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SMC Minutes - Tuesday, 2 April 2002

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

1. Introductions

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

2. Minute of the Previous Meeting (05.03.02)

2.1 The minutes of the meeting of 5 March 2002 were agreed as an accurate record with the exception of line 4, section 6.1.1, which should be altered to 'It was noted that the product was authorised under exceptional circumstances by the EMEA under orphan status rules.' The Chairman informed Members that the amended minutes would be published on the website on Friday 5 April 2002.

3. Matters Arising From the Previous Minutes

3.1 Extension of Clinical Trials Pre & Post Marketing

3.1.1 It was noted that representatives from ABPI medical committee were due to meet with SMC representatives within 4-6 weeks in order to continue discussions on the above topic.  It was agreed that this item be discussed further at a future SMC meeting.

3.2 Imatinib Mesylate Recommendation

3.2.1 It was agreed that the wording on the Summary of Recommendations should be amended from 'approved' to 'recommended'.  Whilst it was agreed that the SMC should adhere to the concept of giving advice under one of 3 categories, the categories themselves should not appear within the Summary of Recommendations.

3.2.2 It was agreed that the paragraph regarding cost-effectiveness should be omitted from page 5, of the confidential SMC Summary Document on Imatinib.

3.2.3 The MRC SPIRIT study was discussed and it was reported that approval for funding of this study was awaited. SMC would be kept informed of the progress.

3.2.4 The question of audit of recommended medicines was raised. The Chairman advised that audit would be required for only 3 or 4 drugs per year.   The resource implications of this were highlighted. SMC representatives were in discussion regarding the methodology of audit and that this subject would be discussed further in future meetings.

3.3 Media Release

The following amendments were agreed in relation to the press release:

  • The fourth word in paragraph 2 should be amended to 'recommended' instead of 'approved'.
  • Third paragraph 'cytogenetic responses' should be made clearer to the audience by paraphrasing to read 'improvement in the clinical response'.
  • In the third paragraph, 'fatal haematological malignancy' should be substituted by 'of this disease'.
  • The word 'significant' in the third paragraph to be deleted.

The following amendments were agreed in relation to the Notes for Editors section of the press release:

  • Second line of the first item should be altered from 'status' to 'use'.
  • In item 2, 'sub-working group' should be deleted.
  • Item 3 should read ".companies to make a submission" rather than "..complete a New Product Submission form".

It was agreed that the press release should be sent to press officers within the Area Boards, the applicant company, the press and the Scottish Executive Health Department.

4. New Drugs Committee (NDC) Update

4.1 NDC Vice Chairman reported that a standard power-point presentation was being produced and would be available to all members should they require it.

4.2 A small sub-group of the NDC had been formed to look at health economic issues. The Vice Chairman of the NDC 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.

4.3 The NDC was considering setting up a User Group, in approximately 6 months┬┐ time, to meet on an occasional basis, to feedback on procedures, critical appraisal and other forms in order to increase efficiency of procedures. 

4.4 It was clarified that the role of NDC would be to look at company submissions and Pharmatrak assessments and make recommendations to the SMC. Final recommendations from the SMC might include a report from NDC, but this would be under the auspices of the SMC.

5. NDC Recommendation Reports

5.1 Pegylated Alpha Interferon

NDC Vice Chairman discussed recommendations on this product (SMC 020402 (1)). The Members agreed to the recommendations with the following caveats:

  • Wording should be brought into line with the phraseology used for Imatinib.
  • Clarity was required on economic argument within the document.
  • A table should be entered in order to highlight the global cost.
  • The last sentence in the recommendation should be removed.

It was agreed that this item be discussed further at the next SMC meeting in May.


6. List of Forthcoming Submissions

6.1 The Chairman drew attention to SMC 020402 (2) with a list of forthcoming submissions.   The Vice Chairman of the NDC advised that only Tenofovir would be discussed at the NDC meeting on 9 April.  It was anticipated that thereafter 3 to 4 submissions would be considered at each meeting.

7. Appeal/Review Mechanisms

7.1 The Chairman drew attention to a revised paper on possible review procedures. After discussion, the Members agreed to the emphasis on transparent and open procedures. It was also agreed that it should be made explicit that competitor companies could not be part of the Appeal process. It was agreed that the second sentence within paragraph 3 of process issues, should be reworded from 'which was not available' to 'which was not submitted'. After further detailed discussions, the Chairman requested that any comments be submitted to him in writing.  He then requested Ms Hosie to review and edit the document for final consideration. 

8. Expert Involvement in NDC

8.1 The possibility of the NDC involving outside experts to assist in the decision making process was raised.  After discussion, it was agreed that SMC020402 (4) be circulated for further discussion at the next meeting.  A major concern expressed was the possibility of delay in concluding SMC recommendations if several experts were to be consulted. The representative from the CLO agreed to check on the legalities in relation to involving experts for only certain drugs.  It was agreed that further discussion was required to discuss practical solutions for patient involvement.

9. Communication

9.1 Frequently Asked Questions Document

A further paper on this topic was tabled (attached).  After discussion, it was agreed that there required to be rewording of the document to clarify various points raised at the meeting.  It was agreed that SMC representatives meet directly after the meeting to discuss further. This item will be discussed further at the next SMC meeting in May, however in the meantime an amended document would be piloted in confidence by several SMC members.

10. Any Other Business

10.1 The Chairman reminded Members that there would be a training session for SMC/NDC members on 23 April 2002.

11. Date of Next Meeting

11.1 The date of the next meeting was confirmed as Tuesday 7 May 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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