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Policy and Procedures for Managing Individual Funding Requests

Responsible Directorate: Responsible Director: Date Approved: Committee:

Commissioning Carol McKenna Version 3: January 2011 Clinical Executive Committee


Version Control: Document Title: Document Number: Contributors:

Version: Date of Production: Review Date: Post holder Responsible for Revision: Primary Circulation List: Web Address: Restrictions:

Policy and Procedure for Individual Funding Requests

Managing

Judith Hooper, Carol McKenna, Vicky Dutchburn, Members or the Exceptional Cases Committee and Appeals Panel 4.0 January 2011 April 2012 Director of Commissioning

Standard for Better Health Map PCT Values: Core Standard Reference: Performance Indicators:

1. All Individual Funding Requests are considered in accordance with this policy and via the procedures outlined in it. 2. The PCT has a robust system in place to ensure consistency in decision making that takes into account legal and national guidance.

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Contents Policy Statement………………………………………………………………………... Introduction………………………………………………………………………………. Aim Of This Policy And Procedure………………………………………………….. Legal Context……………………………………………………………………………. Commissioning Principles……………………………………………………………. Associated Policies And Procedures……………………………………………….. Scope Of The Policy……………………………………………………………………. Accountability And Responsibilities………………………………………………… Responsibility For Policy Review……………………………………………………. Screening And Decision Making Principles……………………………………….. Exceptionality……………………………………………………………………………. Procedures………………………………………………………………………………. Stage One – Screening Process……………………………………………………… Urgent or Emergency Cases…………………………………………………………... Membership Of The Screening Panel………………………………………………… Stage Two- Exceptional Cases Committee………………………………………….. Membership Of The Exceptional Cases Committee………………………………… Stage Three – Appeals Committee…………………………………………………….. Membership Of The Appeals Committee…………………………………………….. Precedence............................................................................................................... Treatment Outside The European Economic Area (EEA)………………………… Equality Impact Assessment………………………………………………………….. Training Needs Analysis……………………………………………………………….. Monitoring Compliance With This Policy…………………………………………… References……………………………………………………………………………….. Appendices Appendix A: Clinical Effectiveness Hierarchy………………………………………… Appendix B: Proforma For Completion By Referring Clinician……………………… Appendix C: Screening Tool For Individual Funding Requests…………………….. Appendix D: Kirklees PCT Guidelines For Considering Restricted Treatments….. Appendix E: Examples Of Standard Letters…………………………………………. Appendix F: Referral Form For Individuals with Mental Health Issues or Learning Disabilities. Appendix G: Process For Considering Mental Health And Learning Disabilities related referrals……………………………………………………………………….. Appendix H: Membership Of The Committees Involved In the Individual Funding Requests Process In Kirklees………………………………………………………….. Appendix I: Proforma For Consideration By The Appeals Committee……………..

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Appendix J: Flow Chart Illustrating the Individual Funding Requests Process…...

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Appendix K: Equality Impact Assessment Tool……………………………………….

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Appendix L: Key Stakeholders consulted/involved in this policy development……

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Policy Statement NHS Kirklees has a systematic and documented process for considering all Individual Funding Requests that will take into account national, regional and local guidance to support decision making. All Individual Funding Requests will be considered via this documented process. This will ensure decisions are consistent and based on the best available evidence and enable the most appropriate care to be delivered within the context of individual clinical need. The policy and procedure will be made publically available on the PCTs website with links to clinical guidance documents where these are available.

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Introduction This policy document sets out the NHS Kirklees procedures for managing requests for an individual to receive a health care intervention that is not routinely funded by the PCT. The vast majority of health care commissioned by the PCT is covered by NHS Service Level Agreements or other Contracts. However, there are a small number of requests for treatment by individual patients each year not covered by either of these. For the purpose of this policy, and in common with the Secretary of Stateâ€&#x;s Directions to Primary Care Trusts and NHS Trusts concerning decisions about drugs and other treatments 2009, the term “health care interventionâ€? includes the use of medicine or medical device diagnostic technique, surgical procedure and other therapeutic intervention.

Aim of this policy and procedure To have a clear policy and procedure to: Manage Individual Funding Requests Consider the legal aspects of priority setting Have a systemic and consistent approach to the management of Individual Funding Requests. This will be achieved by the following objectives: To be compliant with the NHS Confederation guidelines on interpretation of legislation To have systems in place that enable a consistent approach to decision making within appropriate timescales To ensure decisions made are based on the best available evidence at the time of consideration The process for managing new treatments will not be considered as part of this because it is a separate process within the PCT. This policy will aim to provide a robust process of decision making by which all Individual Funding Requests can be considered. In responding to an Individual Funding Request the PCT accepts no clinical responsibility for the health care intervention or its use, or for the consequences of not using the intervention.

Legal Context The PCT has a duty: To allocate healthcare resources, utilising a consistent framework for decision making To promote and provide a comprehensive healthcare service within its allocations and consider how this is best done. To be aware of differences in neighbouring trusts and be able to justify them if necessary (NHS Confederation, 2008a) The PCT needs to be satisfied that any decision follows the procedures and processes described in this document and in doing so ensure requests are considered on their own merits.

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The courts have established that a PCT is not under an absolute obligation to provide every treatment that a patient demands, although they must be able to clearly demonstrate why a treatment has been refused (NHS Confederation, 2008a). A PCT can develop a policy which prioritises treatment to take account of the resources available to it and the competing demands on those resources. Patients with rare or unusual medical conditions have as much right to care as anyone else and have the right to have their requests considered properly, on their own merits and against the PCT‟s policy in each individual case. The need for priority setting process to be central to PCT corporate governance in relation to Individual Funding Requests and commissioning decisions cannot be underestimated because the potential for Judicial Review is increasing. Judicial Review is the process by which the lawfulness of decision making can be challenged and can occur as a result of major service change or refusal to fund treatments for individual patients. There are grounds for a review if: Decisions may be unlawful – acting outside statutory power (e.g. not following direction of Secretary of State) Decisions may be irrational – considering irrelevant/excluding relevant factors Decisions are procedurally improper – (e.g. failure to comply with PCT policy or the PCT policy itself being unlawful or irrational) (NHS confederation, 2008a)

Commissioning principles PCTs have a statutory duty to provide health care for their population and in doing so have to take account of the resources available, usually a fixed budget from central government to commission health care and services. The PCT‟s commissioning principles are used to make decisions in a consistent, fair and transparent way, given that funds are not endless and choices inevitably need to be made. The criteria for commissioning treatments are: Clinical Needs – Consideration should be given to understanding the need and whether we are likely to achieve the greatest possible health outcome for the patient. Health care interventions which produce the greatest benefit in terms of clinical improvement and/or improvements in quality of life should be prioritised. Lawful – As previously discussed at the beginning of this policy as part of the legal responsibilities of the PCT. In addition, as part of this process a Clinician makes a request on behalf of the patient and therefore must be aware of the need to obtain informed consent for the referral as well as ensuring the patient is aware of both the potential benefits and risks of any treatment being requested. Clinically Effective – Commissioning decisions should be based on evidence of effectiveness wherever possible. For example, this could come from sources such as NICE. Cochrane reviews, meta-analysis or randomised control trials (see Appendix A for the Clinical Effectiveness Hierarchy). Cost-effective – Given limited resources the trust must receive optimum value from available resources and recognises that QuALY (Quality Adjusted Life Years) would help judge this, with NICE using a maximum value of £30,000 per QuALY. However it is important to note that cost alone will not be a reason for refusing an Individual Funding Request. Equitable – In this context equity means that if an Individual Funding Request is agreed for a new treatment/drug trial then it could lead to service development which could benefit the wider population. In addition, once a precedent has been set, it is likely that future requests for the same treatment would also qualify for funding, subject to the clinical presentation of the patient. Accessible - While accessibility implies utilisation of local services the PCT also needs to take into account patient choice. The PCT would expect referrals to be 5


made to the NHS services wherever possible but a choice list will be provided to highlight where the PCT will fund treatment outside the local NHS if available and where requested by the patient. Good quality of care and patient experience – Decisions should be based on the potential to deliver good and safe care, improve health outcomes and enhance patient experiences. Individual Funding Requests should be agreed if it meets this criteria and will achieve or has the potential to achieve explicit measures of quality , including: 1. 2.

Patient feedback through local and national surveys, PALS complaints Local and national standards, targets and quality indicators (Dr Judith Hooper, PEC paper, November 2007)

Associated Policies and Procedures This policy and the procedures outlined within it are related to: Policy and procedure for commissioning treatments not covered by existing service level agreements Medicines (and technologies) commissioning policy

Scope of the Policy This policy and the procedure must be followed for all the Individual Funding Requests received by NHS Kirklees. Clinicians making an Individual Funding Request on behalf of their patient are expected to adhere to the procedure outlined in this policy. Advice and support is available from NHS Kirklees contracting team.

Accountability and Responsibilities The Chief Executive and the Board are accountable for the discharge of PCT statutory duties and have a scheme of delegation in place that is set out in the PCTâ€&#x;s standing orders and standing financial instructions.

Lead Director The lead Director with overall responsibility for this policy and procedure is the Director of Commissioning.

Governance Committee Accountability Overall responsibility for the development and implementation of this policy and its procedure has been delegated by the Board to the Governance Committee. The annual report will be made available to the Governance Committee to enable them to: Ensure the systems in place are sufficient to meet patients needs Ensure that decisions made throughout the process are consistent and appropriate Ensure positive health outcomes are being achieved as a result of the decisions made.

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Delegated responsibilities Responsibility for making decisions regarding Individual Funding Requests on behalf of NHS Kirklees is delegated by the Governance Committee to: Screening Panel Individual Funding Requests Committee Individual Funding Requests Appeals Panel The membership, roles and responsibilities of each of these bodies is set out in the procedures section of this document.

Structure of Reporting to the Board

Board

Governance Committee

Individual Funding Requests Management Group

Responsibility for Policy Review Where a need to change any aspect of the structure or process of decision making is identified the screening panel will coordinate a review of this policy. A review may also be required in response to new local, regional and national guidelines as they become available. Changes to other policies within the PCT may occur as part of this process. This could occur following the introduction of new national Guidelines or where a significant number of people are applying for funding for the same treatment or intervention, leading to a review of routinely commissioned treatments/services. When a policy decision needs to be made recommendations will go to: Senior Management Team – for decisions involving policy changes that impact on the management of the PCT Clinical Executive Committee – for clinical decisions Any policy decisions made by either if these groups should then be reviewed by the Individual Funding Requests Management Group to determine how this impacts on the Individual Funding Requests Policy.

