BORDERS FORMULARY COMMITTEE. Minutes of a Meeting held on Wednesday, 13 th April 2011 At p.m. in Discussion Room 1, Education Centre

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1 BORDERS FORMULARY COMMITTEE Minutes of a Meeting held on Wednesday, 13 th April 2011 At p.m. in Discussion Room 1, Education Centre Present: Alison Wilson (Chair) (AW), Declan Hegarty (DH), Ros Anderson (RA), Adrian Mackenzie (AMack), Catherine Scott (CS), Liz Leitch (LL), Tom Cripps (TC) In attendance: Susan Hogg (Minute), 1. Apologies and Announcements: Olive Herlihy 2. Declaration of Interest: None 3. Minutes of previous meeting held on: 9 th February 2011 Sun Vit D3 DH asked if we could have clarification of information going out to GP s. RA replied that we should be specifying that patients are prescribed the Sun Vit D3. RA going to speak to Dr Andrew Pearson and we shall put another article in the bulletin. 4. Matters Arising: 1) SMC Decision Dalteparin Sodium LL reported that the Thrombosis Committee is not due to meet until June 2011 and she will not be able to attend as is on annual leave. 2) SMC Decision Ivabradine 5mg & 7.5mg film coated tablets In formulary for specific use and for patients who are over 70. Approved in formulary and remains approved by SMC for this indication. 3) LL to meet with relevant prescribers in regard to updated NICE technology appraisal regarding Clopidogrel and Dipyridamole in strokes. LL reported that she has ed but no one has come back to her from the team as yet 5. Applications for approval: i) Tinzaparin Sodium (Innohep) CS talked through this application and the supporting evidence. CS explained that Allison Carruthers and Liz Leitch have looked at the costs. This has the most evidence and most centres are already using this for this use. Approved for CAT B but we need to put a system in place for renal patients only. ii) Capsofungin (Cancidas) TC talked to this and would be prescribed on the advice of the consultant micro-biologist. LL is going to talk to the micro team and review evidence and ask for their views on this. Approve for Specialist Use Only CAT B. iii) Octenidine (Octenisan) AMack explained that our consultant micro biologist put in this application and is for two patients. This is not an expensive drug only for use in new patients and if it is to be used in any other group of patients then another application would have to come forward. Approve for new patients only. iv) Ticagrelor LL explained this is an anti plateletsand the reason this has come to the BFC meeting is it has just come through the SMC system but still embargoed until the 9 th May. We have already had an IPTR for one patient and this is for another patient. Approved for Specialist Use only for this patient and a third line option for a 12 month period. Action LL 6. Scottish Medicines Consortium Recommendations 1

2 a) SMC Decisions (advice & embedded below) Recommended for use within NHS Scotland No. EMBARGOED UNTIL 11 th APRIL /11 bendamustine hydrochloride 25mg, 100mg powder for solution for infusion(levact ) bendamustine hydrochloride (Levact ) is accepted for use within NHS Scotland. Indication under review: first-line treatment of chronic lymphocytic leukaemia (CLL) (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate. Bendamustine showed significantly improved response rates and progression free survival when compared with another alkylating agent in patients with previously untreated advanced CLL, although the patients studied may have been younger and fitter than those eligible to receive bendamustine in Scottish clinical practice. Recommended for restricted use within NHS Scotland No. EMBARGOED UNTIL 7 TH MARCH /11 exenatide, 5 or 10 micrograms, solution for injection, pre-filled pen (Byetta ) exenatide (Byetta ) is accepted for restricted use within NHS Scotland. Indication under review: treatment of type 2 diabetes mellitus in combination with thiazolidinediones with or without metformin in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. SMC restriction: restricted to use in combination with metformin and a thiazolidinedione as a third-line pre-insulin treatment option. The addition of exenatide to a thiazolidinedione alone or in combination with metformin modestly improved glycaemic control compared with placebo in studies up to 26 weeks, but was associated with nausea and vomiting in some patients. Exenatide has previously been accepted by SMC for restricted use for the treatment of type 2 diabetes mellitus in combination with metformin and/or sulphonylureas in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. No. EMBARGOED UNTIL 11 th APRIL /10 sevelamer carbonate 800mg film-coated tablets and 2.4g of anhydrous powder for oral suspension (Renvela ) 2

3 ADVICE: following an abbreviated submission sevelamer carbonate (Renvela ) is accepted for restricted use within NHS Scotland. Indication under review: for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. SMC restriction: the second-line management of hyperphosphataemia in adult patients receiving haemodialysis. Sevelamer carbonate has been shown to be therapeutically equivalent to sevelamer hydrochloride in reducing serum phosphorus in patients with chronic kidney disease on haemodialysis. For patients in whom sevelamer hydrochloride is an appropriate choice of phosphate binder, the carbonate salt provides an alternative at no additional cost. Sevelamer carbonate is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus 1.78 mmol/l. As the manufacturer s submission related only to the control of hyperphosphataemia in adult patients receiving haemodialysis SMC cannot recommend the use of sevelamer carbonate in pre-dialysis patients or in peritoneal dialysis patients. Not recommended for use within NHS Scotland No. EMBARGOED UNTIL 11 TH APRIL /03 drospirenone/ethinylestradiol, 3mg/30micrograms, film-coated tablets (Yasmin ) ADVICE: following a resubmission drospirenone/ethinylestradiol (Yasmin ) is not recommended for use within NHS Scotland. Indication under review: oral contraception. Drospirenone/ethinylestradiol has been shown to have similar contraceptive effectiveness to other combined oral contraceptives in routine use, with no significant differences in adverse event profile. The manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC. LL to ask Dr Ailsa Wylie what their procedure is? Send out not recommended to GP. BGH wishes to supply another drug which is in the formulary but the patient has come from abroad on this. An article to go into the bulletin to advice. 692/11 botulinum toxin type A, 50 unit, 100 unit and 200 unit powder for solution for injection (Botox botulinum toxin type A (Botox ) is not recommended for use within NHS Scotland. Indication under review: the prophylaxis of headaches in adults with chronic migraine 3

