IFR Policy V4 Feb13. IFR Policy V4 Feb13 Page 1 of 38

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1 IFR Policy V4 Feb13 IFR Policy V4 Feb13 Page 1 of 38

2 Commissioning Policy Individual Funding Requests Purpose of Policy The following CCGs wish to operate a policy for decision making in respect of Individual Funding Requests on a consistent basis across Norfolk and Waveney: NHS Gt Yarmouth & Waveney CCG NHS North Norfolk CCG NHS Norwich CCG NHS South Norfolk CCG NHS West Norfolk CCG For that purpose the CCGs have agreed to operate to a single policy and work within two IFR Panels, covering non drug, and drug requests. Each Panel will be hosted by a CCG for a period of 12 months who will provide an appropriate chair, in addition to the required clinical representation. Each Panel will be administered by the Norfolk and Waveney CSU. However each constituent CCG remains accountable for its own decision made in respect of IFRs in line with the legal duties of CCGs set out in? This policy will be reviewed annually by the Norfolk and Waveney CCG Chairs & Chief Officer Group. A CCG may leave the arrangement by giving 3 month s written notice. 1 Definitions Treatment means any form of healthcare intervention which has been proposed by a clinician and is proposed to be administered as part of NHS commissioned and funded healthcare. An individual funding request is a request received from a clinician which seeks funding for a single identified patient for a specific treatment. IFR Policy V4 Feb13 Page 2 of 38

3 IFR Policy V4 Feb13 Clinical circumstances means a full history of the patient s medical condition, a full description of the patient s present medical condition and as comprehensive an assessment of the patient s future medical condition and prognosis as the Clinical Team treating the patient is able to provide. The IFR Panel is the committee of CCG clinicians who have been given authority by CCG Governing Bodies to make individual funding request decisions on its behalf. Case by case decision making, in the context of priority setting, occurs when a decision maker decides to allocate NHS resources for a specified treatment for one or more specified patients as a substitute for policy making. This is generally regarded as poor practice because it avoids making an explicit policy. Exceptional clinical circumstances refers to a patient who has clinical circumstances which, taken as a whole, are outside the range of clinical circumstances presented by a patient within the normal population of patients with the same medical condition and at the same stage of progression as the patient. Exceptional means something that is exceptional to a written policy. Exceptionality means that a patient is significantly different to the general population of patients with the condition in question, and is likely to gain significantly more benefit from the intervention than might normally be expected for patients with that condition. Clinical Commissioning Group is a statutory organisation responsible for purchasing health and care services for patients, taking over in part the role of Primary Care Trusts. Rule of rescue is the observation that human beings, in situations where an individual s life is at risk, have the proclivity to take action to rescue the individual regardless of the cost and the chances of success. Action taken, therefore, is in part about meeting the emotional needs of the decision maker. In the healthcare setting the term has been used in a number of ways. In Norfolk & Waveney the term refers to agreeing funding for treatments for patients whose prognosis is grave on the basis that their prognosis is grave and without regard to cost or ability to benefit. Experimental and unproven treatments are medical treatments or proposed treatments where there is no established body of evidence to show that the treatments are clinically effective. The reasons may include the following: The treatment is still undergoing clinical trials for the indication in question. The evidence is not available for public scrutiny. The treatment does not have approval from the relevant government body. The treatment does not conform to an established clinical practice in the view of the majority of medical practitioners in the relevant field. The treatment is being used in a way other than that previously studied or for which it has been granted approval by the relevant government body. IFR Policy V4 Feb13 Page 3 of 38

