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Policy and Procedure for Individual Funding Requests (IFRs) Guidance for clinical practice Activity Log for Joint Referral Panel Operational Details for Previous panels can be found at Appendix 1 Date Approved By Activity Amended by November 2010 NHS Southampton Clinical Leadership Board 12 January 2011 For NHS Hampshire PAC (not convened) Changes to Policy title to ‘Individual Funding Chris Ashdown Requests’ and first joint policy covering NHS Hampshire and NHS Southampton City with joint Panel structure. Housekeeping of document to take account of Chris Ashdown changes to application form which will include reference to potential service development Re-arrangement of exclusions list to separate between: i. Core list of interventions that are “not normally funded”. ii. Criteria-based commissioning for procedures of limited clinical value (PLCV) using the Prior Approval Tool iii. Volume thresholds/ quota-based commissioning 15/02/11 NHS Hampshire PAC / Management Committee Finalising of ‘new’ procedures of limited clinical value, addition of procedure codes and ordering into ‘don’t dos’ and ‘may dos’. Inclusion of revised application form and guidance notes for use in primary care only. (Current application still to be used in secondary care) Chris Ashdown/ Cathy Price/ Marie-Claire Lobo Page 1 of 51 CONTENTS 1 INTRODUCTION .................................................................................................................................. 3 2 REFERRALS TO BE DEALT WITH UNDER THE POLICY - EXCEPTIONALITY................................ 3 3 POLICY SCOPE ................................................................................................................................... 3 5 DECISION-MAKING FRAMEWORK ..................................................................................................... 5 6 PROCESS ............................................................................................................................................ 6 7 HAMPSHIRE AND SOUTHAMPTON CITY JOINT REFERRAL PANEL ............................................... 8 8 PCT APPEALS PANELS ...................................................................................................................... 9 9 PCT APPEAL BODY ............................................................................................................................. 9 10 SERVICE DEVELOPMENTS .............................................................................................................. 10 11 IMPLEMENTATION OF NICE GUIDANCE ......................................................................................... 10 12 MANAGING THE ENTRY OF NEW DRUGS ...................................................................................... 10 Appendices 1 PRIOR APPROVALS .......................................................................................................................... 13 2 EXCLUDED PROCEDURES 3: SOUTH CENTRAL ETHICAL FRAMEWORK ..................................................................................... 33 4 INDIVIDUAL FUNDING REQUEST (IFR) APPLICATION FORM (Secondary care) ........................... 36 5 INDIVIDUAL FUNDING REQUEST (IFR) APPLICATION FORM (Primary Care) ............................... 41 6 SOUTH CENTRAL STRATEGIC HEALTH AUTHORITY CANCER DRUG FUND .............................. 47 7 COSMETIC/ PLASTIC SURGERY...................................................................................................... 49 8 BARIATRIC SURGERY (inc referral form) ....................................................................................... 27 50 Page 2 of 51 1 INTRODUCTION This document sets out the Policy and Procedure for both NHS Southampton and NHS Hampshire with respect to treatments which are not normally funded. These may be treatment requests or referrals made either to an NHS provider outside the local health economy; to a provider where there is no contract in place; generally for a treatment/ procedure that is excluded or to a non-NHS provider i.e. the private sector. These referrals will, for the purposes of the Policy, be known as Individual Funding Requests (IFRs). BACKGROUND The NHS Confederation definition of an individual funding request in " Priority setting: managing individual funding requests." Is as follows:"A request to a PCTS to fund healthcare for an individual who falls outside the range of services and treatments that the PCTS has agreed to commission. There are several reasons why a PCTS may not be commissioning the healthcare intervention for which funding is sought. - It might not have been aware of the need for this service and so has not incorporated it into the service specification - It may have decided to fund the intervention for a limited group of patients that excludes the individual for whom the request is made - It may have decided not to fund the treatment because it does not provide sufficient clinical benefit and/or does not provide value for money - It may have accepted the value of the intervention but decided it cannot be afforded in the current year Such requests should not be confused with - Decisions that are related to care packages for patients with complex healthcare needs - Prior approvals which are used to manage contracts with providers" 2 REFERRALS TO BE DEALT WITH UNDER THE POLICY - EXCEPTIONALITY If, a clinician believes that the case of an individual patient is so singular as to justify funding for an IFR, they may apply for the case to be considered individually.Such cases are known as “exceptional”. Exceptionality - this is best expressed by the question ‘On what grounds can the PCTS justify funding a particular patient over and above others from the same patient group who are not being funded?’ The NHS Confederation guide ‘Priority setting: managing individual funding requests’ 2008 clarifies exceptionality as: In making a case for special consideration, it needs to be demonstrated that: - the patient is significantly different to the general population of patients with the condition in question, and - the patient is likely to gain significantly more benefit than might be normally expected for patients with the same condition The fact that the treatment is likely to be efficacious for a patient is not, in itself, a basis for exceptionality. In the event that an IFR is approved, this does not necessarily set any precedent and relates to the individual patient only. 3 POLICY SCOPE . In general this policy covers - High, Medium and Low Priority Statements Page 3 of 51 - healthcare not normally purchased drugs and devices outside of national tariff IFRs are addressed by a lead manager, commissioning colleagues, members of the public health directorate and a clinically-led joint Referral Panel. Treatments that require Prior Approval for Funding due to their high cost or uncertain cost effectiveness may on occasion be dealt with by the same decision making group. However, it is expected that the PCT has specific conditions whereby permission is granted. Where there is uncertainty as to whether those conditions are met then they may be dealt with by the IFR process. A list of treatments excluded from funding and thus will require IFR application can be found at Appendix 2. NB. The PCTs comply with mandatory Technology Appraisal Guidance published by the National Institute for Health and Clinical Excellence (NICE) This Policy does not address therapies provided purely as a part of clinical research. Research is funded through designated research monies and has a separate management and governance framework. R&D should not be supported from allocations intended for provision of mainstream health services, except where agreed and negotiated via the Research Management and Governance consortium and in line with national policy. Conditions for submission to the IFR panel The patient should be registered with a GP practice belonging to the relevant PCTs or, if not registered with any GP, lives within the geographical responsibility of the PCTs and is eligible for NHS treatment. If this is not clear then the Responsible Commissioner guidance from the Department of Health should be consulted and applied The provider can meet the waiting time target and quality standards as per Healthcare Assurance Standards / Care Quality Commission guidelines Only an NHS GP, NHS GDP or NHS Consultant can make a funding request. Allied health professionals and specialist nurses can also make referrals though these should be endorsed by a GP or consultant. The procedure/treatment is not already purchased under existing service agreements. Patient Choice guidelines will apply where relevant. For a treatment covered under this policy and the PCTs have a contract covering a relevant specialty, the referral should be made by a consultant of the same specialty to a provider with whom the PCTs holds a contract. Where an IFR is required, referrers are asked to consult with the PCTs to see if there is a contract in place with the provider. The PCTs would only consider a specialist referral on the recommendation of a local clinician from the relevant specialty, where there was no appropriate NHS provision or where local NHS resources were no longer able to meet the needs of the patient. Treatment in the private sector will only be considered where there is evidence that NHS provision has been fully explored and exhausted. Private treatment - If a patient has opted to pay for treatment and/or procedures privately, these will not be funded retrospectively and this includes any future continued treatment by the private provider. 4 ROLE OF SHIP PRIORITIES COMMITTEE The SHIP (Southampton, Hampshire, Isle of Wight, Portsmouth) Priorities Committee working on behalf of the constituent PCTs develop and agree clinical policies using an ethical decision making framework and standard procedures, supported by Solutions for Public Health (http://www.sph.nhs.uk/sph-psu/policyrecommendations/ship-policies) The policies are advisory and only become active when a constituent PCT endorses them through its usual approval processes. For Hampshire PCT this is through its Professional Advisory Committee. For Southampton this is through its Clinical Leadership Board. An index of agreed Page 4 of 51 policy statements can be found at http://www.hampshire.nhs.uk/about-us/346-commissioning-policies and www.southampton.nhs.uk. The PCTs may have considered a treatment to be a low priority against other competing healthcare priorities within a limited resource envelope. Not all statements are adopted by the individual PCTs. Adopted statements are maintained by the constituent PCTs, are public facing and easily available to clinicians. 