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SMC Minutes - Tuesday, 5 March 2002

Present:
Professor David Lawson (Chairman); Mr Jeff Ace; Dr Keith Beard; Ms Marion Bennie; Professor Martin Brodie; Ms Michelle Caldwell; Professor Karen Facey; Ms Kim Fellows; Dr John Forbes; Dr Barclay Goudie; Dr David Hood; Mrs Chris McBeath; Dr Robert MacFadyen; Ms Wendy Nganasurian; Mr Chris Nicholson; Dr Brian Paice; Dr Kenneth Paterson; Dr Keith Ridge; Dr Philip Rutledge; Ms Fiona Scott; Ms Angela Timoney; Dr Andrew Walker; Dr John Webster; Mr Mike Wallace; Professor David Webb; Dr Lesley Wilkie; Mr Derek Yuille

In Attendance:
Ms Morag Ferguson; Ms Moira Howie; Mr Hector Mackenzie; Mrs Jill Mitchell; Mr Bill Scott; Dr Hugh Whyte

Apologies:
Mr Tom Divers; Professor Angus Mackay; Dr Marianne Nicholson;Ms Helen Tyrell
 

1. Introduction

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

2.  Minutes of the Previous Meeting (08.01.02)

2.1 The minutes of the meeting of 8 January 2002 were accepted as accurate.

3. Matters Arising from the Previous Minutes

3.1 Appeals/Submission Reviews

3.1.1 The Chairman advised that a paper was being prepared for discussion at the April meeting.

3.2 Extension of Clinical Trials Pre and Post Marketing

3.2.1 A meeting had taken place with ABPI members and a further one was planned.  The outcome of these meetings and any updates would be reported back to the Consortium in due course.

4. New Drugs Committee Update

4.1 Appointment of Vice Chairman

4.1.1 The Chairman of the NDC provided an update on NDC activities.  It was noted that Dr Ken Paterson had been appointed as Vice Chairman of the NDC.

4.2 Submission Packs

4.2.1 The NDC has prepared a submission pack for industry which included an introduction sheet, a submission form and guidance notes for completion of the submission form.  This had been circulated via ABPI and issued to companies identified on the new drugs list.  It was highlighted that for the first three months, NDC would evaluate new chemical entities only and a paper was tabled which outlined forthcoming submissions.

4.3 Economic Working Group

4.3.1 An Economic working group of NDC had been formed.  The group were reviewing the list of products produced via Pharmatrak to identify and plan economic resource implications.

4.4 Training Event

4.4.1 It was noted that it would be beneficial to have a joint meeting between SMC and NDC members.  A joint training event was scheduled for 23 April, 2002, and a programme for the day had been circulated to both SMC and NDC members.

4.5 Expert Involvement

4.5.1 The NDC members requested clarification regarding expert involvement and noted the benefits of such input.  It was recorded in previous minutes that SMC was in agreement with this but no mechanisms for selection had been proposed.  Discussions took place regarding such mechanisms and it was agreed that NDC submit a paper on this topic for the April meeting.

4.6 User Group

4.6.1 It was suggested that a user group be established in conjunction with ABPI to address process issues and to provide a forum for feedback.  It was felt that this would enhance relationships between organisations and provide transparency to the SMC/NDC process.  It was agreed to establish a user group with an initial meeting scheduled for June/July 2002.

4.7 Website Development

4.7.1 It was felt that a secure members section on the website would be beneficial to NDC members to access documents and should be considered as a future development.  It was noted that there would be a financial implication in establishing this and a paper would be submitted to SMC when a detailed costing becomes available.

5. List of Medicines

5.1 A list of products compiled by Pharmatrak was tabled which highlighted forthcoming submissions.

6. NDC Recommendation Reports

6.1 Imatinib Mesylate

6.1.1 The NDC Chairman provided a detailed summary of the assessment and recommendation that had been concluded by the NDC.  Extensive discussion took place regarding the recommendation and the issues highlighted in relation to the assessment.  It was noted that the product was authorised under exceptional circumstances by the EMEA under orphan status rules.  Thus thee were few major clinical outcome results available as yet, the major emphasis being on the cyto-genetic responses obtained.

6.1.2 It was observed that the British Society of Haematologists (BSH) had provided detailed guidelines on the suggested use of this product in the UK.  These views were taken into account in making the final recommendation on this product.  It was agreed that all CML patients receiving the drug in Scotland should be handled in the manner advised by the BSH.  Thus the majority of newly diagnosed patients with CML would be entered into the MRC Spirit trial. 

6.1.3 It was agreed that the following recommendation be made for Imatinib:

Category 2:  Recommended for restricted use within the NHS in Scotland.

Approved for treatment of chronic myeloid leukaemia under the overall supervision of haematologists/oncologists, within the context of the current guidelines on this medicine issued by the British Society of Haematology (November 2001).

REASONS FOR ADVICE

Imatinib is the first treatment to offer major cytogenetic responses in chronic myeloid leukaemia.  This approach appears to provide a significant  advance in the treatment of a hitherto fatal haematological malignancy.

6.1.4 The Chairman stated that the SMC recommendation would be issued to NHS Boards and ADTCs on the Friday following the meeting.  The recommendation would be posted to the SMC website on the first Friday following the April meeting.  This would allow NHS Boards approximately one month prior to the information being made available in the public domain.  The Chairman stressed the confidential nature of the process until the recommendation is made available on the website.

7. Communication

7.1 SMC Communication Strategy

7.1.1 A draft Communication Strategy had been drafted by Ms Ann Single, HTBS.  It was noted that paper copies of recommendation reports from SMC could be requested via the secretariat.

7.2 SMC Website

7.2.1 It was noted that the SMC website (www.scottishmedicines.org.uk) went live at the beginning of March 2002.

7.3 Frequently Asked Questions Document

7.3.1 A draft FAQ document had been compiled by the working group and submitted for discussion.  Members were requested to pass comments via e-mail to Ms Moira Howie, who would collate the responses and finalise the document which would be presented to the SMC for debate in April.

8. Indemnity

8.1 Mr Hector Mackenzie (SEHD) provided a summary of the response that had been received in relation to indemnity of SMC/NDC members.  It was noted that under standard Health Board arrangements, cover would be provided from NHS Boards for nominated members who were NHS/University employees.  It was noted that General Practitioners would require to advise their defence unions in relation to their input to SMC/NDC.  It was confirmed that SEHD would provide cover for lay representatives.

9. Meeting with NHS Board Chief Executives

9.1 The Chairman had met with NHS Board Chief Executives who were supportive of the role and remit of the SMC.  It was highlighted that local mechanisms should be established in order to receive and disseminate SMC advice.

10. Any Other Business

10.1 No further items for discussion were noted.

11. Date of Next Meeting

11.1 The date of the next meeting was confirmed as Tuesday 2 April, 2002, in HTBS Headquarters, Delta House, 50 West Nile Street. Glasgow.

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