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SMC Minutes - Tuesday, 2 September 2003

Minutes of Meeting
Held on Tuesday 2 September, 2003
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman), Mr Jeff Ace, Dr Keith Beard, Mrs Marion Bennie, Mrs Barbara Black, Professor Martin Brodie, Professor John Cairns, Mrs Michelle Caldwell, Mr Tom Divers, Professor Karen Facey, Dr Barclay Goudie, Ms Moira Howie, Dr Chris Lush, Mrs Chris McBeath, Mr Chris Nicholson, Dr Ken Paterson, Dr Philip Rutledge, Ms Fiona Scott, Dr Sandy Simpson, Ms Angela Timoney, Ms Helen Tyrrell, Mr Mike Wallace, Professor David Webb, Dr Derek Yuille

In Attendance: Ms Corri Black, Mr Rob MacPhail, Ms Ali McAllister, Ms Jill Mitchell

Apologies: Dr David Hood, Professor Angus Mackay, Mr Hector Mackenzie, Ms Wendy Nganasurian, Dr Marianne Nicholson, Dr Brian Paice, Dr John Webster, Dr Leslie Wilkie
  
1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting and apologies for absence were noted.   He reminded members of the confidential nature of proceedings.

2 Declarations of Interest

2.1 The Chairman requested members to declare interests in the products to be discussed and the comparator drugs as noted on the assessment reports.

3 Minutes of the Previous Meeting (05.08.03)

3.1 The minutes of the meeting of 5 August 2003 were agreed as an accurate record.

4 Matters Arising From the Previous Minutes

4.1 Olopatadine 1mg/ml eye drops (Optanol® 0.l%w/v eye drops), Alcon Laboratories (UK) Ltd, No. 59/03

4.1.1 The recommendation for Olopatadine 1mg/ml eye drops (Optanol® 0.l%w/v eye drops) will be posted on the SMC website on Monday, 8 September 2003.

4.2 Norelgestromin-ethinyloestradiol (EVRA®), Janssen-Cilag, No. 48/03

4.2.1 The recommendation for Norelgestromin-ethinyloestradiol (EVRA®) will be posted on the SMC website on Monday, 8 September 2003.

4.3 Perindopril/Indapamide (Coversyl Plus®), Servier Laboratories, No.64/03

4.3.1 The recommendation for Perindopril/Indapamide (Coversyl Plus®) will be posted on the SMC website on Monday, 8 September 2003.

4.4 Ezetimibe (Ezetrol®), Merck, Sharp & Dohme/Schering Plough, No. 61/03

4.4.1 The recommendation for Ezetimibe (Ezetrol®) will be posted on the SMC website on Monday, 8 September 2003.

4.5 Travoprost 40mg/ml eye drops (Travatan®), Alcon Laboratories, No.60/03 Abbreviated Submission

4.5.1 It was noted that a full submission in relation to this product had been requested from the applicant company.

4.6 Valganciclovir (Valcyte®), Roche, No. 62/03 Abbreviated Submission

4.6.1 The recommendation for Valganciclovir (Valcyte®) will be posted on the SMC website on Monday, 8 September 2003.

4.7 Desogesterel (Cerazette®), Organon Laboratories, No. 36/03 Resubmission

4.7.1 The recommendation for Desogesterel (Cerazette®) will be posted on the SMC website on Monday, 8 September 2003.

5 Appeals Update

5.1 Zoledronic Acid (Zometa®), Novartis, No. 29/02

It was noted that the independent review panel would meet on Monday, 27 October 2003 and the results of this review would be presented to SMC thereafter.

6 Correspondence

6.1 A letter had been received from Novartis outlining the company's intention not to make a submission to SMC in relation to Ketotifen (Zaditen®).  The consortium agreed that in line with SMC process this information should to be conveyed to NHS Boards and ADTCs in the form of a negative recommendation.   The secretariat will correspond further with Novartis to confirm their position before issuing this advice to NHS Boards and ADTCs.

