Appendix 3 INDIVIDUAL PATIENT DRUG TREATMENT. POLICY AND PROCESS FOR DECISION MAKING September 2007

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1 Appendix 3 INDIVIDUAL PATIENT DRUG TREATMENT POLICY AND PROCESS FOR DECISION MAKING September 2007 Approved by Board: 6 th September 2007 Date Implemented: 1 st October 2007 Review Date: September 2008

2 CONTENTS PAGE 1. INTRODUCTION & PURPOSE 3 PAGE 2. MODEL FOR DECISION MAKING 4 3. OPERATION OF THE PROCESS Referrals 5 Action on Receipt of Referral 6 The Panel 7 Notification of Decision 7 Database 7 4. INFORMATION MANAGEMENT AND REPORTING General 7 Reporting Arrangements 8 Confidentiality and Information Security 8 5. APPEALS PROCESS 8 6. POLICY REVIEW 8 Appendix 1 Flowchart of Decision Making Process 10 Appendix 2 Individual Patient Drug Treatment Request 13 Proforma Appendix 3 IPC Officer Panel / IPC Board Panel responsibilities 15 Individual Patient Drug Treatment Policy Page 2 of 17

3 1 INTRODUCTION & PURPOSE This paper sets outs the policy and procedure that Neath Port Talbot LHB will use to reach decisions on requests for individual patient drug treatment that are not routinely funded through previous commissioning processes. The LHB is under a statutory obligation not to exceed its financial allocation and recent case law (Rogers vs Swindon NHS PCT case no: c1/2006/0312[2006] EWCA Civ392) clearly indicates that cost is an explicit consideration in making a decision whether to fund or not fund any treatment. Neath Port Talbot LHB is: - directed to make funding available for National Institute of Health and Clinical Excellence (NICE) health technology assessments (Welsh Health Circular (2002) 024) - expected to follow recommendations from the All Wales Medicines Strategy Group (AWMSG) within 3 months of ministerial endorsement (WHC (2007) 028) As part of the decision making process, the LHB is also guided by health care standard 12 (WHC (2005) 049) to ensure that patients and service users are provided with effective treatments and care that: a) conforms to the NICE technology appraisals and interventional procedures, and the recommendations of the All Wales Medicines Strategy group b) is based on nationally agreed best practice and guidelines, as defined in National Service Frameworks, NICE clinical guidelines, national plans and agreed national guidance on service delivery; c) takes account of patients physical, social, cultural and psychological needs and preferences; and d) is integrated to provide a seamless service across all organizations that need to be involved, including social care organizations This inevitably means that difficult choices will need to be made for individual patients whose proposed treatments fall outside these processes. These cases will be considered by Neath Port Talbot LHBs IPC Officer Panel Policy Statement Neath Port Talbot Local Health Board is committed to ensuring fair and appropriate allocation of resources to meet the health needs of the Neath Port Talbot population. The LHB has developed a number of separate but integrated policies, which together provide the framework for ensuring the fair allocation of resources and for providing the means to ensure that such decisions are made can be validated. It is the policy of Neath Port Talbot LHB to consider requests for specific dedicated funding for drug treatments only if; 1. The treatment cost is projected to exceed 2,000 per treatment course per patient or the total use exceeds 7,500 per patient per annum and 2. No NICE Or All Wales Medicines Strategy Group advice to fund therapy exists Individual Patient Drug Treatment Policy Page 3 of 17

4 3. The patient has exceptional circumstances as defined in the LHBs policy on Individual Patient Commissioning NB. NHS Trusts do not require LHB permission to provide these drug treatments from their own allocated resources. Experimental/Research Drugs When a clinical trial is planned, patient expectations should not be raised that the continuation of trial treatment will be funded by the NHS after the end of the trial. Ethics and R&D committees have a responsibility to ensure that this information is included in the trial protocol, Patient Information leaflet and the consent form. Neath Port Talbot LHB will not normally make additional funding available unless this has been agreed in advance Where post-trial treatment continues by the drug companies on so called compassionate basis (and therefore at no cost to the NHS), it cannot be assumed that the NHS will subsequently pick up this cost even when the drug receives its licence. Funding of excess treatment costs in research trials will not normally be funded. 2. Model for Decision Making The following principles underpin the model for decision making: Clear process in place for the referral of individual cases to be considered under these arrangements; An assessment of the individual circumstances of the case including a review against eligibility criteria and an assessment of the available evidence base, supported by access to specialist clinical and public health advice where necessary; Minimisation of bureaucracy and time delays with protocol driven systems in place; Decision making via an Officer Panel and Individual Patient Panel (including professionals and lay members); A clear process for documenting and recording decisions taken; An appeals mechanism for challenging decisions. This process is depicted in a process flow chart shown at Appendix 1 It is important that there are clear criteria by which decisions should be based upon and the Neath Port Talbot LHB Ethical Framework will provide the means to support this. Individual Patient Drug Treatment Policy Page 4 of 17

