INDIVIDUAL FUNDING REQUEST POLICY FOR NHS BEDFORDSHIRE:

Transcription

1 INDIVIDUAL FUNDING REQUEST POLICY FOR NHS BEDFORDSHIRE: Process for the Funding of Services and Treatments Not Routinely Commissioned by NHS Bedfordshire and for Prior Approval of Funding for Individual Patients Author: Responsibility: Nikki Barnes All Staff Effective Date: 1 st October 2010 Review Date: April 2011 This policy should be reviewed in conjunction with the Prioritisation Policy Reviewing/Endorsing committees Individual Funding Panel (August 2010) Approved by: Integrated Governance Committee (August 2010) Ratified Board (September 2010) Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 1/55

2 Contents Page Section 1 Aim of Commissioning Section 2 When This Policy Applies Section 3 Principles Applied when Handling Individual Funding 5 Requests (IFRs) - Determination of exceptionality Section 4 Overview of the Prior Approval Process Section 5 Overview of the Individual Funding Request Process 9 Section 6 Appeal Process Stage 1: Individual Funding Panel 12 - Stage 2: Process Appeal 14 Section 7 Relevant Commissioning Policies Beds & Herts Priorities Forum Guidance Joint Prescribing Committee Policies East of England Priorities Advisory 16 Committee NICE Guidance Rare Conditions Expanded Access/Compassionate Use 17 Programmes Drugs Used Outside their Licensed 18 Indications Requests to Continue Funding of Care 18 Commenced Privately Requests for Referral to a Specialist 19 Provider Decisions Inherited from other PCTs Request for Funding for Treatment Abroad One-off Referrals to Independent Sector 24 Providers Requests for Equipment Joint Funding Arrangements Current Acute Referral Pathways Current Mental Health Referral Pathways 25 Section 8 Evaluation and Audit Section 9 Training and Support Section 10 Policy Review Appendix 1 NHS Bedfordshire s Ethical & Commissioning.. 26 Principles Appendix 2 Overview of Individual Funding Request Process 30 Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 2/55

3 (flowcharts) Appendix 3 Individual Funding Request Application Form for 33 Drug Requests Appendix 4 Individual Funding Request Application Form for 42 Non-Drug Requests Appendix 5 Case Review Panel Terms of Reference Appendix 6 Individual Funding Panel Terms of Reference.. 48 Appendix 7 Self-Assessment Template for Independent Sector 50 Providers Appendix 8 Equality Impact Assessment Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 3/55

4 NHS BEDFORDSHIRE INDIVIDUAL FUNDING REQUEST POLICY PROCESS FOR THE FUNDING OF SERVICES AND TREATMENTS NOT ROUTINELY COMMISSIONED BY NHS BEDFORDSHIRE Section 1 AIM OF COMMISSIONING 1.1 NHS Bedfordshire (PCT) receives a fixed budget from central government with which to commission all the healthcare required by its population. The PCT has insufficient resources to fund all types of healthcare that might potentially be available or requested for its population. It is therefore inevitable that the PCT has to make choices about which healthcare treatments to commission. The PCT has a responsibility to make rational decisions in determining the way in which it allocates resources equitably for its population. The PCT has in place processes for prioritising the commissioning of services (as outlined in NHS Bedfordshire s Prioritisation Policy). This Policy describes NHS Bedfordshire s process for dealing with requests for treatments which are not routinely commissioned or which are only commissioned according to specific criteria. Within the resources available, NHS Bedfordshire aims to commission high quality clinical care to which access is available to all its population, equitably and consistently, based solely on clinical need. The PCT believes that the best way to achieve this is by commissioning clear pathways of care which span the interfaces between primary and secondary care (and tertiary when required) and are supported by shared clinical protocols and arrangements for audit and outcome evaluation. NHS Bedfordshire will pursue this approach to commissioning in line with current government policy 1. This will enable the PCT to develop a comprehensive range of care pathways, linked to a variety of care providers, to which the population will have consistent and equitable access based on clinical need. Section 2 WHEN THIS POLICY APPLIES NB It may be helpful to read this policy in conjunction with NHS Bedfordshire s Prioritisation Policy. 2.1 The circumstances which need to be considered on an individual basis via this process include: A request to fund healthcare for a patient which falls outside the range 1 Commissioning a Patient-Led NHS; available at: dancearticle/fs/en?content_id= &chk=/%2bb2qd Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 4/55