5 DECISION-MAKING FRAMEWORK The PCTs have the power to make decisions in commissioning services for its population. It must be shown to act within its powers and reasonably. Decisions can be challenged by Judicial Review in terms of legality, reasonableness or natural justice. There is therefore a decision making framework in place to guide the IFR panel. The PCTs decision making is based on the document at Appendix 4 – the South Central Ethical Framework which covers the following; - evidence of clinical and cost effectiveness - equity - healthcare need and capacity to benefit - cost of treatment and opportunity costs - needs of the community - policy drivers - exceptional need This framework has been developed to support robust and transparent ethical decision-making and has been agreed and adopted by all nine PCTs in NHS South Central. Assessing individual cases The following information should be used by the PCTs’ IFR panel to assess individual cases. Background to the case The patient’s problem and circumstances of the case Previous treatment and funding Proposed treatment and provider details Consideration of similar cases which have been dealt with in the past (but not as setting of precedents) Current contracting arrangements Funding Contracts and providers Exclusions Relevant commissioning policies Comparison Information on what is happening elsewhere (particularly PCTs within the Strategic Health Authority area) Advice from the South Central Priorities Committees Corporate view Views and position of interested parties (patient, patient body, carers, health professionals, politicians, media) Clinicians are involved in the decision making through the IFR panel. Minutes of the panel are reviewed and signed off by the Chair of the Panel. Page 5 of 51 6 PROCESS A flowchart is included for clarity Clinician feels patient should be considered for the panel Clinician completes form – primary and secondary care forms will differ Taken through Prior approval process Form triaged by IFR team Clarity sought from referrer, chair, delegated clinician or relevant commissioning or public health advice Referred to IFR panel Decision made and conveyed to referrer/patient All requests should be in writing using the IFR funding request form (found at appendix 1 and available on the NHS Hampshire and NHS Southampton City website at http://www.hampshire.nhs.uk/about-us/346commissioning-policies and www.southampton.nhs.uk and supported by; a clear description of the exceptional circumstances, based on overriding clinical need, copies of any relevant correspondence; and other supporting documentation e.g. robust evidence of clinical and cost effectiveness, consultant and other specialist assessments, appropriate costings. Referrals must be submitted on the appended form together with all supporting documentation such as relevant clinical history, correspondence from treating specialists and relevant published evidence base. In the first instance, referrers should consider whether the referral is covered by local NHS provision, whether there is a contract in place and that the referral is not contrary to the referral controls set out in this policy. The referral must be clinically led. The PCTs will not accept direct patient requests, or routinely enter into any correspondence with patients and/or their families unless as part of the statutorily applied NHS Complaints Procedure. The PCTs will provide advice to patients regarding the process and recommend they contact their GP or consultant. The referring clinician should act as the patient’s representative and responses to funding requests will be made direct to the referrer. Where a request is declined, the PCTs Page 6 of 51 recognise their obligations under the NHS Constitution to explain decisions to the patient but maintain the importance of the referring clinician’s role in explaining clinical issues and rationale. Before reaching the Panel, all requests will be addressed by the IFR Lead and, in cases where the referral clearly does not meet the exceptional circumstances set out within the exceptions policy, set out in Paragraph 2 above will be declined with a letter of explanation. The IFR lead will approve all referrals that clearly meet the criteria set out in this policy. In cases where the referrer has not made the application on the PCTs’ IFR funding request form and/or has not sent all relevant information plus any supporting documentary evidence, the referrer will be invited to do so, to enable the request to proceed. Those referrals to be considered by the Panel should be exceptional within the guidelines of current policy. The Panel may also consider cases for a treatment not provided for within the policy and, where the consequences of a decision might have wider implications on PCT policy may refer such cases to the ‘parent’ Appeals Panel for the relevant PCTs. All requests, requiring a decision by the Panel together with supporting information will be submitted to the next available meeting. Papers should be circulated at least one week prior to the meeting date. The IFR Lead will share Panel decisions with neighbouring PCTs via a monthly report made to the SHIP Priorities Committee. Referrals leading to a possible policy change, those in an area of contention, or appeals against a Panel decision where no additional information has been provided may be considered by the Appeal Panel for the relevant PCTs. For a cancer patient the panel may feel that the patient does not qualify for treatment on exceptional grounds, In which case the case will be referred to the SHA’s Cancer Drug Fund panel. (Appendix 7) Urgent cases In exceptional circumstances where an urgent decision is required i.e. treatment cannot be delayed and/or the patient’s disease is rapidly progressing it may be necessary for the Panel to consider a case virtually i.e. via e-mail or conference call. Decisions will need to be clearly recorded and conveyed with a final decision based on consensus and Chair’s action. Page 7 of 51 7 HAMPSHIRE AND SOUTHAMPTON CITY JOINT REFERRAL PANEL In order to meet the demand from the volume of referrals, the PCTs have a structure of a joint Referral Panel and ‘parent’ Appeal Panels for each PCT. Panel remit It is important that all decisions made by Panels are transparent, defendable and consistent, observing PCT corporate principles, available NICE guidance, advice from the SHIP Priorities Committee and the available evidence base. After a decision has been made, a full written explanation will be provided to the referrer and patient. All referrals should be directed to the IFR team. All referrals received via other routes should be passed to the IFR team. The IFR team will: Convey information Manage the panel meeting agenda Record Panel decisions Triage applications Where the IFR team is unclear how to triage an application as the information may be complex or unclear advice may be sought from a range of expert advice e.g. Children’s, mental health or dental commissioning advice who may in turn seek advice from members of the Panel or elsewhere. This advice should be recorded. Referrals may be returned to the referrer for greater clarification. A summary of the referrals made, details of the request and outcome of decisions will be logged each month. Where a significant number of referrals are being made in a particular area or specialty these will be flagged to the PCTs. Membership (Joint Hampshire and Southampton Referrals Panel) The Panel should consist of primary care clinicians, the IFR lead or member of his team, an associate director / key contracting manager (Contracting) and a public health consultant. The Panel should be chaired by a senior clinician or public health consultant.. Where appropriate, support should be secured from a medicines management lead and a nursing professional depending on the cases considered. A guide to membership is as follows to ensure clinical participation. Chair (either a GP or public health consultant) Public Health Consultant Associate Director / Key Contracting Manager (Contracting) At least 2 local clinicians/ GPs Nursing/pharmacy representation (as and when required) Commissioning/ IFR lead Minute taker to record decisions The Panel will meet twice a month for which there should be a minimum of 3 clinicians/allied health professionals as a quorum. Additional members may be co-opted as the need arises. The key task of the Panel is to consider and discuss individual cases and to decide to approve funding, reject a request or defer to seek further information. It is intended that the Panel should have representation from both PCTs at each meeting but will act as a decision-making body on behalf of both PCTs. Ideally the chair should rotate. Page 8 of 51 8 PCT APPEALS PANELS The GP/clinician has a responsibility to refer appropriately. Good working relationships should ensure that proper procedures are followed. However, the referrer may wish to appeal against a decision and this should initially be made in writing to the IFR Lead with additional supporting information/evidence. If the information provided contains new evidence the referral should be reconsidered by the original Panel. If their decision remains unchanged the referral will be directed to the relevant PCTs Appeals Panel. Draft terms of reference and membership The Appeals Panels for both NHS Hampshire and NHS Southampton City will remain to consider appeals from referring clinicians on behalf of patients from their relevant PCTs. The Appeals Panel will have the same remit of the Joint Referral Panel but receives funding requests/cases that have already been considered by that Panel and are subject to challenge. New information within an appeal should be considered by the original Panel. In some cases, the Panel may wish to refer ‘upwards’ to the relevant Appeals Panel for one of the following reasons: any funding decision might impact on commissioning policy or would have a bearing on future commissioning decisions across SHIP; or decisions that might be subject to formal legal challenge and/or political/media involvement which affect the reputational risk of the organisation(s) 9 PCT APPEAL BODY If the decision in an individual IFR request made by either the Panel or Appeals Panel is appealed against by the referring clinician, there is a further opportunity to appeal to the NHS Hampshire final appeals body. The Appeals Body comprises of: the Chief Executive of the PCT the Executive Director of Public Health a PCT non-executive Director / Chair of the PCT Board (chairing) A member of the original decision-making Panel may also attend to present the audit trail of the case being considered but would not have a vote in any decision made. Clinical colleagues may be co-opted onto any Panel depending on the subject matter. The role of the Appeals Body is to judge whether the process and framework by which a funding decision is made was fair, equitable and based on the evidence available at the time. It does not take funding decisions itself and, if any new evidence is brought before it, this must be referred back to the previous Panel. Should the Appeals Body overturn the decision of a Panel, then funding would be expected to follow. The grounds for funding decisions need to be accepted as relevant to meeting the overall healthcare needs of the population within resource constraints. The PCTs will not accept appeals instigated by a patient, their family or other non-clinical representative (e.g. local MP). At both the initial referral and appeal stages, cases will be considered with the GP/other referring clinician being the main point of contact. The decision of the PCTs Appeals Body is final. Complaints Patients have the right to raise a formal complaint with the PCT using the NHS Complaints Procedure should they be unhappy with the PCTs handling of their case (i.e. staff attitude, communication or the way in which the policy or procedure has been followed, adherence to procedure). The NHS Complaints Procedure is set out to address concerns over service provision and not funding decisions. It cannot be Page 9 of 51 used to investigate or influence funding decisions and the appropriate process for appeals should be followed i.e. from the referring clinician and not the patient. 10 SERVICE DEVELOPMENTS NHS Hampshire and Southampton City will not introduce new interventions through the individual funding request mechanism. The NHS Contract makes it clear that the hospital provider is expected to seek funding for new treatments through submission of a business case to the commissioner (Schedule 6, point 8.3). There is, therefore, an expectation that new treatments will be properly assessed and prioritised. It is not rational for a PCT to manage a new treatment by considering one patient at a time nor would this be fair, because it breaches a principle commonly adopted by PCTs, namely that: ‘The PCT does not offer treatment to a named individual that would not be offered to all patients with equal clinical need’. NHS Confederation –Priority setting: managing individual funding requests, 2008 11 IMPLEMENTATION OF NICE GUIDANCE NICE guidance is published as a series of Technology Appraisal Guidance documents, Clinical Guidelines, and Interventional Procedures Guidance. These documents are distributed widely within the NHS. The guidance is also available on the NICE web site at www.nice.org.uk. It should be noted that guidelines and Interventional Procedures guidance are not mandatory. Only Technology Appraisal Guidance published by NICE as mandatory carries a duty to make funding available to implement within 3 months of the publication date, unless otherwise stated. Provider contracts take account of a limited percentage – the NICE uplift - to meet the estimated costs of implementation in secondary care. The assumptions used to estimate the reserve involve a significant degree of financial risk. Moreover, this reserve is top-sliced from any growth monies at the beginning of the year. Thus, the cost of funding NICE recommendations has a direct impact upon the ability to fund competing priorities for service development. In light of the above factors it is essential that interventions approved by NICE are used only in accordance with the published criteria. The secondary care clinician should provide evidence that the criteria are met. If published NICE guidance is likely to have significant resource implications for the local NHS, implementation may be delayed for a period of 3 months from the date of publication. This is to enable the necessary administrative arrangements to be put in place. However, the PCTs accept that delayed implementation may not be appropriate for rapidly progressive conditions where delay is likely to compromise the clinical outcome significantly. The NICE reserve does not cover the costs of implementation of NICE guidance in primary care. The funding for this is included within the annual uplift to primary care prescribing budgets. As per Department of Health guidance, the above does not preclude the PCTs from funding health interventions that are not subject to finalised NICE guidance or are currently in the NICE process awaiting guidance. Appropriate procedures for consideration should still be taken. 