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SMC Minutes - Tuesday 1 February 2005

Minutes of Meeting held on Tuesday 1 February 2005
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Mr Jeff Ace, Professor James Barbour, Dr Keith Beard, Ms Chris Beech, Mrs Marion Bennie, Mrs Barbara Black, Dr Corri Black, Professor Martin Brodie, Professor John Cairns, Ms Michelle Caldwell, Mr Tom Divers, Dr Peter Donnan, Dr Barclay Goudie, Dr John Haughney, Dr David Hood, Mrs Moira Howie, Dr Chris Lush, Ms Angela Munday,  
Dr Marianne Nicholson, Mr Chris Nicolson, Ms Wendy Nganasurian, Dr Ken Paterson, Dr Andrew Riley, Dr Phillip Rutledge, Dr Sandy Simpson, Ms Angela Timoney, Ms Helen Tyrrell, Mr Mike Wallace, Dr John Webster, Mr Derek Yuille

In Attendance: Ms Sandra Blevings, Ms Morag Ferguson, Mr Paul Gibbons, Dr Harpreet Kohli,
Mr Hector MacKenzie, Mrs Laura McIver, Miss Rosie Murray, Mrs Maureen Stark

Apologies: Mr John Glennie, Professor Angus MacKay, Ms Fiona Ramsay, Ms Fiona Scott, Ms Pamela Warrington  

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members and apologies for absence were noted. 

1.2 A welcome was extended to Ms Sandra Blevings, Office (CLO) shortly to become adviser to SMC and Mr Paul Gibbons, adviser on Freedom of Information.
 
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.

2.2 Members were reminded that they should complete and return their annual Declaration of Interests for inclusion in the SMC Annual Report 2004, at the earliest opportunity.

2.3 Members were advised that, according to the Medicines and Healthcare products Regulatory Agency (MHRA) guidelines, interests are deemed to have lapsed after a 12 month period.

3 Minutes of the Previous Meeting (07.12.04)

3.1 The minutes of the meeting of 7 December, 2004, were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1  Secretariat Information Technology (IT) Systems

4.1.1 The Chairman advised members that the Secretariat IT Systems had been subject to failure and delays between mid December and mid January.  A series of IT problems had a significant effect on SMC processes, delaying or preventing the flow of work in and out.  The Secretariat had worked hard to minimise disruption and ensure continuity of service.  NHS Quality Improvement Scotland (NHS QiS) have intimated that they are working to rectify the problems and establish a disaster recovery and business continuity plan to prevent a recurrence in the future.

4.2 Freedom of Information (Scotland) Act  2002

4.2.1 Mr P Gibbons provided an update on progress, following a working group of representatives of SMC, ADTCs and NHS Boards.  Whilst SMC, as a Consortium of Health Boards, is not recognised as a public body under the terms of the Freedom of Information Act, it will operate in accordance with the principles of the Act.  A further meeting of the working group will be held to finalise a protocol for dealing with such requests.  The protocol will be submitted to SMC for ratification in due course.

4.2.2 Clinical Experts who agree to provide expert advice on product submissions should be advised that although SMC is not subject to the Act it will operate in accordance with the principles of the Act and may be required to disclose a response to a request, either under the act (via a Health Board) or in accordance with the SMC policy of openness.

4.3 Medicines and Healthcare products Regulatory  Agency (MHRA) Regulations - Draft SMC Response for Approval.

4.3.1 Dr K Paterson provided a draft response to the recent discussion paper from the MHRA on proposals for members of key committees and conflicts of interest.  A number of additional points arose from discussion of the draft response which Dr Paterson agreed to incorporate before finalising and submitting the document to the MHRA.
   
FULL SUBMISSIONS

4.4 mycofenolate sodium (Myfortic): Novartis Pharmaceuticals (No. 144/04)

4.4.1 A summary of SMC advice for mycofenolate sodium (Myfortic), for the prophylaxis of acute renal transplant rejection, was posted on the SMC website on Monday 10th January 2005. 

4.4.2 In accordance with a change in SMC procedures SMC Detailed Advice for mycofenolate sodium (Myfortic), will be posted on the SMC website on Monday 7th February 2005.

4.5 pregabalin (Lyrica): Pfizer (No. 145/04)

4.5.1 A summary of SMC advice for pregabalin (Lyrica), for the treatment of epilepsy, was posted on the SMC website on Monday 10th January 2005. 

4.5.2 In accordance with a change in SMC procedures SMC Detailed Advice for pregabalin (Lyrica), will be posted on the SMC website on Monday 7th February 2005.

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

4.6.1 A summary of SMC advice for efalizumab (Raptiva), for the treatment of chronic plaque psoriasis, was posted on the SMC website on Monday 10th January 2005.

4.6.2 In accordance with a change in SMC procedures SMC Detailed Advice for efalizumab (Raptiva), will be posted on the SMC website on Monday 7th February 2005.

4.6.3 Amendments to wording on the Detailed Advice Document were noted and will be advised to ADTCs and NHS Boards on Friday 4th February 2005.