5 of services and treatments that NHS Bedfordshire has agreed to routinely commission (i.e. an Individual Funding Request) Treatments which require prior approval of funding (a Prior Approval Funding Request). Prior Approval is a process by which the PCT approves funding for treatments on an individual patient basis, in line with agreed clinical criteria. This process is in place to enable NHS Bedfordshire to ensure only patients meeting the clinical criteria are approved, and to assess associated financial risk and to monitor invoices. Section 3 PRINCIPLES APPLIED WHEN HANDLING INDIVIDUAL FUNDING REQUESTS / PRIOR APPROVAL REQUESTS The term treatment used throughout this document includes all health technologies and interventions, including drugs, surgical procedures, diagnostic tests, other investigative procedures, rehabilitation, immunisations, screening. 3.1 When considering individual funding requests, the PCT will apply its Ethical & Commissioning Principles (see Appendix 1) and the following guiding principles: The mechanism through which investment and disinvestment decisions are made is via the Annual Prioritisation Process. NHS Bedfordshire will not expect to make decisions outside this process and in particular will not expect to commit new resources in-year to the introduction of new healthcare technologies (including new drugs, surgical procedures, public health programmes), since to do so risks ad hoc decision making which could destabilise previously identified priorities. This is to prevent any inherent inequality NHS Bedfordshire expects consideration of new drugs/technologies to take place within the established local planning frameworks (i.e. the Annual Prioritisation Process) after consideration by the appropriate committees i.e. the Bedfordshire and Luton Joint Prescribing Committee, the Bedfordshire and Hertfordshire Priorities Forum or the East of England Priorities Advisory Committee, or other bodies as set out in NHS Bedfordshire s Prioritisation Policy. This will enable clear prioritisation against other calls for funding and the development of implementation plans which will allow access for all patients with equal clinical need NHS Bedfordshire accepts that there may be individual cases where a patient s needs cannot be met through existing care pathways. NHS Bedfordshire has set up an Individual Funding Panel to consider the circumstances of individual patients for whom a referral outside existing pathways may be appropriate It is not the role of the Individual Funding Panel to make commissioning policy on behalf of NHS Bedfordshire. Consideration by the Individual Funding Panel will always start from the overall policy position (i.e. Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 5/55

6 whether or not the PCT has a policy/service agreement in place relating to the treatment requested) and will seek to determine exceptionality on that basis. Treatments not currently included in established pathways/policies or identified for funding through the annual priority setting process are not routinely funded Determination of exceptionality : There is no complete definition or consensus amongst NHS organisations on exceptionality. However, in order for individual funding to be agreed there must be some unusual or unique clinical factor about the patient that suggests that they are: Significantly different to the general population of patients with the same condition in question; and Likely to gain significantly more benefit from the treatment than might be expected from the average patient with the same condition. Exceptionality is essentially an equity issue that is best expressed by the question: On what grounds can the PCT justify funding this patient when others from the same patient group are not being funded? 2 The fact that a treatment is likely to be efficacious for a patient, or that a patient has been shown to respond to a treatment (e.g. if they have previously received the treatment privately) is not, in itself, a basis for an exception. If a patient's clinical condition matches the 'accepted indications' for a treatment that is not funded, their circumstances are not, by definition, exceptional. It is for the person submitting the request (i.e. the clinician, or the patient with explicit support from their clinician see section 5.1.1) to make the case for exceptional status. A rare condition does not, in itself, demonstrate exceptionality. The fact that a patient has exhausted all NHS treatment options available for a particular condition is unlikely, by itself, to be sufficient to demonstrate exceptional circumstances. The fact that a patient is not responding to existing medical treatments where a recognised proportion of patients with the same presenting medical condition at that stage do not respond to existing treatments is unlikely, of itself, to be sufficient to demonstrate exceptional circumstances. Personal and social circumstances are unlikely in themselves to be sufficient to demonstrate exceptional circumstances. They will only be taken into account by the Individual Funding Panel where these circumstances contribute to the determination that the patient s clinical circumstances are significantly different to the general population with the same condition and the patient is likely to gain significantly more benefit from the treatment being requested. 2 This policy has been informed by: Describing exceptionality for funding panels (North West PCT Alliance Medicines and Treatments Group, April 2009) Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 6/55