12 MANAGING THE ENTRY OF NEW DRUGS Relevant District Prescribing Committees (DPCs) or Area Prescribing Committees (APCs) are responsible for considering whether new drugs and preparations are suitable for local use. The DPCs/APCs are joint bodies formed with members from provider Trusts and the PCTs. The use of drugs not approved by DPCs/APCs is not generally supported. Page 10 of 51 If a referrer wishes to propose that a drug or preparation be considered for use by clinicians locally, a formal application should be made to the Chief Pharmacist. Additions to the formulary should represent a significant advance over current therapy. The application should be supported by any relevant published research evidence. The application forms can be found at the front of the Joint Formulary file. There is no reserve to meet the costs of introducing new drugs (other than those approved by NICE) within the financial year. If a new drug is supported by the DPC/APC and agreed formally by the PCTs, the costs of its introduction will need to be met from existing resources. This applies equally whether the drug is prescribed within secondary care or in primary care. Where the costs cannot be absorbed, the addition of the drug to the Formulary may need to be deferred until resources allow. Cost pressures on the secondary care drugs budget are negotiated through the annual Operating Plan. The PCTs commission appropriate drug therapy as an integral part of patient care. Individual drugs should not be excluded from contracts as a separate cost item. Page 11 of 51 Page 12 of 51 Appendix 1: Prior approvals Where procedures are either high cost, falling outwith specialised commissioning or cost effectiveness of a procedure is only high when certain criteria are met then the PCTs request prior approval of those procedures. These are known as the Restricted Procedures. Procedures that require the use of the prior approval tool For secondary care consultants, prior approval for a number of common but restricted surgical procedures should be applied for via a secure webbased tool at https://priorapproval.hampshire.nhs.uk Those procedures earmarked for, or already on, the tool are marked with an asterisk(*) below. This will need to be applied for in advance of the treatment being provided. The Map of Medicine tool also provides information on these procedures and thresholds for referral. This list has been prepared by public health. This list is not exhaustive and will be updated regularly. Where policy criteria are met – as described within the tool – instant approval is obtained and a printout made. This will mean that, for certain procedures, the full paper application need not be completed unless the patient does not meet the policy criteria. If patient does not meet the policy criteria and a clinician is of the opinion that a patient is clinically exceptional, an Individual Funding Request will need to be submitted to the IFR team in line with the IFR Policy There are currently seven procedures but a significant number of procedures from the core exclusions list will be added to the tool. The current procedures are: Specialty Low priority procedure OPCS code(s) Guidance on exceptions / exceptions criteria ENT *Grommet insertion for children D151 1. Treatment with grommets will be funded for children with disabilities such as Downs Syndrome and Cleft Palate where the insertion of grommets is part of an established pathway of care. 2. Treatment with grommets will be funded for children to treat a tympanic membrane retraction pocket. 3. Treatment with grommets will be funded for children aged over 3 years old with Otitis Media with Effusion (OME) and without a second disability (such as Downs Syndrome or Cleft Palate) when: There has been a period of watchful waiting for three months in primary care from diagnosis of OME in primary care, followed by a further period of watchful waiting for up to three months in ; secondary care; and OME persists after the three-six months of watchful waiting; and The child has documented speech or language delay or Page 13 of 51 Specialty Low priority procedure OPCS code(s) Guidance on exceptions / exceptions criteria behavioural problems; and The child has a documented hearing level in the better ear of 2530dBHL or worse averaged at 0.5, 1, 2 and 4kHz (or equivalent dBA where dBHL not available) ENT *Grommets in adults D151 This procedure is not routinely funded for adults (≥ 18 years old) except under the following conditions: - A middle ear effusion causing measured conductive hearing loss, persisting for at least 6 months and resistant to medical treatments. The patient must be experiencing disability due to deafness. The possible option of a hearing aid may be discussed, at the discretion of the clinician. - Persistent Eustachian tube dysfunction resulting in pain (e.g. flying) - As one possible treatment for Meniere’s disease. - Severe retraction of the tympanic membrane if the clinician feels this may be reversible and reversing it may help avoid erosion of the ossicular chain or the development of cholesteatoma. - Grommet insertion as part of a procedure for the diagnosis or management of head and neck cancer and/or its complications ENT *Tonsillectomy F34F361 Tonsillectomy will be funded - in children and adults for cancer or suspected cancer; or - in children and adults for cases of quinsy; or - in children and adults for obstructive sleep apnoea where other treatments have failed or are inappropriate; or - in children and adults for tonsillitis if all of the following criteria are met: Sore throats are due to tonsillitis There are 5 or more episodes of sore throat per year (confirmed in Primary Care) There have been symptoms for at least a year Episodes of sore throat are disabling and prevent normal functioning Page 14 of 51 Specialty Low priority procedure OPCS code(s) Guidance on exceptions / exceptions criteria ENT *Bone-anchored hearing aids D131-9 Considered in patients over the age of 5 years who: Have abnormalities of the middle, outer or external parts of the ear or a chronic ear infection, which makes wearing a conventional hearing aid difficult or impossible. Have a hearing loss in both ears that cannot be operated on and for which conventional hearing aids are not felt to be suitable. Can hear sounds well via bone conduction. Can understand 60% or more of speech on a standard test using bone conduction. Are able to keep the area around the fixture clean, alone or with help. Varicose veins *Varicose vein procedures L84-, L85-, L86L87-, L88- This will be commissioned in accordance with the South Central Priorities Committees policy statement. Varicose vein surgery will be funded in people with a body mass index less than 32 who satisfy at least one of the following criteria: a recurrent venous ulcer (OR) a first venous ulcer which persists despite a six-month trial of conservative management (compression stockings, exercise and daily elevation two to three times a day) (OR) haemorrhage from a superficial varicosity Treatment in all other circumstances is LOW PRIORITY and not routinely commissioned. Surgical treatment may be with ligation and stripping, phlebectomy and/or foam sclerotherapy. All techniques which involve heating the vein (whether by laser, radio-frequency, microwave or any other means) are LOW PRIORITY and not routinely commissioned. Gynaecology *Dilatation and Curettage Q103/8/9 Dilatation and Curettage alone should not be used as a diagnostic tool and should not be used as a therapeutic procedure. Dilatation and curettage will be funded if either of the following criteria are met: The patient has had outpatient negative pressure endometrial sampling (e.g. Pipelle™ sampling) with an unsatisfactory histological result Page 15 of 51 Specialty Low priority procedure OPCS code(s) Guidance on exceptions / exceptions criteria Or The patient has had a hysteroscopy and endometrial biopsy with an unsatisfactory histological result Gynaecology *Hysterectomy in heavy menstrual bleeding/ dysmennorhea Q07- (except Q076), Q08- Hysterectomy for heavy menstrual bleeding or dysmenorrhoea will be funded if all the following criteria are met: Other treatments for heavy menstrual bleeding (in accordance with NICE Clinical Guideline 44 “Heavy Menstrual Bleeding”) or dysmenorrhoea such as a Mirena coil have failed or are contraindicated; and There is a wish for amenorrhoea; and The woman no longer wishes to retain her uterus and fertility 2. Hysterectomy for the treatment of uterine problems amenable to surgery but are not related to heavy menstrual bleeding or dysmenorrhoea will be funded Urology *Male circumcision N303 This procedure should only be considered in cases of pathological phimosis where inability to retract the foreskin is due to permanent scarring of the preputial orifice. In boys with lower urinary outflow obstruction and/or with recurrent urinary tract infection (particularly where high grade vesico-ureteric reflux is present) circumcision as an option for potentially reducing further infection should be discussed with parents and boys able to give informed consent. In the absence of medical urgency, the procedure should not be undertaken until the boy is old enough to give informed consent. Circumcision may also occasionally be required in the management of penile carcinoma. MSK/ Pain management *Facet Joint Injections (FJI) for Chronic Low Back Pain/ spinal epidurals for nonradicular pain/ sciatica/ RFthermal denervation of facet joint V544 A521/2 A573 A604 A781/2/3 V481/3/5/7 1) Facet joint injections are not routinely commissioned for patients with diagnosed chronic non specific low back pain. 2) Medial branch blockade will be funded for the diagnosis of cervical, thoracic and lumbar back pain when all the following criteria are met: a) The pain has resulted in moderate to significant impact on daily Page 16 of 51 Specialty Low priority procedure OPCS code(s) Guidance on exceptions / exceptions criteria functioning; AND All conservative management options including psychologically based treatments have been attempted or a patient may not be suitable due to: o communication difficulties o Cognitive impairment o Documented difficulty in tolerating medicines 3) Conventional Radiofrequency lesioning preceded by a positive median nerve diagnostic block can be considered at this point & the patient is part of a comprehensive pain management programme including physiotherapy, psychosocial support, medication and patient education. Facet joint pain is confirmed by controlled diagnostic local anaesthetic block; and The pain has lasted for more than one year; and The pain has resulted in moderate to significant impact on daily functioning; and All conservative management options (bed rest, physiotherapy guided exercise, pharmacotherapy including analgesia and muscle relaxants) have been tried and failed; and The patient is part of a comprehensive pain management programme including physiotherapy, psychosocial support, medication and patient education. Repeat injections: Repeat injection will be funded if the individual has benefitted by maintaining function for > 6 months. Orthopaedics *Trigger finger surgery T723 Surgery will be commissioned for patients diagnosed with trigger finger: • who fail to respond to conservative treatment, including no response following one corticosteroid injection • who have a fixed flexion deformity that cannot be corrected • moderate to severe pain/locking sufficient to cause interference with hand function • persistent symptoms > 3 months Orthopaedics Carpal tunnel release/ A65- In line with DoH pathway Page 17 of 51 Specialty Low priority procedure OPCS code(s) nerve entrapment at wrist Guidance on exceptions / exceptions criteria http://www.pathwaysforhealth.org/xpath2007/xeditor/publisher.asp?d_ref =910220D9BE124C78830F324EFEE93A38& Orthopaedics *Lavage and debridement of the knee in patients with osteoarthritis W852 a. Where the patient has clear mechanical symptoms (not gelling, ‘giving way’ or X-ray evidence of loose bodies). b. When information is required regarding the degree and distribution of joint damage, enabling informed decision making regarding the type of knee replacement that could be performed (partial or total knee replacement).This can be of particular help in young patients with osteoarthritis Ophthalmology *Chalazia (meibomian cysts) C121 In line with Thames Valley (Berkshire PCTS’s) Priorities Committee Policy Chalazia (meibomian cysts) are benign, granulomatous lesions that will normally resolve within 6 months. Treatment consists of regular (four times daily) application of heatpacks. Excision of chalazia will be funded when all of the following criteria are met: - The chalazia has been present for more than 6 months - Where it is situated on the upper eyelid - Where it is causing blurring of vision Oral surgery Wisdom teeth extraction F091/3 As per NICE guidance and will only be accepted where access to secondary care skills and facilities are required such as: The tooth has complex anatomical configuration There is pathology associated with the tooth which may complicate the procedure Patient has medical complications which make management inappropriate in primary care. *Dental implants F088/9 F115/6 1. To restore oral function for patients who have received treatment for head and neck cancer, or other extensive oral pathology or trauma. 