4 The treatment is rarely used, novel, uncertain or unknown and there is a lack of evidence of safety and efficacy. There is some evidence to support a case for clinical effectiveness but the overall quantity and quality of that evidence is such that the commissioner does not have confidence in the evidence base and/or there is too great a measure of uncertainty over whether the claims made for a treatment can be justified. A service development is any aspect of healthcare which NHS Commissioners have not historically agreed to fund and which will require additional and predictable recurrent funding. The term refers to all new developments including new services, new treatments (including medicines), changes to treatment thresholds, and quality improvements. It also encompasses other types of investment that existing services might need, such as pump-priming to establish new models of care, training to meet anticipated manpower shortages and implementing legal reforms. Equitable priority setting dictates that potential service developments should be assessed and prioritised against each other within the annual commissioning round. However, where investment is made outside of the annual commissioning round, such investment is referred to as an in-year service development. An in-year service development is any aspect of healthcare, other than one which is the subject of a successful individual funding request, which the NHS Commissioner has agreed to fund outside of the annual commissioning round. Unplanned investment decisions should only be made in exceptional circumstances because, unless they can be funded through disinvestment, they will have to be funded as a result of either delaying or aborting other planned developments. A policy refers to a written document determining whether or not a particular treatment is commissioned. A policy variation occurs when an existing policy is changed. When there is a proposal which would result in increased access to a treatment (for example by lowering the threshold for treatment or adding a new indication for treatment) the policy variation is a service development and will be treated as such. A Similar Patient refers to the existence of a patient within the patient population who is likely to be in the same or similar clinical circumstances as the requesting patient and who could reasonably be expected to benefit from the requested treatment to the same or a similar degree. When the treatment meets the regional criteria for regional policy making, then the similar patient may be in another CCG in the NCB region. Most often there is more than one patient in this category. The existence of one or more similar patients indicates that a policy position is required of the CCGs. IFR Policy V4 Feb13 Page 4 of 38

5 IFR Policy V4 Feb13 2 The policy 2.1 This policy applies to any patient for whom any one of the Norfolk and Waveney CCGs are the Responsible Commissioner 2.2 Clinicians are entitled to make a request (an individual funding request ) to the IFR Panel for treatment to be funded by the relevant CCG or outside of its established policies on one of two grounds, namely: The patient is suffering from a medical condition for which the Norfolk and Waveney CCGs have no policy ( an individual request ), or The patient is suffering from a medical condition for which the Norfolk and Waveney CCGs has a policy but where the patient s particular clinical circumstances falls outside what the Norfolk and Waveney CCGs has agreed to fund ( an exceptional request ) The CCG IFR panels cannot consider any request for conditions/drugs commissioned by the NCB. Applications should be made direct to the NCB. 2.3 An electronic request form must be completed by the referring clinician. The request forms are available on the Knowledge Anglia website at; or norfolkicd@nhs.net for drug requests and norpct.individualfundingrequests@nhs.net for non-drug requests. Requests for patients covered by the NCB should be sent directly to them, or will be forwarded if sent to either of the Norfolk addresses above. 2.4 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. 2.5 All applications must be accompanied by written support and evidence provided by the clinical team treating the patient explaining: Whether the request for funding is an individual request or an exceptional request The clinical circumstance of the patient. The Clinical Team are required to present a full report to the IFR Panel which sets out a comprehensive and balanced clinical picture of the history IFR Policy V4 Feb13 Page 5 of 38

6 and present state of the patient s medical condition, the nature of the treatment requested and the anticipated benefits of the treatment The planned treatment and the expected benefits and risks of treatment. The Clinical Team shall describe the anticipated clinical outcomes for the individual patient of the proposed treatment and the degree of confidence of the Clinical Team that the outcomes will be delivered for this particular patient The evidence on which the clinical opinion is based. The clinician shall refer to, and include, copies of any clinical research material which supports, questions or undermines the case that is being made that the treatment is likely to be clinically effective in the case of the individual patient The costs of treatment. The patient and the Clinical Team shall set out the full attributable costs of and connected to the treatment. The IFR Panel shall be entitled but not obliged to commission its own reports from any duly qualified or experienced clinician or other duly qualified person concerning the full attributable costs of and connected to the treatment Whether or not there are likely to be Similar Patients either within the Norfolk and Waveney CCGs or across the region. For exceptionality requests the clinician must also provide the case for treating this patient and not other apparently similar patients Any other information necessary. For example for individual requests where funding is being sought to enable a patient to be entered into a clinical trial the protocol for the trial should be forwarded. 2.6 Information that is immaterial to the decision, including information about the social or personal circumstances of the patient which does not have a direct connection to the patient s clinical circumstances, shall not be considered by the IFR Panel. See Appendix The Norfolk and Waveney CCGs shall routinely screen individual funding requests to see whether they represent a service development. The key question used to screen out as a service development will be are there likely to be other similar patients in the region? Three or more cases would indicate that a service development is required. If there is evidence that this patient is representative of other similar patients then in these cases, the individual funding IFR Policy V4 Feb13 Page 6 of 38