6.2 It was noted that correspondence had been received outlining issues surrounding industry experiencing marketing difficulties in relation to established products in the market place.  It was emphasised that the remit of SMC was to undertake review of new medicines from March 2002.  It was emphasised that SMC would not normally be undertaking a review of products launched before this date.  It was also noted that the remit of SMC did not include review of classes of drugs. This role was currently being fulfilled by NICE.

7 Patient and Public Involvement Group (PAPIG)

7.1 A change of name of the group was noted as above.  Notes of the previous PAPIG meeting held on 5 August 2003 were circulated.  In future the notes of the PAPIG meetings would serve as updates for SMC meetings.

7.2 It was noted that the group were appreciative of the developments which had been incorporated into the new website.

7.3 The NHS QIS/ABPI Patient Involvement Group Training event has been scheduled for 23 January 2004.  Further details of the event would follow in due course.

8 Post Marketing Update

8.1 It was reported that Dr Beard was continuing his contact with the audit group of the Scottish Intensive Care Society and that progress has been made in relation to clinical effectiveness audit and monitoring in relation to the use of Drotrecogin.  Similarly, ongoing monitoring was being conducted on use of Imatinib (Glivec®).  It was noted that such work should be encouraged and that these data would be of interest to NHS Boards and ADTCs.  Further updates in respect of such developments would be reported at future SMC meetings.

9 New Drugs Committee Update

9.1 Teriparatide (Forsteo®), Eli Lilly

9.1.1 It was reported that the assessment in relation to Teriparatide (Forsteo®) had been deferred by NDC.  The submission was made to SMC in advance of product launch which provided an opportunity for clarification of health economic data.  

9.2 Health Economic Sub Group

9.2.1 The health economic sub group of the NDC had met and reported that a quality assurance double checking system had been adopted by the assessment team.  The group highlighted the requirement to train additional economic assessors and work would be undertaken to make a proposal to NDC and SMC in due course.  The request from the healthcare planning group to incorporate budget impact data was in progress.

9.3 Recommendation wording

9.3.1Discussion had taken place at NDC with regard to the recommendation classifications which are assigned by SMC.  Instances of marketing material were noted where industry were using top line SMC recommendation statements in marketing.  The NDC had agreed to compile a report in relation to the wording of SMC recommendations which would be submitted to SMC in the near future.

10 NDC Assessment Reports - Full submissions

10.1 Modafinil (Provigil®), Cephalon, No. 63/03

10.1.1 No declarations of interest were recorded in relation to this product or comparator drugs.

10.1.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and summary of comments received from the company.  Detailed discussion followed and the group agreed that Modafinil (Provigil®) for the treatment of excessive daytime sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome should not be recommended for use within NHS Scotland.

10.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 September 2003.

10.2 Moxifloxacin (Avelox®) in CAP, Bayer, No. 69/03

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

10.2.2 The SMC Vice Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation and summary of comments received from the company.  Detailed discussion followed and the group agreed that Moxifloxacin (Avelox®) in community acquired pneumonia, should be recommended for restricted use within NHS Scotland. Minor amendments to wording were noted.

10.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 September 2003.

10.3 Moxifloxacin (Avelox®) in AECB, Bayer, No. 70/03

10.3.1 Declarations of interest was recorded in relation to this product and comparator drugs.

10.3.2 The SMC Vice Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation and summary of comments received from the company. Detailed discussion followed and the group agreed that Moxifloxacin (Avelox®) in acute exacerbation of chronic bronchitis should be recommended for restricted use within NHS Scotland. Minor amendments to wording were noted.

10.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 September 2003.

10.4 Pegfilgastrim (Neulasta®), Amgen, No. 67/03

10.4.1 No declarations of interest were recorded in relation to this product or comparator drugs.

10.4.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and summary of comments received from the company.  Detailed discussion followed and the group agreed that Pegfilgastrim (Neulasta®) for the treatment of neutropenia and the incidence of febrile neutropenia in patient treated with cytotoxic chemotherapy should be recommended for restricted use within NHS Scotland. Minor amendments to wording were noted.