2. To support head and neck and oral prosthesis for patients who have received treatment for head and neck cancer, or other extensive pathology or trauma. Page 18 of 51 Specialty Low priority procedure OPCS code(s) Guidance on exceptions / exceptions criteria 3. To restore oral function for patients with rare genetic or inherited conditions e.g. severe hypodontia (more than six missing teeth), cleft lip and palate 4. To restore oral function for edentulous patients when conventional prosthetic dental procedures will, in the considered opinion of a consultant in restorative dentistry, fail due to lack of bone support, neuromuscular control, or other medical conditions. Plastic surgery *Removal of excess skin following weight loss S02S03 - In order to be considered for plastic surgery, patients should meet all of the following criteria: 1. The patient’s starting BMI before weight loss must have been no less than 45kg/m2 (the threshold for access to bariatric surgery in HIOW). 2. The patient’s BMI must be less than 30kg/m2. (In some patients a BMI of less than 30kg/m2 may not be achievable, due the weight of excess skin. In these circumstances an exception to the policy may be considered, provided that the patient has lost at least 50% of their excess weight, and their clinician confirms that no further reduction in BMI will be possible without removal of excess skin.) 3. The patient’s weight must have been stable for a minimum of 2 years, 4. There must be documented evidence of clinical pathology or disability due to the skin fold in question (eg recurrent infection, intertrigo, cellulites, restricted mobility, inability to undertake physical exercise to maintain cardiovascular fitness). Purely cosmetic procedures, such as removal of surplus skin from the arms, will not be considered. Plastic procedures other than abdominoplasty, mammoplasty, and removal of skin folds from the inner thighs will not normally be funded. Gynaecology Reversal of sterilisation/ vasectomy N18Q29Q37- In circumstances of the death of a partner or only child or where sterilisation caused by proven surgical accident that was not a foreseen consequence of such a procedure. Page 19 of 51 B: Procedures where prior approval is required but the prior approval tool is not in use These are lower volume high cost procedures or treatments where the need is relatively rare but whose use is restricted to certain indications. Provided the criteria are met, the PCT will simply require a proforma as notification indicating patient detail, procedure and where the criteria are met. This will not require the full application form. In recognition of individual Trusts having different notification proforma, the PCT will accept individual formats provided the relevant information included. Where the criteria are not met, then a full application will be required before treatment can go ahead. Gastro-enterology Sacral nerve stimulation in faecal incontinence and constipation A701-4 PLUS site Z112 Sacral nerve and/or Y705 for temp electrodes Sacral nerve stimulation should be offered only to people with faecal incontinence who have ALL FOUR of the following characteristics: Gastric fundoplication for chronic reflux oesophagitis G241 and G243 This applies in reflux oesophagitis only severe incontinence of liquid or solid faeces (at least one episode per week) a structurally intact but functionally deficient anal sphincter an unsatisfactory response to all appropriate non-surgical treatments and any previously attempted surgical ones a satisfactory response to a test procedure. The procedure should only be performed by clinicians designated by the commissioner with a specialist interest in the assessment and treatment of faecal incontinence who follow NICE’s guidance on this interventional procedure. Funded exceptions are where adults have at least one of the following characteristics - regular, significant symptoms of gastro-oesophageal reflux despite receiving at least one year of continuous pharmacological treatment up to the maximum dose licensed for reflux oesophagitis - significant volume reflux placing them at risk of aspiration - anaemia because of oesophagitis Its use in other circumstances of reflux oesophagitis is a low priority Orthopaedics Vertebroplasty V444 Vertebroplasty for the treatment of pain due to vertebral body fracture which is refractory to conservative, medical treatment can be a treatment option for selected patients. The procedure must be performed in line with NICE Interventional Procedure Guidance. Page 20 of 51 The clinician performing the procedure is an accredited interventional spinal radiologist, who is suitably trained and experienced and that data is collected and submitted to the UK Vertebroplasty registry supported by Liverpool University. Indications for Percutaneous Vertebroplasty • Osteoporotic vertebral compression fractures more than FOUR weeks old in the cervical, thoracic, and lumbar spine causing moderate to severe pain and unresponsive to conservative therapy • Painful metastasis and multiple myelomas with or without adjuvant radiation or surgical therapy • Painful fractures due to vertebral hemangiomas • Painful fractures due to vertebral osteonecrosis •Reinforcement of a pathologically weak vertebral body before a surgical stabilization procedure Palmar fasciectomy /Dupuytren’s contracture T521-2 T541 Referral for surgical opinion should only be made in the following circumstances: • patient has a contracture and cannot flatten their fingers or palm on a table • there is functional impairment Ophthalmology Eyelid surgery/ blepharoplasty C13C16C18- Where affecting visual fields. Specialist dentistry Secondary orthodontic treatment F14F15- Orthognathic surgery As per Hampshire & IOW NHS Orthodontic Care Pathway (see NHS Orthodontic Care – Area Referral Panels, Guidance for General Dental Practitioners). Orthodontic care is subject to a separate triage process established in 2008 and circulated to general dental practice Considered for the following categories of patients provided there is one of 1. Marked facial asymmetry 2. Congenital facial syndromes including Cleft Lip and Palate and Pierre Robin 3. Significant skeletal jaw discrepancies causing difficulties with eating and/or speaking 4. Severe orthodontic malocclusions that cannot be corrected by a Page 21 of 51 course of fixed appliances alone Endodontic treatment F13/F17 For those who, in the opinion of a consultant in restorative dentistry, need endodontic treatment to maintain or restore oral function for a successful long-term outcome AND there is no other consideration that may affect successful long-term outcome AND can demonstrate maintenance of good oral health Periodontal treatment F136, F164/7, F635 All the following criteria must be demonstrated Those who are in pain or have significant and intractable periodontal problems for whom periodontal treatment in general dental care has not achieved significant benefits, - for whom specialist periodontal treatment is likely to confer significant health gain; - can demonstrate maintenance of good oral health; - do not smoke at time of referral; - there are no other significant factors within the control of the patient that may affect a successful outcome. Advanced restorative dental F08- Considered to replace permanent teeth missing post major trauma, post cancer treatment or significant congenital absence to allow patient to masticate effectively. Infertility treatments In vitro fertilisation (including the prescriptions of infertility drugs) and ICSI (intracytoplasmic sperm injection) Ophthalmology Short sight/long sight corrective (laser) surgery Opthalmology Anti-vascular endothelial growth factors (VEGFs) for any indication and bevacizumab for diabetic retinopathy, diabetic macular oedema and retinal vein occlusion As per the South Central Specialised Commissioning Group policy criteria C461 May be considered where laser or operative correction is the only treatment available to restore reasonable visual acuity/or where there are substantial other medical reasons that make correction by external visual aids inappropriate. The use of anti-VEGFs for age-related macular degeneration is covered by NICE TAG155. The South Central Priorities Committees policy states that bevacizumab should be made available for all indications other than ‘wet’ age-related macular degeneration, diabetic retinopathy, diabetic macular oedema and retinal vein occlusion (central or branch), subject to clear Page 22 of 51 (central or branch) arrangements for commissioning and evaluation of outcomes. Plastic surgery/ ENT Rhinoplasty EO2EO36-7 E072/3/8/9 Only in cases of post-surgical reconstruction following trauma or for congenital malformation Plastic surgery Dermabrasion, chemical peels and laser treatment S601/2, S091/2, S103, S113 Only for disfiguring burnt out acne where there has been previous specialist treatment Mental health Inpatient treatment for chronic fatigue syndrome Vascular Endoscopic thoracic sympathectomy for hyperhydrosis or excessive facial blushing A752, A762, A772, A782, A792 Facial blushing is often a result of social phobia and is encouraged by an over-active sympathetic nervous system. There is limited evidence suggesting that Endoscopic Thoracic Sympathectomy can control the occurrence of facial blushing and sweating, however, the patient is likely to experience adverse side effects. • It is recommended that other methods be sought to cure the symptoms. • If the procedure is performed the patient should be informed before operating that the probability of compensatory sweating is extremely high and very likely. Pain Management Electronic spinal cord stimulator implants for management of pain Pain Management In-patient pain management programme Bariatric surgery for morbid obesity Mental health The anti-cholinesterase inhibitors (AChEIs) donepezil, galantamine and rivastigmine for the treatment of dementia A483-7 Considered only following failure of other interventions for chronic pain in patients following failed back surgery, complex regional pain syndrome and patients with angina who are not suitable for revascularisation. Must be part of a multi-disciplinary pain management approach including consideration of CBT. Chronic non cancer pain diagnosis confirmed by specialist pain physician, mental health needs optmised, local treatment options exhausted, local clinical psychologist feels is suitable candidate, own GP confirms approval. G27, G28, G30, G31, G32, G33, G87, G481/2, G716 In accordance with service specification managed by South Central Specialised Commissioning Group policy and their own separate funding application form (see Appendix D) The AChEIs donepezil, galantamine and rivastigmine should be available