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SMC Minutes - Tuesday, 6 August 2002

Present:
Professor David Lawson (Chairman); Mr Jeff Ace; Dr Keith Beard; Mrs Marion Bennie; Professor Martin Brodie; Mrs Michelle Caldwell; Mr Tom Divers; Professor Karen Facey; Mrs Chris McBeath; Ms Wendy Nganasurian; Dr Philip Rutledge; Ms Fiona Scott; Dr Sandy Simpson; Ms Angela Timoney; Ms Helen Tyrrell; Mr Mike Wallace; Professor David Webb;Dr John Webster
 
In Attendance:
Dr Corrie Black; Mr Richard Clark; Ms Moira Howie; Mr Hector Mackenzie; Mr Rob MacPhail; Mrs Jill Mitchell; Ms Rosie Murray; Ms Pamela Warrington
 
Apologies:
Dr John Forbes; Dr Barclay Goudie; Dr David Hood; Professor Angus Mackay; Mr Chris Nicholson; Dr Marianne Nicholson; Dr Brian Paice; Dr Ken Paterson; Dr Keith Ridge; Mr Derek Yuille; Dr Leslie Wilkie; Ms Morag Ferguson; Mr Bill Scott; Mr Hugh Whtye

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed Dr Sandy Simpson, Medical Director, Eli Lilly to the meeting.  Dr Simpson replaced Kim Fellows as a member of the Consortium.  Mr Richard Clark, Pharmacy Assessor with Pharmatrak, was welcomed as an observer.  Apologies for absence were noted.  

1.2 The Chairman advised that Dr Robert MacFadyen has resigned from the Consortium as he has accepted a NHS consultancy post in Birmingham.  A replacement for Dr MacFadyen is currently being sourced.

2 Declarations of Interest

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

3 Minute of the Previous Meeting (02.07.02)

3.1 The minutes of the meeting of 2 July, 2002, were agreed as an accurate record with the following points raised:

5.3 Patient Involvement:  Clarity was sought regarding approval from ABPI to support the disclosure of product information.  It was reported that this is being discussed by ABPI and that a decision will be brought to the next SMC meeting.

8.2.1  ADTCs/NHS Board Contact Details:  It was suggested that the list of ADTC/NHS Board contacts is circulated with the minutes to allow members to review and advise of amendments accordingly.

3.2 The Minutes of the meeting of 2 July, 2002,  will be posted on the website on Friday 9 August, 2002.

4 Matters Arising From the Previous Minutes

4.1 Extension of Clinical Trials Pre & Post Marketing

The Chairman advised that there has been no progress on this item to date.

4.2 Bimatoprost (Lumigan): Allergan Ltd

4.2.1 The Chairman advised that the recommendation for Bimatoprost (Lumigan), for the treatment of glaucoma and ocular hypertension, will be posted on the SMC website on Friday 9 August, 2002.

4.3 Imatinib (Glivec) for GIST: Novartis

4.3.1 The Chairman advised that the recommendation Imatinib (Glivec), for gastro intestinal stromal tumours, will be posted on the SMC website on Friday 9 August, 2002.

4.4 Insulin Glargine (Lantus): Aventis

4.4.1 The Chairman reported that further information is awaited in relation to Insulin Glargine (Lantus).  An update will be provided at the next SMC meeting.

5 Appeals Update

5.1 The appeals process was reviewed with the addition of a flow chart for ease of reference.  The Chairman requested members review and feedback comments to the secretariat prior to the next meeting to enable the revised document to be posted on the SMC website.

5.2 The Chairman advised that an addendum detailing information regarding appeals/reviews will be routinely added to the Minutes.

An addendum to the SMC Minutes of 2 July, 2002, detailing the position with Anakinra (Kineret) and Biphasic Insulin Aspart 30 (Novomix 30) will be posted on the SMC website on Friday 9 August, 2002.