Screening and Decision Making Principles The screening panel will assess each individual request taking into account:Appropriateness, comprehensiveness, effectiveness (including that of safety), size of intended benefit (outcomes), alternative interventions and consequences of not having intervention. 7


Individuals requesting funding are screened for: Treatment or drugs not covered by existing Service level Agreements or are specifically identified as exceptions within the Service Level Agreement Treatment availability locally but requested from another provider where additional costs will lead to uncertain extra clinical benefit Treatments or drugs that are not routinely commissioned Treatment or drugs that are new or experimental Complex or unusual cases The following guidance should also be taken into account when considering appropriateness of a request: High Cost Drugs: Individual Funding Requests for high cost drugs. On receiving a request for high cost drug treatment the screening panel will consider available evidence based reviews to inform the decision making process. The request will also be reviewed by a Medicines Management Representative to provide key information that should be considered. A representative from Medicines Management will attend the screening panel to present any information and discuss these cases as required. Introduction of New Drugs or Treatments: Consideration of new drugs/treatments should be referred into established planning frameworks but a decision should be made as to whether an interim commissioning policy is needed to enable the Clinician/patient to access treatment until a decision is made by the Regional Specialist Commissioning Group. Restricted Treatments: Treatments not included in existing pathways are not routinely funded but policy statements on restricted treatments are available. Individual Funding Requests can be considered in relation to these restricted treatments to assess whether the request fits the criteria or if exceptional circumstances exists. A list of currently agreed restricted treatments is supplied in (Appendix D). Rare Conditions: These patients are unlikely to have treatment options covered by NICE guidance or commissioning policies and therefore, in this case Individual Funding Requests should be considered against the commissioning principles Drug Trials: The PCT will not usually provide funding for individuals coming off drug trials unless prior agreement has been obtained prior to a patient commencing a trial. In accordance with the Medicines Act (2004) responsibility for an exit strategy from a trial lies with those conducting it (NHS Confederation, 2008b) Continuing Private Care: Funding for individuals to continue care purchased privately, where an individual has exhausted their own resources or chosen to terminate a private arrangement, will not routinely be funded by the PCT. Applications for funding can be considered via the ECC process in the usual way. Inheriting decisions from other PCT’s: Patients moving into the PCT area and registering with a GP in the PCT area, become the responsibility of the PCT and therefore decisions for treatment already agreed by the previous PCT would normally be upheld as long as it is consistent with the principles in this policy and the Department of Health publication “Establishing a Responsible Commissioner�. Retrospective Payment: patients who have paid for private treatment and then ask for reimbursement of these costs from the PCT. The PCT would not support such applications 8


because prior approval for funding should have been sought through the processes outlined in this policy. Co-payment: patients who pay for some aspects of treatment while being treated in the Public Sector. The NHS Act (2006) does not allow for recovery of charges for healthcare and the Code of Conduct for Private Practice: Guidance for NHS Medical Staff (2003) states that patients wishing to become private patients cannot be treated as both a private and NHS patient during the same visit to an NHS Organisation. The governmentâ€&#x;s current position is to rule out co-payment and it is recommended that PCTâ€&#x;s follow this guidance because it would provide access to a treatment that the PCT was not making available to others (NHS Confederation, 2008b). Patient Safety: The PCT has a responsibility for patientsâ€&#x; safety when being treated in healthcare settings. The Care Quality Commission governs the suitability of providers of NHS services and therefore patients should only be referred to providers registered with the Healthcare Commission. Exceptionality: Exceptionality should be considered in the context of the PCT general policy for an intervention and specified indication. In general, the PCT must justify the grounds upon which it is choosing to fund treatment for a patient when the treatment is unavailable to others with the condition. A patient may be considered exceptional to the general policy if: The patient has demonstrated exceptional clinical circumstances in comparison to the cohort of other patients in the same clinical condition1 (Patient is significantly different to the general population of patients with the condition in question who would normally be refused treatment) It is likely that the requested treatment will be clinically effective (there are good grounds to believe the patient is likely to gain significantly more benefit from the intervention than might be expected for the average patient with that particular condition. e.g. may not tolerate standard treatment options. (Dr K Smith, Yorkshire & Humber SCG)) It is likely that the requested treatment will be a cost effective use of NHS resources (David Lock 2011) When considering Individual Funding Requests the PCT will use the same ethical framework and guidelines for decision-making that underpin its general policies for health care interventions, see commissioning principles above. Where social, demographic or employment circumstances are not considered relevant to population based decisions, these factors will not be considered for Individual Funding Requests. Any assessment of exceptionally will therefore be based primarily on the consideration of clinical need. When a patient has already been established on a health care intervention, for example as part of a clinical trial or following payment for additional private care, this will be considered to neither advantage not disadvantage the patient. Response to an intervention will not be considered to be an exceptional factor. 1 Though this test may need some revision in the case of a patient with a rare condition where there is no policy

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Procedures An Individual Funding Request (IFR) is a request to a PCT to fund healthcare for an individual who falls outside the range of services and treatments that the PCT has agreed to commission (NHS Confederation 2008b). The process should be both thorough and comprehensive taking into account the legal issues and commissioning principles outlined in the policy above. The process of decision making in all cases should therefore be: Consistent – in line with agreed policy Concise – often request for funding are related to care which is required relatively urgently, but not so concise that key issues are marginalised. Transparent and explicable Defensible – based on sound evidence from national or legal guidance The Individual Funding Request Procedure The Individual Funding Request procedure can only be initiated by a clinician i.e. the General Practitioner, Consultant or Dentist making a request for funding for a treatment to the PCT. It is the responsibility of the individual seeking funding in conjunction with the referring clinician to ensure that all relevant information is forwarded to the PCT. This should include: 1. An outline of the patient‟s problem and the circumstances of the case, including any previous treatment 2. A clear statement of the referral/treatment plan proposed 3. Consideration of whether the patient‟s needs could be met within existing pathways 4. If the care could be provided within existing pathways, a statement of why an alternative referral, which would not be offered to others with a similar clinical need, is a priority in this case; 5. If the case is not routinely funded by the PCT through existing care pathways, evidence to show why this patient is exceptional A referral form should be completed by the referring clinician in all cases (see Appendix B) in order to ensure all the above information is received. The only exception to this is when an alternative proforma is available from individual trusts requesting high cost drugs for individual patients. If a referral form is not completed the referral will not be considered until NHS Kirklees receives the information it requires to enable a decision to be made. All requests for funding should be referred in writing in the first instance to the IFR Coordinator. On receiving a request the Coordinator will: Enter the request onto a secure database Assign a unique Individual Funding Request (IFR) number Create a file within which to keep all correspondence and information relating to the request Log all correspondence onto the secure database

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The IFR Coordinator should collate the information supplied for each case and ensure it is passed on to the screening panel to enable them to consider each case and complete the screening matrix (see Appendix C) as comprehensively as possible. The role of the IFR Coordinator is an administrative role tasked with coordinating the IFR process. Any queries to the details of a specific case at any stage of the process should be communicated by the IFR Coordinator in writing via the GP or referring clinician. This will enable accurate records of each case to be maintained and enquires to be answered by the most appropriate person. The IFR Coordinator can be contacted either by the patient or referring clinician if clarification is required regarding the IFR process. There will be three stages for considering IFR requests: Stage One – Screening process Screening cases is recommended as good practice by the NHS Confederation (2008b). The role of screening is to review all applications in relation to current national, regional or local guidance and/or policies as well as identifying any previous precedents that have been set. The screening process will operate within principles set out in the policy document. Outcomes from the Screening Process2 There are 4 potential outcomes from the screening process: Inappropriate Where cases are inappropriate for consideration the reasons for the decision plus any actions to be taken shall be documented by the screening panel and the patient and referring clinician informed within 5-10 working days of the screening panel meeting. Recommendations for Approval Individual Funding Requests can be recommended for approval to the Exceptional Cases Committee as part of the screening process, if the referring clinician is requesting approval for treatment on the restricted treatments list where the patient already meets agreed criteria. Requests can also be recommended for approval if the request clearly meets the criteria specified for that indication in NICE guidance. The patient and referring clinician will be informed within 5-10 working days of the screening panel meeting. Requests for high cost drugs can be recommended for approval by the screening panel if the request is supported by local, regional or national policy or guidance. If clear guidance is not available then the original research will have to be considered to support decision making. If a review of the evidence is unable to provide clear guidance then the request should be considered exceptional and referred to the Exceptional Cases Committee, supported by all the available evidence. In terms of rare conditions the same process of evidence review shall be followed as outlined for considering high cost drugs. The chair of the Exceptional Cases Committee will take responsibility for signing off approved requests.

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2 It should be noted that in severe financial difficulties the following has occurred in 2006 by Huddersfield PCTâ€&#x;s and thereafter by Kirklees PCT until early 2007: Moratorium: In circumstances of severe financial constraint consideration of Individual Funding Requests can be suspended by the PCT, it is lawful and fair to restrict treatments on the basis of costs in extreme circumstances. However it will still be necessary to screen requests and continue t support those that the ECC agree meet the following criteria: The condition is immediately life threatening That undue delay would result in a real and imminent risk of harm, e.g. death, infirmity or handicap That the procedure needs to e carried out within a strict time frame as delay would result in it becoming effective

Refused Individual Funding Requests can be refused as part of the screening process if the individual does not meet agreed criteria, there is no clear evidence supporting the treatment, or where the request does not clearly demonstrate exceptionality. In the event of refusal to fund, the referring clinician will be advised of the reason for refusal and future submission will have to clearly address these issues before a request can be approved or referred to the Exceptional Case Committee. Appeals against a refusal to consider an Individual Funding Request will be referred to Exceptional Cases Committee for further discussion and a decision. The screening panel will refer all cases which they consider may demonstrate exceptionality to the Exceptional Cases Committee for a decision. The screening panel may also refer a request to the Exceptional Cases Committee if they feel there is no clear guidance or criteria available to enable them to make a recommendation. Urgent or Emergency Cases It is recognised that there may be occasions when the screening panel receive cases for consideration that need a decision urgently. Given that there would be difficulties in convening the Exceptional Cases Committee at short notice in cases of extreme emergency (for example, someoneâ€&#x;s life is dependent on a decision being made) the screening panel will pass on its recommendations to the Executive Director of Public Health or the Executive Director with responsibility for Clinical Governance for a decision which would be documented and reported to the Exceptional Cases Committee at the next meeting. While the PCT will endeavour to respond to such urgent requests as quickly as possible, this should not compromise the quality and validity of the decision-making process. At all times the provider is able to fund a health care intervention pending a decision from the PCT and the PCT accepts no responsibility for the clinical consequences of any delay in responding to the request. A copy of standard letters for communication is supplied in Appendix E. Both the patient and referring clinician will be notified of the decision to refer the case to the Exceptional Cases Committee within 5-10 working days of the screening panel meeting.