4.7 caspofungin (Cancidas): Merck Sharp & Dohme Ltd (No. 147/04)

4.7.1 A summary of SMC advice for caspofungin (Cancidas), for the treatment of fungal infections was posted on the SMC website on Monday 10th January 2005.

4.7.2 In accordance with a change in SMC procedures SMC Detailed Advice for caspofungin (Cancidas), will be posted on the SMC website on Monday 7th February 2005.

4.8 metformin hydrochloride (Glucophage SR): Merck Pharmaceuticals (No. 148/04)

4.8.1 SMC Detailed Advice for metformin hydrochloride (Glucophage SR), for the treatment of type 2 diabetes mellitus, will be posted on the SMC website on Monday 7 March 2005.

RE-SUBMISSION

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

4.9.1 A summary of SMC advice for nicotinic acid modified release tabs (Niaspan), for the treatment of dyslipidaemia and primary hypercholesterolaemia, was posted on the SMC website on Monday 10th January 2005.

In accordance with a change in SMC procedures SMC Detailed Advice for nicotinic acid modified release tabs (Niaspan), will be posted on the SMC website on Monday 7th February 2005.

ABBREVIATED SUBMISSIONS

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

4.10.1 SMC advice for levetiracetam (Keppra) 750mg tabs for the treatment of epilepsy, partial onset seizures, was posted on the SMC website on Monday 10th January 2005.

4.11 levetiracetam (Keppra) 100mg oral solution: UCB Pharma Ltd (No: 151/04)

4.11.1 SMC advice for levetiracetam (Keppra) 100mg oral solution for the treatment of Epilepsy, partial onset seizures, was posted on the SMC website on Monday 10th January 2005.

5 Appeals Update

5.1 It was noted that Serono Ltd had notified their intention to make a re-submission for efalizumab (Raptiva)  (No. 146/04).

6 Patient and Public Involvement Group (PAPIG)

6.1 The minutes of a meeting of PAPIG, held on 7th December 2004 were noted.

6.2 It was noted that Ms H Tyrrell had represented PAPIG at a recent meeting with NHS Northern Ireland.  SMC's patient and public involvement process was acknowledged and well received by the meeting.

7 New Drug Committee (NDC): Update

7.1 Review of recent NDC meeting

7.1.1 Members were advised that there was a scheduled increase in the number of submissions to be considered at NDC in February 2005. This increase will mean that final advice for 8 full submissions and 6 abbreviated submissions will be considered by SMC in April 2005.

7.1.2 It has been agreed in principle, that NDC Lead Assessors would be encouraged to present submissions to SMC.  It was agreed that it would be helpful for NDC members to act as observers at SMC before making presentations to the committee.

7.2 NDC Membership

7.2.1 Members wished Mrs M Bennie, NDC Vice Chair, well over a period of temporary absence for Maternity Leave.  Dr J Jones will act as interim Vice Chair in Mrs Bennie's absence.

7.2.2 Mr K Tolley, ABPI representative on NDC, had recently accepted a new post and regretfully had to resign from NDC due to conflicting commitments.  ABPI has identified a replacement representative member.  Mr Tolley has expressed an interest in maintaining his links with SMC in some alternative forum and consideration will be given to the most suitable way of maintaining his association.

8 SMC Chairman's Business

8.1 SMC Chief Pharmacist

8.1.1 Funding has been confirmed for the post of SMC Chief Pharmacist.  On appointment the postholder will be responsible for linking horizon scanning to the work of SMC.

8.2 Horizon Scanning Proposal

8.2.1 Funding has now been secured on a recurring basis, for SMC's horizon scanning proposal.  Arrangements can now proceed to recruit a dedicated horizon scanning pharmacist.

8.3 SMC Conference 2005

8.3.1 The Chief Medical Officer (CMO) Scotland, has agreed to chair an SMC Conference to highlight the work and development of SMC.  A working group has been convened to co-ordinate the event which is expected to take place on 10th October 2005 in the Royal College of Physicians, Edinburgh.

8.4 Meeting with the Chairman of MHRA

8.4.1 The Chairman reported that he had recently had a useful meeting with Sir Alasdair Breckenridge, Chairman of MHRA.  Discussion centred around Orphan drugs and the problems with some new medicines receiving licences for indication which differed somewhat from those studied in clinical trials.

8.4.2 Consideration was given to possible future interaction between SMC and MHRA.  It was agreed that this matter should be discussed further at a future SMC meeting.

8.5 Pharmaco-epidemiological Research in Scotland

8.5.1 It was noted that the Chairman was pursuing information on a possible model for undertaking post-marketing research in Scotland using record linkage. Professor Peter Davey in Tayside was taking a lead in this matter. Members agreed that post marketing surveillance would be valuable to the work of SMC and other organisations.  The Chairman advised that he was pursuing this matter with the Chief Scientist, Professor Roland Jung, and had passed a copy of Professor Davey's paper on this matter to Professor Breckenridge, who is on the steering committee for the UK Clinical Research Collaboration.

