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SMC Minutes - Tuesday 7 December 2004

Minutes of Meeting held on Tuesday 7th December, 2004
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Professor James Barbour, Dr Keith Beard, Ms Chris Beech, Mrs Marion Bennie, Mrs Barbara Black, Professor John Cairns, Ms Michelle Caldwell, Mr Tom Divers, Dr Peter Donnan, Dr Barclay Goudie, Dr David Hood, Mrs Moira Howie, Professor Angus MacKay, Ms Angela Munday, Mr Chris Nicolson, Ms Wendy Nganasurian, Dr Ken Paterson,  
Ms Fiona Ramsay, Dr Andrew Riley, Dr Phillip Rutledge, Ms Fiona Scott, Mr Mike Wallace, Dr John Webster

In Attendance: Ms Sharon Hems, Dr Harpreet Kohli, Mr Hector MacKenzie, Mr Colin McAllister,
Mrs Laura McIver, Miss Rosie Murray, Mrs Maureen Stark

Apologies: Mr Jeff Ace, Dr Corri Black, Professor Martin Brodie, Mr John Glennie, Dr John Haughney, Dr Chris Lush, Dr Marianne Nicholson, Dr Sandy Simpson, Ms Angela Timoney,
Ms Helen Tyrrell, Ms Pamela Warrington, Mr Derek Yuille

1 Welcome and Apologies for Absence

1.1 Professor David Webb, in his first meeting as Chairman, welcomed members and apologies for absence were noted.  Mr Wallace, ABPI, on behalf of the Consortium, congratulated Professor David Webb on his appointment to the Chair of the Scottish Medicines Consortium (SMC).

1.2 A welcome was extended to Mr Colin McAllister, Head of Communications, NHS Quality Improvement Scotland (QiS), and Ms Sharon Hems, temporary member of the Pharmacy Assessment Team, who were observing the work of SMC.

1.3 It was noted that Ms Joy Hosie, representing the Central Legal Office (CLO), had been seconded to the Scottish Executive.  Ms Morag Ferguson will support SMC during her period of absence. 

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 (02.11.04)

3.1 The minutes of the meeting of 2nd November, 2004, were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1 SMC Antimicrobial Prescribing Policy and Practice Group (SAPPPG)

4.1.1 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.

4.2 Freedom of Information

4.2.1 As SMC is a consortium of Health Boards, it cannot respond directly to requests for information under the Freedom of Information Act.  Devolved responsibility for responding to such requests will rest with NHS Boards and ADTCs. 

4.2.2 The Secretariat is currently arranging a meeting between representatives of SMC, ADTCs and NHS Boards to discuss the operation of the scheme in detail.  It is anticipated that this will take place in January 2005, once further representatives are identified. 

FULL SUBMISSIONS

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

4.3.1 SMC advice for miglustat (Zavesca ©), for the treatment of type 1 Gaucher disease, will be posted on the SMC website on Monday13 December, 2004.

4.4 ertapenem (Invanz®): Merck Sharp & Dohme  (No. 134/04)

4.4.1 SMC advice for ertapenem (Invanz®), for the treatment of intra-abdominal infection, will be posted on the SMC website on Monday13 December, 2004.

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

4.5.1 SMC advice for rituximab (MabThera®), for the treatment of stage III - IV follicular lymphoma, will be posted on the SMC website on Monday 13 December, 2004. 
 
4.6 eplerenone (Inspra): Pfizer Ltd (No. 136/04)

4.6.1 SMC advice for eplerenone (Inspra), to reduce the risk of cardiovascular mortality and morbidity in recent myocardial infarction, will be posted on the SMC website on Monday 13 December, 2004.  Minor amendments to wording were noted.

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

4.7.1 SMC advice for paracetamol infusion (Perfalgan®), for the short term treatment of moderate pain following surgery and fever, will be posted on the SMC website on Monday 13 December, 2004.

RE-SUBMISSION

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

4.8.1 SMC advice for laronidase (Aldurazyme), for the treatment of mucopolysaccharidosis, will be posted on the SMC website on Monday 13 December, 2004.

ABBREVIATED SUBMISSIONS

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

4.9.1 SMC advice for insulin detemir (Levemir®), for the treatment of diabetes mellitus, will be withheld pending confirmation of licence/launch.

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

4.10.1 SMC advice for reminyl XL for the treatment of dementia in Alzheimer's disease, will be withheld pending confirmation of licence/launch.

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

4.11.1 SMC advice for rosiglitazone maleate/metformin hydrochloride (Avandmet) for the treatment of type 2 diabetes mellitus, will be posted on the SMC website on Monday 13 December, 2004.