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Membership of the Screening Panel Commissioning /Contracts Manager (Chair) Public Health Clinician Individual Funding Requests Coordinator For high cost drug requests the panel will be supplemented by a senior medicines management representative. For requests in relation to mental health and learning disabilities the screening panel members will be Assistant Director for Mental Health (Chair) General Manager for Mental Health Services Lead Nurse for Mental health and Learning Disabilities Specialist Care Team (see Appendix F for the referral form into this process for individuals with mental health problems or learning disabilities and Appendix G for the process all other referrals will follow). These are the core memberships of the 2 screening panels and if for any reason a member of the panel cannot attend then an agreed deputy will attend the meeting. The panel will meet on a weekly basis. Stage Two – Exceptional Cases Committee In making a decision the Committee will consider all available clinical history, examine the evidence base where necessary. The Committee will: Review each patient request on an individual basis Take into account relevant factors which are unique to the patient, e.g. current health status and existing co-morbidities Consider if the treatment is necessary and appropriate in relation to individual clinical need, with expected benefits outweighing any risks, and whether there are any exceptional needs or circumstance Consider the evidence base for safety and efficacy and if the request is drug related, its licensed indication Consider if the treatment is clinically and cost effective with equity of access and provision across the PCT, utilising clinical information (provided by patientâ€&#x;s GP, Consultant or other appropriate clinical staff) and evidence base (regarding clinical and cost effectiveness of the intervention). Consider consistent with agreed guidance whether PCT, regional or national that may be available Consider other alternative options available for the patient including whether the request can be met by local or alternative providers or whether they are inappropriate for that individual Consider if this establishes precedent or whether there is an existing precedent The panel will use the following resources if information to make the decision as to whether the case referred is an exception: Information provided by the patientâ€&#x;s GP/referring clinician Clinical effectiveness reviews of the intervention requested 13


Evidence that all alternative clinical strategies have been exhausted, e.g. conservative and primary care management of the patient‟s condition (North Yorkshire & York PCT, 2008)

Applications for Consideration via the Exceptional Cases Process. In instances where the matter is to proceed to the Exceptional Case Committee, the IFR Coordinator will: Write to the referring clinician within 5-10 working days confirming that the request will be considered by the Exceptional Cases Committee and requesting further information if required. This letter will also inform them of the date of the next Exceptional Cases Committee Write to other health professionals with clinical involvement in the patient‟s care for clarification of the patient‟s needs, if required and/or appropriate Decision for Approval or Non Approval Whether the request for funding is approved or not, the patient, the referring clinician and the patients GP (where they are not the referring clinician) will be informed in writing of the Committee‟s decision within 5-10 working days of the Exceptional Cases Committee meeting. Where the request was refused the Committee will set out their decision and the reasons for it to the referring clinician and GP. The patient will be informed of the decision and encouraged to see their GP to discuss the reasons behind the decision. If the patient does not accept the outcome they can appeal VIA THE REFERRING CLINICIAN ONLY to the Appeals Committee. Membership of the Exceptional Cases Committee Full membership of the Exceptional Cases Committee is supplied in Appendix H and it is the expectation that all of these people or their deputies will attend every Committee meeting. However, there may be exceptional circumstances where on occasion the Committee is required to carry out its function on a minimum membership. In such circumstances the Committee is quorate with the presence of the following: Director (Chair) Non-Executive Director Clinical Lead Assistant Director of Commissioning No ECC member should be a person who is on either Screening Panel or the Appeals Committee. Evidence to support decision making will be provided by the Public Health Clinician on behalf of the Screening Panel and where a decision needs to be made regarding an individual with mental illness a member of the Screening Panel will attend to present that case to the Committee. These people will not be members of the Committee and will not participate in the decision making process. Only those identified as members of the 14


Committee (see Appendix H) will have the right to make decisions as part of the Exceptions Case process. The Committee will be chaired by the Executive Director or their Deputy. The Chair will be responsible for checking that the decisions made are accurately recorded and for signing any letters sent to patients and clinicians reflecting those decisions. In case of disagreement, the chair has the casting vote if necessary. Stage three - Appeals Committee Individuals wishing to appeal against a decision made by the Exceptional Cases Committee must notify the PCT of their intention, in writing, within 40 working days of the date of the initial decision via their GP or initial referring clinician. The Individual Funding Requests Coordinator will send a letter reminding patients and clinicians of the approaching deadline for appeal at the midpoint of 20 working days post the Exceptional Cases Committee meeting. If the clinician does not lodge an appeal within the allocated timescales the case will be closed and any further correspondence would start the process again. Decision Making Process The purpose of an appeal is to consider procedural irregularities or if it is clear that the Exceptional Cases Committee failed to take into consideration relevant information or took into consideration irrelevant information. Therefore, in making their decision the Appeals Committee will consider whether: a) The Exceptional Cases Committee was quorate b) The decision was consistent with policies and procedures including the Individual Funding Request/Exceptional Cases Committee process c) The decision made was correct based on the information supplied These key questions form the basis for the Proforma followed by the Appeals Committee to ensure consistency of approach to each case (supplied as Appendix 1). An appeal is primarily to consider procedural irregularities. The Appeal Committee will have the responsibility for making the definitive decision on whether the PCT should approve the treatment being requested. A failure in the process of handling an Individual Funding Request does not necessarily mean that the decision that was made was incorrect (Guidelines from the NHS Confederation 2008b). The Appeals Committee can ask for further information to be gained so the ECC can reconsider their decision. Where new information has been supplied as part of the appeal by the clinicians or patient, then the Appeal Committee can reverse the original decision of the ECC, in order to expedite the decision making. If an appeal results in the reversal of the original decision then the Exceptional Cases Committee will be formally notified of the reasons this decision was made. Decision for Approval or Non Approval The Individual Funding Requests Coordinator will write to the patient, referring clinician and GP (where this is not the referring clinician) within 5-10 working days with the Committeeâ€&#x;s decision and their reasons. Patients who remain dissatisfied with the Appeal Committee decision will be given the information on potential courses of action as part of the letter detailing the Appeals Committee decision. 15


Membership of the Appeals Committee Full membership of the Appeals Committee is supplied in Appendix H and it is the expectation that all of these people or their deputies will attend every Committee meeting. However, there may be exceptional circumstances where on occasion the Committee is required to carry out its function on a minimum membership. In such circumstance the Appeals Committee is quorate with the presence of the following Director (Chair) Non- Executive Director Clinical Lead To support the decision making process cases will be presented to the panel by a Public Health Clinician on behalf of the screening panel and where a decision needs to be made regarding an individual with mental illness a member of that screening panel will attend to present that case to the Committee. These people will not be a member of the Committee and will not participate in the decision making process. Only those identified as members of the Committee (see Appendix H) will have the right to make decisions as part of the Appeals process. A flow chart representing the complete Exceptional Cases process is provided in Appendix J Precedence At any point in the decision making process of the Exceptional Cases Committee or the Appeals Committee a precedent could be set. This means that any decision made can be used to inform future decisions for similar requests. If previous decisions are not taken into account this could form the basis for legally challenging the PCT and the decision made on an Individual Funding Request. Given the significance of setting precedence and its potential impact on future decisions all decisions will be recorded on a secure database by the Individual Funding Requests Coordinator. However a decision to allow or refuse funding will not be absolutely binding on the PCT but where the PCT departs from a previous decision, clear evidence must be available to justify and support this departure (examples of this might include a patient presenting with slightly different systems, or someone who due to age/weight/sex/other medication might not respond to treatment in the same way). Where Individual Funding Requests are to be referred to the Exceptional Cases Committee the Screening Panel will review all previous decisions for the same treatment and indication. Any relevant decisions made about previous cases that could have an impact on the decision making process for an individual case will be made available to the Committee. An IFR should not be seen as a mechanism to introduce a new treatment. The request should be seen as genuinely individual. The requesting clinician should also demonstrate that the request is an individual request to fund a treatment, and not about introducing a treatment to a group – however small. Treatment outside the European Economic Area (EEA) Requests for treatment outside the EEA will be considered in line with the Department of Health patient Information Circular (14 march 2007), which states that “patients do not have a right to have treatment outside the European Economic Area (EEA) paid for by their local 16


PCT. Individuals requesting treatment outside the EEA should be aware that PCT’s are advised to consider the following criteria before approving treatment outside the EEA” Clinicians will need to demonstrate how their patient meets the following criteria as part of the Individual Funding Request: The condition is of a serious nature Suitable treatment is not available within the UK or the EEA The treatment abroad is well established, not merely experimental There is a probability of significant benefit to the patient

Equality Impact Assessment All public bodies have a statutory duty under the Race Relation (amendment) Act 2000 to “set out arrangements to assess and consult on how their policies and functions impact on race equality.” This obligation has been increased to include equality and human rights with regards to disability, age and gender. The Trust aims to design and implement services, policies and measures that meet the diverse needs of our service, population and workforce, ensuring that none are placed at a disadvantage over others. In order to meet these requirements, a single equality impact assessment is used to assess all its policies/guidelines and practices. This policy guidance was found to be compliant with this philosophy after applying the Equality Impact Assessment Tool (see Appendix K). Training Needs Analysis No specific training is required before this policy and the procedures outlined within it can be implemented. Monitoring Compliance with this Policy The administration of this process continues beyond the stages described above in order to make informed commissioning decisions in the future. It wll be the role of the Individual Funding Requests Coordinator to: Track all agreed requests to enable the PCT to collate information on patient flows and costs associated with Individual Funding Requests. Any information collected will be collated for an annual report each financial year that will include reporting number of individual requests, those approved and declined and the reasons for that decision at each stage of the process (Screening panel, Exceptional cases Committee and Appeals Committee), number that went to appeal as well as the tracking information and patient outcomes. In certain circumstances it may be necessary to trail a treatment or high cost drug prior to a decision being made. Where this is the case the outcome of the trail will be obtained prior to any decision about further treatment being made.

