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Dávid Dankó, PhD, MSc Corvinus University of Budapest Institute of Management d id d k att uni-corvinus.hu david.danko i i h How can value be measured and valued? ISPOR 5th Asia-Pacific Conference, Taipei, 2 September 2012 Pharmaceutical innovation: underlying dilemmas in the early 21st century Innovation content of new active substances introduced between 1975 and 2002 • Real therapeutic breakthrough has become extremely rare • Innovation seems to be biased towards „sellable” therapy areas, while other areas are largely neglected Therape eutic value e Chemical structure Provides progress in ttreatment eat e t Does not provide progress in treatment New Already known • BUT policy backlashes against some forms of innovation 143 295 • ((10%)) ((18%)) 201 821 More and more new substances cause di disappointment i t t iin real-life l lif settings (14%) (56%) • The business model of the pharma industry is undergoing a slow but thorough transformation SOURCE: BARRAL, P.E. [2004]: 28 ans de résultats de la recherche pharmaceutique dans le monde 1975-2002. IRDES, Párizs © Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (2) 1 Health technology assessment as a tool to assess value Health technology gy assessment ((HTA)) covers all methods for the systematic evaluation of the comparative value of pharmaceutical products and other health technologies linked to pricing & reimbursement decisions by public and private payers preceding to admission to the reimbursement formulary and during formulary management. © Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (3) A definition from practice: HTA is much more than QALY’s and ICER’s! Health Technology Assessment (HTA) is the scientific evaluation of medical technologies regarding their effectiveness, appropriateness, efficiency as well as social and ethical aspects and implications. HTA is bridging the gap between the worlds of Science and Politics. In times of general health budget restrictions, HTA becomes more and more important by providing political decisionsmakers with timely, accurate and sound information on medical technologies. © Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (4) 2 Three main paradigms for HTA 1 ECONOMIC EVALUATION Based on pharmacoeconomics Strict quantitative methods applied by dedicated HTA agency Attempt to arrive at two economic indicators: ICER, budget impact Cost-effectiveness linked to explicit or implicit threshold QUALITATIVE ASSESSMENT 2 3 BALANCED ASSESSMENT Similarity with regulatory approaches Synergies between economic Mainly qualitative methodologies based evaluation and qualitative assessment on collective decision-making decision making Mainly collective decision-making decision making, which is retraceable and publicly No attempt to arrive at ICER: scoring is accessible often used, classification is a priority Consideration of non-financial aspects Cost-effectiveness is one input to a classification /scoring algorithm & broader societal impact Wide consideration of non-financial Supported by structured review aspects & broader societal impact UK © Dávid Dankó NZ PL HU F I How can innovation be measured and valued? J CH S CAN AUS Taipei, 2 September 2012 (5) Criticism towards economic evaluation – is it really able to capture value? Debate around acceptable ICER cutoff point or range Too much technicism, hard-tounderstand Pseudo-objectivity Legitimation role and business Pricing effect and perverted incentives Costliness and capabilities PUBLIC BACKLASH & SHIFT AWAY FROM ONE-SIDED ECONOMIC EVALUATION © Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (6) 3 Overview of qualitative value assessment criteria used in current international practice Australia Better pharmacokinetics Budget impact Clinical efficacy Clinical trial Cost-effectiveness Cost effectiveness Currently untreated disease Depth of action Industrial policy Logistics costs Market size New mechanism Orphan disease Patient equality Place in therapy landscape Public health significance Relative price Second-line therapy Severity of disease Side effect profile Technological innovation Therapeutic value France Italy X Japan X Spain (implicit) X Sweden X X X X (X) X X X X X X X X X X X X X X X X X X X X X X X X X X X SOURCE: OWN COMPILATION Different systems weigh elements differently, and no system covers all elements. Focus is sometimes missing. Assessment criteria used in different countries may cover similar concepts under different terminology. © Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (7) Straightening it out: possible framework for a redundancy-free, balanced system Unmet need (urgency) Costeffectiveness Budget impact Therapeutic value added Explicit local policy priorities More favourable side effect profile Therapeutic value added Szöveg Stronger adherence to treatment Higher effectiveness (degree of p ) response) Cost-effectiveness is necessary but not sufficient for drug