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

4.12.1 SMC advice for creon micro (Creon) for the treatment of pancreatic exocrine insufficiency, will be posted on the SMC website on Monday 13 December, 2004.

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

4.13.1 SMC advice for voriconazole (VFEND) for the treatment of invasive aspergillosis, will be posted on the SMC website on Monday 13 December, 2004.

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

4.14.1 SMC advice for etomidate'-Lipuro for the induction of general anaesthesia , will be posted on the SMC website on Monday 13 December, 2004.

4.15 Ratification of SMC Advice for Issue in January 2005

As there will be no meeting of SMC in January 2005, the Chairman sought approval for the Executive Team to ratify the SMC Detailed Advice and minutes from the December meeting of SMC, for issue into the public domain on 10 January 2005.  Members approved the request.

5 Appeals Update

5.1 It was noted that the company intended to make a re-submission for eplerenone (Inspra): Pfizer Ltd (No. 136/04).

6 PAPIG

6.1 Mrs Nganasurian reported that an invitation to observe an SMC meeting, had been extended to eight Patient Interest Groups who had previously made a submission to SMC. She was pleased to report that seven out of the eight groups have accepted the invitation. One representative per patient group will be invited to attend any one SMC meeting.

Mrs Nganasurian highlighted that several of the products on the agenda were relevant to Patient Interest Groups who had previously made a submission to SMC but no Patient Interest Group submissions had been received in this instance.  She requested that SMC consider the possible reasons for non-submission and it was agreed that informal enquiries about non-submission should be pursued through PAPIG.

7 New Drug Committee: Update

7.1 Review of recent NDC meeting

7.1.1 The Chairman of NDC advised that there were no matters arising from NDC.

8 Chairman's Business

8.1 Comparator Medications

8.1.1 Mrs McIver presented a tabled paper which outlined the proposed process for making the SMC Detailed Advice Document available to the public via the SMC website from February 2005.  The generic framework for the web based version of SMC advice was developed in collaboration with the pharmaceutical industry.  It was agreed that manufacturers of comparator products mentioned within the advice would have the opportunity to comment on the factual accuracy of their data and guidance had been developed to clarify this process.

8.1.2 Mr Wallace, ABPI, commended the proposals as helpful and constructive and was given approval to circulate the proposals to the SMC User Group immediately.  He added a caveat that comparator companies should be reminded of the need to observe confidentiality and timelines for the release of information into the public domain.

8.1.3 A discussion followed on the inclusion of off-label products in SMC advice, it was agreed that it was appropriate to use such a product as a comparator if it was accepted evidence-based practice to use it off-label. 

8.1.4 The Discussion paper on Comparator Medicines was approved for implementation subject to ongoing review.

8.2 Content of SMC Advice

8.2.1 Further to an issue raised in discussion at the recent SMC Industry Briefing, Mrs Howie asked whether there would be any change to the Detailed Advice Document to reflect more fully on SMC deliberations when considering their final advice.  The Chairman acknowledged the importance of the issue. He responded that the revised timetable for SMC and NDC meetings in 2005 would assist in clarifying the matter as it allowed a longer time for company comments on the NDC recommendation to be considered prior to the SMC meeting.  In addition, work was ongoing to develop the content of SMC advice and it was expected that these measures would serve to improve the matter.

8.3 Medicines and Healthcare products Regulatory Agency (MHRA) Regulations

8.3.1 Further to a recent discussion paper from the MHRA on proposals for members of key committees and conflicts of interest, Dr K Paterson is preparing a response on behalf of SMC. Members were requested to forward comments to Dr Paterson.

8.4 Meeting of SMC Chairman with Chief Medical Officer, Scotland (CMO)

8.4.1 The Chairman gave a brief update on his recent meeting with the CMO, Scotland.

8.5 Presentation to NHS QiS Board by SMC Chairman

8.5.1 Following his recent presentation to the Board of NHS QiS, the chairman reported that he had had a useful discussion with Board members particularly in relation to horizon scanning and the monitoring and evaluation of SMC's work.

9 NDC Assessment Reports - Full Submissions

9.1 mycophenolate sodium (Myfortic): Novartis Pharmaceuticals (No. 144/04)

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

9.1.2 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 mycophenolate sodium (Myfortic), for the prophylaxis of acute renal transplant rejection is accepted for restricted use within NHS Scotland. Amendments to wording were noted.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 December 2004.
 
9.2 pregabalin (Lyrica): Pfizer (No. 145/04)

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, a Summary of Patient Information and comments received from the company.  Detailed discussion followed and the group agreed that pregabalin (Lyrica) for epilepsy, is accepted for restricted use within NHS Scotland.  