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References Department of Health (2003) A Code of Conduct for private practice: Guidance for NHS medical Staff www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/DH4 100689 Hooper,J (2007) Functioning of the Exceptional Case System, Report to the Kirklees PCT PEC: 28 November 2007 Lock, D 2011, What does the duty on PCTâ€&#x;s to give reasons for an individual treatment decision mean in practice ; Barrister and Head of Public Law at No5 Chambers North Yorkshire and York PCT, High Cost Healthcare Commissioning Policy. November 2007 Smith K (2008) Yorkshire and Humber Specialised Commissioning Group: Exceptionally. Friday 28 March 2008 The National Health Service Bill (2006) www.dh.govuk/en/publicationsandstatistics/publications/publicationslegislation/DH4134387 The NHS Confederation (2008a) Priority Setting: Legal Considerations. www.nhsconfed.org/publications The NHS Confederation (2008b) Priority Setting: Managing Individual Funding Requests. www.nhsconfed.org/publications The Stationary Office (2004) 2004: The medicines for Human use (Clinical Trials) Regulations. www.opsi.gov.uk/si/si2004/20041031.htm

18


Appendices Appendix A: Clinical Effectiveness Hierarchy A Summary of the Appraisal of Evidence Framework

Reviewsâ€&#x; include the following studies as defined by the Health Development Agency (HAD website 2003):

Are there published reviews that answer the questions?

Evidence Maps Literature Reviews Meta-analysis No Experimental

Yes

Descriptive

Partly

Appraise the review against CASP criteria. Is the review ok?

Is there another type of study? Is the most relevant for answering your questions?

No No Yes

Yes

Check for evidence published since the review

Appraise the study/studies against the CASP criteria Look for further strengths of evidence and review

Synthesise the recommendations

19


Appendix B: Proforma for completion by referring Clinician

EXCEPTIONAL CASES COMMITTEE (ECC) REFERRAL FORM Please use this proforma as your MASTER COPY!!!

Patient‟s Name:

DOB:

NHS Number

Patient‟s Address:

DETAILS OF REQUEST AND SUPPORTING INFORMATION Please ensure that all relevant information is included in this form or is attached to ensure that requests are processed in a timely manner Clinical information: (Please include patient‟s current BMI, if relevant to request)

20


Options tried:

Evidence base to support request:

Evidence as to why this patient is an exception:

21


What outcomes are requested?

Costs (if known):

Signature, position & address of referring clinician:

Print Name:

Details of where to send: ECC Administrator NHS Kirklees, Broad Lea House, Bradley Business Park, Dyson Wood Way, Bradley, Huddersfield, HD2 1GQ Telephone: 01484 464142 Fax: 01484 464577 (Safe Haven)

22


Appendix C - Screening tool for Individual Funding Requests Outcome of Screening Panel Recommend for Approval – Deferred –

Declined -

Onward to ECC -

Action from Screening Panel

Signatures:

Public Health Clinician

Senior Contracts Manager

Head of Medicines Management

Individual Funding Requests Coordinator

Notes: This tool is intended to assist the information gathering process necessary to screen cases and ensure appropriateness of referral to the Exceptional Cases Committee. Normally this would be completed by the Screening Panel. A formal record of information gathered should be kept in order to ensure an auditable process of how decisions were made 23


APPENDIX D: KIRKLEES PCT Guidelines for considering Restricted Treatments January 2011 The function of the Exceptional Cases Committee is: To assess all cases for NHS funding of specific types of treatment which are not routinely funded, criteria for which is listed below To consider cases which are exceptional to the NHS criteria for treatment The following are the types of treatment that shall be considered by the Individual Funding Requests process. If in doubt then the referring clinician should refer to the Individual Funding Requests Coordinator who will ensure the right advice given. Where national, regional or local PCT criteria are available, they are set out in respect of each treatment 1. Breast Reduction (female) Also known as surgery for breast hypertrophy or reduction mammoplasty. The intention of this exception is to provide funding where there are genuine issues with chronic neck or back pain related directly to breast size that cannot be dealt with effectively without surgical reduction of the breasts The national criteria are: 1 The patient is suffering from neck ache, back ache (which should be present most of the time) and/or intertrigo The patient wears a professionally fitted bra which has not relieved the symptoms That patient has a body mass index (BMI) of less than 30 kg/m2 Upper limit of normal BMI is 25 kg/m2. Patients seeking breast reduction have physical restrictions on their ability to exercise and additional weight in breast tissue (sometimes 3-4kg). Major complications for surgery in general and specifically related to breast reduction surgery have been shown to be greater if the BMI exceeds 30. In additional to the national Criteria we would also require: That patient has had a physiotherapy assessment carried out within 6 months of the request being made. The report must be sent with the request and must clearly give an opinion as to the cause of the patientâ€&#x;s pain. No request for funding can be considered without a recent physiotherapy report. Written confirmation of a professional bra fitting being done in the last 6 months BMI to have been measured within 2 months of the request being submitted The patient is aged 18 years or over, to allow for the completion of normal development

24


The PCT‟s have also: Approved:

Breast reduction where there is significant breast asymmetry a difference of at least 2 cup sizes The patient has had a physiotherapy assessment to exclude other causes of back ache.

Declined:

Requests made for cosmetic/aesthetic reasons or for psychological benefit without associated clinical need

2. Breast Reduction (male) The national criteria are: 1 Patients must be post-pubertal and of normal BMI (<=25kg/m2) Appropriate screening for endocrine and drug-related causes should also take place In addition to the national Criteria we would also require: BMI to have been measured within 2 months of the request being submitted Evidence that screening for endocrine and drug-related causes has taken place and their results

3.

Breast Enlargement (Augmentation) Breast enlargement which is part of reconstructive surgery after trauma or previous mastectomy or other excisional breast surgery does not go through the Individual Funding requests process as it is part of the treatment pathway for those conditions. The national criteria are: 1 Breast enlargement is only performed by the NHS on an exceptional basis and is not carried out for “small” but normal breasts or for breast tissue involution (including post partum changes). Exceptions are made for women with an absence of breast tissue unilaterally or bilaterally, or in women with a significant degree of asymmetry of breast shape and/or volume. Such situations may arise as a result of: Previous mastectomy or other excisional breast surgery Trauma to the breast during or after development Congenital amastia (total failure of breast development) Gender reassignment – where requests for breast enlargement occur following gender reassignment surgery the same national criteria outlined above will be used to inform decision making. Additional local criteria: In relation to any requests for breast enlargement the clinician must: 25


Ensure the patient is aged 18 years or over, to allow for the completion of normal development The PCTâ&#x20AC;&#x;s have also: Declined:

Requests made for cosmetic/aesthetic reasons Requests made for psychological benefit without associated clinical need.

Breast Asymmetry Correction of asymmetry will be carried out where there is evidence supplied by a professional bra fitter that there is a difference in breast size of at least 2 cup sizes difference.

4. Revision of Breast Enlargement The national criteria are: 1 Revisional surgery will only be considered if the NHS commissioned the original surgery. It is important that patients understand that they may not automatically be entitled to replacement implants in the future it they do not meet the criteria for augmentation at that time. If revisional surgery is being carried out for implant failure, the decision to replace the implant (s) rather than simply remove them should be based upon the clinical need for replacement and whether the patient meets the policy for augmentation at the time of revision.

5. Mastopexy (breast tightening) The national criteria are: 1 This is included as part of the treatment of breast asymmetry and reduction but not for purely cosmetic/aesthetic purposes such as post-lactational ptosis. 6. Correction of Inverted Nipples The national criteria are: 1 Nipple inversion may occur as a result of an underlying breast malignancy and it is essential that this be excluded. The criteria are: Surgical correction of nipple inversion should only be available for functional reasons in a post-pubertal woman and if the inversion has not been corrected by correct use of a non-invasion suction device The PCTâ&#x20AC;&#x;s have also: 26


Declined:

Requests made for cosmetic/aesthetic reasons. Requests made for psychological benefit without associated clinical need.

7. Abdominoplasty (“Tummy Tuck”) The national criteria are:1 Abdominoplasty and apronectomy may be offered to the following groups of patients who should have achieved a stable BMI (stable is defined as within the acceptable range for at least 2 years) between 18 and 27 Kg/m2 and be suffering from severe functional problems: Those with complex scarring following trauma or previous abdominal surgery Those who have undergone treatment for morbid obesity and have excessive skin folds Previously obese patients who have achieved significant weight loss and have maintained their weight loss for at least two years. Where it is required as part of abdominal hernia correction or other abdominal wall surgery Severe functional problems include: Recurrent intertrigo beneath the skin fold. Experiencing severe difficulties with daily living, i.e. ambulatory restrictions Where previous post-trauma or surgical scarring (usually midline vertical or multiple) leads to very poor appearance and carries a risk of infection Problems associated with poorly fitting stoma bags In addition to the national criteria we would also require: BMI to have been measured within 2 months of the request being submitted The PCT‟s have also: Declined:

Requests made for cosmetic/aesthetic reasons, including stretch marks. Requests made for psychological benefit without associated clinical need

8. Body Contouring Procedures: e.g. buttock lift, thigh lift, arm lift (brachioplasty). The national criteria are: 1 These procedures will only be commissioned to exceptional circumstances and therefore all cases must be referred to the ECC.

27


This is because functional disturbance tends to be less, so surgery is less likely to be indicated except for appearance: in which case it should not be available on the NHS. 9. Liposuction (surgery to remove fatty tissues) for cosmetic reasons The national criteria are: 1 Liposuction may be useful for contouring areas of localised fat atrophy or pathological hypertrophy (e.g. multiple lipomatosis, lipodystrophies). Liposuction is sometimes an adjunct to other surgical procedures. It will not be commissioned simply to correct the distribution of fat. The PCT‟s have also: Approved:

when being used as an adjunct to other surgical procedures e.g. surgery for gynaecomastia. Pathological reasons

Declined:

Removal of diet resistant for cosmetic/aesthetic reasons

10. Prominent “bat” ears (pinnaplasty) The national criteria are: 1 The patient must be under the age of 19 years at the time of referral Prominent ears may lead to significant psychosocial dysfunction for children and adolescents and impact on the education of young children as a result of teasing and truancy. The national service framework for children defines childhood as ending at 19 years. Some patients are only able to seek correction once they are in control of their own health care decisions. Children under the age of 5 rarely experience teasing and referral may reflect concerns expressed by the parents rather than the child. The PCT‟s have also: Approved:

Requests where there is no asymmetry Requests where patients are over 19 years but were under 19 years at the time of referral (the referral may have been delayed in certain circumstances).

