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SMC Minutes - Tuesday 5 October 2004

Minutes of Meeting
Held on Tuesday 5 October, 2004
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman), Mr Jeff Ace, Professor James Barbour, Ms Chris Beech, Mrs Marion Bennie, Dr Corri Black, Professor Martin Brodie, Dr Keith Beard, 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, Ms Fiona Ramsay, Dr Andrew Riley, Ms Angela Timoney, Dr Sandy Simpson, Professor David Webb, Dr John Webster,
Mr Derek Yuille

In Attendance: Ms Joy Hosie, Dr Harpreet Kohli, Mr Rob MacPhail, Miss Rosie Murray, Mrs Maureen Stark

Apologies: Mrs Barbara Black, Mr Nick Bruce, Mr John Glennie, Professor Angus MacKay,
Mrs Laura McIver, Dr Phillip Rutledge, Mr Bill Scott, Ms Fiona Scott, Ms Helen Tyrrell, Mr Mike Wallace, Pamela Warrington

 

1 Welcome and Apologies for Absence

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

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 (07.09.04)

3.1 The minutes of the meeting of 7 September, 2004, were agreed as an accurate record of the meeting subject to a correction of the numbering of item 11, ADTC Feedback.

4 Matters Arising From the Previous Minutes

4.1 Relationship with SMC and NHS Quality Improvement Scotland

4.1.1 The Chairman advised members that following the discussion which had taken place at the previous meeting, significant progress had been made in addressing the ongoing problems with SMC's administrative arrangements and budget allocation.

Steps have been taken to secure SMC's budget for the current financial year and confirmation of the budget for subsequent years is anticipated by the end of October 2004.

Various measures have been introduced to increase SMC's capacity to undertake pharmacy and economic assessments and it is anticipated that this will allow the current backlog of submissions to be cleared by early 2005.

4.2 Scottish Antimicrobial Prescribing Policy and Practice Group

4.2.1 The Chief Medical Officer (CMO) had reviewed SMC's draft report and requested that a small number of amendments/additions be made before issue to NHS Boards and other relevant bodies.  A copy of the revised report was tabled for information.  The report should be regarded as 'In Confidence' until final approval is given by the CMO to release to the agreed distribution list. 

4.3 Freedom of Information

4.3.1 Paul Gibbons, consultant working with SMC regarding Freedom of Information updated members on developments.

SMC, as a consortium of Health Boards, does not have legal status in respect of the Freedom of Information (Scotland) Act.  Accordingly, a form of words has been drawn up for proposed inclusion into the Model Publication Scheme (MPS) for each of the fifteen NHS Boards.  This inclusion will allow the Boards to discharge their responsibility for disclosure of SMC information on behalf of their Area Drug and Therapeutic Committees.  The proposed inclusion will be referred to the FOI National Steering Group for approval.

4.3.2 It is anticipated that the majority of requests for information will be addressed by referral to the Detailed Advice which SMC currently provides to Health Boards and ADTCs on each product. Work is continuing to ensure that this document is in suitable format for full disclosure onto the public domain from the 1st January 2005.

A discussion followed on how to deal with comparator information from competitor companies, which may be included in the SMC Detailed Advice.  It was agreed that as a matter of safety and courtesy, the SMC Detailed Advice should be sent to each competitor company whose data are included.  This should be done when the advice notice is sent to ADTCs and Health Boards, but before the document goes into the public domain.  This will afford the competitor company the opportunity to notify SMC of any factual errors in the scientific information contained therein.
 
It was agreed that further consideration would be needed on how to deal with situations where a generic product is used as a comparator.

4.3.3 Ms Hosie advised that she was seeking further guidance on exemption criteria in relation to 'Commercial In Confidence' information.  The balancing test on whether an exemption applies appears to be the 'overriding harm versus disclosure'.  Ms Hosie will provide written details of her findings to date, for information. 

4.3.4 A further meeting of the FOI Sub Group is scheduled for Tuesday 2 November, 2004, and members will be updated on developments.

4.4 Public Domain Working Group

4.4.1 This item was considered at 4.3.2, above.

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

4.5.1 Dr Beard, as Chair of the Short Life Working Group, provided a summary of the key points discussed by the Group. 

The Working Group acknowledged that the British Society for Rheumatology (BSR) had prepared guidelines, which offered systematic and reviewed recommendations for the prescribing of licensed anti-TNFá therapies in adult patients with active Psoriatic Arthritis (PsA).  As a significant amount of work had been done to prepare the BSR guidelines, and it was anticipated that they would likely form the basis of national guidelines, the Group agreed to use them as a template for discussion.

The Working Group's proposals for Implementation Guidelines will include the following criteria, tailored for use in Scotland:
- Inclusion Criteria
- Exclusion Criteria
- Stopping Rules
- Clinical Monitoring, Audit and Evaluation
- Safety Monitoring

4.5.2 The Chairman thanked the Working Group for having done a superb job within very tight timescales.  Following a detailed discussion of the Working Group's findings the following points were agreed:

  • SMC were happy to consider BSR guidelines for inclusion and exclusion criteria.
  • Short term stopping rules should be in accordance with BSR guidelines, however, initially at least, long term stopping rules should be based on clinical judgement of all the prevailing factors.  It is likely that this therapy will be reviewed by NICE in due course.
  • In principle, each Health Board should have at least one and preferably two lead clinicians, one from rheumatology and the other from dermatology.
  • Adoption of the BSR monitoring format was acceptable, however it was considered desirable to develop a suitable system for collecting and analysing data in Scotland.

4.5.3 It was agreed that representatives from the Working Group should meet with the Chairman and a representative Health Board Chief Executive, to finalise the guidelines for approval at the November meeting of SMC.

