INDIVIDUAL FUNDING REQUEST POLICY for NHS Great Yarmouth and Waveney and NHS Norfolk

INDIVIDUAL FUNDING REQUEST POLICY for NHS Great Yarmouth and Waveney and NHS Norfolk This policy covers: Individual Funding Requests for Medicines(IFR-M) and Individual Funding Requests for Procedures and Therapy (IFR-PT) Policy date: July 2009 Review due: July 2010 Other related policies: Non-Routine and Threshold Procedures and Therapy policy New medicines policy

NHS Great Yarmouth and Waveney and NHS Norfolk INDIVIDUAL FUNDING REQUEST POLICY 1. INTRODUCTION: 1.1 NHS Great Yarmouth and Waveney and NHS Norfolk (referred to in this policy as the PCTs ) receive requests on behalf of individual patients for funding for treatments (including medicines, procedures and therapies) that are: not routinely funded by the PCTs and for which there is therefore no existing contract or service level agreement ( non-routine treatments ); or only funded by the PCTs for patients who meet a set clinical threshold ( threshold treatments ); or new medicines and treatments and/or unlicensed indications (ie uses) for existing medicines and treatments that are not routinely funded by the PCTs ( new medicines and treatments ) and in exceptional cases the PCTs may approve funding for specific treatments that are not available under existing funding arrangements. 1.2 This policy sets out the key principles and processes that will be applied by the PCTs in considering such requests. 1.3 Two other policies of the PCTs are relevant to decisions made in accordance with this policy: Non-Routine and Threshold Procedures and Therapies policy (previously known as the Low Priority Procedures and Threshold policy or LPPT policy) which defines what is meant by non-routine treatments and threshold treatments; and New medicines policy which covers the introduction of new medicines (or new indications (uses) for existing medicines, the method of introduction, etc ). 2. INDIVIDUAL FUNDING REQUESTS PANEL: 2.1 The PCTs have set up a joint Individual Funding Requests Panel ( the IFR Panel ) with delegated authority (accountable to the Boards of the PCTs) to consider whether they should fund such treatments on the grounds that the patients requesting them have circumstances that make them exceptional. If exceptionality can be shown, the PCTs may agree, in line with the principles and decision-making processes set out in this policy, to fund the requested treatments. 2.2 The PCTs IFR Panel is also responsible for monitoring and reviewing its own decision-making processes and, where considered appropriate by the IFR Panel, for monitoring the treatment outcomes of individual cases that it has agreed to fund.

2.3 Before an IFR Panel will consider a case it must first be established that the treatment requested does not fall within treatments that would routinely be funded by the PCTs for the individual patient. If so, the IFR Panel will seek to determine: firstly, whether the patient either: and if so o is an exceptional case; or o has a rare condition and neither the patient nor the benefit they are likely to gain from the treatment can be compared against a cohort of other patients with the same condition; secondly, whether the treatment is both clinically and cost effective and, on that basis, the IFR Panel will decide whether the treatment will be funded or not. 2.4 It is not the role of the IFR Panel to make commissioning policy on behalf of the PCTs. Therefore the IFR Panel will not usually make a decision to fund a patient where by doing so, (because the patient is not, in fact, exceptional, but representative of a group of patients), a precedent would be set that establishes a new commissioning policy for the PCTs. Therefore in the event that the IFR Panel is requested to consider three or more requests for the same treatment and considers that strong evidence has been provided in support of a particular health technology for use in a clearly defined group of patients, it will refer the treatment requests to the PCTs Commissioning (service development) process with a recommendation for further consideration of the treatment for routine funding by the PCTs. 2.5 The PCTs joint IFR Panel will operate as two separate panels as listed below: Individual Funding Requests Panel for Medicines (ie Drugs) Individual Funding Requests Panel for Procedures and Therapies (ie Non-drugs). 3. DETERMINATION OF EXCEPTIONALITY : 3.1. There is no definitive list of the factors that determine exceptionality and each request will be considered by the IFR Panel on a case by case basis. 3.2. Before a request for individual funding can be agreed, the IFR Panel must be satisfied that there is some unusual or unique clinical factor present in the patient; in other words that the patient is significantly different to the general population of patients with the same condition. The following sections offer guidance and illustrative scenarios on the nature of exceptionality but are not intended to be a prescriptive definition.