reimbursement Therapeutic value added is measured SOURCE: OWN COMPILATION along 4 factors Health policy priorities help decide between therapy areas © Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (8) 4 Institutional background in middle-income countries • Several payers, complex decisionmaking processes • Intuitive, rather than analytical, decision-makers at political levels • Budget impact focus, emphasis on financial aspects • • Questions around the practical applicability of economic evaluation CAPABILITY GAP, „institutional cost-effiency” © Dávid Dankó How can innovation be measured and valued? Rational free-riding: Peering on selected international assessment Simplified local evaluation: Very focused, pragmatic local assessment Regional shared service centres for value assessment? Taipei, 2 September 2012 (9) Some preliminary suggestions There is considerable variation in HTA systems all around the world, with tendencies toward balanced assessment frameworks. Economic evaluation has challenges in middle-income countries. Blindly following the track which Central Europe followed in the past few years is not helpful. When developing a system, both the logic and process are crucial. © Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (10) 5 財團法人醫藥品查驗中心 Center for Drug Evaluation How can innovation be measured and How can innovation be measured and valued? Experience from Taiwan Jasmine R. F. Pwu, PhD Division of HTA, CDE Taiwan 12 Disclaimer The views presented in this presentation do not Th i t d i thi t ti d t necessarily reflect those of the CDE 財團法人醫藥品查驗中心 Center for Drug Evaluation 6 About Taiwan • Population – 23 million – Aging society • Parliamentary democracy • 2011 GDP per capita (nominal) ‐ US$21,832 (PPP, IMF) : US$ 39,245 財團法人醫藥品查驗中心 Center for Drug Evaluation Health Care • Total health expenditure ‐ p 6.9% of GDP • National Health Insurance – – – – Introduced 1995 Mandatory, single‐payer social health insurance Comprehensive Low premium & low co‐payment 財團法人醫藥品查驗中心 Center for Drug Evaluation 14 7 財團法人醫藥品查驗中心 Center for Drug Evaluation Well recognized,… By friends… Within ourselves… “The initiation of the National Health Insurance, Is the first time in our history, that people dare to be sick, can afford to be sick, can be sick without any feelings of guilt can have any kind of illness” Po‐Yang 財團法人醫藥品查驗中心 Center for Drug Evaluation …yet with challenges 8 Pre‐negotiated, fixed NHI expenses NHI medical and drug claims (NT$ billion) 財團法人醫藥品查驗中心 Center for Drug Evaluation HTA has played a role in New Drug Application… 財團法人醫藥品查驗中心 Center for Drug Evaluation 9 Consideration factors for listing Regulatory body • Safety • Efficacy BNHI • Comparative effectiveness C ti ff ti • Budget impact • Cost‐effectiveness • Ethical/Law/Social/Political Impact 財團法人醫藥品查驗中心 Center for Drug Evaluation Decisions made during DBC meetings • Listing or not Li ti t • Reimbursement price • Reimbursement criteria/restrictions b / 財團法人醫藥品查驗中心 Center for Drug Evaluation 10 Categories for New Drugs Category 1 Shown substantial improvement in effectiveness, comparing to the best ff i i h b currently‐used drug (therapy) Category 2A Shown moderate improvement Category 2B Shown similar clinical values 財團法人醫藥品查驗中心 Center for Drug Evaluation Price decision Submission Submission price New Drug category International prices Reimbursement price Comparators Restriction in Restriction in use 財團法人醫藥品查驗中心 Center for Drug Evaluation 11 Listing Review Process with HTA Application received Evi‐ dence Principal reviewers made written recommen‐ dations Nominate 2+ DBC members as principal reviewers DBC meetin g Assessment Report in 42 days 財團法人醫藥品查驗中心 Center for Drug Evaluation Listing Review Process Application Received d 42 Days Effectiveness Economic + Assessment Assessment = Evidence Report Drug Beneficiary Committee 財團法人醫藥品查驗中心 Center for Drug Evaluation 12 More like “Qualitative Assessment” • Clinical effectiveness is the key! Cli i l ff ti i th k ! – Treatment effectiveness – Safety – Convenience 財團法人醫藥品查驗中心 Center for Drug Evaluation Qualitative value assessment criteria Taiwan Better pharmacokinetics Budget impact X Clinical efficacy X Clinical trial X Cost-effectiveness ? Currently untreated disease X Depth of action Industrial policy Logistics costs X Market size New mechanism Orphan disease ? Patient equality py landscape p Place in therapy X Public health significance Relative price X Second-line therapy Severity of disease Side effect profile X Technological innovation Therapeutic value X 財團法人醫藥品查驗中心 Center for Drug Evaluation 13 CEA is under development • More and more accepting M d ti • Not mandatory now – Incentive for doing local PE • Still need acceptance, mostly from decision makers 財團法人醫藥品查驗中心 Center for Drug Evaluation Challenges • All potential values considered? All t ti l l id d? • New Act, new process, new value system? • CEA could be helpful, but should be used with care 財團法人醫藥品查驗中心 Center for