Declined:

Requests made for cosmetic/aesthetic reasons or for psychological benefit when aged over 19.

28


11. Repair of external ear lobes (lobules) The national criteria are: 1 This procedure is only available on the NHS for the repair of totally split earlobes as a result of direct trauma 12. Blepharoplasty (surgery for drooping or mis-shaped eyelid). The national criteria are: 1 Surgery on the upper lid is considered to correct functional impairment (not purely for cosmetic reasons) as demonstrated by: Impairment of visual fields in the relaxed, non-compensated stable. Clinical observation of poor eyelid function, discomfort, e.g. headache worsening towards end of day and/or evidence of chronic compensation through elevation of the brow The PCT‟s have also: Approved:

When the condition results from diagnosed pathology

Declined:

Requests made for cosmetic/aesthetic reasons only

Surgery on the lower lid is available on the NHS for correction of ectropion or entropion or for the removal of lesions of the eyelid or lid margin i.e. that cause clinical problems. The PCT‟s have also: Declined:

Where there is excessive skin on the lower lids causing „eye bags‟ but which doesn‟t affect function.

13. Rhinoplasty (surgery to improve the shape of the nose) The national criteria are: 1 Problems caused by obstruction of the nasal airway Objective nasal deformity caused by trauma Correction of complex congenital conditions (e.g. cleft lip and palate) This is agreed for cases where there are functional problems. Correction of complex congenital conditions. (e.g. cleft lip and palate) which are part of the treatment pathway for those conditions do NOT need ECC approval. Other patients must be referred to the ECC. The PCT‟s have also: Declined:

Requests made for cosmetic/aesthetic reasons 29


14. Facial Procedures (face lifts and brow lifts (rhytidectomy)) The national criteria are: 1 These procedures will be considered for treatment of: Congenital facial abnormalities Facial palsy (congenital or acquired paralysis) As part of the treatment of specific conditions affecting the facial skin, e.g. cutis laxa, pseudoxanthoma elasticum, neurofibromatosis. To correct the consequences or trauma To correct deformity following surgery. They will not be available to treat the natural processes of ageing or for cosmetic reasons 15. Osseo-integrated implants (Surgical procedure to improve or repair missing facial bones or teeth) Implementation may be agreed if the patient meets one or more of the following criteria. The patient has: A history of severe denture intolerance and/or severe bone loss Congenitally absent teeth which cannot be effectively treated by orthodontic treatment and/or other restorative means Suffered loss of facial bone, alveolar bone or teeth through an accident or disease 16. Removal of tattoos Cases must be referred to the ECC The national criteria are: 1 Where the tattoo is the result of trauma, inflicted against the patient‟s will (“rape tattoo”) Exceptions may also be made for tattoos inflicted under duress during adolescence or disturbed periods where it is considered that psychological rehabilitation, break up of family units or prolonged unemployment could be avoided given the treatment opportunity. (Only considered in very exceptional circumstances where the tattoo causes marked limitations of psychosocial functioning.) In addition to the national criteria we would also require: To know where the tattoo is located The PCT‟s have also: 30


Approved:

If the tattoo may hinder the patientâ&#x20AC;&#x;s opportunity to gain work

Declined:

Requests for patients who have tattoos which are easily concealed i.e. on their arms, legs etc

17. Hair Depilation (hair removal) The national criteria are: 1 Hair depilation will be agreed on the NHS for patients who: Have undergone reconstructive surgery leading to abnormally located hairbearing skin Have a proven underlying endocrine disturbance resulting in hirsutism (e.g. polycystic ovary syndrome) Are undergoing treatment for pilonidal sinuses to reduce recurrence In addition to the national criteria we would also require: Evidence of the underlying endocrine disturbance Where laser treatment is requested for hair removal and the applicant meets the above criteria up to 10 sessions will be approved at any one time. Following those 10 sessions the referring clinician will be asked to write to NHS Kirklees with evidence of effectiveness before any further treatment can be approved. Where laser treatment for hair removal is requested for hirsutism it will only be approved for the removal of facial hair 18. Circumcision for Religious reasons Cases must be referred to the ECC. These are only agreed for exceptional circumstances for example, when an underlying medical condition means that routine surgery in the usual setting may be unsafe.

19. Reversal of Sterilisation The local criterion is: This procedure is only available when children from existing or previous relationships have died through accidents or illness The PCTâ&#x20AC;&#x;s have also: Approved:

Cases when the patient was very young when the procedure was carried out and evidence from the referring clinician shows that they did not receive any counselling

Declined:

Patients in a new relationship who are not in contact with children from a previous relationship. 31


Patients who claim that they were not told that the procedure was irreversible. 20. Correction of Hair Loss (alopecia) The national criteria are: 1 This is available on NHS when it is a result of previous surgery or trauma including burns.

21. Correction of Male Pattern Baldness The national criteria are: 1 This is excluded from treatment by the NHS 22. Hair Transplantation The national criteria are: 1 This will not be allowable on the NHS, regardless of gender, other than in exceptional cases, such as reconstruction of the eyebrow following cancer or trauma. 23. Skin and Subcutaneous Lesions (fatty lumps (lipomata)) The national criteria are: 1 Lipomata of any size must be considered for treatment by the NHS in the following circumstances: The lipoma (-ta) is/are symptomatic There is functional impairment The lump is rapidly growing or abnormally located (e.g. sub-fascial, sub-muscular)

24. Other benign skin lesions The national criteria are: 1 Clinically benign skin lesions must not be removed on purely cosmetic grounds. This will include, amongst other conditions, skin tags and seborrhoeic keratoses (warts) Patient with moderate to large lesions that cause actual facial disfigurement may benefit from surgical excision. The risks of scarring must be balanced against the appearance of the lesion. Epidermoid or pilar cysts (commonly known as â&#x20AC;&#x153;sebaceousâ&#x20AC;? cysts) are always benign but some may become infected or be symptomatic. Some may require surgical 32


excision particularly if large or located on the face or on a site where they are subjected to trauma.

25. Skin Hypo-Pigmentation The national criteria are: 1 The recommended NHS suitable treatment for hypo-pigmentation is cosmetic camouflage. Access to a qualified camouflage beautician must be available on the NHS for this and other skin conditions requiring camouflage.

26. Vascular Skin Lesions The national criteria are: 1 NHS treatment is allowed for all vascular lesions except for small benign, acquired vascular lesions such as thread veins and spider naevi.

27. Rhinophima The national criteria are: 1 The first-line treatment of this disfiguring condition of the nasal skin is medical. Severe cases or those that do not respond to medical treatment may be considered for surgery or laser treatment. 28. Skin â&#x20AC;&#x153;Resurfacingâ&#x20AC;? Techniques The national criteria are: 1 All resurfacing techniques, including laser, dermabrasion and chemical peels may be considered for post-traumatic scarring (including post-surgical) and severe acne scarring once the active disease is controlled.

29. Botulinum Toxin The national criteria are: 1 Botulinum toxin has many uses within the NHS. It is available for the treatment of pathological conditions by appropriate specialists. Botulinum toxin is not available for the treatment of facial ageing or excessive wrinkles.

30. Botulinum Toxin Type A for Hyperhidrosis ( Regional Policy) Botulinum toxin type A (brands licensed for this indication only) is routinely funded under the following circumstances:

33


When medically necessary for intractable, disabling focal primary Hyperhidrosis, that has not been adequately controlled by topical aluminium chloride/other extrastrength antiperspirants: AND patient is unresponsive or unable to tolerate pharmacotherapy prescribed for excessive sweating (e.g. anticholinergics, betablockers, or benzodiazepines) if sweating is episodic Where excessive sweating has caused demonstrable disruption of professional and/or social life For a maximum of 2 doses per year per patient When used by an appropriately trained specialist (not for GP prescribing) Stopping Criteria: Annual review Treatment should be discontinued if not tolerated or no objective evidence of response 31. Botulinum Toxin Type A for Prophylaxis of Migraine (Regional Policy) Botulinum toxin type A is a high cost medicine which is excluded from PbR Tariff. It is not licensed for this indication and evidence of effectiveness is weak. SCG decisions is not to routinely fund for this indication.

32. Botulinum Toxin Type A for Anal Fissures (Regional Policy) Botulinum type A is a high cost medicine which is excluded from PbR Tariff, it is not licensed for this indication however, a single treatment course of Botulinum toxin A is routinely funded for the treatment of chronic or recurrent anal fissures in adult where: The condition has failed to heal spontaneously Chronic symptoms (pain and/or rectal bleeding) have persisted for more than 6 weeks and all other appropriate non-surgical, pharmacological (e.g. topical diltiazem, topical glyceryl trinitrate) and dietary treatments have been tried and failed.

33. Botulinum Toxin Type A for Overactive Bladder (Regional Policy) Botulinum is a high cost medicine, which is excluded from PbR-Tariff. Botulinum A is routinely funded for the management of overactive bladder in the following patients: Diagnosis of OAB has been urodynamically proven Conservative measures have been exhausted (e.g. bladder training, antimuscarinic drugs) The drug is administered by an appropriately trained specialist

34. Allergy Treatments at a Specialist Allergy Centre The local criterion is:

34


The condition has been thoroughly assessed and standard treatment given by a GP or clinician but the condition has not improved and is considered “resistant” to conventional treatment. This refers to requests for treatment at non-NHS units. Referrals will only be made to one of the 6 specialist allergy centres as per SCG guidance The PCT‟s have also: Declined:

Requests for patients who haven‟t previously undergone conventional treatments and explored local options first.

35. In Vitro Fertilisation 3 The eligibility criteria for IVF currently operating in Yorkshire and Humber are as follows: Application of Eligibility Criteria Eligibility criteria apply at the point patients are referred to tertiary care (with the exception of 6.9, which should be undertaken within tertiary care). Couples must meet the definition of Infertility, as described in 2.2. Overarching Principles Eligibility criteria should apply equally to all assisted conception treatments (IUI, IVF, ICSI) All clinically appropriate individuals/couples are entitled to medical advice and investigation. Couples may be referred to a secondary care clinic for further investigation. Only couples meeting the eligibility criteria should be referred to tertiary care. Treatment limits are per couple and per individual. i.e. a woman in a heterosexual relationship undergoes maximum number of cycles with one partner, she is not entitled to further cycles. A woman in a same sex couple undergoes maximum number of cycles with one partner, her partner is not then also entitled to maximum number of cycles Referrals should be a s a couple and include demographic information for both partners Existing Children Neither partner should have any living children (including adopted children) from that or previous relationships Female Age The female patient must be between the ages of 23-39 years unless there is an absolute indication to start fertility treatment younger. No new cycle should start after the patient‟s 40th birthday. Referrers should be mindful of patients‟ age at the point of referral and the age limit for new cycles.