7 3.1.6 The Individual Funding Panel will not usually make a decision to fund a patient s treatment where by so doing a precedent would be set that establishes new policy because the patient is not, in fact, exceptional, but is representative of a group of patients. NHS Bedfordshire will not offer treatment to one patient which cannot be afforded for all patients in the same clinical circumstances NHS Bedfordshire does not expect to introduce new drugs/ technologies on an ad hoc basis through the mechanism of individual case funding. To do so risks inequity since treatment will not be offered openly and equally to all patients with equal clinical need. There is also the risk that diversion of resources in this way will destabilise other areas of healthcare which have been identified as priorities by NHS Bedfordshire In cases where the Individual Funding Panel feels strong evidence has been provided in support of a particular health technology and/or the treatment is likely to benefit a sub-group of patients the Individual Funding Panel should make a recommendation to the Prioritisation Advisory Panel for further consideration. This will need to take the form of a business case see NHS Bedfordshire s Prioritisation Policy for details of the process to be followed. Support will be requested from the relevant clinician/provider as necessary, e.g. submission of the business case. Section 4 OVERVIEW OF THE PRIOR APPROVAL PROCESS 4.1 Where a clinician wishes to obtain prior approval of funding for treatment of a patient the following process should be followed. This includes requests relating to PBR-excluded drugs and devices (i.e. drugs and devices not included in the national tariff paid to healthcare providers under the Payment by Results system) and Beds & Herts Priorities Forum Guidance. NB: NHS Bedfordshire has developed a number of proformas for PBR-excluded drugs. These proformas are available from the NHS Bedfordshire Individual Funding Co-ordinator on request by ing christine.garrett@nhs.net. 4.2 The referring clinician should submit a prior approval funding request to the Individual Funding Co-ordinator. Drug requests should be submitted using the specific drug proforma, if available (from the Individual Funding Co-ordinator), otherwise sections 1-3 only of the IFR Form should be completed. Other requests should be submitted in the form of a detailed letter including the following information: 1. Patient Initials 2. NHS Number 3. Date of Birth 4. Evidence of compliance with the criteria in the relevant policy/guidance. 5. Level of urgency of case: a. Most urgent (decision needed within a week as the patient s Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 7/55

8 life may be in danger) 3 ; b. Immediate (decision needed within 3 weeks as delay will not be clinically appropriate); c. Routine (decision needed in 4-6 weeks). 4.3 All referrals are initially screened by a nominated officer (PCT Pharmacist for drug requests/ Commissioning Clinician for other treatment requests) on a regular basis. Referrals are initially reviewed against current PCT Policy to assess whether the patient s needs are in line with agreed criteria or would be covered by the PCT s existing portfolio of SLAs. 4.4 Where the information provided confirms that a patient meets the criteria for treatment within an existing commissioning policy, the nominated officer will approve treatment (up to the value of 70,000). This will be communicated back to the referring clinician. For values greater than this amount additional approval is required from the Director of Strategy and Redesign. 4.5 Where funding for treatment is approved, this approval applies to the specific intervention requested only, e.g. a course of a particular drug/regimen. Clinicians will need to submit new applications for prior approval of funding to extend treatment, including for the maintenance or repair of devices. NHS Bedfordshire may refuse to fund treatment in these cases if prior approval has not been sought. 4.6 Where the information provided confirms that a patient does not meet the criteria for treatment within an existing commissioning policy or the PCT has no policy relating to the treatment being requested, the nominated officer will assess whether information has been provided to support an exceptional clinical case. In these circumstances, the application will be considered by the Case Review Panel as an Individual Funding Request (see section 5 of this policy for further details). If no information on exceptionality has been provided, the request for funding will be declined, and this will be confirmed in writing to the referring clinician. 4.7 Where the nominated officer finds that insufficient information has been provided to review the case, the application will be returned to the referring clinician, with an outline of the required information. On receipt of the required additional information the case will be considered as outlined in this policy. However, should the referring clinician fail to respond with the required information within three months the case will be closed by NHS Bedfordshire. If the clinician then wishes at a later date for the treatment request to be considered then a new application will be required. Section 5 OVERVIEW OF THE INDIVIDUAL FUNDING REQUEST PROCESS 3 For treatments that are urgently required, where significant harm may occur through delay, the treatment should be provided to the patient at the provider s risk and retrospective approval for funding should be sought. Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 8/55

9 5.1 Where a clinician or a patient, with explicit support from his/her clinician, wishes to make a referral/request for funding for a treatment not routinely funded within current pathways the following process should be followed. NB: This will compulsorily include any consultant/clinician in a primary, secondary or tertiary centre who wishes to make a referral to another consultant either within or outside his/her own Trust and outside of agreed care pathways. 5.2 Requests should be submitted using the application forms in Appendices 4 and 5 (as far as possible). Supporting information should also be provided including any correspondence from other clinicians/providers as appropriate. It is the responsibility of the person submitting the application to ensure that all relevant information is forwarded to NHS Bedfordshire, and to indicate the level of urgency of the case on the application form. Cases may be: a. Most urgent (decision needed within a week as the patient s life may be in danger) 4 ; b. Immediate (decision needed within 3 weeks as delay will not be clinically appropriate); c. Routine (decision needed in 4-6 weeks). 5.3 The NHS Bedfordshire Case Review Panel will review the application and reject, approve (within agreed financial limits) or defer a decision pending further information as appropriate. The Panel meets two-four times a month depending on the urgency and volume of requests. Terms of Reference for the Panel are included at Appendix In reaching a decision on individual funding the Case Review Panel will consider each case in line with NHS Bedfordshire s Ethical and Commissioning Principles (see Appendix 1). 5.5 It is the responsibility of the person submitting the application (i.e. the clinician or patient, see section 5.1) to provide sufficient evidence to demonstrate the patient s exceptionality, as per section above, and to provide evidence of the clinical and cost effectiveness of the treatment being requested. The Case Review 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. 5.6 The Case Review Panel is not required to accept the views expressed by the patient or the referring clinician 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 4 For treatments that are urgently required, where significant harm may occur through delay, the treatment should be provided to the patient at the provider s risk and retrospective approval for funding should be sought. Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 9/55