7 IFR Policy V4 Feb13 request will be sent back to the clinician with a request to follow normal procedures for introducing new services. 2.8 The IFR Panel shall be entitled to approve requests for funding for treatment for individual patients where all the following conditions are met: The IFR Panel concludes that there are likely to be no Similar Patients to the requesting patient The IFR Panel shall consider whether or not there are likely to be Similar Patients. When this is the case the IFR Panel shall not be entitled to make a decision on the request but shall be entitled to refer the treatment to be treated as a service development / in year service development The IFR Panel is not authorised to make decisions on service developments There is sufficient evidence to show that, for the individual patient, the proposed treatment is likely to be clinically and cost-effective The IFR Panel shall, based on the information before it, take a view on whether the treatment is both effective and cost-effective The IFR Panel is not required to accept the views expressed by the patient or the Clinical Team concerning the likely clinical outcomes for the individual patient of the proposed treatment but is entitled to reach its own views on: The likely clinical outcomes for the individual patient of the proposed treatment; and The quality of the evidence to support that decision and/or the degree of confidence that the IFR Panel has about the likelihood of the proposed treatment delivering the proposed clinical outcomes for the individual patient The IFR Panel shall be entitled but not obliged to commission its own reports from any duly qualified or experienced clinician, medical scientist or other person having relevant skills concerning the case that is being made that the treatment is likely to be clinically effective in the case of the individual patient Individual requests only IFR Policy V4 Feb13 Page 7 of 38

8 The IFR Panel will apply paragraphs 2.5, 2.6, 2.7 and 2.8 of the Advisory Group Commissioning Policy (PAC14): Experimental treatments and unproven treatments when considering individual requests for off-licensed or unlicensed use of a drug or other unproven treatments for the clinical condition under consideration. These paragraphs are given below: The Norfolk and Waveney CCGs will give consideration to supporting experimental treatment or off label use for rare clinical situations for which good quality clinical trials are considered impossible. These will be considered under the individual funding request category. These will be identified on the basis of: the incidence of the clinical condition / circumstance; the nature of the intervention; the nature of the clinical research community. 2.6 When a case has been identified under paragraph 2.5 the Norfolk and Waveney CCGs will consider the following: the potential benefit and risks of the treatment; the biological plausibility of benefit based on other evidence; an assessment of value for money; the priority of the patient s needs vis-à-vis other competing demands. 2.7 The clinician will be expected to provide as much information as possible about the treatment, relevant research upon which the claim for biological plausibility of the treatment is based, and costs, as well as clinically relevant information on the patient. In addition, the clinician will identify the clinical markers and clinical outcomes that will be monitored to assess treatment response. 2.8 When a case has been identified under paragraph 2.5 the funding options which the Norfolk and Waveney CCGs will consider are: Not to fund. Fund on the condition that the patient enters a properly conducted n of 1 trial. This option is currently not open to NHS commissioners. Fund a trial of treatment but make ongoing treatment subject to the demonstration of clinical benefit for the individual patient using criteria agreed in advance with the clinical team. Fund with no evaluation requirements, although an outcomes report may be requested Exceptional requests only The IFR Panel will consider exceptionality in the context of the relevant commissioning policy/policies and guidance note/s. IFR Policy V4 Feb13 Page 8 of 38

9 IFR Policy V4 Feb In determining whether a patient is able to demonstrate exceptional circumstances the IFR Panel shall compare the patient to other patients with the same presenting medical condition at the same stage of progression The IFR Panel shall determine, based upon the evidence provided to the panel, whether the patient has demonstrated exceptional clinical circumstances. The evidence to show that, for the individual patient, the proposed treatment is likely to be clinically effective may be part of the case that the patient s clinical circumstances are asserted to be exceptional The IFR Panel shall take care to avoid adopting the approach described in the the rule of rescue. The fact that a patient has exhausted all NHS treatment options available for a particular condition is unlikely, of itself, to be sufficient to demonstrate exceptional circumstances. Equally, the fact that the patient is refractory to existing treatments where a recognised proportion of patients with same presenting medical condition at this stage are, to a greater or lesser extent, refractory to existing treatments is unlikely, of itself, to be sufficient to demonstrate exceptional circumstances Treating the patient is higher priority than other unfunded developments and the treatment can be afforded The IFR Panel shall have a broad discretion to determine whether the proposed treatment is a justifiable expenditure of the Norfolk and Waveney CCGs resources. The IFR Panel is however required to bear in mind that the resources requested to support the individual patient will reduce the availability of resources for other investments The following are examples of circumstances which in themselves do not justify exceptional funding nor do they support the argument for exceptionality: Likelihood of effectiveness When a proposed treatment is likely to be effective in that individual, this is not, in itself, a basis for exceptionality 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. IFR Policy V4 Feb13 Page 9 of 38

