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SMC Minutes - Tuesday 2 November 2004

Minutes of Meeting held on Tuesday 2 November, 2004
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman), Dr Keith Beard, Ms Chris Beech, Mrs Marion Bennie, Mrs Barbara Black, Professor John Cairns, Ms Michelle Caldwell, Mr Tom Divers, Dr Peter Donnan, Mr John Glennie, Dr Barclay Goudie, Dr John Haughney, Dr David Hood, Mrs Moira Howie, Dr Chris Lush, Professor Angus MacKay, Dr Marianne Nicholson, Ms Wendy Nganasurian,
Dr Ken Paterson, Dr Andrew Riley, Dr Phillip Rutledge, Ms Fiona Scott, Dr Sandy Simpson, Ms Angela Timoney, Ms Helen Tyrrell, Mr Mike Wallace, Professor David Webb, Dr John Webster,
Mr Derek Yuille

In Attendance: Mr Steven Fenocchi, Mr Paul Gibbons, Mr Scott Hill, Ms Joy Hosie, Dr Harpreet Kohli, Mr Hector MacKenzie, Mrs Laura McIver, Miss Rosie Murray, Professor Philip Routledge,
Mrs Maureen Stark

Apologies: Mr Jeff Ace, Professor James Barbour, Dr Corri Black, Professor Martin Brodie,
Ms Angela Munday, Mr Chris Nicolson, Ms Fiona Ramsay, Pamela Warrington

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting and apologies for absence were noted. A particular welcome was extended to Professor Philip Routledge, Chairman of the Welsh Medicines Partnership and Mr Scott Hill, Clinical Effectiveness Pharmacist, Fife, who were observing the work of SMC. 

2 Declarations of Interest

2.1  The Chairman reminded members to declare interests in the products to be discussed and the comparator drugs as noted on the assessment reports.

3 Minutes of the Previous Meeting (05.10.04)

3.1 The minutes of the meeting of 5 October, 2004, were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1 Relationship with SMC and NHS Quality Improvement Scotland / Confirmation of Funding

4.1.1 The Chairman was pleased to confirm that the Scottish Executive had secured funding for the Scottish Medicines Consortium (SMC) for 2005/06 and subsequent financial years on a recurring basis.

4.1.2 An application to the Chief Scientist for funding to carry out an independent evaluation of the work of SMC had regrettably been unsuccessful.  Alternative funding sources were being pursued however, to allow the work to be carried out.

4.2 SMC Antimicrobial Prescribing Policy and Practice Group (SAPPPG)

4.2.1 The Chairman advised that following comment and approval from the Chief Medical Officer (CMO), Scotland, the report from SMC on Antibiotic prescribing was ready for dissemination to NHS Boards and other agreed parties.  The report will first be introduced at the next available meeting of NHS Chief Executives and then circulated to the agreed distribution list.

4.3 Freedom of Information

4.3.1 Mr P Gibbons provided an update on progress towards implementation of the Freedom of Information Act (FOI).

As SMC is a consortium of Health Boards, under the Freedom of Information Act, it cannot respond directly to requests for information.  Instead, NHS Boards must respond to requests for information on behalf of their Area Drug & Therapeutic Committees (ADTCs).  A form of words has been drafted for inclusion in the Model Publication Scheme for each NHS Board to correctly address this issue.  The draft form of words will be forwarded to the Scottish Executive for consideration and approval by the end of November.

A meeting will be arranged between representatives of SMC, ADTCs and NHS Board's to discuss the operation of the scheme in detail.  In particular, systems will be developed to handle requests for information which fall outwith the standard publication scheme.  SMC members were asked to identify suitable representatives from within their own Board area to take part in the discussion.

Mr Gibbons advised that he had been in discussion with the Chairman of the SIGN Council to ensure that SMC, SIGN and NHS QiS progress towards the implementation of FOI in parallel.

4.3.2 Ms Hosie, CLO, had obtained updated guidance from the FOI Commissioners on the determination of exemptions, for commercial reasons.  She will prepare a summary of the guidance for issue to members.

