You are here:

SMC Minutes - Tuesday 2 March 2004

Minutes of Meeting
Held on Tuesday 2 March, 2004
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman); Mr Jeff Ace; Professor James Barbour; Dr Keith Beard; Mrs Marion Bennie; Ms Barbara Black; Professor Martin Brodie; Professor John Cairns; Mr Tom Divers; Dr Barclay Goudie; Dr David Hood; Ms Moira Howie; Dr Marianne Nicholson; Dr Ken Paterson; Ms Fiona Ramsay; Dr Philip Rutledge; Ms Fiona Scott; Dr Sandy Simpson; Ms Angela Timoney; Mr Derek Yuille; Professor David Webb; Dr John Webster; Dr Leslie Wilkie

In Attendance: Ms Joy Hosie; Dr Harpreet Kohli; Mrs Laura McIver; Mr Hector Mackenzie; Ms Ali McAllister; Mrs Jill Mitchell; Miss Rosie Murray

Apologies: Dr Corri Black; Mrs Michelle Caldwell; Dr Chris Lush; Professor Angus Mackay; Mrs Chris McBeath; Ms Wendy Nganasurian; Mr Chris Nicolson; Dr Brian Paice; Ms Helen Tyrrell; Mr Mike Wallace
 
 

1 Welcome and Apologies for Absence
1.1 The Chairman welcomed members to the meeting and apologies for absence were noted.   Ms Fiona Ramsay, Director of Finance, Forth Valley NHS Board and Professor James Barbour, Chief Executive, Lothian NHS Board, were welcomed in observer capacity with full membership commencing in April.

2 Declarations of Interest

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

3 Annual Report

3.1 The SMC Annual Report 2002/03 was tabled for review.  The Chairman requested it be kept in confidence until its formal circulation later in the month. He advised members to pass on any queries from outside sources relating to the annual report following its release, to the Communications Team within NHS QIS.

4 Minutes of the Previous Meeting (03.02.04)

4.1 The minutes of the meeting of 3 February, 2004, were agreed as an accurate record of the meeting with an amendment to No 11.1.1 where a typing error had been highlighted.

5 Matters Arising From the Previous Minutes

5.1 Guidelines on the Release of Company Data (SMC Version)

5.1.1 The paper has been presented to ABPI for comments with a view to agreeing a joint position between SMC and ABPI similar to that between ABPI and NICE.  The outcome will be reported as soon as possible.

5.2 Relationship with SMC and NHS Quality Improvement Scotland

5.2.1 Discussions are still ongoing. It is anticipated the relationship between SMC and NHS QIS will be clarified and structures in place by 31 March, 2004.

5.3 Antibiotic Prescribing Group

5.3.1 The first meeting of the group took place on Monday 9 February, 2004.  A further meeting has been scheduled for May.  Progress will be reported to the consortium in June.

FULL SUBMISSIONS

5.4 Cilostazol (Pletal): Otsuka Pharmaceuticals (No. 86/04)

5.4.1 The recommendation for Cilostazol (Pletal), for the improvement of the maximal and pain-free walking-distances in patients with intermittent claudication, who do not have rest pain and who do not have evidence of peripheral tissue necrosis, will be posted on the SMC website on Monday, 8 March, 2004.

5.5 Alteplase (rt-PA) (Actilyse):  Boehringer Ingelheim (No. 87/04)

5.5.1 The recommendation for Alteplase (rt-PA) (Actilyse), for the treatment of acute ischaemic stroke, will be posted on the SMC website on Monday, 8 March, 2004.

5.6 Clopidogrel (Plavix):  Sanofi-Synthelabo and Bristol Myers Squibb (No. 88/04)

5.6.1 The recommendation for Clopidogrel (Plavix), for the prevention of atherothrombotic events in acute coronary syndrome (without ST-segment elevation) in combination with aspirin, will be posted on the SMC website on Monday, 8 March, 2004.