10.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 September 2003.

11 NDC Assessment Reports - Abbreviated Submissions

11.1 Mirtazapine (Zispin Soltab®), Organon, No. 66/03

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

11.1.2 It was noted that the parent compound in relation to this abbreviated submission is an existing product on the market and a review of this is not within the remit and timelines of the SMC process. 

11.1.3 The NDC Chairman provided an overview of the assessment and draft summary recommendation.  Detailed discussion followed and the group agreed that Mirtazapine (Zispin Soltab®) would be acceptable as a new formulation of existing therapy.  Amendments to wording were noted.

11.1.4 The SMC advice will be issued to ADTCs and NHS Boards on 5 September 2003. 

11.2 Calcium phosphate, cholecalciferol (Calfovit D3®), Trinity Pharmaceuticals, No. 72/03

11.2.1 No declarations of interest were recorded in relation to this product.

11.2.2 The NDC Vice Chairman provided an overview of the assessment and draft summary recommendation.  Detailed discussion followed and the group agreed that Calcium phosphate, cholecalciferol (Calfovit D3®), should be recommended as a new combination product for use within NHS Scotland. Minor amendments to wording were noted.

11.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 September 2003.

11.3 Rosiglitazone maleate/metformin hydrochloride (Avandamet®), GlaxoSmithKline, No. 77/03

11.3.1 The NDC Vice Chairman noted that the NDC recommendation in relation to this product would be deferred as a full submission in relation to a parent compound was due for consideration in the near future. Advice to NHS Boards and ADTCs would be issued simultaneously.

11.4 Estradiol valerate 1.0mg (FemTab 1mg), Merck Pharmaceuticals, Estradiol valerate 2.0mg (FemTab 2mg), Merck Pharmaceuticals, Estradiol as hemihydrate 2.0mg (FemTab Continuous), Merck Pharmaceuticals, Estradiol valerate 2.0mg (FemTab Sequi), Merck Pharmaceuticals

The committee note the change in license holder in relation to these products.  It was felt that submission to SMC would not be required in such instances and that no formal advice to NHS Boards and ADTCs should be made.

12 Forthcoming Submissions

12.1 List of Forthcoming Submissions

A revised list of forthcoming submissions was reviewed. 

13 ADTC Feedback

13.1 Horizon-scanning Information

13.1.1 It was requested that an updated horizon-scanning list be issued to NHS Boards and ADTCs.  It was reported that the new SMC website provided up-to-date information and was about to be launched.

14 Evaluation Project

14.1 Dr Black provided an overview of the evaluation project which she had undertaken.  The project had concluded recommendations which would be addressed by SMC.  A summary of the main report had been compiled and copied to SMC members.  It was reported that the committee found the summary report of great interest and it was noted that this information should be shared with NHS Boards and ADTCs.  The Chairman emphasised that Dr Black was pursuing publication of the work and in the meantime, the report should be treated in confidence.  It was noted that a summary would be printed in the annual report and that a presentation on the findings would be made at the forthcoming industry briefing event to be held in November 2003.

14.2 The Chairman noted that this was preliminary work on evaluation of SMC and the committee agreed that a system of on-going evaluation should be established.  The Chairman noted that grants for such research would be required and agreed to pursue this further with Dr Black.   The Consortium commended Dr Black on her work and requested that she continue to assist them by providing independent evaluations on an annual basis for the next few years.

14.3 The Chairman congratulated Dr Black on her excellent piece of work and looked forward to her continued support in the future.

15 Any Other Business

The Chairman noted the resignation of Professor Karen Facey as member of SMC, thanked her for her many contributions to SMC and wished her well for the future.

16 Date of Next Meeting

16.1 The date of the next meeting was confirmed as Tuesday, 7 October, 2003, at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

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