4.4 Implementation Guidance for etanercept (Enbrel): A Short Life Working Group

4.4.1 The Chairman summarised the background to the identification of unique treatments and the preparation of a protocol for the introduction of etanercept (Enbrel), which is the first unique treatment to be identified by SMC since the circular on this topic from the Executive. Following discussion, members approved the protocol, with minor amendments to wording. The protocol will be circulated to NHS Boards with immediate effect and will be published on the SMC website on Monday 8th November.

4.4.2 It was suggested that further discussion was required on the definition of a unique treatment.  The Chairman noted this perception.  It was agreed that the protocol for etanercept (Enbrel) should be used as a template for any further unique treatments.

FULL SUBMISSIONS

4.5 testosterone 30 mg mucoadhesive buccal (prolonged release) tablets
(Striant - SR):  Ardana Bioscience (No: 128/04)

4.5.1 SMC advice for testosterone 30 mg mucoadhesive buccal (prolonged release) tablets
(Striant - SR) for testosterone replacement therapy in men with primary or secondary hypogonadism, will be posted on the SMC website on Monday 8 November, 2004.

4.6 solifenacin (Vesicare®):  Yamanouchi (No. 129/04)

4.6.1 SMC advice for solifenacin (Vesicare®) for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome, will be posted on the SMC website on Monday 8 November, 2004.

4.7 premique low dose:  Wyeth (No. 130/04)

4.7.1 SMC advice for premique low dose as hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with intact uterus, will be posted on the SMC website on Monday 8 November, 2004. 
 
4.8 losartan (Cozaar) (renal): Merck Sharpe & Dohme (No. 131/04)

4.8.1 SMC advice for losartan (Cozaar) (renal) to delay the progression of renal disease and to reduce proteinuria in type 2 diabetic patients with neuropathy, will be posted on the SMC website on Monday 8 November, 2004.

4.9 aprepitant (Emend):  Merck Sharpe & Dohme  (No. 132/04)

4.9.1 SMC advice for aprepitant (Emend) for the prevenion of acute and delayed nausea and vomiting associated with the highly emetogenic cisplatin-based chemotherapy, will be posted on the SMC website on Monday 8 November, 2004.

5 Appeals Update

5.1 There were no appeals to report

6 Correspondence

6.1 Insulin detemir (Levemir)

SMC considered plans by the manufacturer to withdraw Insulatard (isophane) insulin in disposable pen devices, forcing patients who wish to remain on a disposable pen, to switch to the higher cost insulin detemir (Levemir).  Whilst members noted the effect that the manufacturers decision would have on SMC Advice, previously issued for insulin detemir (Levemir), they considered that as it was a commercial decision taken by the manufacturer it was more properly a matter for individual clinicians and possibly pricing authorities to comment upon.

6.2 SIGN

6.2.1 SIGN has issued a draft report for consultation, which contained favourable comments on a treatment for which SMC had already recommended no use in NHS Scotland.   Discussions had taken place with the Chairman of SIGN in order to prevent potential embarrassment from conflicting opinions between SMC and SIGN.  SMC proposed that in future, subjects which SIGN are considering, should be detailed in advance to SMC and SMC, in turn, will notify SIGN of any advice they have issued which is relevant to the topic under review.  The Chairman of SIGN has agreed to these proposals from SMC.

6.2.2 Members indicated that many clinical specialists in the field had expressed confusion about the range and variability of advice coming from SMC, NICE and SIGN.  It was acknowledged that there were possible areas of confusion and agreed that NHSQIS might be approached to consider the matter with a view to clarifing the position.
 
6.2.3 The Chairman advised that he had received a request from NICE for SMC to provide early advice on a product.  He advised that this was outwith the remit and resources available to SMC at this time.
 
