually, males have a hard time too but we 16 hardly ever talk about this.” Although men might not suffer as much in the pay stakes as women do when children come along there are a number of decisions which can ease the process, especially for women. Those leaving a career to start a family are encouraged to set their priorities early; get the support needed from their family required to balance the long hours and added work load; to decide from the outset what is right for them personally and consider the implications in the long term. I feel good Professor Raynor says the equality divide which still exists today is still some way from being eradicated where work and pay is concerned. But the more women in positions of power the more likely it is they will break down the barriers and we’ll see the balance and fairness suggested in the soon to be implemented Equality Act 2010. “We are still a long way from gender equality that a lot of people would want,” she concludes. “For males it’s the balance between paternity rights and a career. For women it’s pay, maternity rights and a career. Things are changing though. Women in senior positions are seen as role models for other women working within the organisation. Other women look and say ‘if she can do it then so can I’. “This also applies to people who take career breaks and who are still able to succeed. It would be very positive if we had more leeway for paternity leave and a positive attitude from society about a genuine openness about men and women switching the caring roles in the home.” Although in the Survey both sexes agreed that salary was the main motivational factor (figure 3) at work, responses from women showed that work-life balance was more important than their relationship with their boss. A trend reversed in men. The link between relationship with manager and job security for men suggests that keeping the boss sweet in order to maintain in work Quick Read • Great strides made in equality since 1970s • No reason why men or women make better bosses • Long standing assumptions and stereotyping continues • Men earn more than £1,500 on median average salaries • Generally, pay gap is decreasing • Pharma industry attractive to women employees • Women more satisfied with pay than men • Maternity and paternity leave causes problems • Equality improving, but still a long way to go during a period of recession is far more important than it is for women – who consider the balance between being at work and spending time with the family more important. Whether or not the age-old argument of who makes the better boss will ever be agreed, or whether true equality in the pay stakes will ever be resolved remains to be seen. However, as the motivational factors in the Pf Survey show, it’s still obvious that where work is concerned men come from Mars and women come from Venus. For a clearer picture, follow PharmaField on Twitter Pharmaceutical Field September2010 OCTOBER 2010 Plans may threaten patient care The Royal College of General Practitioners (RCGP) has become the latest professional body to question the scale and pace of change proposed in the Government’s White Paper for the NHS. The College’s official response to the proposals broadly backed many of the policies, but expressed concern that the scale of change required was “not justifiable in the context of cost reductions” and could prove “disruptive”. Pharmaceutical Field The gateway to a commercial career in pharma October 2010 The perfect outcome? Life’s a beach A new direction p15 p29 p24 ‘Disruptive’ plans could threaten patient care The Royal College of General Practitioners (RCGP) has become the latest professional body to question the scale and pace of change proposed in the Government’s White Paper for the NHS. The College’s official response to the proposals broadly backed many of the policies, but expressed concern that the scale of change required was “not justifiable in the context of cost reductions” and could prove “disruptive”. The comments echo the views of the Royal College of Nursing (RCN) who have said that the proposals sit within a highly ambitious timescale and present considerable risks to services at a time when the NHS is striving to make £20 billion of efficiency savings. Health Secretary Andrew Lansley defended the proposed speed of change. “The timetable is ambitious, but it is not a timetable which is unachievable,” he said. “With twoand-a-half years with which to learn from pathfinder commissioning consortia and establish shadow arrangements, there is ample time for practices that do not yet feel ready, to secure capability collectively. “These reforms give GPs the overall responsibility for the design Ex-TUC man is new Shadow Health Secretary John Healey, former housing minister and a member of Gordon Brown’s cabinet, has been named as the new Shadow Health Secretary. Healey, who takes over from former health secretary Andy Burnham, was Campaigns Director for the TUC from 1994 to 1997. Labour is now poised to fiercely campaign against PF-OCT-NEWS.indd - Edit IB.indd 1 Andrew Lansley’s proposals for the NHS. “The Government’s plans will damage care for patients and dismantle the NHS as our national health service,” he said. “I look forward to working with Ed Miliband to show clearly and quickly what the Tory plans will mean for people and their families.” of services, which meet their patients’ needs, and facilitate a quick response when failures in those services arise.” RCN welcomed the principles behind the reforms and endorsed the focus on outcomes, choice, patient involvement, professional freedom and the removal of unnecessary bureaucracy. But it warned that “untested proposals” could have a negative impact on patient care and urged the Government to pilot and evaluate its proposals before they are implemented. The RCGP gave its backing to the principle of ‘shared decision-making with patients’, but reiterated its opposition to giving patients freedom to choose their GP. This policy could, it said, be “very damaging in terms of continuity of care, health inequalities and potentially patient safety”. The comments were the latest in a series of official responses to the White Paper that emerged as the consultation process entered its final days. The most high-profile critique was issued last month by the BMA, who warned that positive elements of the proposals could be at risk from other aspects that “seek to accelerate a market-based approach”. The Association said it was concerned that attempts to encourage competition in the NHS would risk shifting the focus on to cost rather Andrew Lansley than quality and could undermine opportunities to work collaboratively across primary and secondary care. Dr Hamish Meldrum, Chairman of Council at the BMA, said that “pitting clinicians against each other in a market-based system creates waste, bureaucracy and inefficiency”. The BMA said plans to hand commissioning responsibilities to GP consortia will only succeed if other clinicians are brought into the process. It said GPs, secondary and tertiary care consultants, public health consultants and clinical academics must all collaborate to ensure commissioning is effective. RCN said the reforms would struggle without harnessing nursing leadership and expertise at all levels of the commissioning process. Abbott to cut jobs Tesco has become the first supermarket chain to sell antiimpotence drug Viagra direct to customers. Following similar over-the-counter rules used by Boots, the supermarket giant is expected to start a price war by selling eight tables for £52. Abbott is to cut 3,000 jobs, many of which will affect Solvay workers following Abbott’s acquisition of the company’s pharmaceuticals business. The planned cuts represent 3% of the combined companies’ workforce of around 93,000 and will affect all departments in both the US and Europe, a spokesperson for the company has said. BMS latest to cut jobs Unite has launched a campaign opposing the proposed NHS reforms in the White Paper. The union said the proposals had “no democratic mandate” and would begin “the rapid privatisation of the health service”. The Unite 4 our NHS campaign opposes the White Paper and the cuts being inflicted on the health service among its 100,000 health sector members. Roche’s primary care sales force is to be the focus of cost-cutting efforts, following problems with a new diabetes treatment, CEO Severin Schwan has revealed. Schwan told Reuters that the primary care sales force would be one area that was looked at as part of a new efficiency drive announced last month. 13/10/2010 13:24 Tesco to start price war Unite contests reforms Roche’s sales force under review Bristol-Myers Squibb has become the latest company to announce job cuts, with the revelation that it is to reduce its workforce by around 3%. The loss of around 840 jobs over the next six-months will be in addition to the 7,000 jobs cut by the company last year. HAPPY IN THE WORKPLACE? HAVE YOUR SAY PF COMPANY PERCEPTION, MOTIVATION & SATISFACTION SURVEY 2011 - OUT JANUARY Severin Schwan Gilenya set for sales rocket Novartis can expect blockbuster sales for its multiple sclerosis (MS) treatment Gilenya (fingolimod), according to Datamonitor. The convenient treatment is the first of a new generation of MS disease modifying therapies addressing key unmet needs of oral administration and increased efficacy. EMA and FDA extend pact The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have extended their confidentiality agreement indefinitely. The deal between the regulatory bodies allows the pair to share information on issues related to medicinal products for human and veterinary use. Merck KGaA vows to fight decision Merck KGaA has vowed to get Cladribine Tablets approved in Europe after the CHMP issued a negative opinion for a marketing authorisation application (MMA). The Committee said that it was unable to offer an MMA due to the benefits of the multiple sclerosis (MS) treatment not outweighing its risks. To read the full story, click on the headline Seroquel XL gets UK OK AstraZeneca has secured UK approval for Seroquel XL (quetiapine prolonged release) as an add-on treatment for major depressive episodes. The drug is indicated in patients with Major Depressive Disorder (MDD) who have not responded to antidepressant monotherapy. Pharmaceutical Field YEARBOOK 2010 OCTOBER 2010 200 not out New cancer strategy revealed for NICE The Government has outlined new plans which it claims could save the lives of up to 10,000 cancer patients each year. The cancer strategy will see substantial investment in five main areas, including boosting the number of specialists and raising cancer awareness, to increase survival rates. NICE has completed its 200th technology appraisal. The landmark figure was reached with the publication of updated guidance for the treatment of chronic hepatitis C. More than four-fifths (83%) of NICE’s 397 decisions to date have been positive, with only 52 treatments failing to be recommended. Herceptin U-turn by NICE Roche’s cancer drug Herceptin (trastuzumab) will soon be available to treat NHS patients with gastric cancer, after NICE reversed its previous negative recommendation. The Institute has recommended the drug for patients with metastatic gastric cancer who have high levels of human epidermal growth factor receptor 2 (HER2), a protein found on the surface of some cancer cells. Thousands of NHS staff are paid more than the Prime Minister, an investigation has found. The NHS has 26,000 staff earning more than 100k a year with nearly 6,500 employees paid more than David Cameron’s £142,500 salary. Pharmaceutical Field YEARBOOK 2010 New CQC chair Amgen’s Prolia (denosumab) has been recommended by NICE for postmenopausal women who are at increased risk of osteoporotic fractures in draft guidance. Prolia is to be used if treatment with oral bisphosphonates alendronate, and either risedronate or etidronate is unsuitable. NICE says the recommendation is a “useful additional” to treatment options for women. Final guidance is expected later in the year. The Health Committee has endorsed the Government’s proposal to appoint Dame Jo Williams as the new chair of the Care Quality Commission (CQC). In details submitted as part of the candidate suitability process Dame Williams outlined a number of priority challenges which matched the Committee’s views. NICE updates hep C guidance Sir Andrew Dillon First GP consortia launched The UK’s first GP consortia have been launched in Cambridgeshire. The two consortia will have control of all commissioning in their areas and have access to a budget of around £215 million. However, the PCT will still have to approve spending decisions until the Government changes the current legislation. Thousands earn more than PM Prolia gets draft OK NICE says no to Yondelis NICE has again failed to recommended ovarian cancer drug Yondelis (trabectedin) in its latest draft guidance. The decision, following a failed appraisal earlier this year, followed a lack of clinical data and concerns over the drug’s effectiveness compared with the most commonly-used treatment. NICE has updated guidance on the use of Pegasys or ViraferonPeg (peginterferon alfa 2a or 2b) and Copegus/Rebetol (ribavirin) for the treatment of chronic hepatitis C. The decision follows changes in the marketing authorisations for Pegasys and ViraferonPeg and recommends their wider use, and, where appropriate, shorter treatment durations for adults. Gilvec