10 The quality of the evidence to support that decision and/or the degree of confidence that the Panel has about the likelihood of the proposed treatment delivering the proposed clinical outcomes for the individual patient. 5.7 Where the Case Review Panel finds that insufficient information has been provided to review the case, the application will be returned to the referring clinician, highlighting the outstanding information required. Should the referring clinician not respond within three months, the case will be closed by NHS Bedfordshire. If the clinician wishes to re-submit the request, this will need to be in the form of a new application. 5.8 The Case Review Panel will decline the request where: There is a clear policy concerning the situation and the patient s circumstances do not meet the criteria for funding, and where there is no evidence that the patient would constitute an exception There is no PCT policy concerning the situation (and therefore the PCT s position is that the treatment is not routinely funded) and where no circumstances of exceptionality have been demonstrated The Case Review Panel concludes that the patient is not, in fact, exceptional, but representative of a group of patients, (see section 5.11 below) The clinical and/or cost-effectiveness of the proposed treatment has not been demonstrated. Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 10/55

11 5.9 The Case Review Panel will be entitled to approve requests for funding for individual patients where the request is in line with NHS Bedfordshire s Ethical & Commissioning Principles (Appendix 1). Funding requests will be approved where the following four conditions are all met: Either o (a) the request for funding for treatment is in connection with a presenting medical condition for which the PCT has no policy or o (b) the request for funding for treatment is in connection with a medical condition for which the PCT has a policy but the patient falls outside the terms of that policy and where there is evidence to suggest exceptional clinical circumstances (as per section above); There is sufficient evidence to show that, for the individual patient, the proposed treatment is likely to be clinically effective; There is sufficient evidence to show that, for the individual patient, the proposed treatment is likely to be cost effective; There is no evidence to suggest that the patient is representative of a group or sub-group of patients. The Panel concludes that there are likely to be no similar patients to the requesting patient (i.e. a patient within the population served by NHS Bedfordshire who is or is likely to be in the same or similar clinical circumstances as the requesting patient in the same financial year, and who could reasonably be expected to benefit to the same or similar degree from the requested treatment) The Panel will record its decision and a member of the Panel will write to the person who submitted the request setting out the Panel s decision and the reasons for it. Where the request has been submitted by the patient s clinician the Panel will expect the clinician to communicate their decision to the patient. It remains the responsibility of the requesting clinician to communicate the outcome of the Panel to the patient In cases where the Case Review Panel feels the patient is not in fact exceptional but is representative of a group of patients the Panel will decline funding for the individual case and will treat the request as a potential service development. In situations where the Panel is aware that a policy decision is imminent the Panel may decide to adjourn the decision, and will communicate this to the patient/referring clinician if the timescales within this policy are unlikely to be achieved. In cases which could relate to a group of patients, where the Case Review Panel feels strong evidence has been provided in support of a particular treatment, the clinician/provider will be asked to submit a business case in support of the routine use of the treatment. Where appropriate, this process will be supported by the Pharmaceutical Advisor and/or Senior Commissioning Manager (e.g. where the service development involves more than one provider). This business case, Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 11/55

12 following consideration at the appropriate forums, will be reviewed by NHS Bedfordshire s Prioritisation Advisory Panel (see NHS Bedfordshire s Prioritisation Policy). In cases where the Case Review Panel feels poor or insufficient evidence has been provided in support of a particular treatment the referring clinician will be advised of NHS Bedfordshire s processes for reviewing potential service developments (Prioritisation Policy) and no further action will be taken by the PCT unless the clinician submits more robust evidence or a business case All cases will be treated as Routine unless otherwise specified by the referring clinician. All routine cases will be reviewed and a decision communicated back to the referring clinician within 4-6 weeks In cases where urgent consideration can be justified an extraordinary Case Review Panel may be convened. Discussion via may also be used, subject to the agreement of Panel members, in order to expedite decision making. In the rare event of a patient s life being in danger the relevant Head of Service, following urgent discussion with the Medical Director, Director of Public Health or Public Health Consultant, can take an immediate funding decision on the patient in accordance with the principles set out in this policy and the timescales set out in section 5.2. However the case must then be ratified at the subsequent Individual Funding Panel meeting All decisions made by the Case Review Panel will go to the Individual Funding Panel for ratification and will be reported to the NHS Bedfordshire Board The Case Review Panel have devolved responsibility to be able to approve individual episodes or packages of care up to the per request value of 25,000 for individual funding requests. For values greater than this additional approval will be required from the Director of Strategy and Redesign Where funding for treatment is approved, this approval applies to the specific intervention requested only (e.g. a course of a particular drug/regimen). Clinicians will need to submit a new funding application to extend treatment, including for maintenance or repair of devices. NHS Bedfordshire may refuse to fund treatment in these cases if prior approval has not been sought. Section 6 APPEAL PROCESS 6.1 Stage 1: Individual Funding Panel Appeal against the Decision made by Case Review Panel The person who submitted the individual funding request can appeal against the decision made by the Case Review Panel. All appeals are Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 12/55