3.3. Exceptionality can be demonstrated in the following circumstances: 3.3.1. Significant difference - where the patient is significantly different from the general population of patients with the same condition AND, if so: 3.3.2. Above average benefit likely - the patient is likely to gain significantly more benefit from the treatment than might be expected to be gained by the average patient with the same condition. Rationale: The PCTs policies on whether to fund a treatment are dependent on the benefits to be derived from the treatment as demonstrated by information derived from clinical trials. This information averages out the range of benefits experienced by individual patients taking part in the trials and therefore provides a suitable basis for policy-making for the average patient. However, there may well be sub-groups of patients who get above-average benefit from the treatment. So, if the clinical circumstances of a patient suggest they: are likely to derive above-average benefit; or in the case of treatments with a low probability of success, have an above-average likelihood of deriving a benefit then this would support a case for exceptional funding of treatment for that patient. 3.4. It is for the requesting clinician to make the case for exceptionality. 3.5. The PCTs consider all the lives of all the patients whom they serve to be of equal value and, in making decisions about funding treatment for patients, will seek not to discriminate on the grounds of sex, age, sexual orientation, ethnicity, educational level, employment, marital status, dependents or other family circumstances or religion. As all such personal and social circumstances are not relevant to any determination of clinical exceptionality, they will not be taken into account by the IFR Panel SAVE where a difference in the treatment options made available to the patient is directly related to the patient s clinical condition or is related to the anticipated benefits to be derived from a proposed form of treatment. 3.6. The following additional circumstances may further strengthen a case for exceptionality, although by themselves they do not confer grounds for exceptional funding: 3.6.1. Unexpected or unpredicted clinical circumstances / Unusual combination of illnesses and treatment history An individual patient can have a unique combination of illnesses, previous treatment history, side-effects, reactions, etc, which may mean the patient no longer fits a standard treatment pathway. 3.6.2. What is exceptional is considering using the treatment at all

When all the usual treatments have failed, clinicians seek out alternatives. Experts may suggest novel uses of treatments, including unlicensed indications with less robust evidence to support their use. Indeed the only evidence to support the use of the treatment may be a case report or a short case series (and these may only relate to a condition or conditions which are not the same but are closely related to the patient s). The strongest argument for the use of the treatment may be one based on biological plausibility. Thus exceptionality in such cases revolves around the use of the treatment rather than the likely benefit to the patient. Whether this supports the case for exceptional funding or not requires an assessment of the strength of the evidence supporting the use of the treatment, the implications for the patient, the patient s clinical circumstances, etc. 3.7. Conversely the scenarios described in this section illustrate a range of circumstances that in themselves do not justify exceptional funding, nor do they support the argument for exceptionality : 3.7.1 Likelihood of effectiveness When a proposed treatment is likely to be effective in that individual, this is not, in itself, a basis for exceptionality. 3.7.2 Meeting the clinical criteria for the licensed use of the treatment A patient who meets the criteria for the licensed indication of a treatment, which is not routinely funded, is not exceptional. 3.7.3 Matching the accepted indications (whether accepted by the patient s clinician or a group of clinicians) for the unlicensed use of the treatment If a patient's clinical condition matches the 'accepted indications' for the unlicensed use of a treatment, which is not routinely funded, this is not, by definition, exceptional. 3.7.4 The patient has reached the end-stage of their condition For many conditions, there is a predictable end-stage. The fact that a patient has now reached the end-stage of the condition is not in itself grounds for exceptionality. However IFR Panels decisions in such cases will take into account and be guided by the NICE guidance on appraising life-extending, end of life treatments. (Appendix 2) 3.7.5 It s the only treatment left Where existing treatments provide incomplete control of the condition, a new treatment can offer the only prospect of improved control. However, the fact that the treatment is the only one that has not yet been tried does not in itself lend support to exceptionality. 3.7.6 The treatment is newly available for a specific phase of a condition