8.6 Liaison with Industry

8.6.1 A tabled paper highlighting action points arising from the Industry Briefing, held on 6th December 2004, was noted by SMC. The SMC User Group will action the points arising at their next meeting.

8.6.2 Mr Wallace, ABPI, referred to the consultation paper issued by ABPI in relation to its revised Code of Conduct.  He advised that the Code should represent a fundamental change of perspective reflecting patients rather than industry. He encouraged SMC to respond to the discussion paper to ensure that the need to publish SMC advice in full was embedded in the Code. In addition, it was noted that the Code prevents pharmaceutical companies from providing information to persons with a non-medical background. This presents difficulties for Patient Information Groups (P.I.G.s) whom SMC encourage to approach companies for information.  Mr Wallace agreed to generate a consultation paper for consideration by SMC on 1st March 2005.

NDC Assessment Reports - Full Submissions

9.1 letrozole (Femara): Novartis  (No. 152/05)

9.1.1 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 expert comments.  Detailed discussion followed and the group agreed that letrozole (Femara,) for extended adjuvant therapy for breast cancer 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 Friday 4 February 2005.
 
9.2 atomoxetine (Strattera): Eli Lilly & Company (No. 153/04)

9.2.1 Declarations of interest were recorded in relation to this product/comparator drugs.  Two members with a personal specific interest left the room for the duration of the discussion.  An opinion from an expert with a personal specific interest was not considered by NDC and SMC.

9.2.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation, expert comments, a Summary of Patient Information, two Patient Interest Group submissions and comments received from the company.  Detailed discussion followed and the group agreed that atomoxetine (Strattera), for Attention Deficit/Hyperactivity Disorder (ADHD), should not be recommended for use within NHS Scotland.  

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 February 2005.

9.3 gemcitabine/paclitaxel (Gemzar): Eli Lilly & Company (No. 154/05)

9.3.1 Declarations of interest were recorded in relation to this product/comparator drugs.  Three members with a personal specific interest left the room for the duration of the discussion.     

9.3.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation, expert comments received from the company a Summary of Patient Information, one Patient Information Group Submission and comments received from the company. Detailed discussion followed and the group agreed that gemcitabine/paclitaxel (Gemzar), for Metastatic Breast Cancer, should not be recommended for use within NHS Scotland. 

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 February 2005.

9.4 cetuximab (Erbitux):  Merck Pharma (No. 155/05)

9.4.1 A declaration of interest was recorded in relation to this product/comparator drugs.  A member with a personal specific interest left the room for the duration of the discussion.     
   
9.4.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation, expert comments, two Patient Interest Group submissions and comments received from the company. Detailed discussion followed and the group agreed that cetuximab (Erbitux), for the treatment of colorectal cancer, should not be recommended for use within NHS Scotland.  Amendments to wording were noted.

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 February 2005.

9.5 bivalirudin (Angiox): Nycomed UK (No. 156/05)

9.5.1 Declarations of interest were recorded in relation to this product/comparator drugs.  Two members with a personal specific interest left the room for the duration of the discussion.     

9.5.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that bivalirudin (Angiox), as an anti-coagulant treatment for patients undergoing percutaneous coronary intervention (PCI), should be for restricted use within NHS Scotland. Amendments to wording were noted

9.5.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 February 2005.

9.6 pregabalin (Lyrica): Pfizer Ltd (No. 157/05)

9.6.1 Declarations of interest were recorded in relation to this product/comparator drugs.  A member with a personal specific interest left the room for the duration of the discussion.     
 
9.6.2 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 pregabalin (Lyrica), for the treatment of neuropathic pain, 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 Friday 4 February 2005.

10 ADTC Feedback

10.1 No matters were raised in relation to ADTCs.

11 Quality Adjusted Life Year (QALY) - Briefing note from Dr A Walker

11.1 The briefing paper was noted, with one comment from the Patient and Public Involvement Group (PAPIG).

12 Any Other Business

12.1 NICE Guidance for teriparatide

12.1.1 The NICE guidance for teriparatide was noted.

12.2 Key Points

12.2.1 Members noted that the Summary of Key points had been a useful assessment document in the past, but with the development of the Detailed Advice Document  (DAD) it was less useful and should be discontinued so that appropriate focus could be given to the content of the DAD.

12.3 Observer

12.3.1 It was agreed that a request from a newly appointed consultant, to observe an SMC meeting, should be granted.

12.4 Patient Interest Group Submissions

12.4.1 It was agreed that Patient Interest Groups who make a submission to SMC should automatically receive a copy of the Detailed Advice Document for the respective drug when it is released into the public domain.

12.5 Meeting of SMC Representatives with Representatives of NHS Northern Ireland

A successful meeting was held with members of NHS Northern Ireland to outline and update on SMC's role and processes.  NHS Northern Ireland are considering the information given and have requested an opportunity to observe meetings of NDC and SMC.

13 Date of Next Meeting

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