Process for the Managed Entry of New Drugs to the Hywel Dda Health Board Formulary (October 2010)

Transcription

1 Process for the Managed Entry of New Drugs to the Hywel Dda Health Board Formulary (October 2010) Consultant or GP completes formulary application form. Interface Pharmacist (IP) receives formulary application form. If AWMSG are not considering the drug as part of their review process - continue down algorithm. Drugs covered by NICE guidance or on existing NICE work programme will not be considered. WAG Minister for Health and Social Services endorse drug (from AWMSG advice). Add to formulary. IP and Medicines Information Pharmacists to complete new product evaluation. Risk assessment using MEPA score completed by Clinical Governance Pharmacist and validated by IP. NICE recommend prescribing of drug in a technology appraisal. Add to formulary. Clinical Formulary group. Clinical discussion on potential use of drug across local health care community. Recommendation made to MMG. Decisions communicated appropriately by IP. Medicines Management Group (MMG). Final recommendation of decision on formulary status of drug and how it should be used in HB. Final decision made by Executive Board.

2 Policy for the Managed Entry of New Drugs to the Hywel Dda Health Board Formulary (October 2010) The Medicines Management Group (MMG) will make final recommendations on decisions of formulary status of all new formulary drug requests. Final decisions can only be made by the HDHB Corporate Directors Group. Process 1. Requests for inclusion of drugs onto the HDHB formulary will be accepted from Consultants in Secondary Care or General Practitioners in Primary Care. 2. Specific Request for Addition to formulary forms are available from the Interface Pharmacist (also will be available on electronic Formulary site once it is operational) for this purpose. Forms must be completely fully and correctly to ensure a timely consideration. The Interface Pharmacist can provide advice in this matter and will contact the requestor where additional details and the rationale for the request are required. 2. A new product evaluation will be completed by the Interface Pharmacist and Medicines Information Pharmacists. This evaluation will be based upon the STEPS methodology, i.e. Safety, Tolerability, Effectiveness, Price, and Simplicity. In addition, a summary page will be included, where necessary with a background section, to assist non-clinicians in reaching a formulary decision. 3. If current guidance from NICE Technology Appraisal (TA) with specific guidance on use of a drug or AWMSG approval (with subsequent endorsement from the Welsh Assembly Government Minister for Health and Social Services) already exists, the drugs will automatically be added to the formulary without the need to produce a new product evaluation. If drugs are already on the AWMSG or NICE work programme (being considered within 12 months), the local formulary process shall be deferred. 4. The current remit of the All Wales Medicines Strategy Group (AWMSG) is to appraise the clinical and cost effectiveness of newly introduced anti-cancer and cardiovascular medicines, in addition to high-cost medicines (costing over 2,000 per patient per year) to a maximum of 32 agents each year. However, in October 2010, AWMSG will appraise all new licensed medicines, with no cost threshold, providing that it is not on the intended work programme for NICE within the succeeding twelve months. For this reason, the local managed entry process will only be applied to drugs AWMSG does not consider appropriate (or workload does not allow) for them to review. 5. A formulary recommendation will be made to the Medicines Management Group (MMG) from the Clinical Formulary group, including rationale for this

3 recommendation. MMG members will receive the full new product evaluations. 6. In addition, MMG members will receive a summary of the Clinical Formulary group meeting debate for the requested drug. This will include the pros and cons put forward in consideration of the evidence and whether the group reached a unanimous or split decision in terms of the final recommendation made. The group will also specify how the drug should be prescribed in terms of whether it should be confined to specific areas within the hospital or whether it may also be prescribed in primary care, or subject to shared care. Financial Considerations 1. Formulary Requests for drugs only to be prescribed in Secondary Care with a net cost impact of > 10,000 pa to the HB, will require a drug business case form to be completed and submitted to the Director of Finance through MMG. 2. Formulary Requests for drugs to be used across the HB with a net cost impact of > 80,000 pa to the HB, will require a drug business case form to be completed and submitted to the Director of Finance through MMG. 3. Wherever possible, potential cost impacts of new drugs will be identified by an annual horizon scanning process carried out by the Interface pharmacist. Note: Directors of Finance for HDHB will receive a completed drug business case for drugs that meet the above criteria within 48 hours of a positive Formulary Sub-group recommendation being made. Logistically the Formulary Sub-group will meet at alternate months to the Medicines Management Group (both will meet every two months), allowing a minimum of 3 weeks notice to Directors of Finance prior to discussion of that drug at MMG. A final formulary decision (including acceptance or rejection of business case) will be made at that Medicines Management Group meeting. Safety Considerations 1. Risk assessments for new drugs will be required in the formulary applications review process. This will partly fulfil the 'purchasing for safety' recommendation from the NPSA and allow risk reduction measures to be put in place (where appropriate) before the new drug is in use. Any new injectable could also be assessed using the NPSA Risk Assessment for Injectables. The MEPA (medication error potential analysis) and NPSA Risk Assessment for Injectables are recognised tools for this process (see attachments). The MEPA score would require a sample of the product/packaging (or electronic proofs of packaging) to assess fully. The assessment will be carried out by the Principal Pharmacist for Clinical Governance and will be validated by the Interface Pharmacist in order to complete a new product evaluation before it is reviewed at the Clinical Formulary group.