FULL SUBMISSIONS

4.6 ibandronic acid (Bondronat) - HCM: Roche (No.122/04)

4.6.1 SMC advice for ibandronic acid (Bondronat) for the treatment of tumour-induced hypercalcaemia with or without metastasis, will be posted on the SMC website on Monday 11 October, 2004.

4.7 ibondronic acid (Bondronat) - MBD: Roche (No.123/04)

4.7.1 SMC advice for ibondronic acid (Bondronat) for the prevention of skeletal events in patients with breast cancer and bone metastatis, will be posted on the SMC website on Monday11 October, 2004.

4.8 esomeprazole IV (Nexium): Astra Zeneca ( No.124/04)

4.8.1 SMC advice for esomeprazole IV (Nexium) for the treatment of gastroesophageal reflux disease will be posted on the SMC website on Monday 11 October, 2004. 
 
4.9 oxycodone (OxyNorm): Napp Pharmaceuticals (No.125/04)

4.9.1 SMC advice for oxycodone (OxyNorm), for the treatment of moderate to severe pain in patients with cancer, will be posted on the SMC website on Monday 11 October, 2004.  Minor amendments to wording were noted and SMC advice was reissued on Friday 8 October, 2004.

4.10 bortezomib (Velcade): Ortho Biotech (No.126/04)

4.10.1 SMC advice for bortezomib (Velcade), for the treatment of patients with multiple myeloma, will be posted on the SMC website on Monday 11 October, 2004.   Minor amendments to wording were noted and SMC advice was reissued on Friday 8 October, 2004

ABBREVIATED SUBMISSIONS

4.11 sumatriptan succinate (Imigran Radis): GlaxoSmithKline

4.11.1 SMC advice for sumatriptan succinate (Imigran Radis) for the treatment of acute migraine, will be posted on the SMC website on Monday 11 October, 2004.

5 Appeals Update

5.5.1 There were no further appeals to report

6 Correspondence

6.1 Study by former SMC Manager, Jill Mitchell

The Chairman advised that Jill Mitchell, former SMC Manager, is undertaking an evaluation study on SMC as part of her MSc thesis.  She is seeking information from SMC members in the form of a short questionnaire (or short telephone discussion).  The Chairman commended the study to members and requested that they collaborate with Jill, if at all possible.

7 Patient and Public Involvement Group (PAPIG)

7.1 Recruitment of Lay Members

Prompted by a recent unsolicited expression of interest from a member of the public in becoming a lay member, the Patient and Public Involvement Group had considered the major issues which should be addressed when handling such enquiries and when recruiting future lay members.

As a result of the Group's considerations a number of recommendations were proposed for approval by SMC.  It was agreed that PAPIG should develop their approach for application when recruitment of an additional lay member is required.
 
8 New Drugs Committee Update

8.1 Review of NDC Decisions by SMC

8.1.1 NDC had reflected on those submissions where SMC had made recommendations, which were at variance with NDC.  NDC concluded that it should continue to be circumspect in its decision-making and base its advice on actual available data.  It was acknowledged that it was the role of SMC to consider the wider perspective and if appropriate, overturn the NDC recommendation.
 
9 NDC Assessment Reports - Full Submissions

9.1 testosterone mucoadhesive buccal (prolonged release) tablets (Striant) (No. 128/04)

9.1.1 No 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 and draft recommendation.  Detailed discussion followed and the group agreed that testosterone 30mg mucoadhesive buccal (prolonged release) tablets (Striant), a testosterone replacement therapy, should be 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 08 October, 2004.

9.2 solifenacin (Vesicare): Yamanouchi (No. 129/04)

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, draft recommendation and comments received from the company.  Detailed discussion followed and the group agreed that solifenacin (Vesicare), for the treatment of urge incontinence, is not recommended for use within NHS Scotland.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 08 October, 2004.

9.3 Conjugated oestrogen, medroxyprogesterone (Premique Low Dose):
Wyeth (No.130/04)

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, draft recommendation, comments received from the company and  Patient Interest Group Submissions.  Detailed discussion followed and the group agreed that conjugated oestrogen, medroxyprogesterone (Premique Low Dose), as a hormone replacement therapy, 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 08 October, 2004.

9.4 Losartan (Cozaar): Merck Sharp & Dohme (No.131/04)

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

9.4.2 The NDC 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 losartan (Cozaar), to delay the progression of renal disease in patients with type 2 diabetes, 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 08 October, 2004.

9.5 Aprepitant (Emend): Merck Sharpe & Dohme (No. 132/04)

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

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 aprepitant (Emend) for the prevention of acute and delayed nausea and vomiting associated with chemotherapy, should be accepted 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 08 October, 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 November meeting of SMC, however a significant number were for abbreviated submissions.  Measures have been put in place to address the backlog of recent submissions.

11 ADTC Feedback

11.1 No matters were raised in relation to ADTCs.

12 An Industry Perspective on NDC - Presentation by Nick Bruce

12.1 Nick Bruce had regretfully submitted his apologies and it was agreed that this item should be re-scheduled for a future meeting.

13 Any Other Business

13.1 Licensing of Medicines & Scottish Medicines Consortium

A draft policy statement on the licensing of medicines and SMC advice, drawn up in consultation with ABPI, was submitted for consideration and approval.  It was agreed that once final editing and formatting was complete the statement should be included on the SMC website.
 
13.2 Re-submission of laronidase (Aldruazyme)

Confirmation was given that the Patient Information Group Submission made at the time of the original submission would be re-issued to the committee for review, together with any additional comments received.

15 Date of Next Meeting

15.1 The date of the next meeting was confirmed as Tuesday 2 November, 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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