fails to get backing NICE has been unable to recommend the use of Glivec at increased levels (imatinib) to treat metastatic gastrointestinal stromal tumours (GIST) in its latest draft guidance. The decision relates to doses of 600 or 800 mg/day for people whose disease has progressed after treatment with a reduced use of the drug. Follow PharmaField on Twitter Dame Jo Williams New DH secretary Una O’Brien has been appointed as the new Permanent Secretary for the Department of Health. In her new role she will be responsible for delivering and managing the transition to a new health and care system and lead on public health matters across government. Director General quits ABPI The ABPI is searching for a new Director General. Dr Richard Barker is to stand down at the Association’s Annual Meeting next May to pursue new opportunities in healthcare. Simon Jose, President of the ABPI, said Dr Barker had been a “champion” for the Association during his six-year stay. The perfect outcome? The days when healthcare standards were judged on meeting process targets are over. Thoreya Swage questions whether the the new NHS Outcomes Framework is indeed the best way forward. Pharmaceutical Field October 2010 T he coalition Government’s grand scheme for the Health Service, Equity and excellence: Liberating the NHS, was launched in July proposing many, and to some, radical changes in the way healthcare is delivered. This was accompanied soon afterwards by a flurry of consultation papers; one of which is a proposed outcomes framework, against which performance of the NHS would be assessed. For a number of years, the NHS has tried to demonstrate its effectiveness using various methodologies and the latest consultation paper is no exception. Transparency in outcomes - a framework for the NHS is the Government’s attempt to bring the NHS to account for the many and varied interventions that are carried out on a daily basis. Showing an improved quality of care has always been difficult particularly with nationally determined process targets which the Government claims to have distorted clinical priorities and restrained innovation. However, it is a tall order to attempt to measure the success of approximately 300 million consultations in general practice and 1400 different types of hospital-based treatments for 7 million routine admissions, as well as a similar number of emergency admissions a year. The paper proposes that the Secretary of State will, following consultation, set the national outcomes against which the newly established NHS Commissioning Board will be held to account. In turn, the GP commissioning consortia will be responsible, through their local commissioning of services, for improving health outcomes by the Board. The document is at pains to say that the indicators for measuring the outcomes will be based on the best available evidence and it will not be used as a stick to punish providers of NHS care. How the framework will work Once the indicators are set, the Board will decide how best to deliver the improvements. This will be done by working with the GP consortia and using the tools and levers available. For example, the Board will be able to commission quality standards from NICE. These will inform the development of commissioning guidance which will provide the details on how the national outcome goals in the framework could be met. The Board will also use the quality standards to design mechanisms for incentive schemes, e.g. Commissioning for Quality and Innovation (CQUIN) and other payment frameworks. it is a tall order to attempt to measure the success of approximately 300 million consultations in general practice and 1400 different types of hospitalbased treatments for 7 million routine admissions The principles guiding the development of the NHS Outcomes Framework include the long held ideals of accountability, transparency and balance with a focus on what matters to healthcare professionals and patients, plus partnership working with other public services as necessary. The requirement for balance is what remains of Lord Darzi’s review of the NHS carried out in 2008 under the previous administration whereby services would be assessed in terms of effectiveness, patient experience and safety. The emphasis of this framework is on ensuring excellence and moving away from minimum standards which is the responsibility of the Care Quality Commission. A new direction has been set with the requirement to have measures that are internationally comparable and the data collected to be publically available. Furthermore, in addition to clinical outcome measures, patient reported outcome measures (PROMs) will feature equally as a means of recognising patient experience and safety. There will also be measures that will only be met if the NHS works with other public sector agencies, such as social services and the new public health service. Work is afoot to construct and consult on outcomes frameworks for these bodies by the Department of Health so that these integrate well with those for the NHS. The first outcomes framework will be modest using current indicators for which data can be collected and is due in 2011/12. The intention is to develop this over time as the NHS landscape changes, with annual reviews of the indicators. Potential measures The potential measures, taken from the principles identified by Darzi, are placed under five domains. Domain 1 – preventing premature deaths Domain 2 – improving the quality of life for people with long term conditions Domain 3 – facilitating the recovery of people who have had episodes of illness or injury Domain 4 – ensuring a positive experience of healthcare Domain 5 – looking after people in a safe environment and protecting them from avoidable harm Domains 1-3 cover effectiveness, whilst domain 4 covers patient experience and domain 5, safety. The domains themselves will be formed of three sections: an overarching indicator, improvement areas and NICE quality standards. The overarching indicator allows the progress of the NHS to be assessed in the broad activity areas that are covered by the relevant domain. Under each overarching indicator there will be identified areas where improvements are expected to be made. These will be accompanied by specific outcome indicators against which the NHS Quick Read • Transparency in outcomes - a framework for the NHS sets out suggested standards to measure effectiveness of the NHS • Judging the Health Service is difficult with the high number of primary and secondary care admissions • The newly established NHS Commissioning Board will be held to account to national outcomes. • Soon to be formed GP commissioning consortia will be responsible for improving health outcomes by the Board • The first outcomes framework will use current indicators and are due in 2011/12; these will be developed with annual reviews of indicators • Potential measures for the NHS are placed under five domains • Domains will be formed of: an overarching indicator, improvement areas and NICE quality standards • Government attempting to shift the focus of the effectiveness of healthcare from process to outcomes • Pharma well placed to assist GP consortia and impose own solutions Commissioning Board will be held to account for progress achieved. Supporting all of these outcomes will be quality standards produced by NICE and commissioned by the Board. The GP consortia are expected to refer to the commissioning guidance – based on the quality standards – when commissioning services locally. NICE has already started with the publication of three quality standards this year covering stroke, dementia and venous thromboembolism (VTE) prevention. A further ten are in development with specialist neonatal care, depression, chronic obstructive pulmonary disease (COPD) and chronic kidney disease furthest down the line – expected publication date June 2011, except for neonatal care which is October 2010. The final tally is anticipated to be around 150 quality standards providing guidance on what high Pharmaceutical Field October 2010 Figure 1 Domain Overarching indicator Improvement areas (outcome indicators) 1. Preventing premature deaths Mortality modified by healthcare Heart disease – premature deaths Cancer – 1 and 5 year survival Stroke - premature deaths Children - premature deaths Older people – healthy life expectancy 2. Improving the quality of life for people with long term conditions (LTCs) PROMs for a number of LTCs Children and young people – school attendance and avoidable admissions Adults – ability to work and avoidable admissions Older people – independent living and avoidable admissions 3. Facilitating the recovery of people who have had episodes of illness or injury Avoidable emergency admissions and re-admissions Planned care Unplanned care 4. Ensuring a positive experience of healthcare Patient experience Patient surveys covering a range of services from primary and secondary care to mental health and end of life care 5. Looking after people in a safe environment and protecting them from avoidable harm Number of incidents reported Safe treatments, environment, discharge, safety and vulnerable groups quality care should look like for a specific pathway or service. The structure of the framework is different from what has been developed in the past and the illustration above (Figure 1) shows what the five domains would look like. All of the above domains, overarching indicators and improvement areas will be supported by quality standards. Clearly the Government is trying hard to shift the focus of the effectiveness of healthcare from process to outcomes and many possible indicators have been identified in the consultation document to get the discussion going. Implications for pharma The Government is keen for GP consortia to have the flexibility to commission services according to local needs, which means getting close to the emerging groups and starting discussions around pathways of care and service redesign. Although the go-ahead pioneer, GP consortia will have their own ideas on how to change services and there will be many who will require more help and support. Pharma is well placed to formulate solutions whether it is change management, lean design or streamlined care pathways. When it comes to comparing performance of the NHS with other Pharmaceutical Field October 2010 the GP commissioning consortia will be responsible, through their local commissioning of services, for improving health outcomes by the Board. The document is at pains to say that the indicators for measuring the outcomes will be based on the best available evidence and it will not be used as a stick to punish providers of NHS care countries, the industry has a great advantage in that it can dip into its operations overseas and bring the wealth of experience to bear in the UK. The fact that the indicators are meant to be evolving over time provides an opportunity for pharma to suggest new and different measures based on the international experience within the industry. The second domain, improving the quality of life for people with long term conditions, opens up a range of possibilities for change and improvements in clinical practice. For example, the consortia will be keen to bring services ‘in-house’ within primary care rather than secondary care for conditions such as diabetes, COPD, chronic kidney disease, coronary heart disease and so on. There will probably be moves to make more use of specialist nurses or community pharmacists who increasingly will be making decisions about patient care without necessarily referring back to the GP. The key sets of documents which will be produced to support the consortia will be the commissioning guidance and the quality standards published by NICE. These standards provide a description of what a high quality service should be, but will not go into the detail thereby allowing innovation locally. It is here that pharma can provide a helping hand to the emerging GP consortia on how to manage various conditions better, VTE for example. The paper has set the scene for assessing the performance of the NHS through outcomes rather than process targets. Clearly further work needs to be done, however, preparations for the new world can be continuing pending the outcome of the consultation in December. Dr Thoreya Swage has several years’ experience in the NHS, both as a clinician (psychiatry) and as a senior manager, including Executive Director for a Health Authority, in various NHS organisations covering acute and primary care. She has expertise in commissioning health services, most recently working with the independent sector as part of the Independent Sector Treatment Programme at the DH. She is currently working for a number of NHS organisations, including DH agencies, to develop a more commercial approach to the commissioning of healthcare. xx A valuable benchmark Everyone is talking about account management, and every company seems to suggest that they are doing it – but what is the reality? NHIS offers an insight into industry perception. D uring June 2010, the National Health Intelligence Survey (NHIS) launched the Account Management Benchmark Survey – a repeat of the very successful survey conducted in 2008. The aim of the survey was to increase understanding of sales executives’: • skill to work across a local health economy • capability to influence new and traditional customers • propensity to work as account managers • confidence of working