LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE

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1 FORMULARY COMMITTEE Minutes of the Formulary Committee meeting held on 29 September 2010 in Room 004, Ground Floor, Pentland House Present: J Carson Dr J Dear Dr J Forbes Dr H Gillett Dr W Jamieson S Kerr Professor S Lawrie L Leitch S McNaughton J Pearson L Shaw T Slaughter Dr D Wilks Dr R Williams In attendance: Z Simpson Apologies for absence: Dr E Brown Dr S Hornibrook L McGuiness I Mohammed Lead Directorate Pharmacist, Royal Infirmary of Edinburgh Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh Formulary Committee Co-Chair and Reader in Health Economics, University of Edinburgh Consultant Gastroenterologist, St John s Hospital General Practitioner, Lothian Lead Pharmacist, Western General Hospital Formulary Committee Co-Chair and Professor and Honorary Consultant Psychiatrist, Royal Edinburgh Hospital (in the chair) Formulary Pharmacist, NHS Borders Associate Director, Contracted Community Pharmacy Services & CHP Development, NHS Lothian Formulary Pharmacist, NHS Lothian Lead Directorate Pharmacist, Royal Infirmary of Edinburgh Clinical Effectiveness Pharmacist, North Cumbria Medicines Management Group Consultant in Infectious Diseases, Western General Hospital General Practitioner, Lothian Medicines Management Team Administrator Consultant Oncologist, Western General Hospital General Practitioner, Lothian Chief Nurse, General Surgery, Royal Infirmary of Edinburgh Clinical Effectiveness Pharmacist, NHS Fife Declarations of interest: The Chair reminded members to declare any interests in any of the products to be discussed. Welcome and Membership The Chair of the committee welcomed Jenny Carson, Pharmacist at the Royal Infirmary of Edinburgh and member of the Paediatrics D & T Committee. Each of the members of the committee introduced themselves in turn. The Chair also announced that Dr Simon Hurding, will be joining the committee, as he takes up his post of Medicines Management Advisor within the Medicines Management Team.

2 Minutes LOTHIAN FORMULARY COMMITTEE 1. Minutes of the previous meeting held on 18 August The minutes of the meeting of 18 August 2010 were approved as an accurate record of that meeting. 2. Matters arising from previous minutes 2.1 adalimumab (Humira ) and infliximab (Remicade ) A FAF1 submission was made following a NICE Multiple Technology Appraisal (MTA) for adalimumab and infliximab to the Formulary Committee in August At that time, classification was deferred pending the receipt of further information A flowchart clarifying costs and providing evidence and justification for drug choice was received and previously circulated to the committee The committee noted the flow diagram and acknowledged it provided a clearer vision on proposed medicine usage and justification of costs Given the significant costs involved, the committee discussed the process of monitoring the overall expenditure per annum following Formulary Committee approval and recognised that a proportion of the cost involved in the submission is already being incurred on a non-approved basis The need for approval of both drugs was discussed. It was noted that infliximab is effective in fistulising Crohn s disease; however there is significant existing clinical experience in the prescribing of adalimumab It was agreed to add adalimumab and infliximab to the Additional List, for Specialist Use only. 3. SMC Recommendations - FAF1s 3.1 dronedarone, 400mg, film-coated tablets (Multaq ) The committee noted and discussed the previously circulated submission and SMC report. Declarations of interest were included within the submission and were noted by the committee. dronedarone (Multaq ) No 636/10 ADVICE: following a full submission dronedarone (Multaq ) is accepted for restricted use within NHS Scotland. Indication under review: in adult clinically stable patients with a history of, or current nonpermanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. SMC Restriction: for the prevention of recurrence of AF in patients in whom conventional first-line anti-arrhythmic medicines are ineffective, contra-indicated or not tolerated. Treatment should be initiated on specialist advice only. Dronedarone appears less effective than amiodarone in reducing atrial fibrillation recurrence but has the potential for improved tolerability compared to comparator medicines.