10 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 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) It is 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 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. 2.9 The IFR Panel may make such approval contingent on the fulfilment of such conditions as it considers fit Very occasionally an individual funding request presents a new issue which needs a substantial piece of work before the Norfolk and Waveney CCGs can reach a conclusion upon its position. This may include wide consultation. Examples in the past have included surrogacy and aspects of genetic testing. Where this occurs the IFR Panel may adjourn a decision on an individual case until that work has been completed The referring clinician making the request will be informed of the IFR Panel s decision as soon as practicable via and/or letter. A letter will be received within five working days at the latest, but in practice it is much sooner. Patient confidentiality will be maintained at all times Clinicians must always make a prior request to the Norfolk and Waveney CCGs for funding in a timely manner before making a referral for treatment, to ensure that: (a) the case is truly exceptional; IFR Policy V4 Feb13 Page 10 of 38

11 IFR Policy V4 Feb13 (b) funding will be available IFR Panel decisions will be communicated to the requesting clinician. Norfolk and Waveney CCG 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 when the communication on the decision has been received. Appeals 2.14 If the referring clinician or the patient is unhappy with the IFR Panel decision: 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 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: a) Due process was not followed; or b) The IFR Panel failed to give a clear rationale for its decision 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 (i.e. 6 weeks) of the date of the IFR Panel s decision 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 relevant Norfolk and Waveney CCG commissioner and arrange for an IFR Appeals Panel to be set up 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 relevant Norfolk and Waveney CCG The IFR Appeals Panel will set out its decision and the reasons for it as soon as practicable in writing via 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 Should the referring clinician or patient remain dissatisfied with the IFR Appeals Panel decision, either of them may pursue the matter through the NHS IFR Policy V4 Feb13 Page 11 of 38

12 Complaints Procedure. Information on how to do this is available from the Norfolk and Waveney CCGs Complaints Managers 2.20 The IFR Appeals Panel is part of the corporate governance process of the Norfolk and Waveney CCGs. The role of the IFR Appeals Panel is to determine whether the IFR Panel has followed its own procedures, has properly considered the evidence presented to it and has come to a reasonable decision upon the evidence In the event that the IFR Panel considers that the IFR Panel has: failed in a material way to follow its own procedures; and/or failed in a material way properly to consider the evidence presented to it (e.g. by taking account of an immaterial fact or by failing to take account of a material fact); and/or come to a decision that no reasonable IFR panel could have reached on the evidence before the Panel, the IFR Appeals Panel shall uphold the patient s appeal and shall refer the case for reconsideration by the IFR Panel The IFR Appeals Panel shall not have power to authorise funding for the requested treatment but shall have the right to make recommendations to the IFR Panel and to request one of the Officers authorised to take urgent decisions The IFR panels are not allowed consider applications which have been turned down by the NCB. Co-operation of Provider Trusts 2.23 The Norfolk and Waveney CCGs require provider trusts and clinicians to follow the Norfolk and Waveney CCGs commissioning policies in the advice and guidance given to patients, prior to making the decision to treat a patient, as set out in the NHS Contract. The Norfolk and Waveney CCGs require the Management of its provider trusts to have oversight of this process. The Norfolk and Waveney CCGs would expect every individual funding request to be sanctioned by provider trust management and reserves the right to refer recurrent inappropriate funding requests to the Chief Executive of the relevant provider trust IFR Policy V4 Feb13 Page 12 of 38