Where a patient s condition has progressed beyond the stage at which the newly available requested treatment is recommended for use the patient s circumstances will not be regarded as exceptional. 4. POLICY GUIDANCE In reaching a decision on individual funding requests, the IFR Panel will consider each case in line with the PCTs Ethical and Commissioning Principles (see Appendix 1) and in accordance with this policy taking into account the principles set out below. Sections 5 to 7 of this policy and Appendices 3 and 4 set out the PCTs and IFR Panel s processes. 4.1. High cost medicines and treatments 4.1.1. In certain circumstances, even if a medicine or treatment may be clinically effective to save or extend the lives of patients, the PCTs may have made a commissioning decision that the medicine or treatment is not cost effective, due to its very high cost, and should not be funded on a routine basis. 4.1.2 Where such a decision has been made, in some cases the PCTs may have decided that the IFR Panel will consider requests that the medicine or treatment should be funded on an individual basis in exceptional cases. Consequently, the IFR Panel will consider such requests for the funding of these very high cost medicines or treatments. 4.1.3 However, in the case of other high cost medicines and treatments that the PCTs have decided not to fund routinely, the PCTs have also decided that the medicine or treatment, although clinically effective, is of such high cost per QALY 1 that they cannot envisage circumstances under which an application to fund the medicine or treatment would be approved. The PCT does not wish to raise the expectations of patients and their families by a reference to the IFR Panel if, whatever the individual clinical circumstances of the patient (ie even if the patient can show both exceptionality and clinical effectiveness), an investment at that level for an individual patient cannot be justified. 4.1.4 In such cases the PCTs shall designate the medicine or treatment as one where it will not consider individual applications for funding based on exceptionality unless the PCTs are reasonably satisfied that, the referring clinician having first established the patient s exceptionality and that the treatment is clinically effective, the anticipated total cost of the treatment (including the cost of the medicine) for that individual 1 The quality-adjusted life year (QALY) is a measure of disease burden, including both the quality and the quantity of life lived. It is used in assessing the value for money of a medical intervention. The QALY model requires utility independent, risk neutral, and constant proportional trade-off behaviour. The QALY is based on the number of years of life that would be added by the intervention. Each year in perfect health is assigned the value of 1.0 down to a value of 0.0 for death. If the extra years would not be lived in full health, for example if the patient would lose a limb, or be blind or be confined to a wheelchair, then the extra life-years are given a value between 0 and 1 to account for this.

patient would be comparable with or less than the anticipated total cost of the routinely funded treatment for the patient s condition. 4.1.5 Where a medicine or treatment has been so designated, the PCTs will keep under regular review: their commissioning policy for the medicine or treatment; and the designation of the medicine or treatment as one where individual funding requests will not be considered except in the circumstances set out in the preceding paragraph. 4.2. Patients with rare conditions not covered by PCT commissioning policies or patients not able to have the usual first or second line treatments 4.2.1 The potential treatment options for patients with rare conditions (where there is no cohort of patients with the condition against which they can reasonably be compared) and/or for whom first or second line treatments are inappropriate for any reason and have never been tried, are unlikely to be covered by NICE Technology Appraisals or by the local commissioning policies of the PCTs. 4.2.2 Nevertheless, the PCTs do not accept that additional NHS investment is justified solely because a medical condition is rare or a patient cannot have the usual treatment. The approval of differential investment in treatment for those with rare conditions would place a higher value on the lives of those patients than on those with more common conditions. The same principle applies to patients who, for whatever reason, cannot have the usual routinely funded treatment for their condition 4.2.3 Such patients cannot, by definition, satisfy the PCTs of the exceptionality of their cases in the usual way (see paragraph 3.3 above) because there is no cohort of patients against whom the patient or the benefit they are likely to gain from the treatment can be compared. Nevertheless, the PCTs will consider requests for funding treatments for such patients through the IFR Panel, who will assess the proposed treatment on the basis of clinical and cost effectiveness alone, ie there will be no requirement in such cases for the patient to first establish exceptionality. 4.2.4 In valuing the clinical and cost effectiveness of treatment for such patients, the PCTs will follow broadly the QALY/ICER system recommended by NICE but may deviate from the strict financial limits set by NICE where in the reasonable opinion of the IFR Panel there are compelling reasons to do so. 4.2.5 In such circumstances the IFR Panel will consider the case made by the treating clinician against the PCTs Ethical and Commissioning Principles (see Appendix 1). 4.3. Requests to continue funding treatment for patients entering or coming

off clinical trials 4.3.1. The PCTs will not fund individual patients entering clinical trials unless prior approval has been obtained. In approving the funding of individual patients for clinical trials, the PCTs will specify the particular elements of the trial that will be funded. 4.3.2. In line with the Medicines Act 2004 2 and the Declaration of Helsinki 3, the responsibility for ensuring a clear exit strategy from a trial AND ensuring that those benefiting from treatment will have ongoing access to it, lies with those conducting the trial not the PCTs. The initiators of the trial (provider hospital trusts and drug companies) have a moral obligation to continue funding patients benefiting from treatment until such time as the patient s PCT agrees to fund through its normal commissioning process. In circumstances where the PCTs decline to commission ongoing treatment, the responsibility for funding remains with the trial initiators indefinitely. Where provider hospital trusts are anticipating treating patients in a trial and there are likely to be issues regarding continued funding, they should raise the matter with the PCT in advance of starting the trial. 4.3.3. For further details, please refer to Department of Health guidance for PCTs on funding excess treatment costs related to non-commercial research studies and applying for a subvention available at http://www.dh.gov.uk/en/publicationsandstatistics/publications/publica tionspolicyandguidance/dh_097628. 4.4. Requests to continue funding of care commenced privately 4.4.1. Requests for retrospective funding of treatment obtained privately will not be authorised. 4.4.2. Patients have a right to revert to NHS funding at any point during their care. However, if they wish to exercise this right, their care will be transferred to local pathways. Requests for individual funding to continue care in a private facility or to transfer to an NHS provider with which a clinician consulted privately has a link, will be considered by the IFR Panel in accordance with the principles set out in this policy. 4.5. Requests for referral to a specialist provider (tertiary, regional or supraregional centre or specialist private provider) 4.5.1. The majority of referrals to specialist centres are made by secondary care consultants. The PCTs expect consultants to refer patients for tertiary/specialist care using established pathways covered by existing contracts. Accordingly, requests for referrals to specialist providers outside existing pathways will need to be assessed by appropriate specialists within the existing pathway. 4.5.2. Should a local consultant consider that a referral outside existing pathways is a priority for a particular patient, the consultant should 2 http://www.legislation.hmso.gov.uk/si/si2004/20041031.htm 3 http://www.wma.net/e/policy/b3.htm