3 3.1.2 The committee noted the FAF1 submission and NHS Lothian Protocol for the restricted use of dronedarone (Multaq ) in adult patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate The committee discussed the protocol and algorithm included within the submission. It was noted that the protocol for use is in line with SMC advice; however there appeared to be some disparity between the protocol and algorithm It was highlighted that side effects in dronedarone compared to amiodarone are lower and there is a reduced risk of mortality, however, premature treatment discontinuation and discontinuation due to lack of efficacy is greater with dronedarone The committee noted that amiodarone is widely used and concerns were raised as to why there is a proposal to use dronedarone for all patients instead of amiodarone It was agreed to send a letter requesting additional clarification on the disparity between the NHS Lothian Protocol for the use of dronearone and the algorithm It was agreed to defer classification, awaiting further information from the clinical team. ACTION: SL 3.2 lenalidomide, 5mg, 10mg, 15mg and 25mg capsules (Revlimid ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were included within the submission lenalidomide, 5mg, 10mg, 15mg and 25mg capsules (Revlimid ) No 441/08 ADVICE: following a re-submission Licensed indication under review: lenalidomide (Revlimid ) is accepted for restricted use within NHS Scotland in combination with dexamethasone, for the treatment of multiple myeloma patients who have received at least one prior therapy. SMC Restriction: use in patients who have received at least two prior lines of therapy. Lenalidomide plus dexamethasone significantly increased the time to progression compared with dexamethasone alone in multiple myeloma patients who had been treated with at least one prior therapy. The health economic case was demonstrated only for a sub-population of patients within the licensed indication. Taking into account the orphan drug status of lenalidomide and the substantial survival benefit it appears to offer SMC concluded that the economic case was demonstrated The committee noted the FAF1 submission for the restricted use of lenalidomide (Revlimid ) in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.

4 3.2.3 The committee noted that the submission would be for 18 patients per annum across SCAN (11 in Lothian) and the total net cost of approx 831,456 does not include savings from a replacement therapy, as there is currently no third-line treatment option available In the first year there would be an estimated additional 4 patients across SCAN (3 in Lothian) costing an estimated extra 1,016,224 due to a backlog of patients awaiting a third line treatment The committee noted that the FAF included a difference in dosage of dexamethosone to SMC advice which is due to the results of a trial demonstrating lower toxicity effects with a lower dose of dexamethasone Adverse effects were noted; commonly neutropenia and thrombocytopenia It was agreed to add lenalidomide to the Additional List, for Specialist Use only. 3.3 paclitaxel albumin powder for suspension for infusion (contains 100mg paclitaxel as paclitaxel albumin (Abraxane ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were included within the submission. paclitaxel albumin powder for suspension for infusion (contains 100mg paclitaxel as paclitaxel albumin (Abraxane ) No 556/09 ADVICE: following a full submission Licensed indication under review: paclitaxel albumin (Abraxane ) is accepted for restricted use within NHS Scotland for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline containing therapy in not indicated. SMC Restriction: Use is restricted to patients who would otherwise receive docetaxel or 3- weekly solvent-based paclitaxel as second-line treatment for metastatic breast cancer. In one study the overall response rate for paclitaxel albumin was significantly superior to solvent-based paclitaxel in a subgroup analysis of patients who had previously received one or more line of therapy for metastatic disease. The health economic case was only demonstrated for a subset of the licensed indication which is the basis for the SMC restriction. Note that paclitaxel albumin may have substantially different pharmacological properties compared to other formulations of paclitaxel and is licensed for use in a 3-weekly dosage schedule The committee noted the FAF1 submission for the restricted use of paclitaxel albumin (Abraxane ) for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline containing therapy is not indicated.

5 3.3.3 The committee noted that the submission is for approx 30 patients per annum and is cost neutral. It estimated that there will be increased usage compared to SMC advice however this has been reflected in the figures The ease of delivery was discussed with paclitaxel albumin being given over a shorter time resulting in reduced chair time compared to docetaxel A reduction in the incidence of neutropenia sepsis is expected and it is anticipated this could result in significant savings, but these are not available at this stage The committee agreed to add paclitaxel albumin to the Additional List for Specialist Use only specifying where docetaxel or solvent-based paclitaxel would otherwise be given. 4. SMC latest Not Recommended Medicines (August and September 2010) The committee noted the following medicine not recommended for use by SMC in NHS Scotland: 4.1 trabectedin, 250 microgram, 1mg powder for concentrate for solution for infusion (Yondelis ), Report No. 634/10, is not recommended for use within NHS Scotland in combination with pegylated liposomal doxorubicin (PLD) for the treatment of patients with relapsed platinum-sensitive ovarian cancer. 4.2 agomelatine, 25mg film-coated tablets (Valdoxan ), Report No. 564/09, is not recommended for use within NHS Scotland for the treatment of major depressive episodes in adults. 4.3 lanthanum carbonate, 500mg, 750mg, 1,000mg, chewable tablets (Fosrenol ), Report No. 640/10, is not recommended for use within NHS Scotland as a phosphate binding agent for use in the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphate levels 1.78mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels. 4.4 pemetrexed, 100mg, 500mg powder for concentrate for solution for infusion (Alimta ), Report No. 642/10, is not recommended for use within NHS Scotland as monotherapy for the maintenance treatment of locally advanced or metastatic nonsmall cell lung cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinumbased chemotherapy. First-line treatment should be a platinum doublet with gemcitabine, paclitaxel or docetaxel.