in the new and changing NHS The survey was posted online and comprised of 45 questions. It remains open and almost 200 people have responded. The questions support a capability model which consists of three domains – knowledge, influencing skills and working across local health economy, and nine elements, as shown in Figure 1. Figure 1: capability mode (NHIS 2010) 9. Team Working and Partnership 1. Own and Competitor Products 8. Commercial Focus 7. Market Analysis, Account Strategy and Planning 2. Use of Supporting Data C. Working across local Health economy A. Knowledge 3. NHS Customers B. Influencing Skills 6. Influence and Impact 4. Customer Focus 5. Interpersonal Communication Skills Figure 2: respondent’s roles KAM, NHS Liaison The results – who has responded? The survey is anonymous to ensure that people answer the questions openly and truthfully. However, a few profiling questions were asked, for example, respondents recorded their primary role and the results are shown in Figure 2. About two thirds of respondents classed themselves as either Key Account Managers or as having an NHS liaison role, 16% indicated Specialist Care Representative Other they were Specialist Representatives, whilst the remainder comprised of a variety of diverse roles, with less than 7% of respondents indicating they had a role as a GP or GP and Specialist Care Representative. You will see in the later analysis that results are shown separately for these three key groups. Almost 80% of respondents had worked in the pharma industry for over 10 years (as shown in Figure 3). This figure hardly differs across the three role types as mentioned above. Respondents were also asked to record how long they had worked in their current role (shown in Figure 4). No clear pattern emerges here with a range of responses from 0-6 months to +10 years for each of the role types. However, around 50% of respondents have been in their current role for between 3 and 10 years, and only about 18% have been in their current role for less than one year. Overall this suggests that those responding to the survey are experienced pharma personnel with a range of experience in their current role which therefore forms an appropriate group to build an understanding of account management experience within the industry. Skill level The interim results shown in Figure 5 compare the varying levels of performance for each of the nine elements of the capability model (Figure 1) for each of the three role types. Pharmaceutical Field October 2010 It is interesting to note that the mean score is higher for the KAM and NHS liaison role across all elements when compared to the other two role types. Also of note is the similarity of the elements which were scored the highest and lowest across the three role types. (Figure 6 & 7) Team working and partnership received the highest score of all the elements for the KAM and NHS liaison role. It is interesting to see the spread of scores across the three role types, for one of the questions supporting that element. Figure 8 shows that 32% of KAM and NHS liaison role respondents scored this question “to a full extent”. This increased to 45% of respondents for the Other role and fell to only 10% for the Specialist Care role showing the value of analysing the results at an individual question level, and the variety of results between the different role types. Unfortunately the analysis of results at this level goes beyond the scope of this article, but it shows the in-depth information that surveys such as this can provide. Figure 3: pharma industry experience Comparison of the time in the industry by role type 100% 90% KAM, NHS Liaison 80% Specialist Care Representative 70% Other 60% 50% 40% 30% 20% 10% 0% 2-4 years <2 years 5-10 years >10 years Time in the Industry Figure 4: time in current role Comparison of time in current role by role type 40% 35% KAM, NHS Liaison 30% Specialist Care Representative 25% Other What do the results say? 20% It is probably worth reflecting on the key capabilities that are required for a successful account manager and how they differ from those for a successful sales person. (Figure 9) It is encouraging to note that Team Working and Partnership and Customer Focus were amongst the top three highest 15% 10% 5% 0% 0-6 months 7-11 months 1-2 years 3-4 years 5-10 years >10 years Time in Current Role Figure 5: self perceived capability scores 5.00 4.80 4.60 Mean Score 4.40 4.20 Maximum Achievable Score Overall Total KAM, NHS Liaison Specialist Care Representative Other 4.00 3.80 3.60 3.40 3.20 3.00 Commercial Focus Market Analysis, Account Strategy & Planning Pharmaceutical Field October 2010 NHS Customers Impact and Influence Use of Supporting Data Customer Focus Interpersonal Communication Skills Team Working & Partnerships Quick Read • • • • • • Results from 2010 NHIS Account Management Benchmark Survey Almost 80% of respondents worked in pharma for over 10 years KAMs and NHS liaison believe they are performing better than other roles Team Working & Partnerships highest perceived element Knowledge of Own & Competitor Products surprisingly lowest element Distinct capabilities between sales manager and account manager scores for the account manager role and fit well with the description given above. However, those elements were also amongst the top three for the Specialist Representative and Other roles, which may not be what would have been expected. When looking at the lowest scoring elements for the KAM and NHS liaison role it is surprising to see Market Analysis, Account Strategy and Planning, and Commercial Focus in that list. This becomes even more surprising when looking back to the 2008 survey which also listed these amongst the lowest scoring elements – additionally the score for both these elements has fallen slightly. Another surprise is that Own and Competitor Product Knowledge is the lowest scoring element for the KAM and NHS liaison role. Surely this element is a fundamental skill for any customer facing role? As should be knowledge of the customer – NHS customer knowledge – which is also in the three lowest scoring elements for two of the three roles, and it is ranked fourth lowest for the KAM and NHS liaison role. Taking an overall view of the results for the KAM and NHS liaison role it suggests a description of a person who believes that most of the time they work effectively in a team or partnership role by using their interpersonal communication skills, by keeping up to date with local and national guidance, and using such supporting data in their interactions. But such interactions may not be informed through knowledge of their own and competitor products, and commercial focus may be hampered through a lower level of market analysis, account strategy and planning. Such a description may be the cause of some concern amongst managers within the industry since it is a similar description to that resulting from the 2008 survey, suggesting that capabilities have not advanced since then. But the major cause of concern should be the low scores which suggest a lack of analysis, strategy formation and planning leading to a low level of commercial focus. The next step Although this is only an interim analysis and the number of respondents is growing on a daily basis – as are the number of companies participating in the survey – it is hoped this has provided an interesting overview of account manager capability, and that it has made apparent how this type of survey can support normal performance measures used within a company to provide a valuable insight into your strengths and weaknesses. Plus the areas where you may have a competitive advantage. This type of survey is also a valuable way to identify future training interventions, and whether any training intervention is providing the outcome you expected. It should be remembered that this survey is a measurement of self perception against a capability model; the real value of this insight being delivered through the comparison to an industry benchmark. The next step would be to perform a similar survey with customers in a manner that would allow a comparison of the self perception score and the customer perception at an individual account manager level. It should also be noted that a small number of companies are interested and have started to perform this type of analysis. If you wish to know more about the survey, the interim results, or how you can benchmark your whole team, please contact Neil. [email protected]. Figure 6: lowest elements by role type Lowest three scores KAM, NHS Liaison Own & Competitor Products Commercial Focus Market Analysis, Account Strategy and Planning Own & Competitor Products Market Analysis, Account Strategy & Planning NHS Customers NHS Customers Use of Supporting Data Impact and Influence Other Specialist Care Representative Figure 7: highest elements by role type Highest three scores KAM, NHS Liaison Other Specialist Care Representative Team Working & Partnerships Interpersonal Communication Skills Use of Supporting Data Interpersonal Communication Skills Team Working & Partnerships Customer Focus Team Working & Partnerships Interpersonal Communication Skills Customer Focus Figure 8: building long term relationships score by role type I am more concerned with building long term, open and honest business relationships, in preference to taking a quick win now which may not help the long term relationship Specialist Care Representative Other KAM,NHS Liaison 0% Not at all 20% To a small extent 40% 60% To some extent 80% To a large extent 100% To a full extent Figure 9 Sales Person Account Manager Usually works alone Works as part of a team Employed to “get the sale” Works to achieve a long term relationship, leading to greater customer retention, and improved profitability Manages a large number of customers Manages a smaller number of customers Customer relationships are simply to achieve the sale Tasked to understand customer’s need and develop their potential over time by meeting that need and through long term customer relationships Employs a common message to “push the product” Marshalls and deploys resources from across their organisation as appropriate to meet customer need Pharmaceutical Field October 2010 NOVEMBER 2010 Market to define value Pharmaceutical Field NICE is to be stripped of its power to decide which treatments are available on the NHS, the Department of Health has confirmed. From 2014, the medicines watchdog’s health technology appraisal role will be downgraded to make way for value-based pricing. The gateway to a commercial career in pharma November 2010 You are not alone New rewards (I can’t get no) satisfaction p20 p18 p26 Market to define value as NICE role ‘downgraded’ NICE is to be stripped of its power to decide which treatments are available on the NHS, the Department of Health has confirmed. From 2014, the medicines watchdog’s health technology appraisal role will be downgraded to make way for valuebased pricing. But the DH said that comments from Health Minister Lord Howe which described NICE’s role in making costeffectiveness decisions as ‘redundant’ had been taken out of context, and that the work of the Institute would remain vital in the future. Speaking at the ABPI’s half-day conference earlier this month, Lord Howe said: “The role of NICE in appraising new drugs is likely to evolve as we develop and implement our plans for value-based pricing, but we are clear that NICE will continue to have an The DH says Lord Earl Howe’s comments that NICE’s HTA role would become ‘somewhat redundant’ have been taken out of context PF-NOV-NEWS - EDIT IB.indd 1 essential advisory role, whatever that shape of value-based pricing will be.” Value-based pricing is expected to be introduced by the end of 2013, when the current PPRS expires. Lord Howe confirmed the Government would commit to the existing PPRS agreement “in full” but said it did not do enough to promote innovation or access. “We need a much closer link between the price the NHS pays and the value that a new medicine delivers. But coming up with a system defining what represents value is not a straightforward matter. Over the next four years or so, we will work with patients and clinicians, with the NHS and of course with industry to define how best to reform the pricing of medicines.” Lord Howe’s remarks echoed the words of Health Secretary Andrew Lansley, who told a UK Prix Galien audience that more needed to be done to promote innovation and to ensure that NHS patients get access to the medicines they need. “In July, Mike Richards, the National Cancer Director, published his report on the international variance in drug use and set out very clearly the deficiencies we have in terms of access to cancer drugs in this country,” he said. “We are addressing that directly, but in an interim fashion. Beyond that, we will shortly be publishing the initial consultation looking at a longer term structure beyond the current PPRS, to a NICE decisions have regularly caused controversy, particularly in the emotive area of cancer. The Government’s introduction of a Cancer Drug Fund is designed to improve access to cancer therapies – but is only an interim measure. The refocusing of NICE, which unions now claim will make the NHS and patients the ultimate losers, will have wider long-term implications. system that is focused on the successful delivery of medicines in this country, based on the value they contribute. And by value, I mean not only the therapeutic