13 IFR Policy V4 Feb13 Urgent treatment decisions 2.24 The Norfolk and Waveney CCGs recognise that there will be occasions when an urgent decision needs to be made to consider approving funding for treatment for an individual patient outside the Norfolk and Waveney CCG normal policies. In such circumstances the CCG recognise that an urgent decision may have to be made before a panel can be convened. The following provisions apply to such a situation An urgent request is one which requires urgent consideration and a decision because the patient faces a substantial risk of significant harm if a decision is not made before the next scheduled meeting of the IFR Panel Urgency under this policy cannot arise as the result of a failure by the Clinical Team expeditiously to seek funding through the appropriate route and/or where the patient s legitimate expectations have been raised by a commitment being given by the provider trust to provide a specific treatment to the patient. In such circumstances the Norfolk and Waveney CCG expects the provider trust to fund the treatment 2.29 Provider trusts must take all reasonable steps to minimise the need for urgent requests to be made through the IFR process. If clinicians from any provider trust are considered by the Norfolk and Waveney CCGs not to be taking all reasonable steps to minimise urgent requests to the IFR process, the Norfolk and Waveney CCGs may refer the matter to the provider Trust Chief Executive Where an urgent decision needs to be made to authorise treatment for an individual patient outside the Norfolk and Waveney CCGs normal policies, the decision will be made by an individual authorised to do so by the relevant CCG (the Authorised Officer) The Authorised Officer shall, as far as possible within the constraints of the urgent situation, follow the policy set out above in making the decision. The Authorised Officer shall consider the nature and severity of the patient s clinical condition and the time period within which the decision needs to be taken. The Authorised Officer shall collect as much information about both the patient s illness and the treatment as is feasible in the time available and shall consider the request for funding in accordance with relevant existing commissioning policies The Authorised Officer shall be entitled to reach the view that the decision is not of sufficient urgency or of sufficient importance that a decision needs to be made outside of the usual process. IFR Policy V4 Feb13 Page 13 of 38

14 2.33 The Authorised Officer shall be entitled to reach the view that the request is, properly analysed, a request for a service development and so should be refused and/or appropriately referred for policy consideration Where the Authorised Officer considers that there is sufficient time to consult the Chair and/or members of the IFR Panel before making an urgent decision, the Authorised Officer shall do so and shall take any views into consideration before making a decision 2.35 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 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 lifethreatening 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. 3 Documents which have informed this policy This policy should be considered alongside the following PAC policies: Ethical Framework to support priority setting and resource allocation within collaborative commissioning arrangements (PAC/1)(See Appendix 3 attached) Orphan Drugs (PAC/2); Ongoing access to treatment following the ending of industry funded clinical trials or funding(pac/3); Guidance produced by the National Institute for Health and Clinical Excellence (PAC/5); In year service developments and the PCT s approach to treatments not yet assessed and prioritised (PAC/8); Ongoing access to treatment following completion of non-commercially funded trial (PAC/10); Ongoing access to treatment following completion of NHS commissioning funded trials (PAC/11); Patients changing responsible commissioning (PAC/12); Defining the boundaries between NHS and private healthcare (PAC/13); Experimental, uncertain and unproven treatments (PAC/14); Ongoing access to treatment following a trial of treatment which has not been sanctioned by the responsible PCT and which is not routinely funded or has not been formally assessed and priorities (PAC/15). These are available for viewing at East of England PCTs Priorities Advisory Group, Commissioning Policy 1: Ethical Framework to underpin priority setting and resource allocation within collaborative commissioning arrangements (Appendix 3) IFR Policy V4 Feb13 Page 14 of 38

15 IFR Policy V4 Feb13 The National Institute for Health and Clinical Excellence, Guide to the Methods of Technology Appraisal The National Institute for Health and Clinical Excellence, Appraising life-extending, end of life treatments Department of Health, The National Health Service Act 2006, The National Health Service (Wales) Act 2006 and The National Health Service (Consequential Provisions) Act Department of Health, World Class Commissioning Competencies, December 2007, dguidance/dh_ Department of Health, The NHS Constitution for England, July 2009, dguidance/dh_ The National Prescribing Centre, Supporting rational local decision-making about medicines (and treatments), February 2009, NHS Confederation Priority Setting Series, 2008, NHS Cambridgeshire and Peterborough Public Health Network. East of England Priorities advisory commissioning policies. May Clinical_Effectiveness/EoE_PAC_Policies_and_Guidance_Notes_Revised_ MAY_2011.sflb.ashx NHS North Staffordshire. Individual Funding Request (IFR policy) Version 4 Guidance note effective from Date of next review As required minimum 3 yearly Acknowledgements With acknowledgement to NHS Norfolk & Waveney original IFR policy, East of England PAC and West Midlands Strategic Commissioning Group. IFR Policy V4 Feb13 Page 15 of 38