13 considered by a separate Individual Funding Panel; the Terms of Reference for this Panel are included in Appendix If the referring clinician has further relevant information available which has not been considered by the Case Review Panel, this can be submitted at this stage The person wishing to make an appeal must notify the Individual Funding Co-ordinator at NHS Bedfordshire of their intention in writing, within three months of the date of the Case Review Panel s decision It is the responsibility of the person submitting the appeal to ensure that all relevant information is forwarded to NHS Bedfordshire, and to indicate the level of urgency of the case on the application form. Cases may be: o Most urgent (decision needed within a week as the patient s life may be in danger) 5 ; o Immediate (decision needed within 3 weeks as delay will not be clinically appropriate); o Routine (decision needed in 4-6 weeks) With the exception of urgent requests, cases will be considered at the next available Panel meeting. If further information is required to prepare the case for consideration, this may delay presentation to the Panel until the next or subsequent meeting. All required information from the patient/trust/clinician must be sent to NHS Bedfordshire at least ten working days before the scheduled date of the next meeting of the Panel In cases where urgent consideration can be justified an extraordinary Individual Funding Panel may be convened. Discussion via may also be used, subject to the agreement of Panel members, in order to expedite decision making A summary of each case referred to the Individual Funding Panel will be prepared by the Case Review Panel, and presented by a member of that Panel to the Individual Funding Panel As per the Case Review Panel the Individual Funding Panel will consider each funding request in line with NHS Bedfordshire s Ethical and Commissioning Principles (Appendix 1) and the Panel will follow the same criteria for funding as used by the Case Review Panel see section The Panel will record its decision and a clinician from the Panel will write, within ten working days, to the person who submitted the request setting out the Panel s decision and the reasons for it. Where the request has been submitted by the patient s clinician the Panel will expect the clinician to communicate the decision to the patient. It remains the responsibility of the requesting clinician to communicate the 5 For treatments that are urgently required, where significant harm may occur through delay, the treatment should be provided to the patient at the provider s risk and retrospective approval for funding should be sought. Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 13/55

14 outcome of the Panel to the patient Cases will be anonymised as far as possible before consideration by the Panel to ensure Panel objectivity and to protect patient confidentiality. Panel members having any conflict of interest with a particular case will be excluded from the discussion of that case The clinician who submitted the request may, on request and as agreed with the Individual Funding Request Co-ordinator, attend the Individual Funding Panel meeting to provide clarification of the reasons for the request. Clinicians attending for this purpose will be excluded from the subsequent Panel discussion of the case. Patients will not be invited to attend the Panel meeting itself Where patients wish to input directly to the appeal process, they are entitled to request an informal interview with members of the Case Review Panel, and a representative of the NHS Bedfordshire s Patient Advice and Liaison Service (PALS) team prior to the case being considered by the Individual Funding Panel. The patient will be invited to bring a friend or relative to the interview. The purpose of the interview is to review the clinical case submitted by the patient/clinician to ensure that all relevant information has been included, and to give the patient the opportunity to ask any questions about NHS Bedfordshire s policies and processes. Consequently it would not normally be necessary or appropriate for legal representatives to attend such interviews, but in the event that the patient wishes to bring a legal representative due notice of this should be given to NHS Bedfordshire prior to the date of the interview. Minutes from the interview, confirmed as accurate by the patient and the members of the Panel in attendance, will be included in the information presented to the Individual Funding Panel when the funding request is considered NHS Bedfordshire has no obligation to commence/continue funding for a treatment whilst an appeal is underway The Panel will provide a summary of its decisions to the NHS Bedfordshire Board, and will flag up to the Prioritisation Advisory Panel and the Board any individual decisions which may have implications for wider PCT policy The Panel has devolved responsibility to be able to approve individual episodes or packages of care up to the per request value of 50,000 for individual funding requests. For values greater than this additional approval will be required from the Director of Strategy and Redesign. 6.2 Stage 2: Process Appeal Appeal against the Process followed by NHS Bedfordshire Should the referring clinician/patient remain unhappy with the process Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 14/55