7 Patient and Public Involvement Group (PAPIG)

7.1 The minutes of the meeting of PAPIG, held on 5 October 2004 were noted.
 
8 New Drugs Committee Update

8.1 Review of recent NDC meeting

8.1.1 The Chairman of NDC gave a brief update, which was noted.

9 NDC Assessment Reports - Full Submissions

9.1 miglustat (Zavesca ©): Actelion (No. 133/04)

9.1.1 No declarations of interest were recorded in relation to this product/comparator drugs.  

9.1.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation and comments received from the company.  Detailed discussion followed and the group agreed that miglustat (Zavesca ©), for type 1 Gaucher disease, should be accepted for use within NHS Scotland. Amendments to wording were noted.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 November 2004.
 
9.2 ertapenem (Invanz®): Merck Sharp & Dohme  (No. 134/04)

9.2.1 Declarations of interest were recorded in relation to this product/comparator drugs.  

9.2.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that ertapenem (Invanz), for severe infection, is accepted for restricted use within NHS Scotland.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 November, 2004.

9.3 rituximab (MabThera®): Roche  (No. 135/04)

9.3.1 No declarations of interest were recorded in relation to this product/comparator drugs.  

9.3.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation, expert comments, comments received from the company and a Patient Interest Group Submission.  Detailed discussion followed and the group agreed that rituximab (MabThera®), for follicular lymphoma in combination with CVP chemotherapy should be accepted for use within NHS Scotland.  Amendments to wording were noted

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 November, 2004.

9.4 eplerenone (Inspra): Pfizer Ltd (No. 136/04)
 
9.4.1 Declarations of interest were recorded in relation to this product/comparator drugs.  One member with a personal specific interest left the room during this agenda item.  

9.4.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation, expert comments and comments received from the company. Detailed discussion followed and the group agreed that eplerenone (Inspra), to reduce the risk of cardiovascular mortality and morbidity in patients with left ventricular dysfunction and heart failure, post myocardial infarction, should be accepted for restricted use within NHS Scotland.  Amendments to wording were noted.

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 November, 2004.

9.5 paracetamol infusion (Perfalgan®):  Bristol-Myers Squibb (No. 137/04)

9.5.1 A declaration of interest was recorded in relation to this product/comparator drugs. 

9.5.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and comments received from the company.  Detailed discussion followed and the group agreed that paracetamol infusion (Perfalgan®), for the short-term treatment of adults and adolescents with moderate pain, should be accepted for use within NHS Scotland. Amendments to wording were noted

9.5.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 November, 2004.

NDC Assessments ¿ Re-submission

9.6 laronidase (Aldurazyme): Genzyme (No. 100/04)

9.6.1 A declaration of interest was recorded in relation to this product/comparator drugs.  An observer with a personal specific interest left the room during this agenda item.

9.6.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation, comments received from the company, expert comments and a submission from a patient interest group.  A lengthy and substantial discussion followed. The group agreed that laronidase (Aldurazyme) for the treatment of mucopolysaccharoidosis l, should not be recommended for use within NHS Scotland. Amendments to wording were noted.

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 November, 2004.  
 
NDC Assessments - Abbreviated Submissions

9.7 insulin detemir  (Levemir®): Novo Nordisk (No. 138/04)

9.7.1 Declarations of interest were recorded in relation to this product/comparator drugs.  A member with a personal specific interest left the room during this agenda item.

9.7.2 The NDC Vice Chairman provided an overview of the assessment, the key issues identified and the draft summary recommendation. Discussion followed and the group   concluded their advice for insulin detemir  (Levemir®) for the treatment of diabetes mellitus. Amendments to wording were noted.

9.7.3 SMC advice will be withheld pending confirmation of the licence and launch date for this treatment.

9.8 reminyl XL: Shire Pharmaceuticals (No. 139/04)

9.8.1 There were no declarations of interest in relation to this product/comparator products.

9.8.2 The NDC Chairman provided an overview of the assessment, the key issues identified and the draft summary recommendation. Discussion followed and the group concluded their advice for reminyl XL, for the treatment of dementia in Alzheimer's disease.  Amendments to wording were noted.

