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SMC Minutes - Tuesday, 2 July 2002

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


 
1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting. Dr Corrie Black, Lecturer in Public Health Medicine, University of Aberdeen and Mr Rob MacPhail, Communications Officer, HTBS were welcomed as observers. 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 (11.06.02)

3.1 The minutes of the meeting of 11 June, 2002, were agreed as an accurate record. The Minutes will be posted on the website on Friday 5 July, 2002.

4 Matters Arising From the Previous Minutes

4.1 Extension of Clinical Trials Pre & Post Marketing

4.1.1 As the designated committee member was not present to advise on progress, extension of clinical trials pre and post marketing will be brought forward for discussion at the SMC meeting on 6 August, 2002.

4.2 Methylphenidate (Concerta): Janssen-Cilag

4.3 Biphasic Insulin Aspart 30 (Novomix 30): Novo Nordisk

4.4 Anakinra (Kineret): Amgen

4.5 The Chairman advised that the recommendations for Methylphenidate, Biphasic Insulin Aspart 30 and Anakinra would be posted on the SMC website on Friday 5 July, 2002.

The Chairman stated that Pharmatrak documents had required editing prior to general dissemination and advised that he is scheduled to meet with Pharmatrak to discuss refining the documentation.

The Chairman advised that applicant companies for Biphasic Insulin Aspart 30 and Anakinra wished to appeal against the SMC recommendation for their products and stated that there may therefore be two appeals in the near future. The Chairman advised that members may be called upon to form an appeals committee. 

5 New Drugs Committee Update (Update from NDC Chairman)

5.1 Glossary of Terms

5.1.1 As a working document, members were encouraged to advise the secretariat of suggestions for additions. The glossary will be posted on the SMC website in the near future. The Chairman thanked the Chairman of the NDC and stated that the Glossary of Terms would be a very useful document for both SMC and NDC members. 

5.2 NDC Recommendation to SMC

5.2.1 The NDC Chairman stated that he would be happy to work with Pharmatrak and Lead Assessors to improve the documentation and is keen to engender the view that a clear recommendation should be presented to SMC with little refinement necessary.

5.3 Patient Involvement

5.3.1 Discussions are ongoing regarding how to involve 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 and it is anticipated that this will be posted on the SMC website with specific questions, e.g. issues regarding disease, management of disease and prevalence in Scotland. A pilot will be undertaken with two Voluntary Health Organisations.

It was reported that HTBS have prepared a similar document providing guidance for patient, carer and voluntary organisations on submissions of evidence to Health Technology Assessments and it was suggested that members may find this document informative.

6 NDC Recommendation Reports

6.1 Bimatoprost (Lumigan): Allergan Ltd

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

6.1.2 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. Bimatoprost was recommended for general use within NHS Scotland for the treatment of glaucoma and ocular hypertension.

6.1.3 The SMC advice would be issued to ADTCs and NHS Boards on 5 July, 2002.

6.2 Imatinib (Glivec): Novartis

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

6.2.2 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. Imatinib (Glivec) for the treatment of gastrointestinal stromal tumours was recommended for restricted use within NHS Scotland.

6.2.3 The NDC Chairman stated that discussions were ongoing with Anna Gregor, Lead Cancer Clinician, to help provide a register of patients with this condition.

6.2.4 The SMC advice would be issued to ADTCs and NHS Boards on 5 July, 2002.  

6.3 Insulin Glargine (Lantus): Aventis

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

6.3.2 The NDC Vice Chair provided a detailed overview of the assessment, the key issues and draft recommendation. Detailed discussion followed and amendments were noted in relation to the recommendation document. 

6.3.3 The Chairman advised that a response has been received from the applicant Company in reply to the draft recommendation from NDC requesting an extension to the timescale to reply. Due to the unique set of circumstances, i.e the June SMC meeting was one week late due to jubilee celebrations, the company had a much shorter timescale within which to reply. The Committee agreed to an extension to the timescale within which to reply under these exceptional circumstances.

6.3.4 Due to the extension in timescale for the Company to formulate a response, SMC advice will not be issued to ADTCs and NHS Boards on 5 July, 2002. Advice will be issued the following month after consideration at the August meeting, i.e. 9 August, 2002.

7 List of Forthcoming Submissions

7.1 A list of forthcoming submissions were reviewed along with those drugs for which SMC are awaiting submissions. The NDC Chairman recommended  that SMC advise Companies, NHS Boards and ADTCs that medicines should not routinely be used in Scotland until reviewed by SMC. The Chairman agreed to include a statement with the recommendations being circulated to NHS Boards and ADTCs on Friday 5 July, 2002, to make this advice. 

