MEETING OF THE BORDERS FORMULARY COMMITTEE HELD ON WEDNESDAY 14 th FEBRUARY P.M. IN THE ESTATES MEETING ROOM MINUTE

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MEETING OF THE BORDERS FORMULARY COMMITTEE HELD ON WEDNESDAY 14 th FEBRUARY 2018 @ 12.30 P.M. IN THE ESTATES MEETING ROOM MINUTE In attendance: Alison Wilson (Director of Pharmacy & Chair of BFC);

1 MEETING OF THE BORDERS FORMULARY COMMITTEE HELD ON WEDNESDAY 14 th FEBRUARY P.M. IN THE ESTATES MEETING ROOM MINUTE In attendance: Alison Wilson (Director of Pharmacy & Chair of BFC); Liz Leitch (Formulary Pharmacist); Dr Paul Neary (Consultant Cardiologist); Catherine Scott (Senior Clinical Pharmacist); Dr Elliot Longworth (GP); Dr Nicola Henderson (GP); Joanne Graham (Registrar); Keith Maclure (Lead Pharmacist); Kate Warner (BFC Minute Secretary) Guests: Dr K Pal (Consultant supporting application item 5a) 1. Apologies: Item Situation ; Background ; Assessment Recommendation Person Timescale No. Responsible 2 Declaration of Interest: - None 3 BFC meeting Draft Minute from meeting 13 th December 2017 was approved with no changes. Remove draft, save, KW 24 hours upload to web 4 Matters Arising From Previous Minute: 4.1 BFC received an update on discussions regarding the Freestyle Libre Sensors decision made at previous formulary meeting with the decision to approve for specialist initiation for 50 patients - 6 months. Lothian also approved but with Consultant/Specialist initiation and subsequent GP prescribing as Lothian consultants do not have access to HPB. Prescription at NHS Borders will be all by specialist initiation and prescription with dispensing through community pharmacy. Prescriptions should not come through Pharmacy at BGH. This has been agreed with the Diabetic team and records of 50 patients commenced will be reviewed for outcomes and benefits. NHS Borders policy supports GP with the message that the product is only available Review any GP10s coming through Pharmacy KMacl Page 1 of 5

2 through specialist initiation and prescription any existing patients would be referred to specialist diabetic team for review. 5 New Medicine Applications: a) Indocyanine green dye; Applicant: Mr K Pal. Indication: To enhance bowel tissue imaging during surgery for colorectal cancer; Generic Name: Indocyanine green dye; Brand Name: N/A; dosage and costs included in application; Number of patients in first year: Prediction is about 25 patients but we will need to secure a new investigating light source before regular use of the ICG; Increase in patients: There might be a very small increase. LL reported to the committee that the application for use of Indocyanine green dye is because it leads to better imaging during surgery. It is hoped that the use of dye and imaging equipment will lead to better surgical outcomes. Benefits and outcomes were reviewed, a clinical paper was included from 2014 and this does support the application. More work and trials are suggested in the clinical paper. There are no comparable treatments. This would be used in secondary care only and no patient monitoring after surgery is required. Application states that the dye is in use successfully in academic centre. Mr Pal arrived at the meeting at this point and brought additional information and photographs to show the dye in use. The dye would not be in everyday use but will be used in some circumstances for some patients; one vial = 1-2 patients. No hypersensitivity or side effect reported. Consultant surgical colleague also keen to use in breast reconstruction surgery. NHS Borders are the first to use this dye/procedure in Scotland although it is used in other parts of Europe. BFC agreed that cost per patient is less that if there is a leak and that this is an improvement in patient care. To-date the department has had the loan of a scanner for the two surgeries used so far. Funding is to be sought for a scanner in the near future. BFC commented that dyes are not usually discussed and approved through this committee but that Pharmacy has been requested to purchase. Other specialities, such as Cardiology, use dyes that are requested through Procurement within their own budget. This dye should be through the respective/surgery budget and ordered and supplied through Pharmacy. b) Levonorgestrel (Kyleena); Applicant: Dr Sally Wielding. Indication: Contraception; Generic Name: Levonorgesterel 19.5mg intrauterine delivery system; Brand Name: Kyleena; dosage and costs included in application; Number of patients in first year: 50; Increase in patients: No increase. Kyleena is a new type of IUD; use would be in line with SMC advice with additional advice from Royal College Of Obstetricians and Gynaecologists to application. The benefits and evidence were outlined to BFC. Kyleena is cheaper than Mirena and less frequent changes are required compared to Jaydess (other IUDs). There are no unexpected safety issues. BFC agreed that Jaydess should be removed from the formulary when this is included. for up to 25 patients and for feedback. Product to be purchased through Pharmacy. Letter/ to applicant. Appropriate route for approval of such products to be reviewed at April BFC agenda item. Shared Care between hospital and general practice. Letter to applicant; include request to remove Jaydess from Formulary LL KW KW KW Page 2 of 5