as an option to treat patients with dementia associated with Parkinson’s disease or dementia with Lewy Bodies if they have noncognitive symptoms causing: significant distress to the individual (for example visual Page 23 of 51 associated with Parkinson’s disease or Lewy Bodies Dementia hallucinations) or leading to behaviour that challenges This is in line with NICE-SCIE Clinical Practice Guideline 42. A701-4 (plus Z126) Neurology Electrical Stimulation (including Functional Electrical Stimulation) for Upper and Lower Limb Dysfunction Respiratory Short Burst Oxygen Therapy for the Relief of Episodic Breathlessness Patients should only be considered treatment with SBOT for the relief of episodic breathlessness If all other treatment options have been tried When the diagnosis is clear and the underlying condition is already being treated optimally Following objective assessment including a record of oxygen saturation by a clinician with a special interest and training in the management of respiratory diseases Existing patients on SBOT will need to be properly reviewed and assessed by a Specialist Respiratory Assessment Service so that the home oxygen therapy that they receive is the most appropriate for their condition, for the right period of time and with appropriate flow rates to obtain optimal benefits and reduce the chance of adverse effects. Specialist assessment is essential prior to any changes in oxygen therapy service being suggested or implemented. These changes may mean that some patients are assessed for LTOT/ambulatory oxygen therapy. Endocrine Human growth hormone (somatropin) in adults with growth hormone deficiency Recombinant human growth hormone (somatropin) treatment is recommended for the treatment of adults with growth hormone (GH) deficiency only if they fulfil all three of the following criteria: This is low priority in accordance with the South Central Priorities Committee policy statement for treatment of unilateral foot drop following a neurological event as part of rehabilitation. Where there is a trial service run by specialist neuro-rehabilitation service, an AFO splint is not tolerated, the patient has sufficient cognitive function, it objectively improves function or prevents falls. It is expected that the local specialist team will manage the rehabilitation and stimulator. They have severe GH deficiency, defined as a peak GH response of less than 9 mU/litre (3 ng/ml) during an insulin tolerance test or a crossvalidated GH threshold in an equivalent test. They have a perceived impairment of quality of life (QoL), as Page 24 of 51 demonstrated by a reported score of at least 11 in the disease-specific ‘Quality of life assessment of growth hormone deficiency in adults’ (QoLAGHDA) questionnaire. They are already receiving treatment for any other pituitary hormone deficiencies as required. This is in line with NICE guidance TA64. HIV Maraviroc and Raltegravir in the management of human immunodeficiency virus type 1 (HIV-1) infection resistant to standard therapy Maraviroc For treatment-experienced adults infected only with CCR5-tropic HIV1 in accordance with the BHIVA guidance; and for patients with triple class infections; and can only be initiated after discussion by a group consisting of a minimum of 3 consultants, an HIV pharmacist and virology input Raltegravir is a LOW PRIORITY for first line treatment in adult patients but, in combination with other anti-retroviral drugs may be used for patients with triple class infections; and can only be initiated after discussion by a group consisting of a minimum of 3 consultants, an HIV pharmacist and virology input For those procedures not listed on the tool but remaining on the exclusions list within the Policy, the normal funding application procedure applies. Page 25 of 51 THRESHOLDS COMMISSIONING Clinical threshold management has been introduced by NHS Hampshire and NHS Southampton City to reduce variation and ensure that elective procedures accessed by patients are at the most appropriate time and consider the entire clinical pathway. The Map of Medicine tool supports this process and is available through NHS Athens accounts. Reduced variation will improve fairness to patients and allow optimum use of funding. Thresholds on activity currently exist for cataract surgery as detailed below but a significant number of procedures from the core exclusions list will be added to the list of volume threshold procedures. If a patient does not meet the threshold policy criteria and a clinician is of the opinion that a patient is clinically exceptional, an Individual Funding Request will need to be submitted to the IFR team in line with the IFR Policy Specialty Low priority procedure Ophthalmology Cataract surgery (threshold criteria) Guidance on exceptions / exceptions criteria C71C72C73C74C75- GPs should refer patients with cataracts that accord with Royal College of Ophthalmologist’s referral principles and meet the following criteria. Optometrists will have carried out the appropriate assessments and referred back to GP for onward referral to secondary care. A copy of the optometrist report (GOS18 or suitable referral form) must be included with the referral. Patients should be referred where best corrected visual acuity as assessed by high contrast testing (Snellen) is: Binocular visual acuity of 6/10 or worse for drivers, OR Binocular visual acuity of 6/12 or worse for non-drivers, OR Reduced to 6/18 or worse irrespective of the acuity of the other eye OR: The patient wishes to/is required to drive and does not meet Driving and Licensing Authority (DVLA) eyesight requirements. NB: In the presence of cataract, glare may prevent the ability to meet the number plate requirement, even with apparently appropriate acuities. Any suspicion of cataracts in children (e.g. altered or absence of red reflex at neonatal or 6 week check) should be referred urgently Page 26 of 51 Appendix 2: EXCLUDED PROCEDURES The following list is not exhaustive and will be subject to regular change as and when evidence is published and priority advice is taken around commissioning. It is for the referring clinician to provide detail of exceptional circumstances as per the appended form in light of the earlier definition of exceptionality provided by the NHS Confederation. Guidance notes are included where appropriate and only as a pointer towards consideration. The recommendations and policy notes of the South Central Priorities Committees will supersede or add to this list as will mandatory NICE Technology Appraisal Guidance. The list below is under constant review and development. Specialty Procedure Plastic/ cosmetic procedures surgery (see Appendix C for further detail) Any procedure carried out for primarily cosmetic reasons is excluded i.e. not funded OPCS codes Notes See Appendix C Rhinophyma correction E094/6 Treatment of ganglions T59 T60- Treatment of bunions (hallux valgus) W791/2 W151 Liposuction/lipectomy (including apronectomy) and submental lipectomy S031/2/3 S621/2 S013 Face/ brow/ buttock/ thigh/ upper arm lift S01- (not S013) S031/2/3 Breast augmentation surgery or correctional procedures B30B31- As per the South Central Priorities Committee policy statement. Post cancer treatment is an exception to this policy and will go ahead as part of established cancer pathways without the need for prior approval Mastopexy (repositioning of nipple) B35- (not B355) Only as part of post-surgical reconstruction Breast reduction surgery B311 Page 27 of 51 Specialty Procedure OPCS codes Pinnaplasty D03- Notes Labiaplasty Removal of benign skin lesions and blemishes including skin tags anywhere on the body E094, H482, S04-, S05-, S06-, S08-, S09-, S10- (not S103) S11- Concern over malignancy will be an absolute exception and should go ahead without application for prior approval subject to clinical audit Alternative/ complementary/ homeopathic therapies Complementary medicine X61- When included as an adjunct to usual therapy – not funded as a separate procedure Gender dysphoria Psychological assessment Gender reassignment Laser hair removal Vocal chord shaving X15- Consideration following full psychiatric assessment by local services. Referrals, following asssessment, to the Charing Cross Gender Identity Service only (meeting ICD10 criteria) and made directly by the relevant mental health team. This service is commissioned by the South Central Specialised Commissioning Group Mental health Inpatient psychotherapy Non-NHS residential placements Adult ADHD and Aspergers’ Orthopaedics On an individual patient basis Sports limbs Hip resurfacing W581, Z843 Kyphoplasty V445 Page 28 of 51 Specialty Procedure OPCS codes Notes X521 Emergency decompression only Appliances and devices for cosmetic purposes (highgrade silicon cosmesis and/or prosthesis) Glucosamine (sulphate and hydrochloride salt) for adult osteoarthritis Serum P1NP measurement in the management of osteoporosis Other Hyperbaric oxygen therapy (HBOT) Co-careldopa intestinal gel (Duodopa) for advanced Parkinsons’ disease Penile implants for erectile dysfunction Low priority as per SHIP Priorities Committee policy statement Cerebellar stimulator implants in spasticity Low priority due to lack of evidence of clinical effectiveness Single-incision sub-urethral short tape insertion for stress urinary incontinence in women M533/4/5 Excluded as per NICE Interventional Procedures Guidance 262 Silver releasing dressings for management of chronic wounds Page 29 of 51 Specialty Procedure OPCS codes Notes Polysomnography in the investigation of children with sleep-related disorders U331 This policy does not apply to the use of PSG in the management of complex craniofacial abnormalities through the nationally commissioned and designated craniofacial service. Trans-catheter aortic valve implantation for aortic stenosis K358, Y013, Y53, Z322 – femoral approach K262, Y494 apical approach In line with the South Central Priorities Committee policy statement. New evidence may become available about this procedure, in which case the policy will be reviewed. Trans-cranial Doppler ultrasonography with frequent transfusion to prevent stroke in children with sickle cell disease Growth Hormone for children born small for gestational age (SGA) If the procedure is funded in exceptional circumstances, the commissioning framework endorsed by the British Cardiovascular Intervention Society1 recommends that it should only be at hospitals carrying out at least fifty trans-catheter aortic valve implantations for aortic stenosis per year. Cannabinoids in the management of Multiple Sclerosis and chronic pain Eculizumab for the management of Paroxysmal Nocturnal Haemoglobinuria (PNH) Therapeutic use of probiotics in adults and children 1 Sethi S. Daniel T, Howell J, Griffen C. A commissioning framework for transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis. (www.bcis.org.uk/resources/documents/TAVI%20National%20Commissioning%20Framework %20FINAL%20160309.pdf) Page 30 of 51 Specialty Laser treatments Procedure OPCS codes Use of neuro-stimulators in the management of essential tremor, primary dystonia, and multiple sclerosis. A09 Pulmonary vein isolation (PVI) for arterial fibrillation K621 PVI should be restricted to patients for whom alternative therapies have proved ineffective, as outlined in the NICE interventional procedure guidance on PVI. Warts, rosacea, scars, thread veins/venous flares, spider naevia, telangiectasia, seborrhoeic keratoses, portwine stains, benign lesions, hair removal, resurfacing Y088 Y113/Y133, S065, S091/2 Routinely excluded but exceptional (particularly facial) disfigurement considered. Clinical photography would normally be required subject to patient consent Tattoo removal S091/2 S065/8/9 Cardiothoracic surgery Closure of patent foramen ovale Oncology Extra-corporeal photopheresis for the treatment of chronic graft v host disease or cutaneous T-cell lymphoma Salvage cryotherapy for recurrent prostate cancer Notes This policy does not apply to closure of patent foramen ovale for stroke prevention. M671 Cryotherapy for localised prostate cancer Page 31 of 51 Specialty Procedure Sorafenib for Hepatocellular Carcinoma (HCC) OPCS codes Notes In line with NICE Single Technology Guidance 189, issued July 2010: ‘Sorafenib is not recommended for the treatment of advanced hepatocellular carcinoma in patients for whom surgical or locoregional therapies have failed or are not suitable. People currently receiving sorafenib for the treatment of advanced hepatocellular carcinoma should have the