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SMC Minutes - Tuesday, 7 May 2002

Present:
Professor David Lawson (Chairman); Mr Jeff Ace; Dr Keith Beard; Ms Marion Bennie; Ms Michelle Caldwell; Professor Karen Facey; Ms Kim Fellows; Dr John Forbes; Dr Barclay Goudie; Dr David Hood; Ms Wendy Nganasurian; Mr Chris Nicholson; Mrs Chris McBeath; Dr Ken Paterson; Dr Philip Rutledge; Ms Angela Timoney; Ms Helen Tyrell; Mr Mike Wallace; Professor David Webb; Dr John Webster; Mr Derek Yuille
 
In Attendance:
Ms Joy Hosie; Ms Moira Howie; Mrs Jill Mitchell; Ms Rosie Murray; Dr Hugh Whyte
 
Apologies:
Ms Morag Ferguson; Professor Martin Brodie; Mr Tom Divers; Dr Robert MacFadyen; Professor Angus MacKay; Mr Hector Mackenzie; Dr Marianne Nicholson; Dr Brian Paice; Dr Keith Ridge; Ms Fiona Scott; Dr Leslie Wilkie
 

 

1. Welcome and Apologies for Absence

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

2. Minute of the Previous Meeting (02.04.02)

2.1 The minutes of the meeting of 2 April, 2002, were agreed as an accurate record with the following amendments noted:

  • Ms Moira Howie was present.
  • No 4.2, second sentence should be amended to (The Vice Chairman stated that the group had, through horizon scanning, produced a list of approximately 16 drugs which were identified to require significant economic assessment in the forthcoming year).

Amended minutes will be posted on the website on Friday 10 May, 2002.

2.2 Clarity was sought regarding the role of Pharmatrak.  It was noted that Pharmatrak was a section within Primary Care Information Unit, Information and Statistics Division, Edinburgh.  This group of pharmacists provide the scientific pharmacy assessment within the SMC process.

3. Matters Arising From the Previous Minutes

3.1 Extension of Clinical Trials Pre & Post Marketing

3.1.1 It was noted that discussions are ongoing and that any progress would be discussed at SMC meeting on 11 June, 2002.

3.2 Pegylated Alpha Interferon Recommendation

3.2.1 A minor amendment to the wording of the Summary of Recommendations was agreed.   The Chairman advised that the recommendation will be posted on the website on 10 May, 2002. 

3.2.2 Media enquiries had been received after the Imatinib recommendation. To avoid confusion, the Chairman reminded members that all media enquiries should be directed to Rob McPhail, Media Officer at HTBS.

3.3 Confidentiality of Recommendation Forms

3.3.1 The Chairman advised that a request had been received from NICE for a copy of the Imatinib assessment report.  It was agreed that company consent must be obtained and that NICE should sign a confidentiality agreement prior to release of data. 

3.3.2 The Chairman stated that the assessment of Imatinib was exceptional in so far as the drug had been licensed many months previously.  For this reason the NICE opinion would be within a few months of SMC advice.  He confirmed the philosophy of SMC would largely be to review newly licensed products.

3.4 MRC Spirit Study

3.4.1 A summary of the background of the MRC Spirit Study of Imatinib was provided.  It was noted that the MRC were reviewing the study and it is hoped that a decision regarding approval and funding will be reached by the summer.  Progress will be reported at a future SMC meeting.

3.5 Audit

3.5.1 The group were briefed regarding a meeting with Dr Anna Gregor, Lead Cancer Clinician, where discussion took place regarding the outcome evaluation of anti-cancer drug use in Scotland. 

3.5.2 The clinical oncology group requested notification of SMC recommendations one month prior to release.  SMC agreed that circulation of recommendations would remain restricted to ADTCs and NHS Boards only and overarching bodies could liaise with central bodies for information if required. 

3.6 Feedback from Training Event

3.6.1 The Chairman stated that feedback from the Training Day on 23 April, 2002, had been positive.  More time for discussion would have been useful.  The members agreed and indicated that the Chairman of the event was excellent.   It was noted that the pharmaceutical industry would benefit from a training event and it was agreed that this would be arranged within the next few months.

4. New Drugs Committee Update (Update from NDC Vice Chairman)

4.1.1 A glossary of terms is being developed and would be circulated to members for comment and posted on the SMC website.

4.1.2 Submissions received to date lack economic data. The group agreed that it would a useful subject to discuss in a User Group Forum.

4.1.3 The SMC secretariat had produced a standard power point presentation which specific members agreed to pilot and refine where necessary. Following this the presentation will be circulated to all SMC/NDC members.

5. NDC Recommendation Reports

5.1 Tenofovir disoproxil (Viread)

No declarations of interest in Gilead Sciences were made.

The NDC Vice Chairman provided a detailed overview of the assessment and draft recommendations.  There followed a detailed discussion of the efficacy measurements and of the economic analysis provided.  Minor amendments were made to NDC advice.   The SMC recommendation will be forwarded to ADTCs and NHS Boards on 10 May, 2002.

6. List of Forthcoming Submissions

6.1 A list of forthcoming submissions was reviewed.  The Chairman of the NDC emphasised that particularly if more than 3 submissions are being reviewed at NDC meetings, paperwork must be received for review 2 weekends in advance of the meeting. 

6.2 It was decided to provide a workplan on the SMC website outlining products to be reviewed within the next 3 months detailing basic details regarding the products, their manufacturer and a broad indication.  This data would be available to ADTCs and NHS Boards.

The website posting would take place after the issue of confidentiality was addressed.

7. Appeal/Review Mechanisms

7.1 The CLO submitted a revised version of the Appeal/Review Mechanisms paper.  The proposal for a review panel comprising members from SMC and ADTCs was agreed.  It was noted that the process of SMC was open and transparent and that the review proposal would be implemented and reviewed after one year.

7.2 Discussion took place regarding external representative bodies and their input to the SMC process.  It was noted that a published SMC workplan would be of benefit.  It was agreed that SMC should provide a policy statement on this issue and this would be drafted for the meeting on 11 June, 2002.

8. Expert Involvement

8.1 The use of specialist expert consultation on SMC submissions where necessary was discussed. The proposal to set up a panel of specialist advisors to provide factual advice as necessary was agreed. All experts being consulted by SMC would require to complete Confidentiality Statements and Register of Interests Forms. Initially, it was agreed that such advice would be available at the NDC stage although this would be kept under review over the coming months.

9. Communication

9.1 Website - Secure Members Section

An overview regarding the development of a secure website and associated costs was provided.  The group agreed to the status quo at present but to review the situation in 6 months. 

9.2 User Group Forum

9.2.1 It was agreed to set up a SMC User Group to give industry the opportunity to meet with the secretariat and a representative of NDC to discuss relevant issues.  It was agreed that the forum would be informal and would be arranged within the coming months.

10. Any Other Business

10.1 A request was made to reschedule the meeting on 1 October, 2002 to Monday 30 September, 2002. This was agreed.  The secretariat would confirm with members in due course after consulting with all SMC members. 

11. Date of Next Meeting

11.1 The date of the next meeting was confirmed as Tuesday 11 June 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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