5 Exceptionality Where requests have been made for individual patient funding to the LHB for drugs or interventions which have been considered by NICE and AWMSG and not recommended for use, this will only be provided if the patient has exceptional circumstances as defined in the LHBs policy on Individual Patient Commissioning: Definition of Exceptionality: 1. In order for funding to be agreed there must be some unusual or unique clinical factor about the patient that suggests that they are i. Significantly different to the general population of patients with the condition in question ii. Likely to gain significantly more benefit from the intervention than might be expected from the average patient with the condition 2. The fact that a treatment is likely to be efficacious for a patient is not, in itself, a basis for an exemption. 3. If a patient's clinical condition matches the 'accepted indications' for a treatment that is not funded, their circumstances are not, by definition, exceptional. 4. It is for the requesting clinician (or patient) to make the case for exceptional status. 5. Social value judgements are rarely relevant to the consideration of exceptional status However, if clinical opinion indicates that prescribing of a drug treatment (where funding is not mandated by a NICE HTA or AWMSG appraisal), has an urgent clinical need, the LHB would expect the indicated intervention to be made available to the patient. This would be under the clinical supervision of the requesting consultant and at the financial risk of the requesting consultant s employer. This stipulation will continue until the full NICE HTA or AWMSG appraisal is made available and the LHB will be directed accordingly or where funding has been agreed on the basis of patient exceptionality. 3. Operation of the Process (Appendix 1) 3.1 Referrals Referrals to the system will be accepted from: - General Practitioners; - Consultants working with Hospital and Community Trusts. Requests for treatment made directly by an individual or a third party (e.g. Assembly Member, Member of Parliament) will not be accepted without the support of the patient s GP or Consultant. If a direct request in the first instance is received the patient will be advised to contact their General Practitioner or Consultant. Individual Patient Drug Treatment Policy Page 5 of 17

6 Referrals will not be accepted from non-nhs providers. Providers making a request on behalf of a patient will be advised that a clinical assessment will be required from the patient s GP or NHS Consultant prior to the request being considered. Referrers will be advised that they need to make a case for the individual patient by completing the pro-forma (Appendix 2) providing a clear statement of the likely effectiveness of the treatment to the individual. Where no NICE guidance or All Wales Medicines Strategy Group advice exists, the Scottish Medicines Consortium evidence will be used. If a request has been received and NICE has advised that the treatment should not be used, the evidence used by NICE will be referred to support the process of making a decision. If there is no Scottish Medicines Consortium advice the referrer will be asked to supply evidence to support the request. If an independent critical appraisal of the evidence has been undertaken e.g. National Prescribing Centre, then this review will also be considered. Evidence submitted solely by the Pharmaceutical Company responsible for the marketing of the drug will need to be critically appraised within the Trust before submission for consideration. 3.2 Action on Receipt of Referrals On receipt of a request for an individual drug treatment the, LHB will undertake a series of checks. These checks are summarised below: Stage 1 Background Checks Residency: - Confirmation that the patient is registered with a practice for which the LHB is responsible and confirmation that the postcode of the patient falls within the boundaries of the LHB. Eligibility for Treatment: - Check that condition being treated is commissioned by the LHB; - Check against NPHS for Wales Evidence-based advice to inform commissioning decisions on Interventions not normally funded to ensure treatment is supported on NHS. - Check against any other local policies or agreed selection criteria e.g. substance misuse - Confirm whether the request for care or treatment has previously been accepted or refused (precedent check) - Check whether the requested treatment falls within HCW commissioning remit If commissioned by another organisation e.g. HCW, refer the funding request immediately and notify the requesting clinician. On confirmation that the above criteria have been satisfied, patient details will be entered onto the IPP database. Individual Patient Drug Treatment Policy Page 6 of 17