option to continue treatment until they and their clinician consider it appropriate to stop’. Cyberknife surgery for cholangiocarcinoma Page 32 of 51 Appendix 3: SOUTH CENTRAL ETHICAL FRAMEWORK Berkshire East PCT Berkshire Priorities Committee (BPC) Berkshire West PCT Buckinghamshire PCT Buckinghamshire and Milton Keynes Priorities Committee (BMKPC) Milton Keynes PCT Oxfordshire PCT Oxfordshire Priorities Forum (OxPF) Hampshire PCT Hampshire and Isle of Wight Priorities Committee (HIOWPC) Isle of Wight PCT Portsmouth City Teaching PCT Southampton City PCT South Central Specialised Services Commissioning Group (SCG) Central South Coast and Thames Valley Cancer Networks (CN) Background The Priorities Committees are committees of representatives of the NHS organisations across all nine South Central NHS Primary Care Trusts (PCTSs) and include lay members as well as clinicians and managers. The purpose of the ‘Priorities Committees’ is to advise the local NHS health economy as to the health care interventions and policies that should be given high or low priority. Primary Care Trusts are under a statutory duty to promote the health of the local community. They are also under a duty not to exceed their annual financial allocation. These legal requirements mean that, from time to time, difficult choices have to be made. The Priorities Committees help PCTSs choose how to allocate their resources to promote the health of the local community. Individual cases are considered by each respective PCTS. A review of the existing ethical frameworks of the Thames Valley and Hampshire and Isle of Wight has contributed to the development of a South Central wide ethical framework to support decision making across all of South Central both within the established Priorities Committees and also within the SCG/networks or individual PCTSs. For the purposes of this document, all the above organisations will be referred to collectively as the ‘Committees’. Purpose of the Ethical Framework The purpose of the ethical framework is to support and underpin the decision making processes of constituent organisations and their Priorities Committees to support consistent commissioning policy through: Providing a coherent structure for discussion, ensuring all important aspects of each issue are considered Promoting fairness and consistency in decision making from meeting to meeting and with regard to different clinical topics, reducing the potential for inequity Providing a means of expressing the reasons behind the decisions made. Reducing risk of judicial review by implementation of robust decision-making processes that are based on evidence of clinical and cost effectiveness and an ethical framework Supporting and integrating with the development of PCTS Commissioning Plans Formulating policy recommendations regarding health care priorities involves the exercise of judgment and discretion and there will be room for disagreement both within and outwith the Committees. Although there is no objective or infallible measure by which such decisions can be based, the Ethical Framework enables decisions to be made within a consistent setting which respects the needs of individuals and the community. The Committees recognise that their discretion may be affected by National Service Frameworks, National Institute for Health and Clinical Excellence (NICE) technology appraisal guidance and Secretary of State Directions to the NHS. Page 33 of 51 The Ethical Framework is especially concerned with the following: 1. EVIDENCE OF CLINICAL AND COST EFFECTIVENESS The Committees will seek to obtain the best available evidence of clinical and cost effectiveness using robust and reproducible methods. Methods to assess clinical and cost effectiveness are well established. The key success factors are the need to search effectively and systematically for relevant evidence, and then to extract, analyse, and present this in a consistent way to support the work of the Committees. Choice of appropriate clinically and patient-defined outcome needs to be given careful consideration, and where possible quality of life measures and cost utility analysis should be considered. The Committees will promote treatments for which there is good evidence of clinical effectiveness in improving the health status of patients and will not normally recommend treatment that is shown to be ineffective. Issues such as safety and drug licensing will also be carefully considered. When assessing evidence of clinical effectiveness the outcome measures that will be given greatest importance are those considered important to patients’ health status. Patient satisfaction will not necessarily be taken as evidence of clinical effectiveness. Trials of longer duration and clinically relevant outcomes data may be considered more reliable than those of shorter duration with surrogate outcomes. Reliable evidence will often be available from good quality, rigorously appraised studies. Evidence may be available from other sources and this will also be considered. Patients’ evidence of significant clinical benefit is relevant. The Committees will compare the cost of a new treatment to the existing care provided and will also compare the cost of the treatment to its overall benefit, both to the individual and the community. They will consider technical cost-benefit calculations (e.g. quality adjusted life years), but these will not by themselves be decisive. The Priorities Committees may use the ethical framework to guide context-specific judgements about the relative priority that should be given to each topic. 2. EQUITY The Committees believe that people should have access to health care on the basis of need. There may also be times when some categories of care are given priority in order to address health inequalities in the community. However, the Committees will not discriminate on grounds of personal characteristics, such as age, gender, sexual orientation, gender identity, race, religion, lifestyle, social position, family or financial status, intelligence, disability, physical or cognitive functioning. However, in some circumstances, these factors may be relevant to the clinical effectiveness of an intervention and the capacity of an individual to benefit from the treatment. 3. HEALTH CARE NEED AND CAPACITY TO BENEFIT Health care should be allocated justly and fairly according to need and capacity to benefit, such that the health of the population is maximised within the resources available. The Committees will consider the health needs of people and populations according to their capacity to benefit from health care interventions. So far as possible, it will respect the wishes of patients to choose between different clinically and cost effective treatment options, subject to the support of the clinical evidence. This approach leads to three important principles: In the absence of evidence of health need, treatment will not generally be given solely because a patient requests it. A treatment of little benefit will not be provided simply because it is the only treatment available. Treatment which effectively treats “life time” or long term chronic conditions will be considered equally to urgent and life prolonging treatments. 4. COST OF TREATMENT AND OPPORTUNITY COSTS. Because each PCTS is duty-bound not to exceed its budget, the cost of treatment must be considered. The cost of treatment is significant because investing in one area of health care inevitably diverts resources from other uses. This is known as opportunity costs and is defined as benefit foregone, or value of opportunities lost, that would accrue by investing the same resources in the best alternative way. The Page 34 of 51 concept derives from the notion of scarcity of resources. A single episode of treatment may be very expensive, or the cost of treating a whole community may be high. 5. NEEDS OF THE COMMUNITY Public health is an important concern of the Committees and they will seek to make decisions which promote the health of the entire community. Some of these decisions are promoted by the Department of Health (such as the guidance from NICE and National Service Frameworks). Others are produced locally. The Committees also support effective policies to promote preventive medicine which help stop people becoming ill in the first place. Sometimes the needs of the community may conflict with the needs of individuals. Decisions are difficult when expensive treatment produces very little clinical benefit. For example, it may do little to improve the patient’s condition, or to stop, or slow the progression of disease. Where it has been decided that a treatment has a low priority and cannot generally be supported, a patient’s doctor may still seek to persuade the PCTS that there are exceptional circumstances which mean that the patient should receive the treatment. 6. POLICY DRIVERS The Department of Health issues guidance and directions to NHS organisations which may give priority to some categories of patient, or require treatment to be made available within a given period. These may affect the way in which health service resources are allocated by individual PCTSs. The Committees operate with these factors in mind and recognise that their discretion may be affected by National Service Frameworks, NICE technology appraisal guidance, Secretary of State Directions to the NHS and performance and planning guidance. Locally, choices about the funding of health care treatments will be informed by the needs of each individual PCTS and these will be described in their Local Delivery Plan. 7. EXCEPTIONAL NEED There will be no blanket bans on treatment since there may be cases in which a patient has special circumstances which present an exceptional need for treatment. Each case of this sort will be considered on its own merits in light of the clinical evidence. PCTSs have procedures in place to consider such exceptional cases on their merits. Authors: Date of Issue: Review Date: South Central Priorities Support Unit Steering Group 12th February 2008 1st February 2011 Page 35 of 51 INDIVIDUAL FUNDING REQUEST (IFR) APPLICATION FORM SECONDARY CARE USE Please note it is the clinician’s responsibility to obtain patient consent to share this and all supporting materials with the PCT. All information will be used and stored in accordance with the data protection act. Photographic evidence, where appropriate, may be submitted separately using only the minimum data set (GP details, initials, DOB and NHS number) to ensure patient confidentiality On completion the request form and all supporting materials as defined within this request form should be posted, faxed or emailed to the IFR team – contact details included at the end of this form. All sections are to be completed in requests from secondary care and specialist provider services. In recognition of the nature of requests from primary care those sections denoted by an asterisk (*) are to be completed at the discretion of the requesting general practitioner. CONTACT INFORMATION Trust / General Practice Surgery Name 1. Address 2. Applicant Details Name: Designation: Tel: Email: 3. Patient Details Name: Hospital ID number: NHS Number: DoB: Registered Consultant: Registered GP name: Registered GP postcode: Referred by (other than GP): Referred from: 4. Application reviewed by Chief Pharmacist or nominated deputy (in the case of a drug intervention) Date of referral: Name: Signature or email confirmation: Page 36 of 51 STATEMENT CONFIRMING APPROPRIATENESS FOR CONSIDERATION AS AN IFR If it is foreseeable that there are one or more other patients within the PCTs’ population who are or are likely to be in the same or similar clinical circumstances as the requesting patient in the same financial year, and who could reasonably be expected to benefit to the same or a similar degree from the requested treatment then the request should properly be considered as a request for a service development and inappropriate for consideration as an IFR except in the circumstances where all the similar patients are expected to be from the same family group, a situation which may arise in the context of a rare genetic disease. 