request that funding for the referral be considered by the IFR Panel. Such requests for individual funding will be considered in accordance with the principles set out in this policy. 4.5.3. The consultant should not refer the patient to another provider without first getting the approval of the panel. The PCT will not fund the treatment of any patient referred to another provider without first obtaining the approval of the IFR Panel. 4.6. New residents in the PCTs areas already on treatment not routinely available locally (Decisions inherited from other Primary Care Trusts) 4.6.1. The PCTs will continue to fund patients who become the responsibility of the PCTs and are already on treatment previously funded by the NHS elsewhere, even where their treatment is not routinely funded by the PCTs provided that their new supervising consultant continues to recommend the treatment as being clinically appropriate and they continue to derive adequate benefit from the treatment. 4.7. Requests for funding for treatment abroad 4.7.1. The PCTs will consider requests to fund treatment outside the UK in line with current Department of Health guidance in force from time to time (see www.dh.gov.uk for more details). 5. APPLICATION PROCESS AND PREPARING A CASE FOR TRIAGE 5.1. Patients are becoming increasingly aware (often through the internet and other media) of new services/treatments/procedures. Many of these new treatments may not be available within existing NHS arrangements or within the NHS at all. In addition many such treatments have not yet been proven to be clinically effective. All applications made as a result of patient requests must have clinical support from either the patient s consultant or GP. 5.2. Where a clinician wishes to make a request for funding for a medicine or treatment not routinely funded by the PCTs within current pathways, the following process should be followed. 5.3. The application process 5.3.1. An electronic request form for individual funding must be completed by the referring clinician. The request forms are available at: www.norfolk.nhs.uk or www.gywpct.nhs.uk on Knowledge Management at nww.knowledgenorfolk.nhs.uk 5.3.2. Requests are to be sent to the contact details specified in the Introduction section of the IFR request form. Any information sent electronically or otherwise will need to conform to the NHS data protection standards laid out in the NHS Information Security Management NHS Code of Practice i. Clinicians will need to provide sufficient clinical details to facilitate a decision and avoid delays. Relevant clinical information should be summarised as specified on the form. Applications will only be considered by the IFR Panel once a fully completed form is submitted.

5.3.3. Details of the information required are set out on the request form. To eliminate avoidable delay, referring clinicians must complete all sections of the form and provide as much information as possible at initial submission. Requests may be sent back to the referring clinician for clarification. IFR Panels are only able to consider cases on the basis of exceptionality (except only in the case of rare conditions or patients not able to have the usual first or second line treatments see section 4.2 above). If the reasons why the patient is exceptional are not included, the request for funding cannot be considered by the IFR Panel. 5.4. Preparing a case for Triage 5.4.1. The PCTs IFR administrator will write to or email the referring clinician confirming that the request has been received and, in cases where information is incomplete, seeking further information. If information relating to the patient is required to be obtained from third parties, the referring clinician must obtain written consent from the patient prior to seeking such information. 5.4.2. In appropriate cases, a clinician from within the IFR Panel may discuss the request with the referring clinician. 5.4.3. The IFR administrator will write to the patient and the patient s GP to inform them of the individual funding request process and to provide them with a patient information leaflet explaining the process. A summary of the case, listing the items of information that will be presented to the IFR Panel, will be included in this letter. 5.4.4. The patient and GP may provide will be invited to provide further written evidence or other information that they would like the IFR Panel to take into consideration. This might include: information on how the patient s condition affects their quality of life; their understanding of the evidence base and how this might apply to them; information from friends or family about the patient s condition and how it affects the patient s quality of life; information from clinicians or patient support groups, etc. However, all such further information which has not been included with the request form must be received by the IFR administrator at least 5 working days prior to the date of the IFR Panel if it is to be taken into consideration at the IFR Panel. 5.4.5. The IFR administrator may also write to other health professionals with clinical involvement in the patient s care (for example a consultant, therapist, etc) for clarification of the patient s needs, evidence base, etc, where required and after gaining consent as appropriate.