16 Appendix 1 In deciding whether to approve funding, the IFR Panel shall remind itself that the policies of the Norfolk and Waveney CCGs provide that medical treatment is made available to patients generally on the basis of their medical conditions and on the likely benefits anticipated to accrue to a patient from a proposed treatment The Norfolk and Waveney CCGs do not discriminate on grounds of social factors (for example, but not limited to: age, gender, ethnicity, employment status, parental status, marital status, religious/cultural factors). Social factors will not be taken into account in determining whether exceptionality has been established. The Norfolk and Waveney CCGs do not generally make treatment for patients under its policies dependent on the patient s social or personal circumstances. Accordingly, when making decisions as to whether treatment should be provided to a patient which is not provided to patients generally, the IFR Panel shall adopt the same approach. Patients often seek to support an application for individual funding on the grounds that their personal circumstances are exceptional. This assertion can include details about the extent to which other persons rely on the patient, or the degree to which the patient has contributed, or is continuing to contribute, to society. The Norfolk and Waveney CCGs understand that everyone s life is different and that such factors may seem to be of vital importance to patients in justifying investment for them in their individual case. However, including such non-clinical, social factors in any decision making raises at least three significant problems for the Norfolk and Waveney CCGs. Across the population of patients who make such applications, the Norfolk and Waveney CCGs are unable to make an objective assessment of material put before it relating to non-clinical factors. This makes it very difficult for the Panel to be confident of dealing in a fair and even-handed manner in comparable cases. The essence of individual funding application is that the Norfolk and Waveney CCGs are making funding available on a one-off basis to a patient where other patients with similar conditions would not get such funding. If non-clinical factors are included in the decision making process, the Norfolk and Waveney CCGs do not know whether it is being fair to other patients who are denied such treatment and whose social factors are entirely unknown. The Norfolk and Waveney CCGs are committed to a policy of non-discrimination in the provision of medical treatment. If, for example, treatment were provided which had the effect of keeping someone in paid work, this would tend to discriminate in favour of those of working age and against the retired. If a treatment were provided differently to patients who were carers this would tend to favour treatment for women over men. If treatment were provided in part on the basis that a medical condition had affected a person at a younger age than that at which the condition normally presents, this would constitute direct age discrimination. IFR Policy V4 Feb13 Page 16 of 38

17 IFR Policy V4 Feb13 Generally, the NHS does not take into account social factors in deciding what treatment to provide. It does not seek to deny treatment to smokers on the grounds that they may have caused or contributed to their own illnesses through smoking, nor does it deny treatment to those injured in dangerous sports in which in which they were voluntary participants. In general, the NHS treats the medical condition and does not inquire into the background factors which led to the condition. The policy of the Norfolk and Waveney CCGs is that it should continue to apply these broad principles in individual applications for funding approval. The Norfolk and Waveney CCGs will, therefore, seek to commission treatment based on the clinical condition of the patient and not based on the patient s non-clinical circumstances. In reaching a decision as to whether a patient s circumstances are exceptional, the Panel is required to follow the principle that non-clinical or social factors including social value judgements about the underlying medical condition or the patient s circumstances are never relevant. Patients and referring clinicians are asked to bear this policy in mind and not to refer to social or non-clinical factors to seek to support the application for individual funding. IFR Policy V4 Feb13 Page 17 of 38

18 Appendix 2 National institute for Health and Clinical Excellence Appraising life-extending, end of life treatments July Summary 1.1 This document sets out supplementary advice to the Appraisal Committees, to be taken into account when appraising treatments which may be life-extending 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 most plausible ICER agreed by the committee generated by 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 life-extending, 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 IFR Policy V4 Feb13 _ Based on Commissioning policy Individual Funding Requests V3 October 2011 Page 18 of 38

