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SMC Minutes - Tuesday, 3 September 2002

Present:

Professor David Lawson (Chairman); Mr Jeff Ace; Dr Keith Beard; Mrs Michelle Caldwell; Professor Karen Facey; Dr Barclay Goudie; Dr David Hood; Mrs Chris McBeath; Dr Chris Lush; Ms Wendy Nganasurian; Mr Chris Nicholson; Dr Keith Ridge; Dr Philip Rutledge; Dr Sandy Simpson; Ms Angela Timoney; Ms Helen Tyrrell; Mr Derek Yuille; Mr Mike Wallace; Professor David Webb; Dr John Webster

In Attendance:

Dr Corrie Black; Ms Joy Hosie (for Morag Ferguson); Mr Hector Mackenzie; Mrs Jill Mitchell; Ms Rosie Murray; Ms Pamela Warrington (for Bill Scott)

Apologies:

Mrs Marion Bennie; Professor Martin Brodie; Mr Tom Divers; Dr John Forbes; Professor Angus Mackay; Dr Marianne Nicholson; Dr Brian Paice; Dr Ken Paterson; Ms Fiona Scott; Dr Leslie Wilkie; Ms Moira Howie; Mr Rob McPhail; Mr Hugh Whyte

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed Dr Chris Lush to the meeting. Dr Lush replaced Dr Robert MacFadyen as a member of the Consortium. Apologies for absence were noted. 

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 (06.08.02)

3.1 The minutes of the meeting of 6 August, 2002, were agreed as an accurate record of the meeting.

3.2 The Minutes of the meeting of 6 August, 2002, will be posted on the website on Friday 6 September, 2002.

4 Matters Arising From the Previous Minutes

4.1 Calcipotriol/Bethamethasone Dipropionate (Dovobet): Leo Pharmaceuticals

4.1.2 The Chairman advised that the recommendation for Calcipotriol/Bethamethasone Dipropionate (Dovobet) for the treatment of staple plaque psoriasis, will be posted on the SMC website on Friday 6 September, 2002.  

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

4.2.1 The Chairman advised that the recommendation for Pegylated interferon alfa-2a (Pegasys) for the treatment of hepatitis C will be posted on the SMC website on Friday 6 September, 2002.

4.3 At this point the Chairman highlighted that there appears to be some continuing confusion in companies regarding the different roles of SMC and NICE. The Chairman emphasised that the role of SMC is to advise NHS Boards and ADTCs and not to highlight individual details of a product or to undertake to comment upon relative benefits between similar new competing products.

5 Appeals Update

5.1 Minor amendments to the appeals process document were suggested. Amendments will be made and the revised document posted on the SMC website.

6 New Drugs Committee Update (Update from NDC Chairman)

6.1 Patient Involvement

6.1.1 It was reported that a Patient Involvement Group has been formed consisting of SMC/NDC members. Discussions are ongoing regarding involvement of patients in the decision making process through voluntary organisations. A template is being developed to provide advice to voluntary organisations on how they can become involved with SMC. This is in the early stages of discussion and it is not anticipated to take effect for several months. The general opinion at NDC was that involvement would perhaps be more appropriate at the SMC stage as it is crucial for NDC to review the scientific facts only, SMC members agreed.

The SMC Chairman advised that a decision from ABPI regarding the disclosure of future products coming to SMC will be reported to the next SMC meeting.

7 NDC Recommendation Reports

7.1 Insulin glargine (Lantus®): Aventis

7.1.1 Declarations of interest were recorded in relation to this product and the comparator drugs.

7.1.2 NICE Appraisal Consultation Document: Long-acting insulin analogues for the treatment of diabetes was tabled for information.

7.1.3 The NDC 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. Insulin glargine (Lantus®) was recommended for restricted use within NHS Scotland for the treatment of patients with diabetes mellitus.

7.1.4 The SMC advice will be issued to ADTCs and NHS Boards on 6 September, 2002.

7.2 Tacrolimus ointment 0.1% and 0.03% (Protopic®): Fujisawa

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

7.2.2 The SMC Vice Chair 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. Tacrolimus ointments (Protopic®) were recommended for restricted use within NHS Scotland for the treatment of adults with atopic dermatitis intolerant of - or unresponsive to conventional treatments - and for children aged 2 years or over who are unresponsive to conventional topical therapies.

7.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 6 September, 2002.

7.3 Drotrecogin alfa [activated] (Xigris®): Eli Lilly

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

7.3.2 Scottish Intensive Care Society: Draft Guidelines for Use of Activated Protein C were tabled for information.

7.3.3 The SMC Vice Chair 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. Drotrecogin alfa [activated] (Xigris®) was recommended for restricted use within NHS Scotland for the treatment of patients with severe sepsis with multi organ failure.

7.3.4 The SMC advice will be issued to ADTCs and NHS Boards on 6 September, 2002.

7.3.5 The Chairman stated that this had been a particularly clear and succinct application and it was agreed that he should write to the Chief Executive of the company to commend them on their submission.

8 List of Forthcoming Submissions

8.1 A revised list of forthcoming submissions was reviewed. 

8.2 Confirmation regarding patient involvement was sought in relation to being able to make significant input to the process. The Chairman advised that on receiving ABPI approval for reporting future workload on a three monthly basis, he will advise members of the Patient Involvement Group of this development. A positive outcome would allow the SMC work schedule, detailing basic information regarding product name, indication and company, to be routinely distributed to ADTCs and posted on the SMC website. This would then permit patient groups to formulate opinions for submission to SMC at the time of consideration of advice on new products to NHS Boards and ADTCs.

8.3 Clarification was sought regarding patient groups contacting manufacturers. The ABPI representative advised that he foresaw no difficulties with this. The SMC Vice Chair reported that discussions are already ongoing with two companies who have submitted to SMC to determine the best way for patients to interact with them.

9 Communication

9.1 User Group Forum

9.1.1 It was reported that the preliminary meeting was constructive and positive in aiming to resolve a number of issues. A sub-group has been formed to revise the current submission form and their advice will be reported to the SMC. The User Group have agreed to meet alternate months. It was agreed that action points from the meeting would be circulated to SMC/NDC members for information.

10 Any Other Business

10.1 Information required for NHS Boards

10.1.1 Confirmation was sought that SMC would be willing to receive comments upon their documentation of advice to NHS Boards. The Chairman advised that he would happy to review any such comments from NHS Boards.

11 Date of Next Meeting

11.1 The date of the next meeting was confirmed as Monday 30 September, 2002, at 12.30 pm (lunch from 12 noon), in HTBS Headquarters, Delta House, 50 West Nile Street, Glasgow G1 2NP.

Please note the change to Monday on this occasion.


ADDENDUM TO MINUTES

Appeals Update (as at 3 September, 2002)

Calcipotriol/Bethamethasone Dipropionate (Dovobet)

Leo Pharmaceuticals have indicated that they wish to submit additional information in relation to their product Calcipotriol/Bethamethasone Dipropionate (Dovobet) and are seeking a review of SMC position in the light of additional information. A resubmission is expected in due course from Leo Pharmaceuticals.

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