6. CONSIDERATION OF INDIVIDUAL FUNDING REQUESTS 6.1. Triage process 6.1.1. Once the preparation of an Individual Funding Request (IFR) for triage is complete, the completed request will be considered in a triage process. 6.1.2. In this phase, the IFRs are assessed for appropriateness in two stages. Triage process Level 1 - a decision is made as to whether the IFR is covered by existing contracts. Triage process Level 2 - if not covered by existing agreements, the request is assessed for: appropriateness to be referred for population decision making, i.e. a policy formulation; or appropriateness for consideration by an IFR Panel and, if so: which IFR Panel to send the request to IFR: Medicines IFR: Procedures and Therapies. 6.1.3. Triage process - Level 1: Initial Assessment by the PCTs' Commissioning Manager/ pharmaceutical advisor The PCTs Commissioning Manager/pharmaceutical advisor will investigate whether there is an existing arrangement in place with an NHS provider to provide the requested service/treatment/ procedure. He/she will then be able to advise whether the proposed referral would be covered by the PCTs existing portfolio of contracts/slas or current individual case commissioning policies. If there is, the referring clinician will be informed and requested to refer the patient to that provider. In the case of a referral by a GP, they will be requested to refer the patient to local services first. However it is the responsibility of referring clinicians to monitor the referral to ensure that it does not breach waiting times guidance. If there is no existing arrangement, the Commissioning Manager/ pharmaceutical advisor may be able to suggest an alternative that will meet the patient s clinical needs. The Commissioning Manager/ pharmaceutical advisor can only prioritise referrals within existing pathways. If the Commissioning Manager/ pharmaceutical advisor has reason to consider that the case falls outside existing contracts/slas and/or commissioning policies, then he/she will refer the case to the PCTs Triage Panel.

6.1.4. Triage process - Level 2: Consideration by Triage Panel 6.1.4.1. This stage in the triage process comprises a meeting to discuss the request led by the nominated senior clinician in the PCT supported by either: Senior Commissioning Manager (for Procedures and Therapies); or Pharmaceutical Advisor (for Medicines). The IFR administrator will arrange for these discussions to take place either face to face or by telephone or other remote communication. 6.1.4.2. The Triage Panel will consider the case and make one of the following four decisions: i) approve the request without reference to the IFR Panel; ii) iii) iv) refuse the request without reference to the IFR Panel; refer the request to the IFR Panel; defer the request for more information to be provided by the referring clinician; or v) refer the request to the PCTs Commissioning (service development) process with a recommendation for further consideration of the treatment for routine funding by the PCTs. (i) Approval of the request without reference to the IFR Panel The Triage Panel may only approve a request at this level of the process where: the requirements of this policy are satisfied, in particular, section 3: Determination of exceptionality ; and there is very compelling clinical evidence or indication, where the expected clinical benefit is significant and where a delay caused by waiting for the IFR Panel decision would be significantly detrimental to the patient ; and the value of the individual episode or package of care is up to the per request value of 10,000. If the per request value exceeds 10,000, the case will be automatically referred up to the IFR Panel, together with the details of any recommendation for funding.

(ii) Refusal of the request without reference to the IFR Panel The Triage Panel may refuse the request where: the case falls within existing contracts/slas and/or commissioning policies; or there is no evidence that the individual patient constitutes an exceptional case. The referring clinician can appeal against an initial refusal of the Triage Panel to refer the case to the IFR Panel either: where he/she obtains further information which has not been considered by the Triage Panel ; or does not agree with the decision of the Triage Panel and any such appeal will be submitted to the IFR Panel for review. (iii) Referral of the request to the IFR Panel Where: there is uncertainty about whether the treatment falls within an existing contract/sla and/or commissioning policy; or the Triage Panel considers that there may be a case for exceptionality, the case will be referred to the IFR Panel. The IFR administrator will send notification of the Triage Panel decision and the reasons for it in writing to the referring clinician. All decisions made by the Triage Panel will be recorded and referred to the next IFR Panel for ratification. 6.2. Preparing a case for the IFR Panel The IFR Panel will consider all cases referred to it by the Triage Panel. The IFR administrator, with support from public health and medicines management, where appropriate, will produce a summary of the case for the IFR Panel. The summary will be attached as a front sheet to the documentation received from the referring clinician, patient, etc. If further information is required to prepare the case for consideration by the IFR Panel, this may delay presentation to the IFR Panel. All required information from the provider hospital trust/clinician must be sent to the IFR administrator at least 10 working days before the scheduled date of the IFR Panel at which the case is to be considered.