Drug Evaluation 14 財團法人醫藥品查驗中心 Center for Drug Evaluation Thank you for your attention! RECOGNIZING AND REWARDING HEALTHCARE INNOVATION THE HEALTHCARE INNOVATION‐ THE SINGAPORE EXPERIENCE Dr Jeremy Lim CEO Fortis Colorectal Hospital, Singapore 15 ABSTRACT • Despite the plethora of ‘Level 1 evidence’, many health systems struggle with effective recognition and implementation of healthcare improvements and innovations. The reasons are complex and include incongruent healthcare financing measures, cultural difficulties in transplanting practices and lack of skilled manpower to implement i innovations. ti • Singapore has established a Health Services Development Program (HSDP) to address the ‘real‐world’ challenges of national implementation. Through the Program which adopts a system level “PDSA” (Plan, Do, Study, Act) approach, Singapore pilots a healthcare innovation in a limited manner, learning what works, what does not work and what needs to be localized, before deciding on whether and how to scale nationally. The HSDP initially focused only on clinical implementation but has since evolved to address also pricing and operational roll‐out challenges such as incenting wider adoption. d d • This presentation discusses why innovation diffusion and adoption are so difficult in the healthcare setting. It also shares the experience of the Singapore HSDP and offers lessons, both positive and negative, learnt which may be applicable to other health systems. Evidence to Practice • Harmful effects of radiation of fetuses – 1956: Oxford‐based epidemiologist Alice Stewart demonstrated, that the chances of childhood cancer were vastly increased by X‐raying pregnant mothers. – 1971: practice was abandoned by medical establishment • "threshold theory“ • Opposition by Britain's foremost epidemiologist of the time, Richard Doll 16 PARiHS framework (Promoting Action on Research Implementation in Health Services) The PARiHS The PARiHS framework framework proposes that successful implementation of evidence into practice is a function of three broad interactive elements (evidence, context, and facilitation). 17 Singapore 710 sq km 5.2 million inhabitants, 3.3 million citizens GDP per capita S$50,123 , 11th in the world FUNDAMENTALS OF THE HEALTH SYSTEM • Co‐payment and Personal Responsibility –“The The Singapore health care delivery system is based on individual responsibility, coupled with Singapore health care delivery system is based on individual responsibility, coupled with Government subsidies to keep basic health care affordable. Patients are expected to pay part of the cost of medical services which they use, and pay more when they demand a higher level of services. The principle of co‐payment applies even to the most heavily subsidised wards to avoid the pitfalls of providing "free" medical services.” • Explicit Rationing –“The basic medical package will reflect good, up‐to‐date medical practice, which is cost‐effective and of proven value. But it will not provide the latest and best p p of everything. The treatment will be y g delivered without frills by trained personnel using appropriate facilities.” • “Muscular state” but strong role of market –Government influences through regulation and payment –Mechanisms to enable market to function 18 PHARMACEUTICAL MANAGEMENT • “Clinically relevant and cost effective drugs that are considered as basic therapies and essential for management of common diseases afflicting the majority of the patients” • Means tested subsidies • Expensive drugs that are not in the Standard Drug List but have been assessed to be clinically necessary, • Clinical controls to assess the eligibility of the patients and to ensure that the drugs prescribed are clinically necessary • Freely available for sale in public and private hospitals • No subsidies available Standard Drug List Medication Assistance Fund Non‐Formulary Drugs Qualitative value assessment criteria Singapore Better pharmacokinetics Budget impact X Clinical efficacy X Clinical trial Cost-effectiveness X Currently untreated disease Depth of action Industrial policy Logistics costs Market size New mechanism Orphan disease Patient equality Pl Place in i therapy th landscape l d Public health significance X Relative price Second-line therapy Severity of disease Side effect profile Technological innovation x Therapeutic value x 19 HEALTH SERVICES DEVELOPMENT PROGRAMME • Established in 2001; S$15 million funding per year • Three categories of new health services are funded: – New cutting‐edge medical technology – Advanced and costly treatments – Major augmentations of existing management Major augmentations of existing management capability for key diseases 20 COCHLEAR IMPLANTS (2001) COMMUNITY PODIATRY (2003) 21 ENDOBRONCHIAL ULTRASOUND (2007) SUMMARY • HSDP – Evidence: Review E id R i built into selection process – Context: Clinical champions and advocates; leadership support – Facilitation: ‘Real world’ piloting and learning 22