6 4.4 roflumilast 500 microgram tablets (Daxas ), Report No. 635/10, is not recommended for use within NHS Scotland as maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (forced expiratory volume in 1 second [FEV 1 ] post-bronchodilator <50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. 4.5 Non submissions None 5. Other Medicines Proposed for Use - FAF2s and FAF3s 5.1 dalteparin sodium (Fragmin ) No interests were included within the submission. A declaration of interest was noted from a committee member The committee noted the FAF2 submission for the use of dalteparin (Fragmin ) for prophylaxis and treatment of venous thromboembolism The submission proposes that dalteparin is to replace enoxaparin for the prophylaxis and treatment of VTE as LJF 1 st choice Draft SIGN guidelines support reduced monitoring with dalteparin, however clarification is still required over full blood counts It was highlighted that there would be a cost saving of approx 100,000 a year from secondary care and additional cost savings from primary care could be made It was noted in pregnancy that no decision has been made, and there is a wealth of experience in the use of enoxaparin. Specific guidance will however be made available The committee noted that a Thrombosis Committee are currently drafting protocols It was agreed to add dalteparin to the Formulary as first choice in replace of enoxaparin and the LJF choices box to be amended accordingly.

7 6. SMC Abbreviated Submissions LOTHIAN FORMULARY COMMITTEE 6.1 esomeprazole 10mg gastro-resistant granules for oral solution, sachet (Nexium ) (No: 639/10) esomeprazole 10mg gastro-resistant granules for oral solution, sachet (Nexium ) No. 639/10 ADVICE: following an abbreviated submission esomeprazole 10mg gastro-resistant granules for oral solution, sachet (Nexium ): is accepted for restricted use within NHS Scotland. Indication under review: primarily indicated for treatment of gastro-oesophageal reflux disease in children 1 to 11 years old. Gastro-oesophageal reflux disease (GORD) Treatment of endoscopically proven erosive reflux oesophagitis Symptomatic treatment of gastro-oesophageal reflux disease Oral suspension may also be used by patients having difficulty swallowing dispersed esomeprazole gastro-resistant tablets. Restricted Advice: the use of esomeprazole for this indication and age group should be restricted to patients in whom licensed doses of a generic proton pump inhibitor have been ineffective. The gastro-resistant granules for oral solution have demonstrated bioequivalence to the tablet and capsule formulations. Doses of 10mg esomeprazole in children aged 1 to 11 resulted in the same exposure to drug as seen with the 20mg dose in adolescents and adults. There is no evidence of comparative efficacy in this population. The Scottish Medicines Consortium has previously accepted this product for use in patients in the years age group, for the treatment of erosive reflux oesophagitis, the long-term management of patients with healed oesophagitis to prevent relapse, and the symptomatic treatment of gastro-oesophageal reflux disease The committee noted the above abbreviated submission It was noted that the paediatric clinical team may wish to use this due to it being a licensed product, and have been advised that a FAF1 submission would be required It was agreed to classify as Not preferred in Lothian, as suitable alternatives exist.