6.3. IFR Panel consideration 6.3.1 IFR Panels will be conducted in accordance with the procedures described in Appendix 3: Individual Funding Request Panels Terms of Reference. 6.3.2 In certain cases of an emergency or life threatening situation in which urgent consideration is required, the process described in section 7.2 will be followed. 6.4. Communicating decisions made by IFR Panels 6.4.1. The referring clinician making the individual funding request will be informed of the IFR Panel s decision as soon as practicable via e-mail and/or letter. Patient confidentiality will be maintained at all times. 6.4.2. Clinicians should always make a prior request to the PCTs for individual funding in a timely manner before making a referral for treatment, to ensure that: i) the case is truly exceptional; ii) iii) funding will be available; and the 18 week referral to treatment target is met. 6.4.3. IFR Panel decisions will be communicated to the requesting clinician. PCT staff will not communicate IFR Panel decisions directly to the patient or their representative. It is the responsibility of the referring clinician to notify the patient in a timely manner of the IFR Panel decision. 7. INDIVIDUAL FUNDING REQUEST PANELS 7.1. Terms of reference for the IFR Panel Please see Appendix 3 for Terms of Reference for the IFR Panels. 7.2. Urgent requests 7.2.1. In cases where the referring clinician considers that the request cannot await the next IFR Panel and urgent consideration can be justified: i) an extraordinary IFR Panel may be convened or another method of rapid IFR Panel consideration of the case (eg via telephone, video conference call or e-mail) will be considered, subject to agreement of the IFR Panel members; or ii) alternatively a clinically trained member of the IFR Panel with voting rights may make a decision after urgent discussion with at least two other clinically trained members of the IFR Panel. 7.2.2. A written record must be made of any such urgent request and the decision made, and these will be reviewed and ratified by the full membership of the IFR Panel at the next IFR Panel meeting.

7.2.3. For all urgent requests, the IFR Panel will aim to make a decision within 10 working days of receipt of the request. Trusts should treat all urgent and life-threatening situations based on the clinical need. PLEASE NOTE FOR REQUESTS MARKED AS URGENT A DECISION WILL BE GIVEN WITHIN 10 WORKING DAYS. IF THE REFERRING CLINICIAN CONSIDERS THAT TREATMENT CANNOT BE DELAYED AND DECIDES TO TREAT IMMEDIATELY THEN THE COST OF SUCH TREATMENT IS INCURRED AT THE RISK OF THE PROVIDER. 8. IFR APPEAL PROCESS AND IFR APPEALS PANEL 8.1. Grounds for appeal 8.1.1. If the referring clinician or patient is unhappy with the IFR Panel decision: 8.1.1.1. in any case where further relevant information becomes available which has not been considered by the IFR Panel, the referring clinician may ask the IFR Panel to reconsider the case specifically in the light of this further information; and 8.1.1.2. where all the relevant information was available to the IFR Panel when the decision was made, but the referring clinician remains dissatisfied with the decision, they may request that it be reviewed by the IFR Appeals Panel on one of the following grounds only: i) due process was not followed; or ii) the IFR Panel failed to give a clear rationale for its decision. 8.2. Appeals process 8.2.1. In the case of failure to follow due process or an inadequate rationale for the IFR Panel decision, the referring clinician may request an IFR Appeals Panel review by making a formal request in writing to the Chair of the IFR Panel and copied to the IFR administrator within 30 working days (ie 6 weeks) of the date of the IFR Panel s decision. 8.2.2. The Chair will consider the request and refer the case to the IFR administrator within 15 working days. The IFR administrator will then notify the PCTs commissioners and arrange for an IFR Appeals Panel to be set up. 8.2.3. The IFR Appeals Panel will review the process followed by the IFR Panel. The IFR Appeals Panel will reach a decision within 30 working days of the IFR administrator referring the case back to the PCTs. 8.2.4. The IFR Appeals Panel will set out its decision and the reasons for it as soon as practicable in writing via e-mail or letter to both the IFR Panel