benefits to patients, but also the benefit to society. But if we don’t recognise the value associated with innovation, we will not get the new medicines we need and will not get the growth in our economy that we need to sustain our preeminent position in pharmaceutical research.” Last month, the ABPI called for a change in NICE’s remit to equip it for the value-based era. “As debate begins on the design of a future value-based approached to how the NHS pays for its medicines, it’s vital we have a parallel debate on the role and focus of NICE,” said Richard Barker, Director General of the ABPI. “If we want the NHS and the UK to benefit from a vigorous life sciences sector, the reshaping of NICE’s remit is an urgent priority. A focus on the future value of innovation, rather than decisions made on narrow costeffectiveness criteria, would mean NICE could play an important pivotal role in an outcomes-driven NHS.” Dr Barker said that the issue of how drugs are reimbursed will be just one factor in how patient access to medicines can be improved. “How they are built into NICE’s view of clinical best practice and quality standards, and then brought into wide use in the NHS, will clearly be of equal importance,” he said. IMS predicts growth GSK sales have fallen in the thirdquarter following the suspension of Avandia and decreasing use of Relenza as the flu pandemic peters out. The company posted a total sales decline by 2%, but saw figures increase by the same amount when Avandia and the H1N1 product were removed. The global pharmaceutical market is expected to recover in 2011, with predicted growth of 5-7%, according to IMS Market Prognosis. IMS Health has estimated a market value of $880 billion for 2011 and accelerated growth compared to the 2010 rate of 4-5%. ABPI Code changes The ABPI has voted in favour of amendments to the ABPI Code of Practice which aim to increase transparency and help break down barriers to trust. The amendments include stricter regulations on the promotional items industry representatives can provide to healthcare professionals (HCPs). Teva buys Théramex Merck Serono is to sell Théramex, its Monaco-based women’s health business, to Teva for 265 million euros. Teva will acquire 100% of the shares of Théramex S.A.M. of Monaco and Théramex S.p.A. of Italy, as well as the distribution rights of Théramex products in certain countries, including Spain and Brazil. The Government will increase NHS funding by the minimum needed to meet its “real terms increase” pledge as part of the comprehensive spending review. Funding will rise by just 0.1% above inflation from next year onwards from £104bn to £114bn in 2014-15. The DH has decided not to introduce generic substitution as proposed by the 2009 PPRS, following public consultation. The Government said that it intends to stand by the 2009 PPRS agreement, but would explore other ways of supporting the use of generics. Pfizer to buy King 10/11/2010 12:00 GSK posts losses Andrew Witty Funding to rise DH rejects after CSR substitution George Osborne Cancer fund confirmed A £600 million Cancer Drugs Fund has been confirmed by Health Secretary Andrew Lansley. From April 2011 until the end of 2013, cancer patients will get greater access to drugs recommended by their doctor through £200m of funding each year. Pfizer is to acquire King Pharmaceuticals, a diversified specialty pharmaceutical discovery and clinical development company, for $3.6 billion. The merger will create one of the leading broad portfolios for pain relief and management in the biopharmaceutical industry. King’s products in this area include Avinza, the Flector Patch and Embeda, the first approved opioid pain product with design features intended to discourage misuse, as well as other compounds in development. To read the full story, click on the headline CHMP sees Lucentis future Follow PharmaField on Twitter Novartis’ Lucentis (ranibizumab) has been given a positive opinion for the treatment of visual impairment due to diabetic macular edema (DME) by the CHMP. Data from the RESTORE and RESOLVE studies showed the treatment was superior in providing rapid and sustained visual acuity gain when compared to current care types. Pharmaceutical Field YEARBOOK 2010 NOVEMBER 2010 New drugs expected to earn £5bn Management commission launched The combined sales of seven emerging breast cancer drugs are expected to reach nearly $5bn in seven major markets by 2019, says a new report. The Pharmacor 2010 findings from the Breast Cancer study predicted sanofi-aventis’s Iniparib as a potential blockbuster in the US, France, Germany, Italy, Spain, UK and Japan with sales in excess of $1bn predicted. A new commission has been launched by The King’s Fund to assess the leadership and management needs of the NHS. It will evaluate national and international evidence about the current state of leadership and management and outline the capabilities needed to meet future challenges. RA treatment given OK AstraZeneca and Pozen’s combination RA treatment Vimovo has received a positive agreement for approval in 23 EU countries under a Decentralised Procedure. The treatment, indicated for the symptomatic treatment of osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS), was approved following a positive conclusion from the Netherlands Health Authority acting as the Reference Member State. Trusts’ finances in good shape Union issues warning The majority of NHS trusts and Primary Care Trusts are managing their budgets well, a report by the Audit Commission says. The Auditors’ Local Evaluation and Use of Resources 2009/10 showed a sustained improvement nationally over five years and found that the NHS returned a surplus of £1.5 billion during an audit of the 2009/10 accounts. The NHS and patients will pay a high price for drugs if NICE is stripped of its safeguarding powers, UNISON says. The union, who recently failed in legal action against Andrew Lansley as part of a campaign to save the NHS, warns the NHS and patients will be the “ultimate losers” under new proposals to introduce value-based pricing (VBP). Professor Chris Ham Blockbusters expected A new report into the future of fixed dosing combination product development has predicted a number of potential blockbusters. Exforge, Janument, Certria, Vimovo, Dudoart and Duoplavin were all highlighted as having huge sales potential in The future for fixed combination product development. David Stout EU Survey reveals MabThera approved scepticism Less than a quarter of doctors believe the Government’s proposed reforms will improve patient care, a new survey commissioned by The King’s Fund and Doctors.net.uk has revealed. More positively, however, over 60% of GPs believe there are GPs in their area with the capacity to lead new GP consortia. Pharmaceutical Field YEARBOOK 2010 Roche’s MabThera has been approved by the European Commission as a maintenance treatment for follicular lymphoma. The approval is based on results from the PRIMA study which demonstrated the use of MabThera for two years doubled the likelihood of patients living without their condition deteriorating. Mixed outcomes for Victoza NICE has recommended a 1.2mg dose of Victoza (liraglutide) for the treatment of type 2 diabetes mellitus. But it has failed to recommend a daily 1.8mg dose saying the increase did not show any “significant additional benefit”. NICE backs Tyverb decision NICE has backed its advisory committee’s decision on breast cancer drug Tyverb (lapatinib) following an appeal by GSK. A review found the committee followed the “correct procedures” and did not “exceed its powers” when it failed to recommended the drug’s use – except in clinical trials – in draft guidance back in June. Vidaza appeal fails NICE has again decided against recommending Celgene’s myelodysplastic syndromes (MDS) treatment Vidaza (azacitidine) in preliminary draft guidance. The Appraisal Committee decided that its benefits did not justify the high cost of the drug – even with a proposed Patient Access Scheme (PAS). Trio fail appraisals NICE has failed to recommend a trio of cancer drugs in three separate pieces of guidance. GSK’s Arzerra (ofatumumab) does not justify its cost, says the appraisal committee, with NICE unable to complete appraisals on Pfizer’s Torisel (temsirolimus) and Napp Pharmaceuticals’ Treanda (bendamustine) due to a lack of evidence. You are not alone The pharmaceutical sales force is not the industry’s sole ambassador in the field. With companies seeking to improve operational efficiencies and capitalise on available resources, marketers and medics are increasingly being deployed in more customer-facing positions. But how much do you understand the benefits of a crossfunctional approach? Karen Westaway puts the developing role of the field-based medic under the spotlight. Pharmaceutical Field November 2010 T he battle to become customer-centric continues to drive global business strategy in the modern marketplace. As the saying goes, if you’re not thinking about the customer, you’re not thinking. For the pharmaceutical sector, the pursuit of customercentricity remains a complex and unusual challenge; while the majority of sectors continue to find customers in short supply, the drug industry faces a problem of a different kind: it has too many. The rapid proliferation of healthcare stakeholders and influencers in recent years has given pharmaceutical companies a split customer-base – loosely defined as clinicians and payers. As a consequence, the challenge to be customer-centric is a difficult one. A key component of a truly customer-focused organisation is the culture of collaboration. Customer-centricity and crossfunctional working go hand in hand. The product-oriented sales culture that characterised too many historic business strategies and led to a territorial approach where information was rarely shared across organisational silos is dying. Today the silos are being broken down and the smartest companies are tailoring solutions to suit customer needs, built upon linkage and cooperation across all internal business functions. The glue for cross-functional working in a customer-centric culture is marketing. But, for pharma, without the collective intelligence of the sales and medical teams, the glue just won’t stick. Marketing guru Philip Kotler describes marketing as “the homework your company does to figure out what people need and what your company should offer”. Moreover, he says that marketing hopes to understand the target customer so well that selling isn’t necessary. Clearly then, strong marketing should not only be the lifeblood of any customer-centric organisation, but the vein must run ceaselessly across all business functions. Marketing does not begin with the product, it begins with the customer. A bigger playing field So what does all this mean for medical sales professionals? Traditionally, the field-force has been Pharmaceutical Field November 2010 considered pharma’s most valuable customer-facing asset. Arguably, this may still be true. But it is not the only one. Nowadays, the industry deploys a wide range of field-based personnel. There has been significant growth in the number of field-based medical and marketing professionals, with the wider aim of developing a more comprehensive and holistic understanding of individual customer groups and their needs. These insights are fed back through the cross-functional brand team and used to develop products and services that can help customers meet their objectives. This proactive approach is a far cry from the traditional methodology whereby R&D would develop a product then pass it across to marketing who would, in turn, conjure up a few messages and throw them over the fence to the field force and hope for the best. Crossfunctional working within customercentric organisations is based on an integrated, collaborative approach across medical, marketing and sales. It begins with the customer, rather than the product, and it lasts throughout the customer life-cycle. Well, that’s the theory. The question is, just how cross-functional are you? How much insight do you have into the roles your colleagues from other business functions play – and, indeed, how what they do can impact on your customer interactions? In this short series of articles looking at cross-functional working, we explore the three distinct business disciplines that must successfully integrate if the goal of customer-centricity, and subsequent commercial gain, is to be achieved; medical, marketing and, of course, sales. We begin with the medical team. Developing the medics The idea that the medical department is a critical component in the commercial operation of every pharmaceutical organisation is no doubt an anathema to the vast majority of those who work within it. Historically, medics have played a discrete supporting role in the commercialisation of products, allowing sales and marketing professionals to focus on selling drugs. But in an era driven by health economic imperatives and HTAs, medical departments are increasingly being called upon to take more responsibility for the commercial performance and market access of pharmaceuticals. Marketers are urging medical teams to maximise the interactions they have with their customer-base – engagement that cannot be promotional, but can have an undoubted impact on the success of a product. Despite the widespread need for companies to generate and present cost-effectiveness data to payer customer-groups, the value of