35


Female BMI The female partner‟s BMI should be between 19 and 30 prior to referral to tertiary services. Patients with a higher BMI should be directed to healthy lifestyle interventions prior to referral Reversal of Sterilisation We will fund IVF treatment for patients who are sterilised. (i.e. for patients who have been sterilised or have unsuccessfully undergone reversal of sterilisation) Previous Self Funded Couples Previous self-funded cycles will not affect an individual‟s entitlement, but may be used when assessing capacity to benefit Length of Relationship Cohabiting couples who have been in a stable relationship for a maximum of 2 years Welfare of the Child The couple should be assessed as meeting the requirement contained within the HFEA Appendix entitled „Welfare of the Child‟ HIV/Hep B/Hep C Special procedures for accessing treatment apply and patients may be referred from the Assisted Conception Unit to a different regional centre IUI and DI Up to three cycles of IUI (stimulated or non-stimulated) will be provided for couples with unexplained fertility, mild endometriosis or mild male factor infertility. They will then access IVF treatment if appropriate Up to six cycles (dependant on availability of donor sperm) will be offered for couples with male azoospermia Donor Sperm Donor sperm will be funded Donor Eggs Patients eligible for treatment with donor eggs will be placed on the waiting list for treatment with donor eggs. Unfortunately, the availability of donor eggs is severely limited in the UK. There is therefore no guarantee that eligible patients will be able to proceed with treatment. Patients will be placed on the waiting list for an initial period of 3 years after which they will reviewed to assess whether the eligibility criteria are still met We will fund the additional costs associated with treatment using donor eggs but the responsibility for sourcing donor eggs sits with the provider 36


Egg and Sperm Storage Embryo and storage will be funded for patients who are undergoing NHS fertility treatment. Storage will be funded for a maximum of 3 years or until 6 months post successful live birth, whichever is the shorter Any embryos frozen prior to implementation of this policy, will be frozen for a maximum period of 3 years from the date of policy adoption Any embryo storage funded privately prior to the implementation of this policy, will remain privately funded In Addition NHS Kirklees requires: You have both been thoroughly investigated and no other treatment is considered appropriate You must both be referred to the Assisted Conception Unit at Leeds Teaching Hospitals NHS Trust by a named consultant gynaecologist As a couple, you should have had no previous NHS funded attempt The couple must be willing to have anonymised data on outcome shared with commissioners BMI to have been measured within 2 months of the request being submitted. 36. Surrogacy Criteria across Yorkshire and Humber is: Surrogacy arrangements will not be funded, but we will fund treatment (IVF component and storage) in identified (fertile) surrogates, where this is the most suitable treatment for a couple infertility problem and the eligibility criteria are met. 37. Hip Arthroscopy Hip arthroscopy for hip impingement syndrome and other hip joint pathology is not commissioned by NHS Kirklees. Any request for this procedure should be considered via the IFR process. Should a request for Hip Arthroscopy be approved special arrangements for governance, consent, audit and research should be in place and followed.

38. Co-careldopa 2000mg/500mg Intestinal gel for administration via PEG tube for the treatment of advanced levodopa-responsive Parkinsonâ&#x20AC;&#x;s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results (Regional Policy) Co-careldopa/Duodopa is not routinely funded for use in Parkinsonâ&#x20AC;&#x;s disease

37


39. Infliximab for the Treatment of Hidradenitis Supportiva (Regional Policy) Infliximab is routinely funded for the treatment of Hidradenitis Supportiva with the following restrictions: Refractory/unable to tolerate commonly used first and second line treatments; including self care, antibiotics (most commonly rifampicin and clindomycin). Roacutane, corticosteroids, immunosuppressants (cyclosporine, azathioprine and methotrexate) AND DLQI of greater or equal than 21 AND GHQ12 score>15 (or> 20 and all systemic agents not used in that patient) AND One or more admission to control symptoms in the last 12 months It is expected that Infliximab will be funded for a trial period of 4 months, with continuation of funding being agreed only if the patient responds adequately. Routine funding shall continue until the patient loses response. 40. Mecasermin for the Treatment of Growth Failure in Children and Adolescents Mecasermin is routinely funded for growth failure in children and adolescents within its licensed indications Prior approval is expected for contract monitoring purposes before commencing treatment for new patients.

41. Rituximab for Systemic Lupus Erythematosis (SLE) (Regional Policy) Retuximab is not licensed for this indication. RTX (1g intravenously given on days 1 and 15) will be routinely funded in patients with SLE who meet all of the following criteria may receive rituximab: Diagnosed with severe SLE, defined as 1 system with BILAG score „A‟ or 2 systems with score „B‟ with progressive organ involvement (brain, heart, lungs, kidneys, musculoskeletal, haematological): AND Patients who have failed or have a contraindication to other standard immunosuppressive including cyclophosphamide, and steroids (patients who have received mycofenolate for lupus nephritis may receive rituximab without an Individual Funding Request approval: mycofenolate is now regarded as an equivalent therapy to cyclophosphamide and evidence is available that most patients who failed MMF will also/or already have failed cyclophosphamide) Definition of failure is defined as single system BILAG score „A‟ or 2 or more systems with BILAG „B‟ despite a course of pulsed cyclophosphamide therapy or side effects of bone marrow suppression beyond acceptable limits or hepatitis. Or other drug associated toxicity>grade 3 by CTC criteria for Adverse Events (CTCAE)*, which require stopping cyclophosphamide) (CTCAE defined by NIH national Cancer Institute) Contraindications to cyclophosphamide are defined as presence of concurrent sepsis, strong suspicion of concurrent sepsis with cyclophosphamide 38


Monitoring of treatment and assessment of treatment failure Effectiveness of response of rituximab will be evaluated at 3 months post infusions BILAG score of C demotes complete response, BILAG score of B denotes partial response, BILAG score of A denotes non response Re-treatment with two 1g rituximab doses would be suitable for patients who meet the criteria set put above (3), respond to BILAG B or C but have flare of disease, at least 6 months after initial rituximab with BILAG score either „A‟ or „B‟ again. 12 months is the observed median time for retreatment for rituximab in SLE IFRs will not be expected for patients previously given rituximab under this policy, and who meet the treatment criteria if their disease flares Many new medicines are launched within the NHS each year. Some of these are improvements to those already available. Others are completely new medicines which are reviewed by the PCT‟s. For certain medicines, the information on their effectiveness or safety is not considered reviewed by the PCT‟s and the policy may later during the year. The process for decision making in relation to high cost or new medicines is outlined in full in the Kirklees Individual Funding Request Policy. References 1. NHS Modernisation Agency. Information for Commissioners of Plastic Surgery; referral and guidelines in plastic surgery. 2005 2. NICE guidance No11. In vitro fertilisation 3. Yorkshire and the Humber Specialised Commissioning Group. Commissioning Policy: Specialised Fertility Service. May 2011 Treatment requiring prior approval The following treatments require prior approval on a case by case because of their limited clinical value before funding can be secured. These treatments fall outside the remit of the Individual Funding requests process. However, where a request is submitted for a case to be considered exceptional to the criteria it will be considered through the Individual Funding Request process.

39


Criteria for Tonsillectomy: A six months period of watchful waiting under the care of the GP is recommended prior to tonsillectomy to establish firmly there pattern of symptoms and to allow the patient time to fully consider the implications of the operation. Patients may be considered for tonsillectomy if they meet ALL of the following criteria: A

Or B

Sore throats are due to tonsillitis AND five or more episodes of sore throat per year (evidence required) AND symptoms for at least a year AND the episodes of sore throat are disabling and prevent normal functioning. (e.g. time off work/school, pyrexia, inability to swallow, difficult breathing) (Applicable to teenagers and adults only). Severe halitosis (offensive breath odour) which has been demonstrated to be due to tonsil crypt debris

Once a decision is made for tonsillectomy, this should be performed as soon as possible, to maximize the period of benefit before natural resolution of symptoms might occur (without tonsillectomy)

40


Criteria for Grommets for Otitis Media with Effusion At least 50% of otitis media with effusion (OME) will resolve spontaneously within 3 months. Therefore a period of watchful waiting for at least 3 months is the best management strategy for children with otitis media with effusion. Referral for an ENT opinion for consideration of grommets should only be considered for patients satisfying the following criteria: There has been a period of at least three months watchful waiting from the date of the first appointment with an audiologist or GP

AND either A, B or C A For Children aged 3 and over: OME persists after 3 months and the child (over 3 years of age) suffers from at least one of the following: At least 5 recurrences of acute otitis media in a year; OR evidenced delay in speech development; OR educational or behavioural problems attributable to persistent hearing impairment, with a hearing loss of at least 25dB particularly in the lower tones (low frequency loss) Please provide actual dB hearing loss OR a second disability such as Downâ&#x20AC;&#x;s syndrome or cleft palate OR severe collapse of the eardrum B

C

The child (any age) has had at least 5 occurrences of acute otitis media in tha last year with additional complications such as perforations, persistent discharge, febrile convulsions, sensorineural deafness or cochlear implant For children aged under 2 years- the child has: OME with prolonged effusion (6 months or longer) AND measured hearing loss AND disability attributable to hearing loss (delay in speech development pr other problems)

41


Criteria For Dilatation and Curettage/Hysteroscopy (for heavy menstrual bleeding) Patients will not receive D & C:

As a diagnostic tool for heavy menstrual bleeding As a therapeutic treatment for heavy menstrual bleeding Patients will receive hysteroscopy As an investigation for structural and in the investigation and histological abnormalities where ultrasound has management of heavy menstrual been used as the first line diagnostic tool and bleeding only when it is carried out: where the outcomes are inconclusive Post-dilatation, pre-procedure when undertaking endometrial ablation

Criteria for Hysterectomy (for menstrual bleeding) Patients will only receive hysterectomy for heavy menstrual bleeding when: A

B C

Levonorgestrel IUS has failed to relieve symptoms AND other treatments (such as non-steroidal anti-inflammatory agents, tranexamic acid, endometrial ablation and uterine-artery embolisation) have failed, are inappropriate or are contraindicated in line with NICE guidelines If a Mirena速 IUS has been refused on ethical grounds, the patient has failed to respond to at least 2 alternative treatments. Please detail the treatments tried. The patient has contraindications to the Levonorgestrel intrauterine system. Please provide full evidence of contraindications.