6 New Drugs Committee Update (Update from NDC Chairman)

6.1 Expert Involvement

6.1.1 The NDC Chairman advised the committee on NDCs desire to set up a panel of specialist advisors to provide advice on specific issues as necessary. He advised that a letter will be sent to ADTCs and NHS Boards requesting nominations from specialties and sub specialties within NHS Scotland.  Those nominated will be sent a letter inviting them to join an expert panel and will be given a paper outlining the requirements for expert involvement.  It was reported that nominations will be reviewed by the committee to ensure equity across expertise.  All experts being consulted by NDC would require to complete Confidentiality Statements and Declaration of Interests Forms. The issue of indemnity is being reviewed and will be clarified at the next SMC meeting.   Details of proposed membership of the panel would be presented to SMC as soon as practical.  This initiative was approved.

Involvement in this initiative from lay experts and the voluntary sector was discussed.  Although it was recognised that this could be a valuable contribution to the group it is hoped that the current template that is being developed for patient involvement will address this issue.  It was agreed that lay involvement in NDC would be reviewed and discussed at a later date.

The Chairman stated that it was not the intention to contact specialist organisations but that a general panel would be set up initially and the committee would co-opt as necessary.

The Committee agreed that it would be of great benefit to have an expert panel.  The secretariat will now write to ADTCs/NHS Boards to request nominations.

6.2 Evaluation of Work

6.2.1 Following a request from a member of the NDC, its Chairman asked if it was intended to evaluate the work of the SMC/NDC over a period of time.  The SMC Chairman advised that it is hoped that an annual report will be produced by the end of this year followed by an open meeting in January and therefore this is not something that would be considered imminently.  It was reported that Audit Scotland has undertaken similar projects in the past and may be interested in undertaking an evaluation.  It was recognised that there is a timing issue and that more assessments would need to be completed before an evaluation could commence. Members were supportive of the suggestion of looking at how effective both committees are in supplying information and what impact it is having at local levels in NHS Scotland.

7 NDC Recommendation Reports

7.1 Calcipotriol/Betamethasone Dipropionate (Dovobet): Leo Pharmaceuticals 

7.1.1 No declarations of interest were recorded in relation to this product and the comparator drugs.

7.1.2 The SMC Vice Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation.  Detailed discussion followed and amendments were noted in relation to the recommendation document.

The Chairman reported that correspondence had been received from Leo Pharmaceuticals advising that they are anticipating a change in the market authorisation for Dovobet from a twice daily to once daily application, almost certainly by the end of September.  This would have a significant effect on the cost of the product.

The committee noted that long term efficacy for the combination product has not been established.  Members concluded that Calcipotriol/Betamethasone Dipropionate (Dovobet), for the treatment of stable plaque psoriasis, was not recommended for routine use within NHS Scotland.

7.1.3 The SMC advice would be issued to ADTCs and NHS Boards on 9 August, 2002.

7.2 Pegylated interferon alfa-2a (Pegasys): Roche

7.2.1 Declaration of interests were recorded in relation to this product and the comparator drugs.

7.2.2 The SMC Vice Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation.  A brief summary of the points raised by the availability of the EPAR was made and a pre-published paper from the New England Journal of Medicine was tabled. Detailed discussion followed and amendments were noted in relation to the recommendation document. Pegylated interferon alfa-2a (Pegasys), for the treatment of hepatitis C, was recommended for restricted use within NHS Scotland in a manner similar to pegylated interferon alfa-2b.

7.2.3 The SMC advice would be issued to ADTCs and NHS Boards on 9 August, 2002.

8 List of Forthcoming Submissions

8.1 A list of forthcoming submissions were reviewed along with those drugs for which SMC are awaiting submissions. 

8.2 A draft work programme for issue to ADTCs was presented.   It was suggested that additional columns detailing information regarding appeal status, anticipated advice etc be added.  The document will be refined further prior to circulation.  The Chairman advised that general support from ABPI is awaited before the information will be distributed to ADTCs.

9 Communication

9.1 User Group Forum

9.1.1 The User Group Forum has been scheduled to meet on 13 August, 2002.  It is envisaged that the meeting will be productive and co-operative providing a useful outcome for both industry and the SMC. 

10 Any Other Business

10.1 Proposed Meeting Dates 2003

10.1.1 A list of meeting dates for 2003 was reviewed.  Members agreed to the dates proposed, namely the first Tuesday of each month.

11 Date of Next Meeting

11.1 The date of the next meeting was confirmed as Tuesday 3 September, 2002, at 12.30 pm (lunch from 12 noon), in HTBS Headquarters, Delta House, 50 West Nile Street, Glasgow G1 2NP.

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