strong The sales force may be the industry’s biggest collective customer facing body, but the vital commercial interactions it has at the sharp end are greatly enhanced by the field-based work that takes place elsewhere within each organisation. Employees at every level and in every division need to nurture a deep understanding, not only of customer needs, but also of the important role others around them play within an organisation – in particular those who have key touch-points with customers. Quick Read • Cross-functional working is a key component of building a customer-centric organisation • Sales professionals are not the only field-based professionals within pharma companies • Medical and marketing personnel are being deployed in more customer-facing roles • Medics can help accelerate trial recruitment, time to market and product uptake through improved early interactions with customers • Medics interaction with customers is governed by strict regulation by the ABPI Code • Dialogue cannot be solicited or promotional • Sales professionals need to develop a detailed understanding of how other internal roles support/impact their customer interaction clinical data has never diminished. The effective communication of such data can deliver significant longterm benefits for a product, but this process is not the sole responsibility of the sales force. It begins, long before sales teams start taking commercial messages to market, with those important early interactions between medics and customers. How? Well, medical teams can influence the speed at which a clinical trial recruits patients through effective engagement with key investigators. Medics have been performing this valuable role for years, but many are unaware of the commercial gains that can be made if a trial completes recruitment ahead of schedule. Equally, medics also perform a vital role in talking to potential customers in the months between the completion of clinical trials and regulatory approval. These interactions can neither be promotional or solicited, but the quality of these dialogues can be critical to the eventual success of a product. The interim period between the presentation of trial data and securing a license can often equate to a considerable amount of time – dead time if companies are not making the most of available data. For example, in cases where drugs are likely to achieve fast-track licensing, there can be a gap as long as a year between the original data presentation and the award of a license. During this time, companies can be leveraging the data and preparing potential customers to use the product once it becomes commercially available. To capitalise on the opportunity, medical and scientific staff are being encouraged to evolve beyond their traditional mindset. In the spirit of customer-centric, cross-functional work, marketers are urging medics to develop commercial competencies and become agile thinkers. Fieldbased medics must develop a greater understanding of the impact their dialogues with customers can have on the uptake of a product. Further down the line, the benefits to sales professionals are obvious. Ensuring compliance The process does not, of course, come without risk and regulation. The ABPI Code of Practice provides strict governance around this sensitive area. STAYING WITHIN THE CODE • • • • Medics visits cannot be solicited – they must be requested Medics must present a drug as a generic rather than a brand Branded materials must not be used Medics must use clinical papers and clinical data Pre-license, companies cannot proactively seek customer engagement about their products – they can only engage reactively following a customer request. What’s more, once in situ medics must talk about a drug in a generic sense and present information based only on clinical papers and clinical data. Glossy branded materials and leavepieces are strictly prohibited by the Code. Despite these strict guidelines, opportunities to raise awareness do exist – so long as the fine line between education and promotion is understood and respected. For example, if a medic is with a customer discussing a clinical trial, providing they stay within the rules of the Code, there is nothing to prevent them delivering information about other ongoing clinical trials, or having a broader discussion about their company’s pipeline. This may help drive faster patient recruitment to a trial or compassionate use programmes. Moreover, dialogue between medics and customers provides a powerful opportunity to build advocacy in the lead up to launch. In an environment where healthcare budgets are reducing and businesses are seeking operational efficiencies, pharma companies are now looking to make the most of available resource to drive commercial advantage. As a consequence, the evolution of more commercially aware medical teams is gathering pace. Marketers are working more closely with medics to help improve competencies such as communication skills and objection handling. Proactive brand teams are developing ‘Engagement Guides’ to provide medics with a framework for how to communicate during calls. There is an increased emphasis on driving a greater understanding of how specific aspects of a clinical paper can be presented in ways that have the most positive impact on the commercial uptake of a product in the future. On the broader stage there are increasing examples of companies convening pan-European medical team meetings where medics discuss pipeline products and their projected market size if licenses are successfully achieved. Presentations are focusing on the importance of medics achieving outcomes and actions from every customer interaction. Their over-riding rationale is to drive trial recruitment, accelerate time to market and facilitate quicker approval and faster uptake. Their collective purpose is not promotional – it never can be – but is about improving efficiencies, capitalising on early interaction with key customers and, ultimately, helping ensure patients gain quicker access to beneficial drugs. The role of the field-based medic is, therefore, taking on broader horizons. There is now a steady emergence of Clinical Engagement Managers being deployed by pharmaceutical companies to talk about clinical data in an engaging and communicative fashion. In the process, these medical teams are now playing an incredibly powerful role in preparing customers for their products once they have been licensed. Benefits to sales The long-term efficiencies that can be gained from more effective medical engagement are significant. And nowhere will these benefits be felt greater than in the sales force. The key to success, of course, is in sharing information, understanding customer insights and using it to develop messages that align the individual needs of all the key stakeholders and influencers in your marketplace. These can be crafted as part of a collaborative effort by the brand team, and will ultimately lead to sales teams being equipped with the most effective and resonant product messages to present to customers. The sales force may be the industry’s biggest collective customerfacing body, but the vital commercial interactions it has at the sharp end are greatly enhanced by the field-based work that takes place elsewhere within each organisation. Employees at every level and in every division need to nurture a deep understanding, not only of customer needs, but also of the important role others around them play within an organisation – in particular those who have key touch-points with customers. For the sales professional, it is important to understand that, despite the apparent solitude of your fieldbased role, you are not alone. The commercial imperatives of marketing pharmaceuticals are a collective responsibility that began long before your brand won its license. Delivering a cross-functional approach that ultimately generates a truly customer-centric culture requires the right attitude and a commitment to pool expertise, share information and collaborate effectively. Communication, a core competency of every sales professional, lies at the heart of a cross-functional approach. The interactions you have with peers and colleagues from across your organisation will have a major impact on the dialogues that take place between you and your customer. Being customer-centric means aligning the resources of your company to the ever-changing needs of customers and, in the process, building mutually profitable relationships. It is a mindset, and it encompasses every aspect of an organisation. Next month, we will look at the role marketing plays in a crossfunctional brand team. Karen Westaway is Joint Chief Executive of WG Group. WG provides a range of bespoke services to improve market access opportunities for pharmaceutical companies in the UK. For further details, please visit www.wg-group.co.uk Pharmaceutical Field November 2010 (I can’t get no) satisfaction The age-old question of whether we work to live, or live to work, still rumbles on today. But with companies doing more than ever to improve working practices, why is it that work-life balance is still a major concern? Pf’s Iain Bate reports. I t would seem there’s never been a better time to be an employee. Of course there’s the worry of job security and the complaint about being underpaid, which, let’s face it, will always be a contentious issue, but companies are now doing more than ever to please their workforce and bring an equilibrium of work-life balance. Pf ’s annual Company Perception, Motivation and Satisfaction Survey, which provides an accurate insight into the attitudes of sales personnel in the industry, showed that work-life balance was the third main motivational factor whilst at work. However, despite it being one of the main drivers, it was surprisingly voted one of the least satisfying aspects for respondents. Clearly employers still need to do more. The survey says More than a third of people in the survey said they were still unhappy at their level of work-life balance; despite advances in maternity and paternity leave, and the right to request flexible working hours for those with children under six, aimed at increasing morale and happiness within the workforce. Women were the least satisfied when juggling life at home and at work with 44% admitting their level of unhappiness. Unsurprisingly parttime staff said they were the most satisfied when questioned on their level of satisfaction with 60% saying they had no complaints between working only a few hours a day then enjoying favourite pastimes or family time. The younger generation – 25 years old to 34 years old – enjoyed the balance between work, rest and play the most with those aged between 45 and 54 complaining of an in-balance. Professor Suzan Lewis, research leader of the Human Resource Management department at Middlesex University, says it’s not uncommon for the there to be a distinct difference between the levels of motivational and satisfaction where work-life balance is concerned. “It is often due to a gap between policy and practice,” she explains. “There is evidence that polices can be undermined even in supportive companies by non supportive managers or a culture in which it is not acceptable to ask for flexible working hours, especially for men. “However, another factor is workload. As people have more and more intense workloads, policies such as flexible working arrangements are often used as tools to work harder, for example, taking work home or working at weekends. Or, if people who work reduced hours find there is no replacement for the work that they are no longer doing – as is often the case, either their colleagues have to pick up some of their work, causing relational problems, or they have to work harder to fit in a full workload in reduced time. I have seen plenty of evidence of all these things.” Within the industry, (see Figure 1) NHS Liaison officers were the most satisfied with more than half giving the thumbs up to the balance in their ‘downtime’ and work life. However, only a few doors away, hospital specialists were the least satisfied with 41% hoping for some sort of change. Despite having the benefits of holiday or sick pay, full time staff employed in the industry (45%) were only slightly more satisfied than counterparts working for an agency (44%). The working week Alongside the ‘perks’ of a job, it’s the amount of time whilst at work which seems to be the main bugbear for employees. According to the Office of National Statistics, full-time workers in the UK average 37 hours per week, part-timers do on average 15.5 hours and just over a fifth of people in employment work more than 45 hours a week. While this may be more compared to EU standards, other developed countries such as Australia, Japan and the US have a higher proportion of ‘long hour workers’ than the UK. The main regulations governing working time are the Working Time Regulations 1998 (WTR). The WTR implement the previsions of the original directive and include conditionals relating to weekly working time, rest entitlement and annual leave, plus special provisions for those working through the night. The basic WTR rights and protections include: Pharmaceutical Field November 2010 Figure 1 • • • • • • Job title Satisfied Dissatisfied No opinion 1st line manager 33% 35% 32% NHS liaison 52% 12% 36% Sales representative 47% 26% 27% Key account managers 47% 30% 23% Hospital specialists 38% 41% 23% A limit of an average of 48 hours a