7.2 In answer to a point of clarification, the Chairman emphasised that SMC advice was to NHS Boards and ADTCs. Individual clinicians were not debarred from prescribing licensed medicines in Scotland under exceptional circumstances for an individual patient but could be held accountable to their Trust were this to happen on a frequent basis before SMC advice was promulgated.

8 Communication

8.1 User Group Forum

8.1.1 The User Group Forum has been scheduled to meet on 13 August, 2002. It is envisaged that this will help to resolve any unforeseen process issues and clarify/amend existing processes in the light of experience. 

8.2 Information required by ADTCs and NHS Boards

The Chairman reported that there is no further update regarding information required by ADTCs and NHS Boards.

8.2.1 ADTCs/NHS Board Contact Details

The Chairman requested members review the list of ADTC and NHS Board contacts who routinely receive recommendations from SMC and to advise secretariat of any errors or amendments.

It was agreed that NICE should be included in the mailing list for the routine distribution of SMC recommendations issued on the Friday following the SMC meeting. Committee members were advised that they would be kept informed of the NICE work programme.

8.3 Frequently Asked Questions Document

8.3.1 The NDC Chairman stated that on review of the Frequently Asked Questions document at the NDC meeting there was concern that some questions had not been addressed. The SMC Chairman advised that this is a working document and any feedback is welcome. The current document will be posted on the SMC website in the near future.

8.4 General Distribution of Recommendations

8.4.1 It was suggested that the same vehicle used for HTBS to flag up recommendations to the public could be adopted by SMC whereby there is a subscription area on the website where interested parties can request details with the press release. The Chairman agreed to explore this and discuss at SMC meeting on 6 August, 2002.

9 Any Other Business

9.1 SEHD Indemnity

9.1.1 It was reported that the Scottish Executive Health Department has agreed to indemnify members in relation to their membership of the SMC and NDC.

9.1.2 The Central Legal Office representative agreed to clarify the SEHD position of indemnity with regards to the use of experts.

9.2 Appeals Process

9.2.1 In view of the pending appeals, clarity was sought regarding the appeals process. The Chairman stated that only the submitting company, NHS Boards or ADTCs are eligible to appeal. He confirmed that in line with the procedure for appealing decisions, an Independent Review Panel (IRP) will be appointed by the SMC comprising 7 members made up of 3 members from the SMC (ideally, but not exclusively people, who by reason of absence, have not been involved in the particular case, and in any event not including any members of the NDC) one of whom shall be appointed to chair the panel and 4 appointed members from ADTCs (or their equivalents) and/or other respected experts in the relevant scientific field. The Chairman confirmed if nominated experts had an interest in the submitting company they would not be eligible to sit on the appeals panel. The IRP would review the original material considered by the Company, Pharmatrak, the NDC and the SMC and also any letters submitted by the applicant. Their conclusions would then be available for comment by NDC before being considered by SMC.

A case for appeal would be submitted to the Chairman of the SMC and discussed with the applicant. Senior Officers of SMC (Chairman, Vice Chairpersons and Vice Chairman of NDC) would consider the request and decide upon its appropriateness.

The Chairman confirmed that companies could appeal in following circumstances:

In the event that a disagreement on interpretation of the original data seemed appropriate and cannot be resolved, the Chairman shall report the facts to the next meeting of the SMC and establish a group to carry out an independent assessment of the science (IRP).

In the event that it is agreed that there are substantial new data, the case shall be treated as a new application and referred to Pharmatrak/NDC, go through the normal SMC process, and be treated as a review application.

It was agreed that a copy of the appeals process would be attached to the minutes and posted on the website.

9.3 Alzheimer Scotland

9.3.1 Members noted correspondence from Alzheimer Scotland highlighting issues arising from the variations in policy and practice of health boards on the prescribing of anticholinesterases drugs in Scotland. The Chairman has advised Alzheimer Scotland of the remit of the SMC and has referred them to the Health Technology Board for Scotland.

10 Date of Next Meeting

10.1 The date of the next meeting was confirmed as Tuesday 6 August 2002, at 12.30 pm (lunch from 12 noon), in HTBS Headquarters, Delta House, 50 West Nile Street, Glasgow G1 2NP.


APPEALS UPDATE

Anakinra (Kineret), Amgen

Amgen have submitted additional information in relation to their product Anakinra (Kineret) and are seeking a review of SMC advice in the light of these additional data. 

Biphasic Insulin Aspart 30 (Novomix 30), Novo Nordisk 

Novo Nordisk have indicated their desire to submit additional information in relation to their product Biphasic Insulin Aspart 30 (Novomix 30) and have requested a review of SMC advice.

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