7 Stage 2 Information Gathering Information is to be provided by the patients GP or Consultant on the standard pro-forma with supporting references / documentation as appropriate. Requesting clinicians will be encouraged to provide complete information which the absence of may otherwise delay decision-making. The LHB will check that the proposed treatment is not already covered within existing Long Term Agreement/Service Level Agreement Stage 3 Evidence of Effectiveness Evidence Base The LHB Officer Panel will review the evidence supplied by the referring clinician or team and check that it is appropriate to be considered with the request. Where the referrer has indicated that there is no formal published evidence (for example, NICE guidance, AWMSG, SMC) the LHB will request that the referrer provides published, peer reviewed evidence to support the application. Where the evidence is insufficient or contradictory, a formal view will be sought from the Director of Public Health Medicine. 3.3 The Panel The IPC Officer Panel will meet to review the requests received on a regular basis. This panel will be supported by the Individual Patient Commissioning Coordinator and where appropriate will be advised by the NHS Trust/LHB Interface Pharmacist. The IPC Officer Panel / IPC Board Panel responsibilities (Appendix 3) are contained within the LHB Individual Patient Commissioning Policy. 3.4 Notification of Decisions A decision letter will be forwarded to the requesting clinician, and will indicate whether the case has been approved or rejected and the reason for the decision. If the letter has been rejected then a copy of the Appeals Policy will be included with the notification letter. 3.5 Database All decisions will be entered onto the database using the unique reference number generated at the time of request. 4. INFORMATION MANAGEMENT AND REPORTING ARRANGEMENTS 4.1 General A database containing details of all decisions will be maintained, including a record of the basis upon which treatments were funded on the basis of exceptionality. The database will be used to: - Log all new requests and decisions; - Monitor trends; Individual Patient Drug Treatment Policy Page 7 of 17

8 - Review historic decisions. 4.2 Reporting arrangements The IPC Officer Panel will produce an aggregate report of all requests and decisions. A report of Officer Panel recommendations and decisions will be provided monthly for consideration and ratification by the LHB IPC Board Panel. As a result of cases approved by the IPC Board panel, an analysis of trends including cases turned down will be presented quarterly to the Executive Committee for consideration and possible alternative commissioning arrangements. An exception report will be presented quarterly to the Clinical Governance Committee with a mechanism for addressing clinical governance concerns with provider trust. LHB Finance staff will prepare a bimonthly report of expenditure against budget by treatment category, which will highlight actual and projected expenditure. This report will be prepared bimonthly for the Executive Committee 4.3 Confidentiality and Information Security In operating this policy the LHB will have due regard to the need to ensure that patient confidentiality is maintained at all times and that the LHB complies with the requirements of the Data Protection Act and Caldicott Review. Referrals will be directed to the IPC Coordinator who will ensure that the information is stored securely and accessed only by authorised personnel. 5. APPEALS PROCESS It is important that any decision making process builds in an appropriate mechanism for dealing with patients who wish to appeal against the decision. Any appeal will be dealt with according to the LHB IPC Appeals Process. 6. POLICY REVIEW This policy will be reviewed within 12 months of its date of adoption. Individual Patient Drug Treatment Policy Page 8 of 17

9 Individual Patient Drug Treatment Policy Page 9 of 17

10 INTERIM LHB DECISION MAKING PROCESS FOR INDIVIDUAL PATIENT DRUG TREATMENT- APPENDIX 1 Consultant /GP Application to the LHB on pro-forma must include full detail & supporting evidence 1, 2. Application matched against criteria Pro-forma Request received by LHB, entered onto database, confirmation of receipt letter sent to referrer. Review for appropriateness & inclusion of all requested information. Application referred to IPP board panel for decision, due to cost limit, inability of Officer panel to make decision or application does not meet criteria Application considered by weekly Officer /Screening panel on basis of exceptionality 3 and supporting evidence Information received Request for further information sent, response requested within 10 days IPP board panel makes decision Officer Panel makes recommendation Approved - P1 to BSC, notification to referrer and provider Application rejected notification to referrer Approved, P1 to BSC, notification to referrer and provider Application with officer panel recommendation taken to next IPP board panel for ratification or decision. Not approved, notification to referrer Database updated 1 each application must be accompanied by supporting evidence. The LHB will review the evidence supplied by the referring clinician or team and check that it is appropriate to be considered with the request. Where the referrer has indicated that there is no formal published evidence e.g. NICE guidance, AWMSG, SMC the LHB will request that the referrer demonstrates that evidence to support the treatment has been published through peer reviewed journals, or that a patient has benefited from treatment in the past e.g. in a clinical trial situation.