week over a 17 week period A limit of an average of 8 hours work in a day which night workers can work A right to 11 hours rest a day A right to a day off each week A right to an in-work break if the working day is longer than six hours 28 days paid leave for full-time workers per year. Under the WTR, employers are also legally obliged to provide special leave in certain circumstances, for example, court service or military training and service. Pharmaceutical Field November 2010 A review of the literature between long days at work and health for the Health and Safety Executive in 2003, said that “there is some evidence that working long hours can lead to stress or mental ill-health”. Stress-related absence levels have increased in the past year and are now the main cause of long-term absenteeism in the public sector. According to the Chartered Institute of Personnel Development (CIPD), workers in the public sector took an average of 9.6 days off sick last year, three more than the private sector, as a result of stress. Although stress is considered a personal problem, Professor Lewis believes companies can still do more to reduce the pressure placed on staff in the office. “Through management support and line manager training – to value people who want work-life balance – employees are less likely to get burnt out than those who work all the time,” she continued. “Also, companies can help by questioning deeply embedded assumptions that ideal workers should be available and visible all the time. Good employers value workers’ outputs, rather than the amount of time they spend at work.” Pharma fights back More and more companies now realise the importance of providing the right blend between time spent at work and at home. Pharma is no different and recently had several high profile companies included in the US Working Mother magazine’s 100 Best Companies 2010. Abbott, AstraZeneca (AZ), Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Genentech, Merck (MSD in the UK), Novo Nordisk, Pfizer and sanofi-aventis were all included in the list for their various work-life balance friendly policies. Quick Read • Third of respondents in Pf survey unhappy with work-life balance • Men more satisfied than women • 60% of part-time staff satisfied with work-life balance • Younger workers more satisfied than elder colleagues • UK full-time workers average 37 hours per week; part-time 15.5 hours; and a fifth work more than 48 hours per week. • Long hours and high workloads result in high levels of absence through stress Nearly 90% of employees at Abbott enjoy flexible working schedules where an on-site childcare centre at its headquarters in north Chicago, Illinois, looks after children full-time and also offers therapy for disabled children. AstraZenca provides childcare programs and peer mentoring schemes. It also hosts the Working Parents Network which offers advice on familyfriendly topics such as meal planning and managing home finances. Boehringer Ingelheim entered the top 100 for the first time after providing an impressive range of benefits for both mothers and fathers. Bristol-Myers Squibb now allows expectant mothers 24 job-guaranteed weeks off after the birth of a baby and has recently opened its fifth childcare centre, with full-time, part-time and back-up care for over a hundred children. BMS also stages summer camps and free classes on healthybaby care. Eli Lilly’s provides access to the company’s 267-acre park near their headquarters in Indianapolis, Indiana, and free memberships to local gyms. It was also noted that in 2009, 90% of employees adjusted their working hours in their favour. The latest “coolest addition” for employees at Genentech is CareerLab, a facility at HQ in south San Francisco, which offers career counseling, skills workshops, mentoring sessions and networking events. Companies can help by questioning deeply embedded assumptions that ideal workers should be available and visible all the time. Good employers value workers’ outputs, rather than the amount of time they spend at work. Merck continued the trend of trying to adjust work-life balance and morale when it launched its Exceptional Caregiving website in 2009. The site provides a variety of resources for those raising kids, teens and young adults with special needs. The company also doubled its adoption aid benefit to $10,000 and gave parents who adopt one fully paid week of leave. Novo Nordisk was one of the highest companies on the list. It launched the popular ‘Saving and Paying for College’ seminar for employees with children of all ages. Parents can also enjoy 80 hours of cheap in-home or centrebased back up care annually for use with dependents and ill family members. Female Pfizer employees have the opportunity to use the company’s Reproductive and Neonatal Resource Service, which provides a personal nurse and helps them locate top infertility centres across the US. New mums are also allowed to spend the last three weeks of their pregnancy at home and are granted 32 weeks off after the birth. Sanofiaventis was particularly noted for offering online tutoring and SAT test prep for kids ages four to 18 and financial, as well as medical aid, for children in need of developmental therapy, special types of dependent care or upgrades to make their homes more accessible. The right mix Despite pharma companies introducing more working practices in an attempt to keep employers in work, and happy while they’re there, the CIPD still believes that even in these difficult economic times, employers should protect their workforce from being overworked. Where employees are working consistently long hours, this has a negative impact on their employment performance or wellbeing. “I do think it’s a company responsibility (to improve satisfaction levels of work-life balance),” added Professor Lewis, “not just ethically but also because there is lots of evidence that workers with good work-life balance are more effective. It’s also a governmental responsibly to ensure the wellbeing of individuals, families and companies. Anything companies can do to challenge assumptions that ideal workers do not need work-life balance is helpful – but it’s not easy as these assumptions are rarely challenged.” It would seem the message is simple – although not always practical for employers: promote a restructuring of working time and the methods in which people work to correct the balance between work life and time spent at home; and finally get the best out of people whilst at work. After all, a happy worker is a productive one. • Are you being paid enough? • Do you feel secure in your job? • Is your work-life balance leaning the right way? Have your say on these issues and many more. The Pf Company Perception, Motivation and Satisfaction Survey. online at www.pharmafield.co.uk Pharmaceutical Field November 2010 DECEMBER 2010 Pharma not providing value for money, say MPs The majority of UK MPs do not believe the pharmaceutical industry provides value for money for the NHS, new research has shown. The study, conducted jointly by ComRes and Westminster Advisers, says the sector must do more to demonstrate its value to the nation’s health. Pharmaceutical Field The gateway to a commercial career in pharma December 2010 Choppy waters Chorus of approval Transparency and disclosure p12 p18 p22 Pharma not providing value for money, say MPs The majority of UK MPs do not believe the pharmaceutical industry provides value for money for the NHS, new research has shown. The study, conducted jointly by ComRes and Westminster Advisers, says the sector must do more to demonstrate its value to the nation’s health. It also suggests that a high number of MPs do not trust the communications they receive from the industry. The Pharmaceutical Industry and Parliament: a joint report on parliamentary opinion towards the pharmaceutical industry reveals that while MPs from all three main parties have a high regard for the economic importance of the pharmaceutical sector, a worrying 62% believe that the prices the industry charges the NHS for medicines do not deliver value for money. Almost two thirds of MPs (64%) NICE says no to Avastin again NICE has again failed to recommend the use of cancer drug Avastin for use on the NHS – this time in breast cancer. The Institute decided against recommending the drug when used in combination with chemotherapy for people whose breast cancer has spread in final draft guidance. It is the second time inside a month that NICE has failed to recommend Avastin following its recent appraisal for the treatment of metastatic colorectal cancer (p9). support the introduction of a valuebased pricing system. The research highlights that only 40% of MPs trust the communications they receive from the industry. The highest levels of scepticism appear to be among Labour MPs, with 74% of those surveyed believing the industry does not provide value for money and only 23% trusting industry communications. More than half (53%) of Conservative MPs trust the communications they receive. Tony Black, Head of Healthcare Research at ComRes, said: “Value for money is the be all and end all for all public policy debates at the present time. Improving levels of trust among MPs towards the communications they receive from the pharmaceutical industry is crucial if pharma is to put itself on the right side of the value debate.” Proposals to introduce value-based pricing were unveiled last month, with the new pricing method set to be introduced towards the end of 2013 when the current Pharmaceutical Price Regulation Scheme (PPRS) expires. The present PPRS caps the profit pharma companies can make from NHS sales at 29.4%. However, under the Government’s proposed model, companies can set initial prices which are then reviewed to establish cost effectiveness – with either the NHS or pharma reimbursed against the original cost, dependent upon the outcome of the review. However, the ABPI has warned that the new model may not deliver the NHS savings the Government anticipates. Its Director General, Richard Barker, recently told a conference audience: “There is an unrealistic belief in the Government’s mind that the result is that prices will fall. But I don’t think we know. Value-based pricing is thoroughly logical, but not a magic bullet.” The ComRes/Westminster Advisers survey showed that only 34% of MPs agreed Britian has poor uptake for new, innovative medicines relative to other European countries, and that 41% ‘don’t know’. The report indicates that there is scope for the industry to take a greater initiative in educating parliamentarians about this critical issue. THIS IS EXCITING/CHALLENGING/VISIONARY/ DEMANDING/ARE YOU? THE 21 BEST JOB OPPORTUNITIES IN THE PHARMACEUTICAL INDUSTRY. THIS IS EXCITING.CO.UK PF-DEC-NEWS - EDIT IB.indd 1 PAS not enough for Afinitor NICE has failed to recommend Novartis’ Afinitor (everolimus) for the second-line treatment of advanced renal cell carcinoma (RCC). Draft guidance concluded that Afinitor does not provide enough benefits to justify its high cost, despite Novartis submitting an amended Patient Access Scheme (PAS). 08/12/2010 15:50 Ex-ABPI Review chief secures highlights life Government role sciences Former ABPI President Chris Brinsmead has been appointed as the Government’s Life Sciences Business Adviser. Brinsmead will support close and collaborative working in life sciences, both in the UK and overseas, with the NHS and academia to provide independent advice and challenge to Government. A Government review of private sector growth has identified healthcare and life sciences as one of six key business sectors where opportunities for growth can be maximised by policy changes. The review has been welcomed by industry trade associations, as has its announcement of measures designed to follow recommendations made by the Office for Life Sciences in 2009. Patent box holds GSK key Chris Brinsmead New IFPMA President David Brennan, Chief Executive Officer of AstraZeneca, has been elected as the new International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) President. Brennan succeeds outgoing IFPMA President Haruo Naito, President and CEO of Eisai. John Lechleiter, who is Chairman, President and CEO of Eli Lilly, and Masafumi Nogimori, President and CEO of Astellas Pharma, have been elected as Vice Presidents. GSK plans to invest £500 million should the Government’s proposed Patent Box tax regime be established. The system offers a lower rate of corporation tax on profits generated from UK-owned intellectual property which would fund several initiatives and could create an estimated 1,000 jobs. To read the full story, click on the headline Bayer commits to job cuts Bayer is to shed 4,500 jobs as part of its plans for future growth and to enhance its innovative capabilities. The company aims to make major investments in the development of its pipeline, marketing and emerging markets by saving €800 million annually from 2013. Rebranding at Bayer Bayer Schering Pharma has rebranded itself as Bayer HealthCare. The decision follows plans to strengthen the Bayer Group and steadily reduce the number of its other corporate brands. Chairman Marijn Dekkers said the current number of brands has “diluted” the group and that the change would improve the company’s worldwide reputation. AZ chief predicts more cuts AstraZeneca CEO David Brennan has warned of further cuts and job losses within the company. Brennan says AZ will be continually looking at its commercial