8 6.2 ethinylestradiol 30 microgram and levonorgestrel 150 microgram, (Rigevidon 30/150 microgram) film coated tablets (No: 646/10) ethinylestradiol 30 microgram and levonorgestrel 150 microgram, (Rigevidon 30/150 microgram) film coated tablets (No: 646/10) ADVICE: following an abbreviated submission ethinylestradiol 30microgram/levonorgestrel 150microgram (Rigevidon ): is accepted for use within NHS Scotland. Indication under review: oral contraception. For patients in whom ethinylestradiol/levonorgestrel is an appropriate contraceptive, Rigevidon provides an alternative to existing preparations at a lower cost. 6.3 ethinylestradiol 20 microgram / gestodene 75 microgram (Millinette 20/75 microgram) film-coated tablets. ethinylestradiol 30 microgram / gestodene 75 microgram (Millinette 30/75 microgram) film-coated tablets (No: 644/10) ethinylestradiol 20 microgram / gestodene 75 microgram (Millinette 20/75 microgram) film-coated tablets. ethinylestradiol 30 microgram / gestodene 75 microgram (Millinette 30/75 microgram) film-coated tablets (No: 644/10) ADVICE: following an abbreviated submission ethinylestradiol 20microgram/gestodene 75microgram and ethinylestradiol 30microgram/gestodene 75microgram (Millinette ) is accepted for use within NHS Scotland. Indication under review: oral contraception. For patients in whom ethinylestradiol /gestodene is an appropriate contraceptive, Millinette provides an alternative to existing preparations at lower cost.

9 6.4 ethinylestradiol 20microgram / desogestrel 150microgram (Gedarel 20/150 microgram) film-coated tablets ethinylestradiol 30microgram / desogestrel 150microgram (Gedarel 30/150 microgram) film-coated tablets (No: 643/10) ethinylestradiol 20microgram / desogestrel 150microgram (Gedarel 20/150 microgram) film-coated tablets ethinylestradiol 30microgram / desogestrel 150microgram (Gedarel 30/150 microgram) film-coated tablets (No: 643/10) ADVICE: following an abbreviated submission ethinylestradiol 20microgram/desogestrel 150microgram and ethinylestradiol 30microgram/desogestrel 150microgram (Gedarel ) is accepted for use within NHS Scotland. Indication under review: oral contraception. For patients in whom ethinylestradiol /desogestrel is an appropriate contraceptive, Gedarel provides an alternative to existing preparations at lower cost. 6.5 Ethinylestradiol 30/40microgram/levonorgestrel 50/75/125microgram (TriRegol ) (No: 645/10) Ethinylestradiol 30/40microgram/levonorgestrel 50/75/125microgram (TriRegol ) (No: 645/10) ADVICE: following an abbreviated submission ethinylestradiol 30/40 plus levonorgestrel 50/75/125 microgram (TriRegol ): is accepted for use within NHS Scotland. Indication under review: oral contraception. For patients in whom phasic ethinylestradiol and levonorgestrel is an appropriate contraceptive, TriRegol provides an alternative to the existing preparation at lower cost The committee noted the above abbreviated submissions It was highlighted that the Family Planning service are in the process of conducting price comparisons and potential savings It was agreed to defer classification, pending the receipt of further information from the clinical team.

10 7. Formulary Additions and Amendments 7.1 ADULT Minor Ailments Formulary 2010 for use in community pharmacy The committee noted the above document which is a revision of the 2006 version The fully revised Minor Ailments Formulary was discussed in relation to changes to the LJF and product availability The committee agreed to approve the Minor Ailments Formulary with changes as discussed LJF Support for Chronic Medication Service The committee discussed the above information regarding the LJF support for the Chronic Medication Service planned for distribution with the abbreviated list to community pharmacists The committee read and agreed the communication for circulation; with the deletion of the first paragraph. 8. NICE/SIGN/NHS QIS Clinical Guidance 8.1 NICE CG 106 Barratt s oesophagus The committee noted and discussed the above NICE Clinical Guideline which included no pharmacological reference. 8.2 NICE CG 107 Hypertension in pregnancy The committee noted and discussed the above NICE Clinical Guideline It was agreed to review the clinical guideline in line with the current LJF. 8.3 NICE CG 108 Chronic heart failure The committee noted and discussed the above NICE Clinical Guideline The committee agreed the guideline was very much in line with the current LJF It was agreed to check the formulary regarding hydralazine advice. 8.4 NICE CG 109 Transient loss of consciousness The committee noted and discussed the above NICE Clinical Guideline which contained no pharmacological reference.