42


Criteria for Sacral Nerve Stimulation (Regional Policy) Sacral Nerve Stimulation for the treatment of: Adults with refractory urinary urge incontinence OR urinary-frequency syndrome Women with non-obstructive urinary retention Faecal incontinence Chronic constipation For the treatment of: 1. Adults with urinary urge incontinence OR urinary-frequency syndrome OR Women with non-obstructive urinary retention. SNS is routinely commissioned ONLY for patient who meet the following criteria: Have a confirmed diagnosis defined by urodynamic assessment Symptoms are refractory to behavioural and lifestyle modification, pelvic floor exercises and pharmacological therapy Have been approved for and have undergone a positive trial period (14 days) of temporary stimulation known as percutaneous nerve evaluation (PNE) resulting in a 50% or greater improvement in voiding function based on the results of a voiding diary Are able to record voiding diary data, so that clinical results of the implantation can be evaluated Have been fully informed of the procedure, the risks and the possibility of it having no benefit â&#x20AC;&#x201C; and are still keen to go ahead 2. Faecal Incontinence (NICE IPG99) In patients with faecal incontinence and a structurally intact anal sphincter, SNS will be routinely funded only where the patient has ALL of the following characteristics: Severe incontinence of liquid or solid faeces An unsatisfactory response to all appropriate non-surgical treatments (including antidiarrhoeal medication and pelvic floor muscle training) and any previously attempted surgical ones A satisfactory response to a 2-3 week test procedure Sacral nerve stimulation surgery/implantation must be performed by clinicians with a specialist interest in the assessment and treatment of faecal incontinence who follow NICE Interventional Procedure Guidance No 99. (2004) 3. Chronic constipation SNS is funded ONLY where all the following criteria apply: A minimum 1 year history of chronic constipation* that significantly interferes with activities of daily living Symptoms have failed to respond to maximal non-surgical therapies (dietary modification, bulking agents, laxatives, biofeedback) Successful outcome** of a 21 day screening period of continuous low amplitude stimulation via PNE 43


Have been fully informed of the procedure, the risks and the possibility of it having no benefit and are still keen to go ahead *defined as two or fewer bowel evacuations per week on average and/or straining to evacuate on >25% of attempts to evacuate and/or sensation of incomplete evacuation after defecation on >25% of occasions ** defined as an increase in evacuation frequency to three or more bowel movements per week, and/or a reduction by>50% in the number of episodes of straining and/or a decrease by >50% in the sensation of incomplete evacuation. SNS is not commissioned for patients with Stress incontinence, the most common type of urinary dysfunction Urinary retention due to obstruction (e.g. from benign prostatic hypertrophy, cancer, or urethral stricture) Urge incontinence due to neurological conditions (such as diabetes with peripheral nerve involvement, MS or spinal cord injury)

44


Criteria for Spinal Cord Stimulation (Regional Policy) SCS device and leads fall outside PbR tariff. Clinicians are responsible for deciding if the treatment is appropriate for individual patients. NICE Technology Appraisal Guidance 159 recommends SNS for adults with chronic neuropathic pain who: Continue to experience chronic pain (measuring at least 50mm on a 0-100mm visual analogue scale) for at east 6 months despite all other reasonable treatment alternatives having been tried with an unsatisfactory outcome. And Who have had a successful spinal cord stimulation trial (this determines suitability for permanent implantation by assessing tolerability and the degree of pain relief likely to be achieved by full implantation) Spinal cord stimulation is NOT commissioned for adults with chronic pain of ischaemic origin: Except in the context of research as part of a clinical material (due to lack of evidence of clinical effectiveness) Spinal cord stimulation will only be commissioned after an assessment by a multidisciplinary team (MDT) experienced in chronic pain assessment and management of people with spinal cord stimulation devices, including experience in the provision of ongoing monitoring and support If different spinal cord stimulation systems are considered to e equally suitable for a person the least costly should be used. (Assessment of cost should take into account acquisition costs, the anticipated longevity of the system, the stimulation requirements of the person with chronic pain and the support package offered.)

45


Appendix E: Examples of Standard letters

Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: ecc.administrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence) Dear Re: Treatment Requested:

DOB:

The Screening Panel met on (DATE) and discussed your request for funding for the above named to undergo the above procedure. Unfortunately, the Screening Panel was unable to make an informed decision because of insufficient information with regards this patientâ&#x20AC;&#x;s case and the requested treatment. The Screening Panel would like further information with regards to:

The case has therefore been deferred until you can provide the information requested above. If the information is not received within 40 working days of the date of this letter this case will be closed. If you have any enquiries please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Commissioning / Contracts Manager 46


Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: eccadministrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence)

Dear Re: The Screening Panel met on (DATE) and discussed your request for funding for the above procedure. I am writing to inform you that the Screening Panel could not make a final decision until they had received some more information from your clinician. I have written to request this further information required in order for your case to progress If this information is not received from your clinician within 40 working days of the date of this letter, your case will be closed. If you have any enquiries please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Commissioning / Contracts Manager

47


Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: ecc.administrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence and invoices) Dear Dr. Re:

DOB:

Treatment requested: The Screening Panel met on (DATE) and discussed your request for funding for the above procedure. I am writing to inform you that the Screening Panel has approved this request. The evidence provided was sufficient for the panel to approve the request as your patient met with the criteria set by NHS Kirklees. You may now make an NHS referral for this patient to a Care Quality Commission registered provider, please enclose a copy of this letter with your referral as confirmation that NHS Kirklees has agreed the funding. If you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number.

Yours sincerely

Chair of the Exceptional Cases Committee 48


Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: ecc.administrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence) Dear

RE: The Screening Panel met on (DATE) and discussed your request for funding for the above procedure. I am writing to inform you that the Screening Panel has approved this request. The evidence provided from your referring clinician was sufficient for the panel to approve the request as you met with the criteria set by NHS Kirklees. I have written to (CLINICIAN) who will now make the necessary arrangements to refer you. If you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number.

Yours sincerely

Chair of the Exceptional Cases Committee

49


Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: ecc.administrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence) Dear Re:

DOB:

Treatment Requested: The Screening Panel met on (DATE) and discussed your request for funding for the above named to undergo the above procedure. I am writing to inform you that the panel has declined this request. The recorded rationale behind this decision is based on the evidence provided. There is no evidence that this patient meets the criteria because…………….. If you feel your patient is an exception to the criteria, or your patient‟s circumstances change in the future, you may re-apply by completing a new referral form. The patient has been informed of the decision and has been advised to discuss the rationale with you If you have any enquiries please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number.

Yours sincerely

Commissioning / Contracts Manager 50


Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: ecc.administrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence) Dear Re: The Screening Panel met on (DATE) and discussed your request for funding for the above procedure. I am writing to inform you that the committee has declined this request. The recorded rationale behind this decision is that there is no evidence that you meet the criteria set by NHS Kirklees for this procedure. (CLINICIAN) has also been informed of this decision. If you would like to discuss the rationale behind this decision, you should contact your GP or referring clinician as soon as possible. However, if your circumstances change your referring clinician can reapply, providing new clinical evidence. If you have any enquiries please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number.

Yours sincerely

Commissioning / Contracts Manager 51


Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: eccadminstrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence)

Dear Re:

DOB:

Treatment requested: The Exceptional Cases Committee met on (DATE) and discussed your request for funding for the above named to undergo the above procedure. Unfortunately, the committee was unable to make an informed decision as there was insufficient information about this patient‟s case. The Exceptional Cases Committee would like further information with regards to:-

The case has therefore been deferred until you can provide the information requested above. If you have any enquiries please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number.

Yours sincerely

Chair Executive Director of …………………………………….

52


Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE email: eccadministrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence) Dear Re: The Exceptional Cases Committee met on (DATE) and discussed your request for funding for the above procedure. I write to inform you that the committee could not make a final decision until they had received further information from your referring clinician. I have written to request this further information. If you have any enquiries please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number.

Yours sincerely

Chair Executive Director of …………………………………

53


Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: ecc.administrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence and invoices) Dear Re:

DOB :

Treatment Requested: The Exceptional Cases Committee met on (DATE) and discussed your request for funding for the above named patient to undergo the above treatment. I am writing to inform you that the evidence provided was sufficient for the committee to approve this request. You may now make an NHS referral for this patient to a Care Quality Commission registered provider. Please enclose a copy of this letter with your referral as confirmation that the PCT has agreed the funding. If you have any enquiries please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number.

Yours sincerely

Chair Executive Director of ……………………

54


Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: ecc.administrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence) Dear Re: The Exceptional Cases Committee met on (DATE) and discussed your request for funding for the above procedure. I am writing to inform you that the evidence provided was sufficient for the committee to approve the request as an exceptional circumstance. I have written to (CLINICIAN) who will now make the necessary arrangements to refer you. If you have any enquiries please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number.

Yours sincerely

Chair Executive Director of ……………………………

55


Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: ecc.administrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence) Dear Re:

DOB:

Treatment requested: The Exceptional Cases Committee met on (DATE) and discussed your request for funding for the above named to undergo the above procedure. I write to inform you that the committee has declined this request. The recorded rationale behind this decision is ………………………………… The patient has been informed of the decision and has been advised to discuss the rationale and the possibility of an appeal with you. If you decide to pursue an appeal, you will be required to submit additional information to support the appeal. This should be sent to the Individual Funding Requests Co-ordinator at the address above, within 40 working days of the date of this letter. The Appeals Committee will then investigate whether the decision made previously was correct and check that the appropriate guidelines were followed. If you have any enquiries please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely Chair Executive Director of ……………………….. 56


Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: ecc.administrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence) Dear Re: The Exceptional Cases Committee met on (DATE) and discussed your request for funding for the above procedure. I am writing to inform you that the committee has declined this request. If you would like to discuss the rationale behind this decision, you should contact (CLINICIAN) as soon as possible. (CLINICIAN) has also been informed of this decision. If you wish to pursue an appeal, a notification of appeal should be made in writing by your referring clinician to the Individual Funding Requests Co-ordinator at the address above within 40 working days of the date on this letter. If no further information is received in this time period this case will be closed. If you have any enquiries please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number.