5.7 Anastrozole (Arimidex): AstraZeneca UK Ltd (No. 90/04)

5.7.1 The recommendation for Anastrozole (Arimidex), for the adjuvant treatment of postmenopausal women with oestrogen receptor (ER) positive early invasive breast cancer who are unable to take tamoxifen because of a high risk of thromboembolism or endometrial abnormalities, will be posted on the SMC website on Monday, 8 March, 2004.  A minor amendment to the wording of the advice was accepted.  The amended recommendation will be reissued to the company and NHS Boards on Friday 5 March, 2004.

5.8 Rosiglitazone (Avandia): GlaxoSmithKline (No. 91/04)

5.8.1 The recommendation for Rosiglitazone (Avandia) monotherapy for type 2 diabetes mellitus patients for whom metformin is inappropriate, will be posted on the SMC website on Monday, 8 March, 2004.

ABBREVIATED SUBMISSION

5.9 Avandamet (Rosglitazone maleate/metformin hydrochloride):  GlaxoSmithKline (No. 77/04) Abbreviated Submission

5.9.1 The recommendation for Avandamet (Rosglitazone maleate/metformin hydrochloride) for the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated doses of oral metformin alone and cannot be treated with a sulphonylurea in combination with metformin, will be posted on the SMC website on Monday, 8 March, 2004.

6 Appeals Update

6.1 Pimecrolimus Cream (Elidel)  No. 35.03:  Novartis

6.1.1 Novartis have advised of their intention to seek an independent review following the SMC recommendation for Pimecrolimus Cream (Elidel).  A panel is currently being identified and it is anticipated a meeting will take place in April/May 2004.

7 Correspondence

7.1 Publicity Mailing to Prescribers in Scotland

7.1.1 The Chairman highlighted an inappropriate and misleading publicity mailing to prescribers in Scotland regarding a product that had not been recommended by SMC.  He has written to the company expressing concern and will feedback comments to the consortium in due course.

7.2 Implementation of SMC/NICE/NHS QIS Outcomes - Audit

7.2.1 The Chairman highlighted a proposal from Roche to present data on the implementation of outcomes on products assessed by SMC.  It was agreed that this would be informative.  The secretariat will invite a company representative to a future SMC meeting to make their presentation.

8 Patient and Public Involvement Group (PAPIG)

8.1 Minutes of the PAPIG meeting held in January were presented for information.

8.2 A proposal for a training package for new lay members was tabled for review.   The Chairman requested members review and feedback comments at the next meeting.

9 Process Issues

9.1 Wording of Advice following absence of submission from Company

9.1.1 A template detailing wording of advice following absence of a submission to SMC  was tabled for review.   The document was approved and discussion followed regarding timescale for implementation.  The Chairman stated that a timeframe had not been defined formally.  SMC still aim to review products as soon as practical, if possible within 3 months of launch.   SMC would enter into dialogue with companies who failed to make a submission within an appropriate  timeframe before any action described above was taken.

9.2 Medical Devices

9.2.1 It was identified that SMC need to make a policy statement with regarding their remit on devices containing drugs.  Discussion will take place and the subject brought forward to a future meeting.

10 New Drugs Committee Update

10.1 Experts

10.1.1 It is recognised that further work needs to be done regarding the use of clinical experts.  Nominated members of the committee have agreed to review the current process and feedback proposals in due course.

11 NDC Assessment Reports - Full Submissions

11.1 Duac- Once Daily Gel (Duac- Once Daily Gel):  Stiefel Laboratories (UK) Limited  (No. 92/04)

11.1.1 No declarations of interest were noted in relation to this product or comparator drugs.

11.1.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation.  Detailed discussion followed and the group agreed that Duac- Once Daily Gel for the treatment of mild to moderate acne vulgaris, should be accepted for restricted use within NHS Scotland.  Amendments to wording were noted.

11.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 March, 2004.

11.2 Nicotinic acid modified release tablets (Niaspan modified release tablets):  Merck Pharmaceuticals (No. 93/04)

11.2.1 Declarations of interest were recorded in relation to this product or comparator drugs.

11.2.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation and comments received from the company.  Detailed discussion followed and the group agreed that Nicotinic acid modified release tablets (Niaspan modified release tablets), for the reduction of elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hypercholesterolaemia and mixed dyslipidaemia, should not be recommended for use within NHS Scotland.  Amendments to wording were noted.