operations for potential savings insisting “there is more to go at”. HAPPY IN THE WORKPLACE? HAVE YOUR SAY PF COMPANY PERCEPTION, MOTIVATION & SATISFACTION SURVEY 2011 - OUT JANUARY Novartis builds on portfolio Novartis is to build on its diversified healthcare portfolio to sustain future growth. The company plans to accelerate growth through its healthcare segments; by strengthening leadership in biosimilars and first-to-market launches to drive performance in Sandoz; and through meningococcal vaccines. Joseph Jimenez Pharmaceutical Field YEARBOOK 2010 DECEMBER 2010 New public Novartis Pharmaceuticals health service to cut US jobs launched Novartis Pharmaceuticals Corporation (NPC) is to axe approximately 1,400 positions. Imminent patent expiries mean that its General Medicines US field force will be cut. But with product launches expected within the primary care and momentum within the Specialty Care business, the company says growth potential remains strong. The Government has launched a new public health service, Public Health England (PHE) with a budget mostly to be controlled by local authorities. The new body will bring together experts from bodies such as the Health Protection Agency and will focus on national health threats and strategies for improving public awareness of disease prevention. EC approves rare cancer drug Pfizer’s Sutent has become the first treatment to be approved for patients with pancreatic neuroendocrine tumours (NET) in Europe. The European Commission has approved a new indication for the treatment of unresectable or metastatic, well-differentiated pancreatic NET following Phase III trial results. More cuts at Pfizer Pfizer is to cut more jobs than initially planned. The company had planned to reduce its workforce by 15% (over 19,000 jobs), following its $68 million acquisition of Wyeth last year. But it now says it expects to exceed its original workforce reduction target, having cut numbers by 18,000 up to the end of Q3. Pharmaceutical Field YEARBOOK 2010 Andrew Lansley New twist in sanofi bid Sanofi-aventis could see its proposed acquisition of Genzyme scuppered after the biotechnology firm entered talks with rival pharma companies. Takeover talks began in July but the pair has been unable to agree a deal. Media sources claim Takeda, GSK, Eli Lilly, Johnson & Johnson and Pfizer have all entered talks with Genzyme. MabThera boost for patients Patients with advanced follicular nonHodgkin’s lymphoma are set to benefit after NICE recommended the use of MabThera (rituximab) as a first-line maintenance treatment in preliminary draft guidance. Evidence showed the drug could significantly help to delay the growth and spread of the cancer in those that have responded to first-line induction therapy with the drug in combination with chemotherapy. NICE says no Thousands affected by Roche to Javlor restructuring Roche is to cut thousands of jobs as part of its Group-wide Operational Excellence Program. 6,300 jobs will be affected, with the Pharmaceuticals Division, particularly global sales and marketing, losing more than 5,000 positions. NICE has failed to recommend bladder cancer treatment Javlor (vinflunine) in preliminary draft guidance. The Institute said the treatment is too expensive for the NHS and that manufacturer Pierre-Fabre had failed to supply suitable evidence of its clinical effectiveness. Lundbeck changes structure Avastin not effective enough Lundbeck is to overhaul its sales force structure. The traditional sales model will be replaced by a new structure that includes Directors of Healthcare Development and mental health specialists. NICE has failed to recommend Avastin (bevacizumab) for metastatic colorectal cancer in final draft guidance. NICE said Roche’s Patient Access Scheme was complex and the drug’s high costs did not match its benefits. Roche was invited to submit additional data, but no new information was received to justify its costs to the NHS. No change on Tarceva NICE has reiterated its decision not to recommend Tarceva (erlotinib) as a maintenance treatment for non-smallcell lung cancer in a second draft of its guidance. The independent Appraisal Committee decided that although Roche had provided evidence that the drug could potentially extend life, it was not sufficiently robust. NICE favours diabetes drugs Patients suffering from diabetes or heart disease are more likely to receive new medicines than cancer patients through NICE’s appraisal scheme. New analysis showed that between 2007 and 2009 only one out of 23 cancer treatments received a full recommendation, compared to 4 out of 7 appraisals for cardiovascular or metabolic products. Choppy waters A recent survey by MGP and Brainsell reveals pharmaceutical advisers and senior medicines management pharmacists believe the transition to the planned NHS reforms may not be a smooth one. T he White Paper Equity and Excellence: Liberating the NHS sets out the new Government’s strategy for the Health Service. The intention is to create an NHS which is more responsive to patients, and achieves better outcomes, with increased autonomy and clear accountability. One of the central features of the proposals in Liberating the NHS is to devolve commissioning responsibilities and budgets as far as possible to those who are considered best placed to act as patients’ advocates and support them in their healthcare choices. The aim is to empower GP practices to come together in wider groupings or ‘consortia’ to commission care on their patients’ behalf and manage NHS resources. PAMMtrak is a bi-annual survey that gathers the views of, and highlights the key issues facing, pharmaceutical advisers and senior medicines management pharmacists. In October 2010, healthcare publisher MGP and specialist market research company Brainsell carried out a specific survey of this PAMMtrak audience to assess how they see the future in the light of the Government’s White Paper. The results of this online survey are based upon the first 100 responses and make very interesting reading for those working in the pharmaceutical industry. Only 17% of pharmaceutical advisers and senior medicines management pharmacists who responded to the questionnaire are positive about the future under the new commissioning arrangements; whilst 58% are either quite or extremely negative. Indeed, more than 80% believe that their colleagues feel either quite or extremely negative about the proposed changes. The new NHS Only 17% of pharmaceutical advisers and senior medicines management pharmacists who responded to the questionnaire are positive about the future under the new commissioning arrangements; whilst 58% are either quite or extremely negative. Indeed, more than 80% believe that their colleagues feel either quite or extremely negative about the proposed changes. When asked about their greatest concerns over the new arrangements, typical comments included: “The destruction of the PCT and SHA organisation and expertise, the loss of their functions particularly in regard to quality and patient safety.” “The proposals to completely remove PCTs. I agree there is potential opportunity to make some savings in management costs but the many functions and benefits that PCTs bring to the NHS are I’m afraid going Pharmaceutical Field December 2010 Pharmaceutical Field December 2010 Quite negative Extremely negative Chart 2 - Thinking about the proposed NHS commissioning arrangements, do you think the following organisations will: (a) have clinical guidelines/care pathways: (b) have prescribing formularies: 80% Have prescribing formularies Have clinical guidelines/care pathways 70% 60% 50% 40% 30% 20% 10% ng bo ar ds bo a ng m iss io ni ni io na l N at io na Re g co m io om m iss lc P G na l io N at rd s tic es ac pr P G ln etw or ks Cl ed er a af co ns or ti in ica tio rti ns a sts tru co ns o P G tio n ng m co m co m Re gio na l G Fo un da bo ar ds iss io ni ng bo ar ds es ac tic pr m iss io ni ln ica in G tio ra Cl ed e af rti P co ns o P etw or ks ns a so r ti co n P G tio n tru sts 0% Chart 3 - In which type of arrangement do you think you will be most likely to be providing medicines management advice Don’t know 0% Other (please specify) 10% Company that you have ownership in 20% Individual provider 30% Employed directly by a foundation trust 40% Employed directly by a GP practices 50% Employed by a private provider company 60% Employed by a social enterprise spun out from a PCT When asked to think about which organisations under the proposed new NHS commissioning arrangements will Neither positive nor negative Employed directly by a GP consortium federation Assumed responsibilities Quite positive nd a “The drug budget being passed to GP consortiums.” “It may become fragmented with individual consortia each taking their own focus. This may have benefits if benchmarking and sharing across consortia are developed.” “Prescribing teams having to create their own limited companies and therefore not being NHS staff. Working for GP consortia and, again, not being an NHS employee.” “Loss of capacity, expertise and leadership within medicines management, particularly in primary care, where the majority of the QIPP changes (major cost savings) will be delivered.” “Greater focus on direct work for GP practices, budget management, formulary management, working on GP agenda rather than PCT agenda. Employed directly by consortia? More outsourcing/industry involvement.” “It will be positive as working with doctors more closely.” Extremely positive Employed directly by a GP consortium Respondents were also asked: “What do you consider will be the major changes to medicines management under the proposed new NHS commissioning arrangements?” Typical responses included: Chart 1 - Thinking about the DH White Paper Equity and Excellence: Liberating the NHS, how do you feel about the proposed changes to the structure of the NHS? Fo u to be thrown out with the bath water and we will have a system in total chaos.” “The disintegration of medicine management services and rising prescribing costs.” “Fragmentation, particularly with respect to medicines management.” “Medicines management teams can be quite large in some areas, if we are to be directly employed by GP consortia, how are they expected to pay for the whole team? Will they want to? Therefore, jobs may be lost.” “The lack of pharmacy networks if pharmacy moves to consortiums.” “That GPs will not sufficiently comprehend the value of our offering and choose not to use our medicines management services but go elsewhere for them.” “Uncertainty as to where we will be. Will there be a role for us and will this be within the NHS umbrella?” “Losing my job.” Chart 4: Under which type of commercial arrangement(s) do you think that you will be working? 70% 60% 50% 40% 30% 20% 10% 0% Salary Fee related to target achievement Fee per project Percentage of drug budget savings Fee per month Other (please specify) Don’t know Chart 5: What will be the main medicines management activities that you are likely to be providing under the new commissioning arrangements? Don’t know Other (please specify) Other (please specify) Medicines use reviews Reducing events rates Care pathway redesign 0% Formularly development 10% Cost minimistaion 20% Prescribing reviews 30% Formulary management 40% Managing prescribing budget 50% Implementing national guidance 60% Prescribing incentive schemes 70% Compliance and concordance management 80% Chart 6: Under the new commissioning arrangements, how likely are you to engage in joint working with the pharmaceutical industry in the following areas? Staff training Patient education Funding of project staff Support for guideline implementation Very Likely Likely Economic analysis Not Likely Don’t know Audit Facilitation of pathway redesign Medicines management services Secondments 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% have prescribing formularies, clinical guidelines/care pathways, and provide medicines management advice the results point largely to foundation trusts and GP consortia/consortia federations. It is interesting to see that under the new arrangements roughly 50% of pharmaceutical advisers and senior medicines management pharmacists consider that they will be employed directly by GP consortia and 28% by GP consortia federations. Additionally, roughly a fifth considers that they will be employed by either a social enterprise spun out from a PCT or a private provider company. The majority of respondents consider that they will be working in a salaried post. Although interestingly over 16% think that they will be working on a ‘fee per project’ basis, over 10% on a fee related to target achievement and over 8% on a percentage of drug savings basis. From the list of medicines management activities that they consider that they will be involved in it would seem that these will be in managing the prescribing budget, formulary management, cost minimisation, prescribing reviews and formulary development. More than half also consider that they will be involved in care pathway design and implementing national guidance. The link with pharma The respondents were also asked how likely they would be under the new commissioning arrangements to engage in joint working with the pharmaceutical industry in a range of activities. The responses were largely positive with the leading areas where they would be likely or very likely to engage with the industry being training, patient education, project staff support, economic analysis