4 (headaches on at least 15 days per month of which at least 8 days are with migraine). In pooled analysis of two phase III studies, botulinum toxin type A was superior to placebo for the primary endpoint, headache days. However, there were weaknesses in the clinical data that limit the ability to assess its likely clinical effectiveness in the target treatment population. Overall the manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC. 693/11 calcium acetate 435mg/magnesium carbonate 235mg tablet (Osvaren ) calcium acetate 435mg/magnesium carbonate 235mg tablet (Osvaren ) is not recommended for use within NHS Scotland. Indication under review: treatment of hyperphosphataemia associated with chronic renal insufficiency in patients undergoing dialysis (haemodialysis, peritoneal dialysis). The combined preparation of calcium acetate/magnesium carbonate has been shown to reduce hyperphosphataemia associated with chronic renal disease. However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. 700/11 bendamustine 2.5mg/mL powder for concentrate for solution for infusion (Levact ) bendamustine (Levact) MM NON-SU bendamustine (Levact ) is not recommended for use within NHS Scotland. Indication under review: for the front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment. 701/11 bendamustine 2.5 mg/ml powder for concentrate for solution for infusion (Levact ) bendamustine (Levact ) is not recommended for use within NHS Scotland. Indication under review: for the front line treatment of indolent non-hodgkin's lymphomas as monotherapy in patients who have progressed during or within 6 months following 4

5 treatment with rituximab or a rituximab containing regimen. 702/11 paliperidone 1.5mg, 3mg, 6mg, 9mg, 12mg prolonged release tablets (Invega ) paliperidone (Invega ) is not recommended for use within NHS Scotland. Indication under review: For the treatment of psychotic or manic symptoms of schizoaffective disorder. Effect on depressive symptoms has not been demonstrated. 703/11 cannabinoid oromucosal spray (Sativex ) cannabinoid oromucosal spray (Sativex ) is not recommended for use within NHS Scotland. Indication under review: as an add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. LL to send information to Dr David Simpson. Scottish Medicines Consortium Short Life Working Group on new oral anticoagulants DaD AW for information but this has could have a huge impact on our prescribe budget. SMC are going to arrange the initial workshop around this waiting for that change in license indications for any of the drugs. Revised SMC Budget Impact Template Dalteparin_LMWH Displacement Analysis_Feb 2011 (for information) - Dabigatran Budget Impact_March 2011 (for information) 7. Borders Joint Formulary Update: LL LL explained that all the changes were in blue for ease of distinguishing and the review rationalised the inhaled preparations on the basis of cost and ease of use. In regard to spacers we now have a first and second choice and all combined inhalers have been reviewed and these are in order of cost effective. 5

6 Eye section of the formulary. We have a new Ophthalmologist, Dr Jonathon Ross and LL went over the amendments, many of which are for more cost-effective options. All amendments to the formulary were approved by the group. As AW had to leave to attend another meeting CS took over as Chair. 8. NHS Circular: 4 PCA(M)(2011) Treatment of Erectile Dysfunction: Patients with Severe Distress DH queried whether or not Alan McLaren, Nurse Specialist was the correct person to be carrying out this work with this group of patients. This problem can cause many patients severe distress and that is one of the reasons they meet the criteria. LL agreed to write to the urologist and ask for his comments and bring back to the next ADTC. 9. Minor Ailments Formulary for Community Pharmacy AMack explained that this was for noting within the community pharmacy contract and directed to community pharmacists using the evidence based product. LL asked if aqueous creams could be removed and AMack agreed to make the necessary changes Action: AMack 10. Important Change to Copyright Permissions - Advance Information CS explained to the group why this had been brought to the meeting. After discussion it was agreed that any requests should go through the admin office. LL suggested that the person doing the summary could have the copy of the supporting paperwork. CS going to circulate the paper round the group for information. 11. BFC Annual Report 2010/11: TC paragraph one second sentence Its purpose is to provide the Board with the assurance that mechanisms are in place and effective across NHS Borders to manage requests to prescribe medicines. TC felt that the wording The members of the committee review the evidence and make recommendations to the ADTC would be more appropriate and AW and himself would meet to discuss. The issue was also raised on where the group should sit? It was agreed to bring this back to the next meeting. 12. Patient Safety: Nothing to discuss. 13. Lothian Formulary Committee Minutes 26 th January 2011 & 2 nd March NICE GUIDANCE: (for information) CardioQ-ODM oesophageal doppler monitor Noted 15. Any Other Business: The point was raised where a one of use of a non formulary drug was used. It was agreed that we need to speak to Dr Cliff Sharp in regard to the use of Vyvance. One new patient has been commenced, by an outside hospital on Vyvance. Dr Cliff Sharp will attend the ADTC to support his NMA for this patient and drug. This product is licensed in the States but not licensed here. There is no adult ADHD service in the Borders so do we support the decision to carry on their supply as they will run out before the next ADTC. Agreed to prescribe for the short term until we have had a full discussion through the group process. 16. Date Of Next Meeting: 8 th June p.m. in the Estates Meeting Room 6