3 c) Fluticasone Furoate (Trelegy Ellipta); Applicant: Emma Dodd. Indication: Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting ß2-agonist; Generic Name: Fluticasone furoate / 55mg / 22mg inhalation powder; Brand Name: Trelegy Ellipta; dosage and costs included in application; Number of patients in first year: no in application; Increase in patients: yes. This application is the second three-in-one device inhaler for COPD. Trimbow was approved a few months ago. Product is for patients requiring LABA added to LCS/LABA. SMC has restrictions which were outlined to BFC. Questions were raised when the Trimbo application was discussed; same cost as Trimbow. There have not been any patients for Trimbow to date. This product is supported by Emma Dodd s team who would like to add to formulary. BFC agreed that prescribing should be by Specialist initially followed by GP prescribing. d) Sildenafil original NMA and Approval letter; Applicant: Dr Ruth Richmond. Indication: Severe Raynaud s related to underlying connective tissue disease (usually systemic sclerosis, but occasionally in SLE or other connective tissue diseases), unresponsive to standard agents such as nifedipine at maximal tolerated dose, resulting in digital ulceration or critical ischaemia, using the drug as a daily therapy; Generic Name: Sildenafil; Brand Name: dosage and costs included in application; Number of patients in first year: 3; Increase in patients:. Sildenafil has been previously approved by BFC at the June 2015 meeting for Specialist Initiation Only. Other two options then were more expensive than Sidenafil. There is evidence for this off label use of Sidenafil and this request to change the prescribing would enable GPs to subsequently prescribe. This would alleviate the requirement for a clinic appointment. e) Tofacitinib citrate; Applicant: Dr Adrian Tan. Indication: In combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Tofacitinib can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate. SMC restrictions in application.; Generic Name: Tofacitinib citrate 5mg film-coated tablets; Brand Name: Xeljanz ; dosage and costs included in application; Number of patients in first year: 10; Increase in patients: Yes, depending on how much response is shown to treatment and if the side effect profile is as claimed by the manufacturer. BFC heard that the application is in line with SMC advice and restrictions were outlined. Costs and treatment benefits were reviewed. Impact will be on secondary care prescribing only. No primary care prescribing initially. Monitoring will be given to patients GP and through secondary care. Interactions were discussed and BFC requested that Dr Tan draw GP attention to these. Oral agents may be becoming more available Page 3 of 5 Specialist Initiation and subsequent general use, hospital and general practice BFC Approved as AMBER Category Letter to applicant including request to draw GP attention to interactions. Formulary meeting to be organised for further discussion. KW KW