and guideline implementation. Roughly a third stated that they would be unlikely to engage with pharma in this way, meaning that two thirds may be happy to do so. With the emphasis for commissioning shifting to GP consortia it seems that those involved in delivering medicines management have an uncertain future. However, this survey suggests that it is important that companies build strong relationships with the emerging GP commissioners and their medicines management teams and that there is a strong opportunity to do so. Pharmaceutical Field December 2010 Transparency and disclosure: ensuring fair play The onset of draconian anti-bribery legislation is forcing pharma companies to review their compliance policies and procedures. The global crackdown on “white collar crime” presents one of the biggest challenges to the life sciences sector. Pf explores a new survey of compliance in Europe. Is your company doing enough? S uggestions of bribery and corruption have hogged the national headlines in recent weeks, not least with England’s ill-fated bid to host the 2018 FIFA World Cup. But Panorama-style exposés into alleged inducements are not restricted to the beautiful game – the issue has been plaguing the corporate environment since time immemorial. And pharma, for one, has never escaped the insinuation. Earlier this year, Pf led with news of the US Department of Justice opening an international investigation into corruption in the pharmaceutical industry. Last month, the European Commission revealed it had carried out more antitrust raids at European offices of pharmaceutical companies. Alongside this, the global industry continues with rhetoric that places ‘trust’ at the heart of its collective strategy to improve its profile with both the public and customers alike. Yet the sense that there’s a pharma-Panorama just around the corner remains. Next April, new Anti-Bribery legislation comes into effect in the UK. Designed to tighten ethical procedures across the corporate sector, it has been described as one of the most draconian anti-corruption laws in the world. Pharmaceutical Field Decemmber 2010 Crucially, it creates a new offence of “failing to prevent bribery”, making businesses with any UK interest criminally liable if staff, subsidiaries, intermediaries or “associated persons” offer bribes on their behalf across the world. Guilty individuals can face up to 10 years imprisonment. Unsurprisingly, the new legislation is creating much unrest in boardrooms across the UK. Surveying pharma For sure, the pharmaceutical industry is sitting up and taking note. A new survey of European life sciences companies has revealed high levels of anxiety right across the sector. The 2010 European Trends in Aggregate Spend, Transparency and Disclosure Report, conducted by Cegedim Relationship Management, found that 93% of respondents are concerned that regulatory compliance will be a major challenge to the life sciences industry in Europe over the next three years – and that it is expected to impact the industry’s image significantly. Moreover, the survey reinforced the view that the challenge of managing compliance in an environment where anti-corruption legislation is emerging globally, will drastically change the way companies interact with healthcare providers and customers. “It came as no surprise to learn that the greatest concern is the changing compliance landscape and how this will affect daily processes and the image of the industry as a whole,” said Bill Buzzeo, Cegedim Relationship Management Vice President and General Manager, Global Compliance. “Life Sciences companies need a way to respond to a rapidly evolving industry that is presented with stiffer regulatory requirements in addition to extreme competitive pressures and market access challenges.” In response, companies are investing heavily in compliance and assessing policies and procedures. But concerns remain about the need to extend monitoring beyond traditional sales The challenge of managing compliance in an environment where anti-corruption legislation is emerging globally, will drastically change the way companies interact with healthcare providers and customers. and marketing functions. The survey indicates that European companies are already looking at what is happening in the US regulatory environment as they seek to define and establish new standards for best practice. Three quarters of respondents believe that the methods of tracking promotional spending currently being used in the US will be deployed in Europe – but the report warns that the cultural differences between Europe and the US may have implications for regulators and companies alike. “In the US, organisations must proactively disclose a large amount of information; from violations to every aspect of healthcare practitioner spend, under the Sunshine Act that comes into effect in 2013, specific to 2012 interactions with healthcare practitioners and organisations,” the report states. “This enforcement model reflects the high levels of regulation and enforcement applied across every US industry, from finance to utilities. In Europe, however, there is a far greater emphasis on self-policing. Life sciences companies are being asked by the authorities to improve information transparency and provide aggregated spend information. But at the moment, the final concept of transparency – and whether it will be enforced – is still to be determined.” Broader benefits Bill Buzzeo Pharmaceutical Field December 2010 The US is, of course, ahead of its European counterparts in terms of anti-bribery regulation. Its market has been heavily regulated for many years and the imminent Sunshine Act makes even greater demands for spend transparency. In anticipation of the Act, US companies have made real progress with their operational compliance – improving data quality and regulatory reporting requirements. Evidence suggests that, as a direct result, US companies are beginning to benefit from leveraging the insights enabled by such data capture, and sharing information across their organisations to drive productivity. In Europe, however, the report suggests that compliance officers – where they exist – are still “determining policy and assessing the implications of global, regional and local regulatory requirements.” In the UK, the ABPI has recently agreed proposals to update its Code of Practice to increase transparency and disclosure – with the changes coming into effect in 2011. As usual, the majority of change within the Code focuses on sales and marketing – notably the interactions between commercial professionals and their customers. But, the report notes, it is important to gain businesswide involvement in compliance activity – from senior management commitment, to the IT people involved in executing regulatory compliance programmes and the business people who own the data. “In the US, it has become apparent that the most successful regulatory compliance programmes are owned and driven by business people. Following this model will help European Life Sciences companies reduce time to market and the cost of regulatory compliance,” the report states. “Furthermore, growing numbers of US companies are turning to dedicated third party solutions for support in the compliance activity – with around 44% either already using or planning to take this approach.” The survey reveals that European companies are beginning to follow suit, although in much smaller numbers. “As the US forges ahead with operational regulatory compliance projects, it has become apparent that managing the volume of regulatory change and reconciling diverse data sources to deliver transparency, is too challenging to handle internally. The use of third party providers is becoming key in adhering to policies and procedures while effectively Quick Read Key findings from the Report • 83% of respondents work for European pharmaceutical companies • 93% of total respondents agree that regulatory compliance will be a major challenge in Europe • 82% believe that anticorruption regulation (Foreign Corrupt Practices Act, UK Anti-Bribary Law) will impact the regulatory enviornment and global transparency requirements • 62% agree that the implementation of transparency guidelines will generate promotional spend decreases • 83% agree the implementation of transparency guidelines will lead to better resource allocation • 53% of respondents anticipate their investment in aggregate spend transparency to grow • 22% of companies in Europe are using Excel today to monitor expenditure. This is set to drop to 10% as organisations increase their dependency on third party solutions to meet compliance requirements tracking aggregate spend, identifying suspicious financial transactions and streamlining regulatory compliance monitoring.” But there is one area where Europe is already ahead of the game, at a planning level at least, namely, leveraging transparency and aggregate spend information to derive benefits above and beyond compliance. 83% agree the implementation of transparency guidelines will lead to better resource allocation; whilst almost two thirds (62%) agree implementation of transparency guidelines will generate promotional spend decreases. To download a copy of Cegedim Relationship Management’s 2010 European Trends in Aggregate Spend, Transparency and Disclosure Report, go to www. cegedim.com/eucompliance Pf YEARBOOK 2010 D I R E C TO RY Advance Recruitment “Advance Recruitment specialises in medical sales and marketing recruitment for leading healthcare, ethical pharmaceutical, dental and veterinary companies throughout the UK. Our business has been built on achieving results in the search and selection of Medical Sales Professionals, Sales Managers, Marketing Personnel, Trainers, Export Managers, Nurse Advisors and Field Service Engineers. We recruit at all levels from Graduate or RGN Trainee through to Experienced Sales Executives, Managers and Directors.” Advance Recruitment, Stafford Court, 145 Washway Road, Sale, Cheshire. M33 7PE Freephone : 0800 783 0920 tel: 0161 969 9700 fax: 0161 969 9766 www.advancerecruitment.net Ashfield In2Focus Ashfield In2Focus is the UK’s leading provider of contract sales and nursing solutions. Our extensive offering includes the provision of primary care, specialist secondary care and nurse teams as well as dedicated training, business analytics and sales force effectiveness services. As part of the contract sales and marketing services division of Irish company, United Drug, we offer the pharmaceutical industry tailored solutions throughout the product life cycle. This opens unique and exciting career opportunities to both current and new employees. All of this, twinned with our wealth of experience ensures that we are continually delivering exceptional results. Phone: 01530 562300 Email: [email protected] www.ashfieldin2focus.com Chase When it comes to all of your recruitment needs, it is reassuring to know that CHASE provide resourcing solutions to major blue chip pharmaceutical and biotech companies in the UK. Such reassurance comes from our ability to find quality candidates and ensure applications are processed efficiently. Unique to CHASE’s recruitment team is the fact that the majority of Consultants have either previously worked in the pharmaceutical industry or have HR experience. CHASE is all about putting the right people in the right place at the right time. CHASE offers a full recruitment and Contract Sales service to our clients. Judy Phillips – Recruitment Director 0131 553 6644 www.chasepharmajobs.com Quintiles Quintiles – the global pioneer in pharmaceutical services -helps pharmaceutical, biotechnology and healthcare companies develop and market innovative therapies and services and deliver new drugs and cures for the world’s most challenging diseases. For more than 25 years, Quintiles has built its work on scientific rigor, therapeutic expertise and unparalleled service. With offices in more than 50 countries, Quintiles is positioned to accelerate new therapies to market — ensuring a higher level of healthcare for the people all over the world -,as well as offering global career opportunities and excellent rewards for our 23,000 employees. Phone: 01344 601550 Fax: 01344 601035 Emai:l [email protected] www.quintiles.com Royce Royce Consultancy is the premier recruitment agency for the Pharmaceutical, Biotech and Healthcare Industry; we also work with not for profit and government organizations, offering a bespoke service, tailored to all our customer requirements. We are proud of our legacy of exceptional career matches, delivered through our award winning consultant team, providing national coverage and local expertise. We take a consultative approach, deliver a world class service and are the leading provider of Direct Recruitment and Global Executive Search and Selection. Tel: 01344 601 144 Fax: 01344 601 036 Email: [email protected] Contact Kerry Bambrick - Sattar, Director Europe, Royce Consultancy URL: www.roycejobs.com Zenopa At Zenopa we have over 20 years of experience recruiting Sales personnel for the Pharmaceutical industry. Our client base consists of many of the larger pharmaceutical companies as well as the SME’s in the industry. We recruit nationally and have offices in Leeds, Buckinghamshire and Scotland. Zenopa are quality assured and externally audited to ensure we practice “Recruitment with integrity”. To actively progress your career or to register with us call Zenopa on 01494 818 050.