11 2 If, in the opinion of the responsible clinician, the situation is critical or life threatening, and any delay will compromise the life of that patient, the clinician, with the agreement of the Trust MD, should initiate treatment. Applications for funding in these cases will be considered retrospectively and must be supported by the Trust Drugs and Therapeutic Committee, following the same process & considering the evidence subsequently submitted. Where requests have been made for individual patient funding to the LHB for drugs or interventions which have been considered by NICE and AWMSG and not recommended for use, this will only be provided if the patient has exceptional circumstances as defined in the LHBs policy on Individual Patient Commissioning: 3 The LHB will accept referrals based on funding requests on the grounds of exceptionality: 1. In order for funding to be agreed there must be some unusual or unique clinical factor about the patient that suggests that they are i. Significantly different to the general population of patients with the condition in question ii. Likely to gain significantly more benefit from the intervention than might be expected from the average patient with the condition 2. The fact that a treatment is likely to be efficacious for a patient is not, in itself, a basis for an exemption. 3. If a patient's clinical condition matches the 'accepted indications' for a treatment that is not funded, their circumstances are not, by definition, exceptional. 4. It is for the requesting clinician (or patient) to make the case for exceptional status. 5. Social value judgements are rarely relevant to the consideration of exceptional status Individual Patient Drug Treatment Policy Page 11 of 17

12 Individual Patient Drug Treatment Policy Page 12 of 17

13 APPENDIX 2 Request for Individual Patient Drug Treatment Approval Please complete all sections fully, as incomplete information may delay the decision of the LHB Individual Patient Placement (IPP) panel. Drug Treatment Details (name/form/dose): Indication for Treatment: Requesting Consultant: (Name & Contact Details) Is this an off-/unlicensed use? Yes/ No Location for administration of drug: PATIENT DETAILS Patient initials: Diagnosis (with staging if appropriate): Date of Birth: Hospital number: NHS No: Patient Health / Disease Status scores: (if appropriate) Relevant Medical History: Patient postcode: LHB: TREATMENT APPROVAL STATUS The drug treatment has been considered for this indication by: AWMSG NICE Appraisal Outcome: Please provide any other relevant information including the outcome of any SMC, Drug & Therapeutics Committee or New Cancer Drug Group discussions: Detail of alternative treatment strategy: Reason for not using alternative: (please provide detail of risk/benefits) List of references to be considered as evidence/ information in support of application: (please provide lin to journal web-sites where possible)

14 TREATMENT PLAN Dosage Regimen and estimated duration of treatment: Cost of new drug (per treatment and per annum): Plans to review treatment including criteria for stopping therapy: Implications of not funding this treatment: PROPOSED TREATMENT OUTCOMES Are national guidelines for the management of this condition being followed: Yes / No If no, please give detail. Has this treatment been undertaken previously? Yes / No Please confirm outcome data is comparable to national standards. Will the intervention in this case contribute to the evidence base e.g. via a clinical trial, research database? Yes / No /Not Applicable PATIENT EXCEPTIONALITY Provide details of why the treatment of this patient is exceptional to the general population with referenced supporting evidence: Signature of Referrer: Date: FOR LHB USE ONLY Date application received: Date to LHB panel: Approved: Yes / No Review date: Reason for non approval: Exceptionality: (if applicable) Signed Chair - IPP officer panel: Date: Signed Chair - IPP board panel: Date: Please return to: Nursing Directorate, Neath Port Talbot Local Health Board, Suite A, Britannic House, Llandarcy, Neath, SA10 6JQ Safe Haven Fax No: Individual Patient Drug Treatment Policy Page 14 of 17