11 8.5 NICE STA 196 Imatinib for the adjuvant treatment of gastrointestinal stromal tumours The committee noted and discussed the above NICE Single Technology Appraisal for information No material differences exist between NICE and SMC advice, regarding the not recommended drug, imitinab. QIS advise to adhere to SMC advice. 8.6 NICE STA 197 Dronedarone for the treatment of non-permanent atrial fibrillation The committee noted and discussed the above NICE Single Technology Appraisal for information. 8.7 NICE STA 198 Tocilizumab for the treatment of rheumatoid arthritis The committee noted and discussed the above NICE Single Technology Appraisal Differences were highlighted between NICE and SMC advice and QIS advise health boards to continue to adhere to SMC advice. 8.8 NICE MTA 195 Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor The committee noted and discussed the above NICE Multiple Technology Appraisal The committee noted this MTA supersedes SMC advice in particular to differences with abatacept It was agreed to update the web tables in line with the MTA guidance and request a FAF1 from the clinical team. /ZS 8.9 NICE MTA 199 Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis (review of technology appraisal guidance 104 and 125) The committee noted and discussed the above NICE Multiple Technology Appraisal which replaces previous TAs The committee agreed no changes are required to the LJF SIGN 120 Management of chronic venous leg ulcers The committee noted and discussed the above SIGN Guideline Pentoxifylline was noted in the SIGN guideline as an unlicensed medication to improve healing in patients, which is not currently mentioned within the LJF It was agreed that the full SIGN guideline would be reviewed in conjunction with the LJF. 9. Drug Safety Issues MHRA Advice/NPSA Advice 9.1 General Practice, Significant Event Analysis - rivaroxaban The committee noted and discussed the above significant event analysis received from a General Practice in relation to rivaroxaban.

12 9.1.2 It was noted that further information regarding the LJF section had been fed back to the practice and a bulletin article had been done previously. The committee agreed that clear guidance was available in the LJF section. 10 For Information Only 10.1 Formulary Committee Reports and Letters The committee noted the following Formulary Committee reports and letters: droperidol parenteral (Xomolix ) rosuvastatin (Crestor ) anastrazole (Arimidex ) SMC No. 198/05 and 322/06 exemestrane (Aromasin ) letrozole (Femara ) esomeprazole (Nexium ) plerixafor (Mozobil ) atazanavir (Reyataz ) darunavir (Prezista ) calcipotriol and betamethasone dipropionate gel (Xamiol ) doripenem (Doribax ) SMC Nos. 529/09 and 539/09 enoxaparin (Clexane ) nebivolol (Nebilet ) ropinirole (Adartrel ) rotigotine (Neupro ) hypertonic sodium chloride 7% (Nebusal ) aripiprazole (Abilify ) dutasteride (Combodart ) filgrastim (TevaGrastim ) Letters to ADTC FC 7-Jul-2010 and 18-Aug Antimicrobial Management Team Minutes 12.1 The committee noted the approved Antimicrobial Management Team Minutes, from meetings held on 09 June 2010 and 11 August Formulary Committee Meeting Schedule 2011 The committee noted the 2011 meeting dates for information as follows. Wednesday 26 January 2011 Wednesday 02 March 2011 Wednesday 20 April 2011 Wednesday 25 May 2011 Wednesday 6 July 2011 Wednesday 17 August 2011 Wednesday 28 September 2011 Wednesday 09 November 2011 Wednesday 14 December 2011

13 14. AOCB None LOTHIAN FORMULARY COMMITTEE 15. Date of Next Meeting 15.1 The committee noted that the next meeting would be held on 10 November 2010, at 2pm in the Room No 004, Pentland House, 47 Robb s Loan, Edinburgh. (The deadline for submission of papers for this meeting is close of play Tuesday 26 October 2010.)

BORDERS FORMULARY COMMITTEE. Minutes of a Meeting held on Wednesday, 13 th October 2010 At p.m. in the Committee Room, Education Centre

BORDERS FORMULARY COMMITTEE. Minutes of a Meeting held on Wednesday, 13 th October 2010 At p.m. in the Committee Room, Education Centre BORDERS FORMULARY COMMITTEE Minutes of a Meeting held on Wednesday, 13 th October 2010 At 12.30 p.m. in the Committee Room, Education Centre Present: Alison Wilson (Chair) (AW), Ros Anderson (RA), Liz