19 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 estimate for the ICER exceeds the upper end ( 30,000) of the range normally considered by the Appraisal Committees to represent a cost effective use of NHS resources. Each candidate treatment will also need to meet the criteria set out in section The Institute will normally recommend to the Department of Health that it should give consideration to a data collection exercise for treatments recommended for use on the basis of the criteria set out in section 2. The purpose of this will be to assess the extent to which the anticipated survival gains are evident when the treatments involved are used in routine practice. The outcome of this exercise will be evaluated when the guidance for that treatment is reviewed. 2 Criteria for appraisal of end of life treatments 2.1 This supplementary advice should be applied in the following circumstances and when all the criteria referred to below are satisfied: The treatment is indicated for patients with a short life expectancy, normally less than 24 months and; There is sufficient evidence to indicate that the treatment offers an extension to life, normally of at least an additional 3 months, compared to current NHS treatment, and; The treatment is licensed or otherwise indicated, for small patient populations. 2.2 When the conditions described in 2.1 are met, the Appraisal Committee will consider: The impact of giving greater weight to QALYs achieved in the later stages of terminal diseases, using the assumption that the extended survival period is experienced at the full quality of life anticipated for a healthy individual of the same age, and; The magnitude of the additional weight that would need to be assigned to the QALY benefits in this patient group for the cost-effectiveness of the technology to fall within the current threshold range. 2.3 In addition, the Appraisal Committees will need to be satisfied that: The estimates of the extension to life are robust and can be shown or reasonably inferred from either progression free survival or overall survival IFR Policy V4 Feb13 Based on Commissioning policy Individual Funding Requests V3 October 2011 Page 19 of 38

20 (taking account of trials in which cross-over has occurred and been accounted for in the effectiveness review). and; The assumptions used in the reference case economic modelling are plausible objective and robust. 3 Review of the resulting guidance 3.1 The guidance produced using these criteria will be subject to review in accordance with the Institute s current arrangements. The review will normally take place no later than 2 years after the guidance has been issued. The review can be either brought forward or delayed, depending on the outcome of any data collection exercise or the availability of other new evidence. 3.2 Treatments approved following the application of the supplementary advice will not necessarily be regarded or accepted as standard comparators for future appraisals of new treatments introduced for the same condition. 3.3 Second and subsequent licences for the same product will be considered on their individual merits. 3.4 The Appraisal Committee will take into account the cumulative population for each licensed indication in considering the strength of any case, for justifying decisions which employ, in whole or part, the supplementary criteria outlined above 4 Implementation and evaluation 4.1 This supplementary advice will be effective from 5 January The Institute intends to ensure that this supplementary advice is robust for the long-term and that it achieves its intended purpose. It will therefore be subject to a methodological evaluation. The Institute will design and manage this evaluation, the results of which will be published and used to make modifications to the supplementary advice, if necessary. IFR Policy V4 Feb13 _ Based on Commissioning policy Individual Funding Requests V3 October 2011 Page 20 of 38

21 Appendix 3 Commissioning Policy (PAC/1) Ethical Framework 1 Definitions The Norfolk and Waveney CCGs have determined that they will operate their IFR policy under the previous Ethical Framework used by PCTs in the East of England until such time as that Framework is superceded. The policy below therefore should be interpreted as the term PCT applying as necessary to the Norfolk and Waveney CCGs, with regard to Specialised Commissioning. From 01 April 2013 responsibility for specialised commissioning and contracting sits with NHS England. NHS commissioned care is healthcare which the patient s responsible CCG has agreed to fund. The CCGs have policies which define the elements of healthcare which the CCGs are and are not prepared to commission, and individual funding request processes to consider commissioning care for individual patients outside those policies. Strategic planning is the process by which an organisation determines its vision, mission, and goals and then maps out measurable objectives to accomplish the identified goals. The outcome is a strategic plan which sets out what needs to be done and in what time scale. Strategic planning focuses on what should be achieved in the long term (3, 5, 7, or 10 year time span) while operational planning focuses on results to be achieved within one year or less. Strategic plans should be updated through an annual process, with major re-assessments occurring at the end of the planning cycle. Strategic planning directs how resources are allocated. A service strategy is a strategy relating to a specific service. The annual commissioning round is the process by which major funding decisions are taken, including the allocation of new money coming into the NHS. This involves a complex process of prioritisation which involves a series of decisions. This process occurs during the months of October to March for the following financial year. A service development is any aspect of healthcare which the CCGs have not historically agreed to fund and which will require additional and predictable recurrent funding. The term refers to all new developments including new services, new treatments (including medicines), changes to treatment thresholds, and quality improvements. It also encompasses other types of investment that existing services might need, such as pump-priming to establish new models of care, training to meet anticipated manpower shortages and implementing legal reforms. Equitable priority setting dictates that potential service developments should be assessed and prioritised against each other IFR Policy V4 Feb13 Based on Commissioning policy Individual Funding Requests V3 October 2011 Page 21 of 38