4 and this is considered a therapeutic advance; it will not replace Barcitinib. BFC requested clarity regarding options available, including cost effectiveness, as there have been a number of new drugs added in and there may be some that can be removed from the formulary. Dr Paul Neary left after this item at 13:15 for clinic f) Belimumab; Applicant: Dr Adrian Tan. Indication: Add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. positive anti-dsdna and low complement) despite standard Therapy; Generic Name: Belimumab; Brand Name: Benlysta; dosage and costs included in application; Number of patients in first year: 1; Increase in patients: No. BFC reviewed this alternative to what is currently used off-label for this indication. Evidence and trial studies were outlined. Page 4 of 5 Dr Jo Graham left after this item at 13:20 for clinic. 6 SMC Recommendations January February 2018 decisions to be updated with local decisions, links to SMC advice and published. LL KW Borders Joint Formulary Updates: 7.1 Application Pembrolizumab. BFC discussed the Lothian process of approval of new medicines where commitment to spend is not discussed with NHS Borders. Patient numbers and financial net effect is within the application that is agreed on our behalf. Lothian are looking to use Pembrolizumab at a different dose from licensed and from the SMC approved dose. Indication as application metastatic NSCLC. The SMC advice and application request was outlined for the committee. There is clinical evidence for Lothian to approve the dose. BFC agreed that this was a case of being clinically approved but not financially approved and should be tabled at Medicines Resource Group meeting to discuss if this is a decision that can be made on our behalf. BFC also agreed that new Clinical Directors in Borders should be included in this process and discussed with regard to ownership of their budgets. 8 Other Items for Approval 8.1 BFC reviewed an update to Border Joint Formulary Abbreviated booklet that is given to new prescribers. Second choice NOAC was changed to Edoxaban. There is a plan for several sections of formulary reviews over coming months. 8.2 The updated Non Formulary Request (NFR) Form was tabled at BFC and the amended parts outlined; there was a discussion about sign off and approval. NFRs are for individual patients and this is part of NHS Borders policy and medicines management. BFC discussed the responsibility taken for the financial implications and having funding available to make the requests. It was agreed that a new folder would be used to save the NFRs separately under drug name/date application. Create a summary of this item for meeting with Cliff Sharp. Add to paper; how decisions are being made. BFC Approved new version upload to web etc. BFC approved changes to form. LL AW LL KW LL

5 For Information and Noting 9 ed communication regarding chapters of the Single National Formulary has been recently forwarded to relevant Clinicians. The deadline for meeting dates is very short notice. Nominations have been requested for some Therapeutic sections through ADTC Collaborative with Infections to SAPG. Nominations to be forwarded from Alison Wilson 10 Draft Minute of Tissue Viability Group; 30 th November 2017 was not available in time for BFC meeting. 11 Wound Formulary Group November meeting cancelled; next scheduled meeting 28 th February BFC Noted Gather and forward nominations. KW Include April agenda KW Include April agenda KW Minute of Lothian Formulary Committee minute of meeting held on 24 th January 2018 BFC Noted 13 A.O.C.B. 1. BFC discussed the NFR for Olanzapine. Patient was approved virtually for one dose as a trial. This trial was very successful and BFC approved the application to continue. 2. Glucodrate is to be removed from Formulary as the manufacturer is discontinuing. 3. An MRHA warning has been received for Esmya due to potential liver damage. There have been no new starts on this treatment and Obs & Gynae have been alerted to contact any patients; there are no new patients. Scriptswitch to be linked to document on Intranet. Next Meeting: Wednesday 11 th April 2018 at 12:30 Education Centre Discussion Room 1 Items for next meeting: Page 5 of 5

MEETING OF THE BORDERS FORMULARY COMMITTEE HELD ON WEDNESDAY 8 th FEBRUARY P.M. IN THE ESTATES MEETING ROOM MINUTE

MEETING OF THE BORDERS FORMULARY COMMITTEE HELD ON WEDNESDAY 8 th FEBRUARY 2017 @ 12.30 P.M. IN THE ESTATES MEETING ROOM MINUTE In attendance: Alison Wilson (Director of Pharmacy & Chair of BFC); Liz Leitch