Yours sincerely

Chair Executive Director of …………………………………… 57


Broad Lea House Dyson Wood Way Bradley Business Park Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: ecc.administrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence)

Dear Re:

DOB:

Treatment Requested: Following the Appeals Committee meeting on (DATE) I regret to inform you that your request for funding for the above patient to undergo the above procedure has been declined. The Appeals Committee supported the original decision made by the Exceptional Cases Committee. The rationale behind the decision was …………………………… The Appeals Committee is the final stage of the PCT process. If there is a change in your patient‟s circumstances please feel free to make a new referral. Your patient has been informed of this decision and has been advised to discuss the rationale with you. If you have any enquiries please do not hesitate to the Individual Funding Requests Coordinator on the above number. Yours sincerely

Chair Executive Director of …………………………….. 58


Broad Lea House Dyson Wood Way Bradley Business Park Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: ecc.administrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence)

Dear Treatment Requested: Following the Appeals Committee meeting on (DATE) I regret to inform you that your request for funding for the above procedure has been declined. The Appeals Committee supported the original decision made by the Exceptional Cases Committee. The recorded rationale behind this decision was ………………………… The Appeals Committee is the final stage of the PCT process. If there is a change in your circumstances and you have the support from your clinician, a new referral can be made. If you are unhappy with the way in which the process was conducted you can make a complaint to the Complaints Manager at the above address. Telephone: 01484 464000. (CLINICIAN) has been informed of this decision. If you have any enquiries please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely Chair Executive Director of ……………………………………… 59


Broad Lea House Dyson Wood Way Bradley Business Park Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: eccadministrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence and invoices) Dear Re:

DOB:

Treatment requested: The Appeals Committee met on (DATE) and discussed your request for funding for the above named patient to undergo the above procedure. I am writing to inform you that the Appeals Committee has over ruled the original decision made by the Exceptional Cases Committee and therefore agreed to this funding request. You may now make an NHS referral for this patient to a Care Quality Commission registered provider. Please enclose a copy of this letter with your referral as confirmation that NHS Kirklees has agreed the funding. If you have any enquiries, please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Chair Executive Director of …………………………… 60


Broad Lea House Dyson Wood Way Bradley Business Park Bradley Huddersfield HD2 1GZ Tel: 01484 464142 Fax: 01484 464577 DATE e-mail: eccadministrator@kirklees.nhs.uk IFR No: 0 (Quote IFR no. on all correspondence) Dear Re: The Appeals Committee met on (DATE) and discussed your request for funding for the above procedure. I am writing to inform you that the Appeals Committee has over ruled the original decision made by the Exceptional Cases Committee and therefore agreed to this funding request. I have written to (CLINICIAN) who will now make the necessary arrangements to refer you. If you have any enquiries please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number.

Yours sincerely

Chair Executive Director of …………………………..

61


Appendix F: NHS Kirklees use Case No.

Out of Area Health Panel Adult & Child & Adolescent Mental Health & Learning Disability Please ensure that all relevant information is included in this form or is attached to ensure the request is processed in a timely manner. If information is missing the form will be returned without authorisation. Please contact NHS Kirklees on the number below for further information regarding making a referral. Patient’s Name:

DOB:

GP & Practice:

NHS No.

Patient’s Address:

Request for: (Please include 3 options of placement/treatment considered to meet identified needs, as appropriate, include provider details and cost if known – to be from different providers, NHS providers to be considered as a first option)

62


Clinical supporting information: (Please include a full holistic assessment with specialist information/assessments included as appropriate, e.g. patientâ&#x20AC;&#x;s current BMI, if relevant to request)

Previous Options tried: (Please also include details of any previous out of area or self funded options)

Evidence base to support request & preferred option:

What outcomes are expected? (include measurable & timeframes)

63


Please complete as relevant with evidence: 1. Not having the treatment would result in a real and imminent risk of harm:

2. The placement for treatment needs to be done within a strict time-frame, otherwise delay would result in it becoming ineffective.

Is the patient known to local services?

Y

N

Name of agreed care co-ordinator or responsible team:

Name & address of referring clinician

Signature, position of referring clinician:

(please print):

Tel No:

Date form completed:

Fax No:

64


Referral supported by: Lead Clinician

Y

N

Name:………………………………………………………… Head of Service

Y

N

Name:………………………………………………………… Please return the completed form to: Mental Health Lead Nurse Continuing Care Team Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GZ Tel: 01484 464579 Safehaven Fax: 01484 464577 NHS Kirklees Use Only: Decision:Start Date:Provider:Cost:Comments:-

Signed:(print next to signature) Lead nurse: Approved Budget Holder:

65


Appendix G:

Process for Out of Area Adult & Child & Adolescent Mental Health/Learning Disabilities referrals Notes Referral to XXX within NHS Kirklees: Full holistic Nursing assessment â&#x20AC;&#x201C; including specialist assessments, e.g. Risk (note 1) Completed OOA proforma

XXX to check full information is available â&#x20AC;&#x201C; take case to panel Yes (note 2) No (note 3) Panel (note 4) meets weekly on Mondays Decisions made will be confirmed back to referrers within 48 hours, by telephone & followed up in writing. If deferred, further information is requested (note 3) Decisions will be recorded and updated on NHS Kirklees database within 48 hours. Regular Reviews will take place with timescales determined by clinical need or determined by panel (note 5) Updated review summaries will be included in case files & on the data base, within 5 working days

1) Advice re process & clarity re assessments to include can be received from Mental Health Lead Nurse, Continuing Care Team, Tel: 01484 464579 2) Completed accurate information has to be with the XXX, 1 working day prior to the next panel to be included on the agenda 3) If the form is not completed fully the referrer will be asked for the missing information, within 1 working day of receipt of referral. There will be a maximum, 1 month period of time for the referring clinician to respond to the information queries. If no response is received within the timescale that request file, will be closed 4) Core Panel Members: Assistant Director(MH/LD/CC); (chair) NHS Kirklees Clinician Coordinator/administrator This is the core membership of the panel and if for any reason a member of the panel cannot attend then the assigned deputy will attend.

66


Required Changes to Packages will be presented to the chair for consideration & approval (note 6) this includes requests for 1-1 care

5) Initial reviews will be completed by identified Clinicians/key workers/teams. A summary will be sent to XXX, within 5 working days of the review Information required: Named care coordinator, Copy of agreed care plan, Next review date & summary of progress. . 6) Information required clinical supporting information, anticipated revised costings, expected outcomes

In Hours Adult / CAMHS Urgent or Emergency cases It is recognised that there may be occasions when cases require a decision urgently. (for example, when it is identified that there is significant risk of self harm or risk to others), the chair of the panel will discuss the recommendations with the clinical lead and the decision will be recorded as per the above process, and included for information at the next panel meeting.

Out of Hours; authorisation for Adult / CAMHS placements, please contact the NHS Kirklees on-call Director via the HRI switchboard 01484 342000 The referrer will need to submit the required paper work â&#x20AC;&#x201C; as per the agreed process to Vicky Dutchburn, Assistant Director Commissioning & Strategic Development (MH/LD/CC) via the SAFE HAVEN FAX - 01484 464577; by 12 noon next working day

NHS Kirklees Independent contracts â&#x20AC;&#x201C; either in area or Out of Area Where NHS Kirklees has an agreed contract with an independent provider, local referrers and services need to complete the above and seek prior approval before utilising the provision. The chair of the panel will discuss the recommendations with the clinical lead and the decision will be recorded as per the above process, and included for information at the next panel meeting.

67


Appendix H

Membership of the Committees involved in the Individual Funding Requests process in Kirklees

Screening Panel Commissioning / Contracts Manager Public Health Consultant Individual Funding Requests Coordinator Exceptional Cases Committee Executive Director Non-Executive Director Clinical Executive Committee Representative Assistant Director of Commissioning Individual Funding Requests Coordinator Appeals Committee Executive Director Non-Executive Director Clinical Executive Committee Representative Individual Funding Requests Coordinator

68


Appendix I: Proforma for consideration by the Appeals Committee

Was the original ECC quorate?

Yes No

Did the ECC make the correct decision based on the information at the time?

Yes No

Has extra information been supplied?

Yes No

If extra information has been supplied has the case been referred back to ECC? Yes No If extra information has been supplied has it amended original ECC decision?

Yes No

Is the original ECC decision upheld?

Yes No

69


Appendix J: Flow chart illustrating the Individual Funding Requests Process

Referral by Clinician for consideration by ECC

Review by Screening Panel

Referral not appropriate according to criteria in screening matrix

Consistent with existing policy guidelines/evidence

Exceptional

Refer to next ECC for consideration

Inform referring Clinician and Patient

ECC Recommendation for Approval

Appeal upheld Issues with ECC process/decision

Not Approved

Inform referring Clinician and Patient

Requests Appeal

Feedback to ECC

Appeals Committee

Refused No issues with ECC process identified

Inform referring Clinician and Patient Supply information on what to do next if unhappy with the process

70


Appendix K: Equality Impact Assessment Tool

Insert Name of Policy / Procedure Yes/No 1.

Does the policy/guidance affect one group less or more favourably than another on the basis of:

Comments

No

Race

No

Ethnic origins (including gypsies and travellers)

No

Nationality

No

Gender

No

Culture

No

Religion or belief

No

Sexual orientation including lesbian, gay and bisexual people

No

Age

No

Disability - learning disabilities, physical disability, sensory impairment and mental health problems

No

2.

Is there any evidence that some groups are affected differently?

No

3.

If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable?

No

4.

Is the impact of the policy/guidance likely to be negative?

No

5.

If so can the impact be avoided?

N/A

6.

What alternatives are there to achieving the policy/guidance without the impact?

N/A

7.

Can we reduce the impact by taking different action?

N/A

71


Appendix L: Key stakeholders consulted/involved in the development of the policy Key Participant Yes/No

Feedback requested Yes/No

Feedback accepted Yes/No

Dr Judith Hooper, Executive Director of Public Health

YES

YES

YES

Carol McKenna, Director of Commissioning

YES

YES

YES

Sheila Dilks, Executive Director of Patient Care and Professions

YES

YES

YES

Sandra Haigh, Senior Contracts Manager

YES

YES

YES

Claire Inwood, Individual Funding Requests Co-ordinator

YES

YES

YES

Hempsons Solicitors

YES

YES

YES

Val Aguirregoicoa, Non Executive Director

YES

YES

YES

Vanessa Stirum, Non Executive Director

YES

YES

YES

Vicky Dutchburn, Assistant Director Commissioning

YES

YES

YES

Clinical Executive Committee, NHS Kirklees

YES

YES

YES

Neill McDonald, Head Medicines Management

YES

YES

YES

Stakeholders name and designation

72


/Policy_and_Procedures