22 within the annual commissioning round. However, where investment is made outside of the annual commissioning round, such investment is referred to as an in-year service development. A policy variation occurs when an existing policy is changed. When there is a proposal which would result in increased access to a treatment (for example by lowering the threshold for treatment or adding a new indication for treatment) the policy variation is a service development and will be treated as such. An in-year service development is any aspect of healthcare which the CCGs agree to fund outside of the annual commissioning round. Unplanned investment decisions should only be made in exceptional circumstances because, unless they can be funded through disinvestment, they will have to be funded as a result of either delaying or aborting other planned developments. An individual funding request is a request received from a provider, or a patient with explicit support from a clinician, which seeks funding for a single identified patient for a specific treatment. Priority setting is the task of determining the priority to be assigned to a service, a service development, a policy variation or an individual patient at a given point in time. Prioritisation is needed because the need and demands for healthcare are greater than the resources available. Prioritisation is decision making which requires the decision maker to choose between competing options. Opportunity cost is the loss of healthcare gain for one group of patients which is forgone when a commissioner decides to invest in a healthcare intervention for another group of patients. If, for example, a commissioner can only afford to fund one of the following: a cancer treatment, a screening programme, or 6 more palliative care beds, then the opportunity cost of choosing the cancer treatment can be seen to be the loss of the benefit that would have been delivered by either the screening programme or the palliative care beds. Exceptional refers to a person, service or situation who/which demonstrates characteristics which are highly unusual, uncommon or rare. 2 The purpose of this policy The purpose of setting out the principles and considerations to guide priority setting is to: Provide a coherent structure for decision making, ensuring all important aspects of each issue are considered. Promote fairness and consistency in approach to decision making across the East of England region. IFR Policy V4 Feb13 _ Based on Commissioning policy Individual Funding Requests V3 October 2011 Page 22 of 38

23 Provide a means of expressing the reasons behind the decisions made. Principle 1 CCGs have legal responsibility for NHS healthcare budgets and their primary duty is to live within the budget allocated to them. Principle 2 CCGs have a responsibility to make rational decisions in determining the way in which they allocate resources and to act fairly in balancing competing claims on our resources between different patient groups and individuals. Principle 3 Competing patient and service needs should have a fair chance of being heard and, as such, all potential calls on new and existing funds should have the opportunity to be considered against other competing service developments within the resources. Principle 4 The values and principles driving priority setting at all four levels should be consistent. Principle 5 Regional policies, once agreed by the PAC are binding on all CCGs. Principle 6 Health services are commissioned on the basis of basis of evidence of effectiveness, cost effectiveness, impact on health and affordability. Access to services should be on the basis of equal access for equal clinical need. Individual patients or groups should not be distinguished on the basis of age, gender, sexuality, race, religion, lifestyle, occupation, social position, financial status, family status (including responsibility for dependents), intellectual/cognitive functioning or physical functioning. CCGs have a responsibility to address health inequalities between groups within their populations. There are proven links between social inequalities and inequalities in health, access to health care and health needs. In making commissioning decisions, priority may be given to interventions targeting health needs in sub-groups population who currently have poorer than average health outcomes (including morbidity and mortality) or poorer access to services. Principle 7 The NHS should only invest in treatments and services which are of proven effectiveness unless it does so in the context of well designed, sufficiently powered and properly conducted clinical trials. The health impact of an effective intervention at individual and population level should also be taken into account. Principle 8 IFR Policy V4 Feb13 Based on Commissioning policy Individual Funding Requests V3 October 2011 Page 23 of 38