9.8.3 SMC advice will be withheld pending confirmation of the licence and launch date for this treatment.

9.9 rosiglitazone maleate/metformin hydrochloride (Avandmet): GlaxoSmithKline  (No. 140/04)

9.9.1 Declarations of interest were recorded in relation to this product/comparator drugs.

9.9.2 The NDC Chairman provided an overview of the assessment, the key issues identified and the draft summary recommendation. Detailed discussion followed and the group agreed that rosiglitazone maleate/metformin hydrochloride (Avandmet) for type 2 diabetes mellitus, should be accepted for use within NHS Scotland. Amendments to wording were noted. 

9.9.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 November, 2004.

9.10 creon micro (Creon): Solvay Healthcare  (No. 141/04)

9.10.1 There were no declarations of interest in relation to this product/comparator products.

9.10.2 The NDC Chairman provided an overview of the assessment, the key issues identified and the draft summary recommendation. Detailed discussion followed and the group agreed that creon micro (Creon) for the treatment of pancreatic insufficiency, should be accepted for restricted use within NHS Scotland. Amendments to wording were noted. 

9.10.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 November, 2004.

9.11 voriconazole (VFEND):  Pfizer Limited  (No. 142/04)

9.11.1 Declarations of interest were recorded in relation to this product/comparator drugs.

9.11.2 The NDC Chairman provided an overview of the assessment, the key issues identified and the draft summary recommendation. Detailed discussion followed and the group agreed that voriconazole (VFEND)  for the treatment of invasive aspergillosis, should be accepted for restricted use within NHS Scotland. Amendments to wording were noted. 

9.11.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 November, 2004.

9.12 etomidate -Lipuro:  B Braun Medical Limited  (No. 143/04)

9.12.1 There were no declarations of interest in relation to this product/comparator products.

9.12.2 The NDC Chairman provided an overview of the assessment, the key issues identified and the draft summary recommendation. Detailed discussion followed and the group agreed that etomidate¿-Lipuro for general anaesthesia in children, should be accepted for use within NHS Scotland. Amendments to wording were noted. 

9.12.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 November, 2004.

10 Forthcoming Submissions
 
10.1 A revised list of forthcoming submissions was reviewed. It was noted that there was an increase in the number of NDC recommendations to be considered at the December meeting of SMC. Measures put in place to address the backlog of recent submissions are beginning to take effect and it is hoped that the backlog will be fully addressed by March 2005.

10.2 Members were asked to note that there would be no meeting in January 2005, but this change to the meeting schedule would allow a longer period between NDC and SMC meetings thereby permitting members to receive details of company comments well in advance of meetings.

10.3 Pharmaceutical companies will wish to note that when the next general election is called, the issue of SMC advice will be subject to a period of purdah.

11 ADTC Feedback

11.1 No matters were raised in relation to ADTCs.

12 SMC Website Statistics

12.1 Ms Murray gave a brief explanation of the usage statistics for the SMC website.  Members noted the website statistics.

13 Any Other Business

13.1 No other business was raised.

14 Handover to New Chairman

The retiring Chairman, Professor David Lawson, expressed his profound thanks individually to all those concerned in the formation, development and continuing work of the Scottish Medicines Consortium. He was greatly impressed with the progress of SMC over the last three years, during which time almost 150 submissions had been considered, and advised upon. The pressures upon both the assessment teams, members of New Drugs Committee and members of SMC itself had been unrelenting. However they had been surmounted with enthusiasm. Members of the SMC team were to be congratulated upon their successful development of an internationally recognised contribution to medicines management. It was his privilege to hand over the Chair of the Scottish Medicines Consortium to David Webb, Christison Professor of Therapeutics and Clinical Pharmacology in the University of Edinburgh.

Professor Webb accepted the Chairmanship and thanked Professor Lawson for providing the vision and expertise required for the successful establishment in Scotland both of ADTCs and subsequently the Scottish Medicines Consortium. Professor Webb, in accepting the Chair, expressed his aim to continue to build on Professor Lawson's work.

15 Date of Next Meeting

The date of the next meeting was confirmed as Tuesday 7 December, 2004, at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

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