4 Dissemination/ Communication Following each Medicine Management Group meeting: 1. Positive Recommendations will be added to the HDHB electronic drug formulary (once in operation). 2. A summary of the recommendations made at the MMG will be sent on the day following the meeting. 3. Letters will be sent promptly to requesting clinicians informing them of the recommendations made at the meeting. 4. Minutes of the meeting will be circulated within a fortnight. 5. Messages will be added to the HD ScriptSwitch profile (active on the computer systems of most GPs across the HDHB). 6. Messages will be added to the hospital pharmacy systems across HDHB. 7. Recommendations made will be added to the HDHB Pharmacy Intranet site (once in operation). 8. Recommendations will be presented by the Interface Pharmacist at the locality GP Prescribing Leads meetings. 9. Recommendations will be presented by pharmacists to health care staff at Directorate meetings. 10. A summary of recommendations will be incorporated into the HDHB Newsletter. 11. Any policy amendments will be made and re-circulated to the MMG for confirmation before they are sent to HDHB Governance Committee for implementation. 12. A list of pending formulary requests will be kept on the Pharmacy electronic site (once in operation) until a final formulary decision is reached. 13. A summary of recommendations will be sent to the Community Pharmacies in HDHB. Review 1. All Request for Non-formulary medicine forms will be audited every 2 months to ensure that formulary applications have been submitted if necessary.

5 2. All new drugs added to Joint formulary will be audited every 6 months after formulary inclusion for a period of 2 years in Primary and Secondary care to ensure cost predictions are not exceeded Exceptions and Non- Formulary Requests 1. The formulary applies to prescribing and recommendations to prescribe. For this reason it is requested that routine recommendations for non-formulary drugs arising from secondary care should be referred to the Interface Pharmacist to discuss potential formulary request with relevant Consultant ( one off cases will not give rise to a formulary request unless it can be reasonably expected that another such instance will arise). Interface pharmacist will not intervene in specific patient cases. 2. For non-formulary drugs costing < 500 per annum, the drug may be dispensed for one individual patient, for one specific Consultant following approval by the Lead Hospital Pharmacist. Requesting Consultants will be invited to submit a formulary request at this point and informed that prescriptions for further patients for this drug will need to be discussed with the Interface Pharmacist. A Request for Non-formulary medicine form will need to be completed. 3. Where a decision is required for a non-formulary drug costing > 500 per annum, agreement of the County Management Team is required. This process may be facilitated through the County Lead for Pharmacy and Medicines Management. A Request for Non-formulary medicine form will need to be completed. 4. In cases of non-urgent clinical need for an individual patient for a nonformulary drug costing > 2000 per annum, the case should be referred to the Individual Patient Commissioning panel. 5. Drugs on the formulary will be categorised according to the following definitions to clarify how and where a drug should be prescribed: Hospital only - All prescriptions are issued from hospitals or use only applies to restricted use within hospital. Specialist initiated - A specialist should undertake the initiation and stabilisation of drug. Follow up prescriptions may be issued by GPs, if they agree to take on responsibility for future prescribing. This group includes drugs for which shared-care protocols exist. 1 st line - A suitable first choice for GPs and non-specialists. 2 nd line - Also suitable for the above, but reserved until first line agent has been tried or rejected on grounds of side effects or allergy. In many cases these will be the more expensive agents.

6 Appeals Process It is recognised that there may be rare occasions when there is a genuine difference of scientific opinion and/or interpretation of available data and there is a responsibility to ensure that due process has been followed. An appeal may be lodged in writing, by the original requesting clinician with the Interface Pharmacist within 30 working days of being informed of a formulary rejection. An appeal will be considered where: 1. There has been a failure to act fairly and in accordance with the Joint formulary managed entry process. 2. A decision is contrary to the evidence submitted. 3. Submission of new relevant supporting data or evidence Initially, the matter will be reconsidered at the next meeting of the MMG. If there is still a disputed decision, an Appeal Panel will be constituted. The requesting clinician will be informed. The Appeals Panel will consist of three members nominated by the Medical Director of HDHB, including a pharmacist, a GP and a Hospital Consultant, none of whom have been involved with the original formulary consideration. The acceptance of its conclusions will be at the discretion of HDHB Corporate Directors Group. This protocol will be reviewed by end of October 2012.