and the referring clinician. It is the responsibility of the referring clinician to notify the patient in a timely manner of the IFR Appeals Panel decision. 8.2.5. Should the referring clinician or patient remain dissatisfied with the IFR Appeals Panel decision, either of them may pursue the matter through the NHS Complaints Procedure. Information on how to do this is available from the PCTs Complaints Managers. 8.3. Terms of reference for the IFR Appeals Panel 8.3.1. The IFR Appeals Panel will be convened when necessary to consider appeals against IFR Panel decisions. Please see Appendix 4 for Terms of Reference for the IFR Appeals Panel. 9. EVALUATION AND AUDIT On-going evaluation will take place through regular reporting to the two PCTs Professional Executive Committees and Boards. Process audits of, for example, time taken to consider cases, consistency of decisions, etc, will be undertaken from time to time and at least on an annual basis. 10. TRAINING AND SUPPORT Opportunities for training for IFR Panel and IFR Appeals Panel members in evaluation of evidence and health care ethics will be established and provided on a rolling basis. 11. POLICY REVIEW This policy will be reviewed annually by a policy review team (nominated by the IFR Panel) and reports will be submitted to the Professional Executive Committee and Board. This policy is due for review in July 2010.

APPENDIX 1: NHS GREAT YARMOUTH AND WAVENEY AND NHS NORFOLK ETHICAL AND COMMISSIONING PRINCIPLES Background Primary Care Trusts (PCTs) 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. The PCTs have insufficient resources to fund all types of health care that might be requested for/by their populations. It is therefore inevitable that from the time to time the PCTs have to make hard choices about which types of healthcare to commission. This document sets out the principles the PCTs will use to make these decisions in order to make the process consistent, transparent and fair. Purpose To provide a coherent structure for discussion, ensuring all important aspects of each issue are considered. Promote fairness and consistency in decision making with regard to different clinical topics. Provide a means of expressing the reasons behind the decisions made. Many of the decisions taken by the PCTs will involve the exercise of judgement and discretion and there will be room for disagreement both within and outwith the relevant decision making committees. Although there is no objective or infallible measure by which such decisions can be based, these Ethical and Commissioning Principles enable decisions to be made within a consistent setting which respects the needs of individuals and the community. The PCTs 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. The PCTs will make commissioning decisions based on the following principles: 1) Health Outcome The aim of commissioning is to achieve the greatest possible improvement in health outcome for our population, within the resources that we have available. In deciding which treatments to commission, the PCTs will prioritise those which produce the greatest benefits for patients in terms of both clinical improvement and improvement in quality of life. 2) Clinical Effectiveness and Safety We will ensure that the care we commission is based on sound evidence of effectiveness. We will usually expect this to come from sources such as the National Institute for Health and Clinical Excellence, well designed systematic reviews and meta-analyses or randomised controlled trials. The key success factors in evaluating clinical effectiveness 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 prioritisation and commissioning. 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. We will promote treatments for which there is good evidence of clinical effectiveness in improving the health status of patients and will not normally recommend a 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. 3) Cost Effectiveness We will take into account cost-effectiveness analyses of healthcare interventions (where available) to assess which interventions yield the greatest benefits relative to the cost of providing them. We 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. We will consider technical costbenefit calculations (eg quality adjusted life years (QALY)), but these will not by themselves be decisive. 4) Equity We consider each individual within our populations to be of equal value. We will commission and provide health care services based solely on clinical need, within the resources available to us. We will not discriminate between individuals or groups on the basis of age, gender, gender identity, sexual orientation, race, religion, lifestyle, occupation, social position, financial status, family status (including responsibility for dependants), intelligence, disability, physical or cognitive functioning. However, where treatments have a differential impact as a result of age, sex or other characteristics of the patient, it is legitimate to take such factors into account. The PCTs have a responsibility to address health inequalities across our population. We acknowledge the proven links between social inequalities and inequalities in health, access to health care and health needs. Higher priority may be allocated to interventions addressing health needs in sub-groups of our population who currently have poorer than average health experience (eg higher morbidity or poorer rates of access to healthcare). 5) Access The PCTs will ensure that the care we commission is delivered as close to where patients live as possible. Some services cannot be provided in local settings and we may need to commission some services from distant providers in order to ensure quality, safety and value for money. The PCTs will also ensure that they commission safe services for their populations. 6) Patient Choice The PCTs respect the right of individuals to determine the course of their own lives, including the right to be fully involved in decisions concerning their health care. However, this has to be balanced against the PCTs responsibility to ensure equitable and consistent access to appropriate quality healthcare for all the population. In commissioning healthcare, the PCTs will: i) ensure that in assessing the effectiveness of health care, we take account of outcomes that are important to patients and the patient s experience of the care; ii) ensure, wherever possible, that within the care commissioned or provided there are a range of alternative options available, and that patients are given the necessary support to make an informed choice;