15 adopted in reaching the Individual Funding Panel s decision, they may ask for it to be reviewed as a Process Appeal. A Process Appeal will generally only take place once an appeal against the decision reached has been considered by the Individual Funding Panel The person wishing to appeal against the process followed must notify the Individual Funding Co-ordinator at NHS Bedfordshire of their intention in writing, within three months of the date of the Individual Funding Panel s decision Process Appeals will be handled on behalf of NHS Bedfordshire by the NHS Hertfordshire Individual Funding Panel. The Hertfordshire Panel will consider whether the original decision of the NHS Bedfordshire Individual Funding Panel was valid in terms of process, factors considered and criteria applied 6. In deciding an appeal, the Hertfordshire Panel will consider whether: a) the decision was consistent with the principles of NHS Bedfordshire, as set out in the Ethical and Commissioning Principles b) the decision was consistent with the Individual Funding Request Policy c) the decision was consistent with previous similar decisions d) in reaching the decision the Panel had: taken into account and weighed all relevant evidence given proper consideration to the claims of the patient or their clinician and accorded proper weight to his or her claims against those of other patients or groups of patients competing for scarce resources taken into account only material factors acted in utmost good faith taken a decision that is in every sense reasonable It is important to note that the Hertfordshire Panel will not consider new information in support of a case. If new information becomes available, the NHS Bedfordshire Case Review Panel should be asked to reconsider the case in light of this The decision reached by the Hertfordshire Panel will be communicated to the person who submitted the request by NHS Bedfordshire. Where the appeal has been submitted by the patient s clinician the Panel will expect the clinician to communicate their decision to the patient. It remains the responsibility of the requesting clinician to communicate the outcome of the Panel to the patient If the Hertfordshire Panel finds that there was a failing in the process, as 6 McCloskey, B. Judicial Review, A Good Practice Guide for Health Authorities. (1999) Association of Directors of Public Health with Dearden Management, Bristol. Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 15/55

16 defined in paragraph 6.2.3, they will refer the case back to the NHS Bedfordshire Individual Funding Panel to make a definitive decision on whether NHS Bedfordshire should approve the treatment being requested. A failure in the process of handling an individual case request does not necessarily mean that the decision that was made was incorrect Patients or clinicians who remain unhappy with the outcome of the appeal may pursue the matter through the NHS Complaints Procedure. Information on this can be obtained from NHS Bedfordshire s Patient Advice and Liaison Service (PALS) at PALS@bedfordshire.nhs.uk or via SECTION 7 RELEVANT COMMISSIONING POLICIES When considering individual funding requests, NHS Bedfordshire will apply the following policies and guidance: 7.1 Bedfordshire & Hertfordshire Priorities Forum Guidance For a number of treatments the PCT has developed (in partnership with NHS Hertfordshire) specific policy statements setting out restrictions on access, based on evidence of effectiveness or relative priority for funding. A current list of Priorities Forum guidance is available at Clinicians or patients uncertain about the status of a particular treatment should contact NHS Bedfordshire s Individual Funding Co-ordinator for further advice. 7.2 Bedfordshire & Luton Joint Prescribing Committee (Area Prescribing Committee) For a number of medicines, the PCT has developed in partnership with NHS Luton specific policy statements setting out restrictions on access, based on evidence of effectiveness or relative priority for funding. A current list of JPC Policies can be obtained from NHS Bedfordshire s Prescribing Team. Clinicians or patients uncertain about the status of a particular medicine should contact NHS Bedfordshire s Medicines Management Team or Individual Funding Team for further advice. 7.3 East of England Priorities Advisory Committee (PAC) For a number of medicines and treatments, the PCT has signed up to specific regional policy statements setting out restrictions on access, based on evidence of effectiveness or relative priority for funding. A current list of PAC policies can be obtained from NHS Bedfordshire s Medicines Management Team. 7.4 NICE Guidance Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 16/55