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 December, 2004.

9.3 efalizumab (Raptiva): Serono Ltd (No. 146/04)

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

9.3.2 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 efalizumab (Raptiva), for chronic plaque psoriasis should not be recommended for use within NHS Scotland. 

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 December, 2004.

9.4 caspofungin (Cancidas): Merck Sharp & Dohme Ltd (No. 147/04)
 
9.4.1 Declarations of interest were recorded in relation to this product/comparator drugs. 

9.4.2 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 caspofungin (Cancidas), for the treatment of fungal infections, 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 10 December, 2004.

9.5 metformin hydrochloride (Glucophage SR): Merck Pharmaceuticals

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 concluded their advice for metformin hydrochloride (Glucophage SR), for the treatment of type 2 diabetes mellitus. Amendments to wording were noted

9.5.3 The SMC advice will be withheld pending confirmation of licence/launch date for this treatment.

NDC Assessments - Re-submission

9.6 nicotinic acid modified release tabs (Niaspan): Merck Pharmaceuticals (No. 93/04)

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

9.6.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation, comments received from the company, and expert comments.  Discussion followed. The group agreed that nicotinic acid modified release tabs (Niaspan) for the treatment of dyslipidaemia and primary hypercholesterolaemia, 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, 10 December 2004.  
 
NDC Assessments ' Abbreviated Submissions

9.7 tamsulosin hydrochloride (Flomaxtra XL): Yamanouchi Pharma Ltd  (No.149/04)

9.7.1 There were no declarations of interest in relation to this product/comparator drugs.
 
9.7.2 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 tamsulosin hydrochloride (Flomaxtra XL) for the treatment of benign prostatic hyperplasia.  A current Summary of Product Characteristics (SPC) was requested.

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

9.8 levetiracetam (Keppra) 750mg tabs:  UCB Pharma Ltd (No. 150/04)

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 agreed that levetiracetam (Keppra) 750mg tabs, for the treatment of epilepsy should be accepted for restricted use within NHS Scotland.  Amendments to wording were noted.

9.8.3 The SMC advice will be issued to ADTCs and NHS Boards on, 10 December 2004.
 
9.9 levetiracetam (Keppra) 100mg oral solution: UCB Pharma Ltd (No. 151/04)
           
9.9.1 There were no declarations of interest 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 levetiracetam (Keppra) 100mg oral solution for the treatment of epilepsy should be accepted for restricted use within NHS Scotland. Amendments to wording were noted. 

9.9.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 December, 2004.

10 Forthcoming Submissions
 
10.1 A revised list of forthcoming submissions was reviewed.   The Chairman indicated that there was currently a backlog in outstanding assessments of one month and he was keen to redress the situation as quickly as possible.  It was agreed that a list of assessments pending could be shared with ADTCs.
 
10.2 In the interests of consistency, consideration was given to sharing details of forthcoming submissions with SIGN. The Chairman noted that it would be desirable to have a consistent approach, particularly as SIGN will become part of NHS QiS in January 2005.  It was agreed that further discussions to progress this matter would take place between SMC and NHS QiS in January 2005.

10.3 A member of the SMC User Group expressed concern over those products which are known to have received a licence but the manufacturers have omitted to make a submission to SMC.  The Chairman acknowledged the concern and was mindful of the need to address the matter. 

11 ADTC Feedback

11.1 No matters were raised in relation to ADTCs.

12 Any Other Business

12.1 Feedback from the SMC Industry Briefing Day: Monday 6th December 2005

12.1.1 Mr Wallace, thanked the Secretariat for arranging and the speakers for presenting the SMC Industry Briefing, 2004.  He reported on the following issues that emerged from discussion:

  • Industry had demonstrated an interest in progressing evaluation and monitoring processes for SMC.
  • Delegates proposed that membership of the SMC User Group should be on a rotational basis to allow wider industry participation.

12.2 SMC User Group

12.2.1 Mr Wallace provided an update on the latest meeting of the SMC User Group highlighting the following points:

  • The profile of SMC's abbreviated submission process was raised.
  • Industry had accepted the proposals for involving comparator companies in the issue of SMC Detailed Advice Documents and had expressed a willingness to co-operate with the review process.

12.3 Publication of SMC Advice in Professional Journals

12.3.1 It was noted that SMC Advice, in common with NICE Advice, had been published in the British National Formulary (BNF) from the September 2004 edition.  SMC Advice is also now available in the Pharmaceutical Journal. 

13 Date of Next Meeting

The date of the next meeting was confirmed as Tuesday 1 February, 2005, 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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