iii) iv) recognise that evidence of effectiveness usually relates to groups rather than individuals. We have set up a mechanism for considering individual funding requests to allow individuals to be considered as an exception to commissioning policy where evidence is available to suggest that an intervention not routinely funded may be of particular benefit to them in relation to other patients who might not be funded; as a general rule, decline to provide individual funding for care that is not routinely commissioned or provided solely on the basis that an individual, or a clinician involved in their care, desires it. This is in line with our responsibility to ensure consistent and equitable access to care for all our population. It reflects our concern not to fund for one individual care which cannot be openly offered to everyone in our population with equal clinical need; v) decline to provide a treatment of little benefit, simply because it is the only treatment available; and vi) consider treatments which effectively treat life time or long term chronic conditions equally to urgent and life-prolonging treatments 7) Affordability The PCTs may not be able to afford all interventions within their available budgets, even where they are supported by evidence of clinical and cost-effectiveness. Where this is the case, further prioritisation will be undertaken based on criteria including national and local policies and strategies and local assessment of the health needs of the population to ensure that we do not exceed our available resources. The PCTs are duty-bound not to exceed their budgets, and in achieving this 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 areas. This is known as opportunity cost 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 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. 8) Needs of the Community Public health is an important concern of the PCTs, and the PCTs will seek to make decisions which promote the health of their entire communities. 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 PCTs 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 clinician may still apply to the PCTs for funding on the basis that there are exceptional circumstances which mean that the patient should receive the treatment. 9) Quality The PCTs will aim to commission high quality services as evidenced against national and international best practice. The quality of services will be measured where possible not only in terms of quality of outcomes and clinical effectiveness but also in terms of process and organisational efficiency, reducing dependency on health care, the quality of patient care, and the quality of the patient experience.

10) 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 PCTs. The PCTs 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. 11) 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. The PCTs have procedures in place to consider such exceptional cases on their merits and this will be done through the Individual Funding Request Policy of the PCTs. 12) Disinvestment As well as commissioning new services on the basis of the criteria above, the PCTs will keep existing services under review to ensure that they continue to deliver clinically effective and cost-effective services at affordable cost. Where possible we will seek to divert resources from less effective services to more effective ones.

APPENDIX 2: APPRAISING LIFE-EXTENDING, END OF LIFE TREATMENTS National Institute for Health and Clinical Excellence Appraising life-extending, end of life treatments 1. Summary 1.1 This document sets out supplementary advice to the Appraisal Committees, to be taken into account when appraising treatments which may be lifeextending for patients with short life expectancy, and which are licensed for indications affecting small numbers of patients with incurable illnesses. The additional advice will apply when such treatments have an incremental cost effectiveness ratio (ICER) in excess of the upper end of the range normally approved by the Appraisal Committees, using the reference case outlined in the Institute s Guide to the Methods of Technology Appraisal, and which may offer demonstrable survival benefits over current NHS practice. 1.2 The current appraisal methodology recognises that there will be circumstances in which it may be appropriate to recommend the use of treatments with high reference case incremental cost effectiveness ratios. It states (with reference to the Institute s standard appraisal criteria) that: Above a most plausible ICER of 30,000 per QALY gained, the Committee will need to identify an increasingly stronger case for supporting the technology as an effective use of NHS resources. The Appraisal Committee has, in the past, made recommendations above the normal threshold range when it has explicitly identified additional benefits not readily captured in the reference case. This has occurred when the treatment involved has been lifeextending, licensed or otherwise indicated for small populations with incurable illnesses. 1.3 In developing this supplementary advice, the Institute has taken account the Appraisal Committees previous decisions, together with the relevant principles in the guide to the use of Social Value Judgements. It has also had regard to the consideration given by the Citizens Council, at its meeting in November 2008, to the circumstances in which it might be appropriate to support the use of treatments outside the Institute s cost per quality adjusted life years (QALY) threshold range. In addition, the Institute has taken account of its responsibility to recognise the potential for long term benefits to the NHS of innovation. In this context, it considers it appropriate for its Appraisal Committees to have regard to the importance of supporting the development of innovative treatments that are anticipated to be licensed for small groups of patients who have an incurable illness. 1.4 The objective of this supplementary advice is to ensure that the Appraisal Committees fully consider all the benefits which it is appropriate to take into account in appraising treatments designed to extend life, at the end of life for small populations and in particular to ensure that where benefits are not, or not adequately captured in the reference case, that the Appraisal Committees are provided with an appropriate supplementary analysis. For this supplementary advice to be applied, a treatment will need to have been through an appraisal by NICE where the most plausible reference case point