17 Drugs and technologies that are approved as the result of a NICE technology appraisal need to be implemented within 3 months of the appraisal being published. NHS Bedfordshire will seek to ensure implementation of NICE technology appraisals without delay but recognises that delays may be inevitable where significant service change and/or development are required as part of the implementation (see NHS Bedfordshire s Prioritisation Policy). NICE also produces clinical guidelines, which are a valuable source of good practice, but the health service is not statutorily required to implement them in the same manner as applies to the technology appraisal guidance. Neither is NHS Bedfordshire statutorily required to fund NICE Interventional Procedure Guidance (IPG). 7.5 Treatments not covered by NHS Bedfordshire Commissioning Guidance Patients with rare conditions, including patients for whom established treatments are inappropriate for some reason, are unlikely to have potential treatment options that are covered by NICE guidance or local policies. Patients should neither be advantaged nor disadvantaged simply because their condition is uncommon. The PCT does not accept that additional NHS investment is necessarily justified because a medical condition is rare. An approach approving differential investment for those with rare conditions would seek to place a value on the lives of patients with rare conditions which was higher than those with more common conditions. Applications for funding for treatment for patients with rare conditions will be considered via the Individual Funding Request process. Where such a patient (or their clinician) makes a request for funding and the reviewing Panel concludes that there are likely to be no similar patients to the requesting patient, then that patient will not need to satisfy the requirement of exceptionality. A similar patient is defined as: a patient within the population served by NHS Bedfordshire who is or is likely to be in the same or similar clinical circumstances as the requesting patient in the same financial year, and who could reasonably be expected to benefit to the same or a similar degree from the requested treatment. Nevertheless, all such treatment requests must still meet the clinical and cost effectiveness requirements in order to be approved for funding. 7.6 Requests to continue funding for patients entering into or coming off drugs/treatments/devices trials or Expanded Access/Compassionate Use Programmes NHS Bedfordshire does not expect to fund patients entering commercially-funded clinical trials unless prior approval for funding individual patients in such trials has been obtained from NHS Bedfordshire. In approving the funding of individual patients for clinical trials, NHS Bedfordshire will also make it absolutely clear what particular elements of the trial that it is willing to fund. Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 17/55

18 NHS Bedfordshire does not expect to provide funding for patients to continue medication/treatment commenced as part of a clinical trial or Expanded Access/Compassionate Use Programme. In line with the Medicines Act and the Declaration of Helsinki 8, 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. The initiators of the trial (provider Trusts and drug companies) have a moral obligation to continue funding patients benefiting from treatment until such time as NHS Bedfordshire agrees to fund through the annual priority setting process. Where the treatment is not prioritised through the annual priority setting process, the responsibility remains with the trial initiators indefinitely. 7.7 Drugs used outside their licensed indications Drugs that are used outside their licensed indications in secondary care are included in reference costs and uplifts where such use is common practice. This means these costs are included in the nationally-set tariff paid to healthcare providers. Funding for new, rarely used, unlicensed and/or investigational drugs (novel/uncertain treatments) outside of a research trial will remain the responsibility of the provider. Where it is considered there is sufficient evidence base for such use to be considered for the routine management of patients, then a business case should be submitted in advance to the commissioner to take through the due process (minimum time usually three to four months). NHS Bedfordshire will not normally fund novel or uncertain treatments (including research trials, other than through nationally agreed systems e.g. Medical Research Council trials). 9 It is the responsibility of the clinician who prescribes an experimental drug to ensure compliance with his/her Trust s clinical governance processes and research ethics processes. The clinician s employer (e.g. provider Trust) carries corporate responsibility for the care provided to the patient. The Individual Funding Panel may seek reassurance of the relevant governance arrangements for individual cases. 7.8 Requests to continue funding of care commenced privately Patients have a right to revert to NHS funding at any point during their care. However, if they wish to exercise this right, NHS Bedfordshire will expect their care to be transferred to local pathways. Funding for the patient to continue care in a private facility, or to transfer to an NHS provider with which a clinician consulted privately has a link, will not routinely be authorised. Where personal circumstances may make such funding appropriate, the case will require consideration by the Individual Funding Panel, taking full account of the national Guidance on NHS patients who wish to pay for additional private care 10 and the NHS As per East of England PCTs High Cost Drugs Commissioning Arrangements Guidance on NHS patients who wish to pay for additional private care (Department of Health, 2009) e/dh_ Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 18/55

19 Bedfordshire policy, Defining the Boundaries between NHS and Private Care (available at ). 7.9 Requests for referral to a specialist provider (tertiary, regional or supra-regional centre or specialist private provider) The majority of referrals to specialist centres are made by secondary care consultants. NHS Bedfordshire expects consultants to refer patients for tertiary/specialist care using established pathways covered by Service Level Agreements. Accordingly, requests for referrals to specialist providers outside existing pathways will need to be considered first by NHS Bedfordshire after assessment by appropriate specialists within the existing pathway. Should a local consultant feel that a referral outside existing pathways is a priority for a particular patient, the consultant should ask for the case to be considered by NHS Bedfordshire as an individual funding request. The consultant should not refer the patient to another provider without first obtaining the approval of NHS Bedfordshire. NHS Bedfordshire will decline to fund any patient referred to another provider where funding approval has not been obtained prior to the referral being made Decisions inherited from other Primary Care Trusts Occasionally patients move in to the area and become the responsibility of NHS Bedfordshire when a package of care or treatment option has already been started by another PCT that was previously responsible for the patient s care. NHS Bedfordshire will normally honour such decisions where the care pathway has already been initiated, providing that the treatment is in line with NHS Bedfordshire s Ethical & Commissioning Principles. The patient s care will be transferred to locally commissioned services as soon is clinically appropriate Request for funding for treatment abroad NHS Bedfordshire will not routinely fund treatment outside the UK, in recognition that: It is more difficult to ensure equivalent clinical standards, patient safety and performance requirements in treatment facilities falling outside of direct UK Government jurisdiction It is more difficult to ensure effective patient care and follow on care with treatment facilities with whom the PCT does not have an established contractual or clinical relationship There may be additional treatment or patient/carer travel costs which might fall to the PCT, and which would generally be better used to fund direct patient care for the wider group of patients for whom the PCT has funding responsibility There may be additional transactional costs associated with putting in place small scale contractual arrangements with non-uk based treatment facilities, and these costs would generally be better used Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 19/55