15 Appendix 3 Responsibilities of Individual Patient Commissioning Officer Panel and Board Panel The Officer Panel will check that processes set out in Stages 1 to 3 have been followed correctly and will consider cases where the annual cost of treatment for IPP is less than 15k or 25k under Continuing NHS Care. Where the panel is satisfied that the criteria and process has been completed they will consider making a recommendation for approval, which will go to the IPP panel for ratification (NB. No approval correspondence will be sent to the referrer, provider or BSC finance until the decision has been ratified by the IPP board panel) Where an urgent decision is required and the IPP Board Panel will not sit within 2 working days, a decision may be taken in consultation with IPP Board Panel member /Executive Director, where at least one member of the Panel is drawn from a clinical background. The approval will be followed by decision at next IPP meeting. The Officer panel will be authorised to approve applications where the annual costs of the care package or treatment falls within the following limits: Individual Patient Placements costing less than 15k per annum Continuing NHS Care Placements costing less than 25k per annum The Officer panel will not be authorised to approve applications in the following circumstances: - Where annual [or annualised costs] exceed the limits shown above - Where there is no evidence to support the procedure or treatment and it is likely therefore that the treatment will not be approved - Where there are exceptional circumstances [as defined in LHB Policy on Individual Patient Commissioning] that require further consideration. Such decisions will be taken by a LHB Board Panel comprising clinical and lay members of the LHB. Officer / IPP Board Panel responsibilities With Policy Without Policy Non Urgent Urgent Correspondence Recommendation by Officer panel Inform all parties Officer Panel to IPP decision. of interim actions board panel for followed by ratification To be followed by confirmation of ratification at next final decisions Recommendation by Officer Panel to IPP board panel for decision IPP board panel. Officer panel decision To be followed by ratification at next IPP board panel. Inform all parties of interim actions followed by confirmation of final decisions

16 NB. The Officer panel will decide if an application is classified as urgent i.e. BPAS Termination of Pregnancy, Substance Misuse or High Cost Drug application. Officer Panel Membership Membership: The panel shall comprise: Medical Director* / Public Health Director* (Chair) Deputy Nurse Director* Strategic Development Manager Medicines Management /HoPMM or Senior Pharmacist* Deputy Director of Finance Head of Commissioning This panel will meet weekly and will only be quorate if there are at least two health professional members * or appointed deputies. It will have the power to make decisions in urgent cases but all decisions of this panel must be ratified by the IPP board panel, but this should not delay the initiation of treatment. The panel will be supported by professional advice from the Interface Pharmacist as appropriate and administratively by the Individual Patient Co-ordinator Referral to LHB Board Panel Cases that fall into the categories defined in the previous section will be considered by an LHB Panel. This Panel will meet monthly [or more frequently if there are urgent decisions required]. LHB s will convene a panel and the membership of the Panel is shown below: LHB Lay Member [Chair] LHB Lay Member LHB Nurse Director LHB Head of Commissioning GP CHC representative NPHS representative The terms of reference for the Panel will be to: Scrutinize high cost placements in terms of clinical and financial appropriateness Monitor the overall position in terms of patient placements and financial commitments Identify opportunities for commissioning new services to meet individual needs taking into account cost, quality, access arrangements Ensure that highest standards of corporate governance inform continuing care arrangements Individual Patient Drug Treatment Policy Page 16 of 17

17 Consider requests where there are exceptional circumstances or where the patient/clinician has requested that the case be considered as an exemption [using the checklist provided within IPC Policy Appendix 3] Report to LHB Board on Continuing Care and Individual Patient Placements The Panel will be able to make decisions providing that a minimum of 3 members are present, including a lay member, LHB manager and at least one member with a clinical background [nurse or GP]. The Panel could operate on a virtual basis via an or conference call link if appropriate. In the event of Panel member being unavailable, substitutions will be permitted providing that the substitute panel member is drawn from the same professional or representative background. [For example, the LHB voluntary sector member could act as a substitute for the LHB lay member]. The Panel members [or their substitutes] do not necessarily have to be members of the LHB. V:\LHB\Commissioning & Service Development (CS)\Commissioning & SaFF (General)\Commissioning- General (CSD 2)\Commissioning Prioritisation Process\Policies\HCD\NPTipdtPOLICYAugust07.doc Individual Patient Drug Treatment Policy Page 17 of 17

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