5. I confirm that it is not expected that there will be more than one patient from within the PCTs’ population who is or is likely to be in the same or similar clinical circumstances as the requesting patient in the same financial year and who could reasonably be expected to benefit to the same or a similar degree from the requested treatment unless similar patients are expected to be from the same family group. Tick box as appropriate Yes No DIAGNOSIS AND PATIENT’S CURRENT CONDITION 6. Patient Diagnosis (for which intervention is requested) (a) In case of cancer: What is disease status? (e.g. at presentation,1st/2nd or 3rd relapse) What is the WHO performance status? (*) How advanced is the cancer? (stage) Describe any metastases: (b) In case of non-cancer: What is the patient’s clinical severity? (Where possible use standard scoring systems e.g. WHO, DAS scores, walk test, cardiac index etc.) (c) For all conditions (i.e. cancer and non-cancer) Please summarise the current status of the patient in terms of quality of life, symptoms etc INTERVENTION REQUESTED (NB: Intervention refers to requested treatment, investigation, etc) Page 37 of 51 7. Details of intervention (for which funding is requested). If the intervention forms part of a regimen, please document the full regimen (e.g. Drug X as part of regimen Y (consisting of drug V, drug W, drug X and drug Z). Regarding anticipated cost Acute Trusts to provide this from finance departments and primary care to seek advice from their Practice Based Commissioning Locality Manager. 8. Is requested intervention part of a clinical trial? Name of intervention: Dose and frequency (*): Planned duration (*) Of intervention: Route of administration (*): Anticipated cost (inc VAT) Are there any offset costs? (*) Describe the type and value of the offset costs (*) Funding difference being applied for (*) Delete as appropriate: Yes/No (refer to pharmacy if required) Delete as appropriate: Yes / No If Yes, give details (e.g. name of trial, is it an MRC/National trial?) Is the drug funded through a clinical trial? Delete as appropriate: Yes / No a) What would be the standard intervention at this stage? b) What would be the expected outcome from the standard intervention? c) What are the exceptional circumstances that make the standard intervention inappropriate for this patient? d) Please explain how this individual has an exceptional ability to benefit from the requested intervention over and above another individual with the same condition. e) If the requested intervention was not available what would your next planned intervention be? 10. Summary of previous intervention(s) this patient has received for the condition. Dates Intervention (e.g. drug / surgery) Reason for stopping / Response achieved Reasons for stopping may include Page 38 of 51 (not exclusively): Course completed No or poor response Disease progression Adverse effects/poorly tolerated 11. Anticipated start date Processing a request usually takes up to 2 weeks from the date received by the PCTs. If the case is more urgent than this, please state why: EVIDENCE OF CLINICAL EFFECTIVENESS 12. Where the intervention is a drug / medicine is the requested drug / medicine licensed for the requested indication in the UK? 13. Has the Trust Drugs and Therapeutics Committee or equivalent Committee approved the requested intervention for use? (if drug or medical device) (*) 14. Give details of National or Local Guidelines / recommendations or other published data / evidence base supporting the use of the requested intervention for this condition? (*) Delete as appropriate: Yes / No (refer to pharmacy if required) Delete as appropriate: Yes / No If No, Committee Chair or Chief Pharmacist approved: Yes / No PUBLISHED2 trials / data (Please forward papers / web links for peerreviewed papers where available. This needs to be supplied for all secondary care and specialist provider requests – the request will not be considered if these have not been included.) (a) How will you monitor the clinical effectiveness of this intervention? (b) Detail the current status of the patient according to these measures. (c) What would you consider to be a successful outcome for this intervention in this patient? (d) What is the minimum time frame/course of treatment at which a clinical response can be assessed? (e.g. after a single course of treatment) 15. What is the anticipated toxicity of the intervention for this patient? 16. Are there any additional clinical factors of the patient that need to be considered not already Delete as appropriate: Yes / No If Yes, please give details: 2 Full published papers, rather than abstracts, should be submitted Page 39 of 51 included in 8c or 8d? 17. Form completed by Name: Signature or email confirmation: PCT use only Record of communication: Points for Discussion Recommendation: Date: Contact details for IFR Submissions All applications should be made using the Individual Funding Request Application Form and provide all the required information as outlined in the Funding Request Form. The form should be completed electronically / typed – hand written submissions will not be accepted. Submissions should be sent (by post or fax or email) to: Individual Funding Request team NHS Hampshire Omega House 112 Southampton Road Eastleigh Hants SO50 5PB Tel: 02380 623254/5/6 Fax: 02380 620343 E-mail: [email protected] Page 40 of 51 INDIVIDUAL FUNDING REQUEST (IFR) APPLICATION FORM FOR USE IN PRIMARY CARE Contact details for IFR Submissions All applications should be made using the Individual Funding Request Application Form and provide all the required information as outlined in the Funding Request Form. The form should be completed electronically / typed – hand written submissions will not be accepted. Please ask your Practice Manager to load this form onto your practice server for ease of use. General guidance can be found directly below but, if you have any questions as to whether to submit an application or regarding the form itself, please contact the IFR team on the number or email address below as this may well save you a lot of time! General enquiries without patient identifiable data can also be emailed to [email protected] Submissions should be sent (by post or fax or email) to: Individual Funding Request team NHS Hampshire Omega House 112 Southampton Road Eastleigh Hants SO50 5PB Tel: 02380 623253/5/6 Fax: 02380 620343 E-mail: [email protected] Page 41 of 51 General guidance on completion We recognise that the IFR application form is not easy to complete and that you may not complete it often. We have therefore devised a shorter format than the application form previously available which we have now reserved for secondary care. The guide below should avoid requests for additional information and delays in decision-making. As set out above, please contact the team on the details above if you have any queries. The list below details some of the top 10 referrals received last year and the information required by the PCTs to make an informed decision Breast reduction – this will require details of patient’s BMI, breast size, confirmation that patient has had a professionally fitted bra, evidence of any intervention to address symptoms e.g physiotherapy for posture, details of how quality of life is affected. Psychological issues and distress are consistently not supported by the clinical Panel as a deciding factor on funding. Breast augmentation for asymmetry, lack of breast development or tubular breast development – this is routinely considered as a ‘cosmetic’ procedure and has no direct physiological clinical benefit. In this case, clinical photography – as with any ‘plastics’/’cosmetic’ procedure may well be a useful adjunct to an application compared to a written description. Although this cannot be insisted upon due to the sensitivity of such requests and patient consent, Panels find this a very useful aid to decision-making. Photographs are stored securely and anonymously to ensure patient confidentiality and will be returned on request. Abdominoplasty - guidance regarding this procedure for removal of excess skin following massive weight loss is included in NHS Hampshire’s Policy and Procedure for IFRs found on our website at http://www.hampshire.nhs.uk/about-us/346-commissioning-policies under the paragraph marked ‘noncontractual referrals’. We receive many cases for this procedure particularly following multiple Caesarean sections and there is little evidence to support direct physiological benefit. Pinnaplasty – the PCTs receive many requests for this procedure in children suffering from teasing and bullying at school. This is no longer commissioned routinely and the Referral Panel, whilst sympathetic with such cases, regrettably does not approve requests based on a child’s distress. Bariatric surgery – this is managed by the South Central Specialised Commissioning Group on a separate application. This can be accessed either via the number above or direct from the South Central SCG on 023 8062 7284 or by emailing [email protected]. The PCTs’ IFR policy and procedure of which the application below is part of includes a bariatric referral form in the appendices. IVF – access to IVF is also managed by the South Central SCG to regional policy criteria. In short, this is restricted to childless couples where the woman is aged between 30 and 34 and following either diagnosis of absolute infertility or three years of attempting to start a family where there is no clear diagnosis. Referrals meeting the criteria can only be made by a secondary care fertility specialist. Cases outside the criteria that you deem exceptional can be made to the PCTs using the form below. Asperger’s/autism diagnosis in adults – we expect that all such patients have had a baseline mental health assessment by the local adult mental health team to exclude other co-morbidities. The PCTs have arrangements in place to organise specialised assessments on a named patient basis. A summary of the patient’s daily functioning and social situation and how such an assessment may benefit should be submitted – the application form need not be completed but could act as a guide. Please contact the IFR team to discuss. Varicose veins – the policy criteria governing access to varicose vein treatment are clear and evidencebased. The link between symptoms reported by many patients e.g heaviness, aching, itching and varicose veins; and hence surgical intervention are not supported by the evidence. For more detail, NHS Page 42 of 51 Hampshire has an excellent summary on ‘Pages4Primary Care’ which explores this and can be shared with your patient. Functional electrical stimulation (FES) – this is a particularly common request to treat ‘dropped foot’ for neurological problems (eg stroke, MS) and may well be due to the local presence of the national FES Centre in Salisbury. This has been extensively reviewed on at least two occasions by the South Central Priorities Committees and, whilst agreed as a more ‘elegant’ approach to dropped foot in terms of greater walking speed/distance and lower fatigue, it is not a cost-effective option for the local NHS. Our Panel reviews on a named patient basis particularly where the standard use of ankle-foot orthosis has been proven to be intolerant or where there is a falls history/risk. PATIENT INPUT Direct patient applications cannot be accepted by the PCTs but patient accounts may be included in the application should they wish to contribute towards their case. We would expect GPs to act on their patient’s behalf and to make necessary enquiries. Any appeals should also be clinically-led. SECONDARY CARE APPLICATIONS We would encourage primary care clinicians to request specialists/ secondary care consultants to complete funding applications themselves for treatments that require specialist intervention, expertise or opinion. We would support all Practices should there be any problems in obtaining secondary care support in completion of funding applications which we would expect to come directly from the Trusts themselves. Page 43 of 51 IFR APPLICATION FORM PRIMARY CARE USE ONLY Nb Secondary care clinicians please complete usual funding application form Please note it is the clinician’s responsibility to obtain patient consent to share this and all supporting materials with the PCTS. All information will be used and stored in accordance with the Data Protection Act. CONTACT INFORMATION GP and Surgery Name 1. Address inc. postcode 2. Position: Tel: Email: 3. Patient Details Name: NHS Number: DoB: Date of referral: DIAGNOSIS AND PATIENT’S CURRENT CONDITION 4. Patient Diagnosis (for which intervention is requested) Diagnosis Please summarise the current status of the patient in terms of quality of life, symptoms etc INTERVENTION REQUESTED (NB: Intervention refers to requested treatment, investigation, etc) Page 44 of 51 5. Details of intervention (for which funding is requested) If costs are known, please state (optional) Name of intervention: 6 Is the requested treatment available locally? (state where if possible) 7 Are there any clinical factors that need to be considered that would set this patient out as exceptional? The following is an excerpt from the NHS Confederation guide ‘Priority setting: managing individual funding requests’ 2008 which clarifies this: Exceptionality - this is best expressed by the question ‘On what grounds can the PCTs justify funding a particular patient over and above others from the same patient group who are not being funded?’ THIS IS THE MOST IMPORTANT PART OF THE APPLICATION AND WOULD EXPECT THE MOST DETAIL TO BE INCLUDED HERE In making a case for special consideration, it needs to be demonstrated that: - the patient is significantly different to the general population of patients with the condition in question, and - the patient is likely to gain significantly more benefit than might be normally expected for patients with the same condition The fact that the treatment is likely to be efficacious for a patient is not, in itself, a basis for exceptionality. Social and psychological circumstances, whilst recognised, are not considered decisive factors in funding For more detail please refer to the case studies here thttp://www.phcn.nhs.uk/case book/2/PHCN%20Casebook %20Issue%202,%20p1%20E xceptionality%20guidance.do c Page 45 of 51 8 Summary of previous intervention(s) this patient has received for the condition. Dates Intervention Reason for stopping / Response achieved 9 Please summarise any additional supporting information and attach all relevant clinical correspondence in support of the application 10 Form completed by Name: Signature or email confirmation: Page 46 of 51 Appendix 6 SOUTH CENTRAL STRATEGIC HEALTH AUTHORITY CANCER DRUG FUND From 1 October 2010 cancer patients will have greater access to the cancer drugs that their doctors recommend for them due to an extra £50 million in funding being made available nationally by the Department of Health. Following Health Secretary Andrew Lansley's announcement in July, an extra £50 million will be made available across the UK to allow thousands of patients to receive innovative new cancer drugs that may extend life or improve quality of life. Clinically led panels have been set up in each region, putting doctors in charge of deciding how this funding is spent for their patients locally, together with advice from relevant cancer specialists. The funding will be available until the end of March 2011 when a further cancer drugs fund scheme will be introduced. In the NHS South Central region, the portion of additional cancer funding amounts to £3.4m. A specialist panel, chaired by Dr Peter Hockey, Deputy Medical Director South Central SHA, has been formed to deal with requests from doctors for additional cancer drug funding. Members of the panel are drawn from a pool of volunteers consisting of: Oncologists Haematologists GPs Public Health consultants Palliative care consultants The chair will select appropriate members according to specialist expertise and area of interest of panel members. At least one site-specialist expert for each application being considered will be included in the panel When an application for funding is received the chair will identify appropriate members from the pool. The panel will consider applications within ten working days of receiving the application and communicate the outcome to the referring specialist. The referring specialist will be invited to present the case for funding, but will not be included in the decision making process. Frequently Asked Questions: How much money is available for the new Cancer Drug Funding across the South Central Region? The figure for NHS South Central is £3.4m Why has this money been made available? This is additional funding for cancer drugs. It is intended to enable individual patients to receive clinicallyrecommended treatments they have been unable to access following full consideration of funding options by their PCTs. It provides a process that enables specialist clinicians to take treatment decisions for the benefit of patients where funding for a cancer drug has been refused through usual commissioning channels. This process is to implement the Secretary of State’s vision that oncologists should have greater freedom to prescribe those cancer drugs which they believe to be in the best interest of individual patients. Is this funding available every year? This funding is an interim measure available from the 1 October 10 until 31 March 2011 although the government has set out its plans to establish a further Cancer Drugs Fund from April 2011 How do clinicians access this funding for their patients? Page 47 of 51 This is additional funding for cancer drugs. It is intended to enable individual patients to receive clinicallyrecommended treatments they have been unable to access following full consideration of funding options by their PCTs Application for funding is made to NHS South Central via the following link: [email protected] Who sits on the specialist Panel? The panel is chaired by Professor Peter Johnson, Professor of Medical Oncology, Cancer Research UK Centre, Southampton General Hospital. Applications will be considered by a clinical panel consisting of oncologists and haematologists plus representation from primary care, public health and palliative care. How will the panel decide on who gets funding? The panel will assess requests based on a test of clinical ‘reasonableness’, which will include evaluation of the evidence submitted to demonstrate the likelihood and extent of clinical benefit to the patient from the drug treatment requested. Who manages the Cancer Fund? The fund is managed by South Central Specialised Commissioning who will support the panels, but will not participate in the decision-making processes. Specialised Commissioning will be responsible for liaison with PCTSs, to obtain evidence of their decisions on prior exceptional/individual funding requests, and to ensure that the service costs of the drugs funded by the Panel will be met. Do all Cancer patients have access to this fund? Yes, although funding will be determined on a case by case basis. Existing PCT funding routes should have been adequately explored and exhausted before a call is made on SHA funds. This includes exploring PCT processes for considering individual / exceptional funding requests. Does the funding extend to radiopharmaceuticals? Yes, the primary focus of the funding is on improving access to cancer drugs, which can include radiopharmaceuticals. Will there be any monitoring of the outcomes? Yes, referring specialists will be asked to provide updates at 6 week intervals on the results of treatment. Specialists who unreasonably fail to provide updates will not be able to apply for further funding by this mechanism. Does an appeals process exist if cancer funding is not agreed through this process? Yes, a referring oncologist may appeal against the Panel’s decision within 2 weeks. Who do I contact for further information? Please contact: Joanne Funderburk Project Officer Programme & Project Team South Central Strategic Health Authority First Floor, Rivergate House Newbury Business Park London Road Newbury RG14 2PZ Email : [email protected] Tel: 01635 275611 Page 48 of 51 APPENDIX 7 COSMETIC/ PLASTIC SURGERY Overall the policy for funding of cosmetic/plastic surgery is that this is not normally funded and only considered following surgery, trauma or for congenital malformation. (Post-surgical reconstruction would be part of service level agreements for surgical services in any case.) The effect of the problem on essential activities of day-to-day living is a key factor in decision-making. In such cases, psychological treatment such as counselling or cognitive behavioural therapy may be considered as an appropriate alternative to surgery. It is not necessary to obtain a psychiatric opinion and this should only be sought at the specific request of the PCTs. We would expect psychiatrists to treat related problems through established procedures that the PCTs commission from the mental health trust and this would not include surgery. Exceptions criteria in previous policies for procedures such as breast augmentation, breast reduction, mastopexy, implant removal and replacement, gynaecomastia, pinnaplasty and abdominoplasty have been removed with referrers asked to provide individual detail of exceptional circumstances and conditions in line with the points above. We would request that all applications for ‘plastics’ procedures should be accompanied by suitable clinical photography that demonstrates the extent of the problem. This, of course, would be subject to patient consent. Page 49 of 51 APPENDIX 8 Bariatric surgery referral form South Central Specialised Commissioning Group GENERIC REFERRAL FOR BARIATRIC SURGERY ASSESSMENT CHECK LIST FOR ELIGIBILITY Statement to be signed by the referrer and sent to: South Central Specialised Commissioning Group Omega House 112 Southampton Road Eastleigh SO50 5PB Name of Referrer (please print): _________________________________________________________ GP or NHS Trust Consultant: __________________________________________________________ Address/Tel: ____________________________________________________________________ ____________________________________________________________________ Postcode: __________ PCT: __________________________________ NHS No: __________________________________ Provider’s Patient Reference: _____________________ Name: ______________________________ _____________________________________________________ Address:___________________________________________________________________________________ ___________________________________________________________________________________________ ___________________________________________________________________________________________ Postcode: __________________ Date of Birth: ______________ (Age: ) Home Telephone No: ________________________________ Work Telephone No: ________________________________ Mobile Telephone No: ________________________________ Patient’s GP: _______________________________________ Page 50 of 51 Criterion Yes/No Inclusion Criteria For Bariatric Surgery 1 BMI _______________ (weight in kg divided by height squared in m2) 45 kg/m2 in the presence of serious co-morbidity which will be improved by bariatric surgery 60 kg/m2 in the absence of serious co-morbidity 2 The following conditions will be accepted as meeting the definition of a serious co-morbidity: Established ischaemic heart disease (please give details) Type 2 diabetes requiring oral medication or insulin (please state which) Life-threatening sleep apnoea (please give details of investigations and present therapy) Severe uncontrolled hypertension (please give average BP and list drugs) Benign intracranial hypertension with severe, sight-threatening papilloedema (please give details) History of transient ischaemic attacks or stroke (please give details) Severe lower limb major joint disease requiring orthopaedic intervention which is precluded on safety grounds due to patient’s BMI (please state proposed surgical procedure) Other co-morbid condition which has been agreed by the PCT as exceptional, on an individual patient basis 3 The patient has been receiving intensive management by a specialist obesity service. 4 All available non-surgical measures have been tried, but have failed to maintain significant (ie >10% ) weight loss. 5 There are no specific clinical contraindications and the patient is fit for surgery. 6 The patient has realistic expectations of the outcomes of surgery, and understands that cosmetic plastic procedures to remove excess skin folds will not be funded by the NHS. 7 The patient understands the long term commitment and compliance required. 8 PCTs will consider requests for obese patients who fall outside these criteria to be offered surgery in exceptional circumstances (eg where the patient has a BMI less than 45, but has life-threatening co- morbid conditions which will be significantly improved by bariatric surgery. Please provide clinical details of any criteria met by patient and include list of medication Please give any other relevant information I confirm that all the above appropriate access criteria have been met and this patient is therefore eligible for NHS funded bariatric treatment. Referrer’s signature: _____________________________Date of referral: ___________________ Page 51 of 51