20 to fund direct patient care for the wider group of patients for whom the PCT has funding responsibility In line with sections 6A and 6B of the National Health Service Act 2006 (as inserted into that Act by the 2010 Regulations), NHS Bedfordshire will consider applications for funding for treatment within an EEA (European Economic Area) country. NHS Bedfordshire will not normally provide funding for hospital care received in an EEA state, unless prior approval has been sought and confirmed in writing by the PCT and, where relevant, the Department of Health, ahead of treatment commencing. This applies to the following types of special services 11 : o A service that involves a stay in hospital accommodation for at least one night, o Medical treatment that involves general anaesthesia, epidural anaesthesia or intravenously administered sedation, o Dental treatment that involves general anaesthesia or intravenously administered sedation, or o A service whose provision involves the use of specialised or cost-intensive medical infrastructure or medical equipment Applications for prior approval of funding of treatment in an EEA country should be submitted in the form of a letter to NHS Bedfordshire s Individual Treatments Co-ordinator, and must include the following information: The patient s name and contact details The patient s date of birth and gender The treatment or service the patient requires Whether or not an NHS or overseas health professional (and what type of professional) has confirmed their need for this treatment (supporting evidence must be provided) What kind of treatment they propose to access overseas Where and at what facility How much the treatment is likely to cost as estimated by the overseas provider The application for prior approval of funding will be considered by NHS Bedfordshire s Case Review Panel within twenty working days of the date of receipt of the application. Should the application not contain sufficient information for the Panel to make a decision, the applicant will be informed of this within ten working days of NHS Bedfordshire receiving the application. NHS Bedfordshire will then determine the application within ten working days of receipt of the required further information, Other than in the circumstances set out in section below, the Panel will approve funding of treatment where: 11 As defined in Section 6A and 6B of the National Health Service Act 2006 (as inserted into that Act by the 2010 Regulations) Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 20/55

21 o it is necessary to treat or diagnose a medical condition o it is the same as or equivalent to treatment that NHS Bedfordshire would make available within the UK; and o NHS Bedfordshire cannot provide treatment to the patient without an undue delay. In other words, treatment cannot be provided within a period of time that is acceptable, on the basis of medical evidence as to the patient s clinical needs, taking into account the patient s state of health at the time the decision under this section is made and the probable course of the medical condition to which the treatment relates. In determining whether there might be an undue delay, the Case Review Panel will have regard to: The patient s medical history; The extent of any pain, disability, discomfort or other suffering that is attributable to the medical condition to which the service is to relate; Whether any such pain, disability, discomfort or suffering makes it impossible or extremely difficult for the patient to carry out ordinary daily tasks; The extent to which the provision of the service would be likely to alleviate, or enable the alleviation of, the pain, disability, discomfort or suffering; and The patient s estimated treatment time within the NHS The circumstances in which the Case Review Panel may not fund a claim that meets the criteria in section above are: The applicant incurred the expenditure as part of a business arrangement involving actual or potential financial benefit to the applicant Where an E112 (now known as an S2) has been issued Applications for prior approval which do not meet all of the criteria in section above will be considered on a case by case basis. In no circumstances will a request for prior approval be granted unless the intended service is necessary to treat or diagnose a medical condition of the patient. The PCT will take into account the matters set out in section above. The PCT will also have regard to whether o The service is not one which would be provided by the NHS, in the circumstances of the patient s case o The treatment is experimental o There is a proven or well-evidenced clinical risk to the patient or to wider public health if the patient travels abroad o There are inadequate aftercare or follow-up arrangements in place for the treatment in question o There is clear evidence of previous neglect or fraudulent actions on the part of the provider Where the PCT approves a request for prior approval of funding for treatment in an EEA country, this is simply an acknowledgment of the patient s right to access such treatment. The PCT will not play a role in referring the patient to providers in other countries. Nor does prior Individual Funding Request Policy/Nikki Barnes/May10/version3 Page 21/55