11.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 March, 2004.

11.3 Macrogol 4000/PEG 4000 (Idrolax® 10 g): Schwarz Pharma Limited (No. 94/04)

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

11.3.2 The SMC Vice Chairperson 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 Macrogol 4000/PEG 4000 (Idrolax® 10 g), for the treatment of constipation in adults and children aged eight years and above, should not be recommended for use within NHS Scotland. Amendments to wording were noted.

11.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 March, 2004.

12 Forthcoming Submissions

12.1 List of Forthcoming Submissions

12.1.1 A revised list of forthcoming submissions was reviewed.  The SMC executive group are currently reviewing high cost products and progress will be reported at a future meeting.

13 ADTC Feedback

13.1 Declarations of Interest

13.1.1 The NDC Chairman highlighted a recent HDL - A Common Understanding: Guidance on Joint Working Between NHS Scotland and the Pharmaceutical Industry.   Health Boards and Trusts have been asked to establish a register of interest for all NHS employees and Primary Care contractors and produce local standing specifying who is responsible for keeping and maintaining the register.  To avoid duplication he proposed ADTCs within Scotland follow the same methodology adopted by SMC. The Chairman advised he would write to ADTCs to recommend they keep a formal record of activities in a standardised format.  Clarification will be sought regarding whether the directive applies only to those involved in joint working.

14 SMC User Group Forum

14.1 Minutes of the SMC User Group Forum held on 10 February, 2004, were presented for review.

15 Jill Mitchell

15.1 The Chairman thanked Jill Mitchell for her very substantial contributions to SMC since its inception and wished her well for the future.  Jill is leaving SMC in early March and will relocate with her family to Newcastle.   She was presented with a picture and a necklace on behalf of members of SMC and NDC, as a small token of the high esteem in which has been held during her time with the Consortium.

16 Any Other Business

16.1 Website

16.1.1 The Chairman informed members of the number of activity on the SMC website in the preceding six  month period.  An appendix  of detailing this information is attached.

16.2 Membership

16.2.1 New SMC membership has now been agreed and will become effective from April 2004.  The Chairman thanked members for their enthusiasm and desire to continue.   NDC members rotating to SMC will have observer capacity only at the March NDC meeting leading to membership of SMC in April, this will ensure members are not open to discussion regarding products at both NDC and SMC meetings.

17 NICE - Annual Report

17.1 The NICE Annual Report 2002/03 is now published.  The Chairman encouraged members to review.

18 Date of Next Meeting

18.1 The date of the next meeting was confirmed as Tuesday 6 April, 2004, at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

SMC WEBSITE STATISTICS

6 MONTHS PERIOD TO END FEBRUARY 2004

Website hits464,700
No. users 18,600
Average hits/users25
Average users/day101
Average hits/day2,525
  No.%
Website - Subscriptions 238 100
              - Industry101 43
              - NHS Scotland 90 38
              - External* 39 16
              - Patient Interest Groups3 1
Others 5 2
*New Zealand, Hungary, Israel, Spain, Channel Islands, England, Wales

 

Website: Geographical distribution of hits  
 Hits % 
UK311,857  67.0 
Europe - EU43,679  9.4 
           - Non EU8,209  2.0 
North America - US78,795  17.0 
                     - Canada4,192  1.0 
Central America 661  0.1 
South America1,109  0.4 
Asia - SE3,666  0.8 
       - Japan2,697  0.6 
       - India S/C1,637  0.4 
       - Other2,290  0.6 
Australasia5,442  1.2 
Africa481  0.1 
Total464,715  100.0 
EU Countries Hits
Netherlands10,747    
Germany9,565   
Sweden5,302   
Spain4,212   
Denmark3,911   
France3,326   
Belgium1,706   
Ireland1,295   
Italy1,172   
Portugal863   
Austria471   
Finland352   
Poland291   
Slovenia228   
Hungary129   
Greece109   
Total43,679   

 

Back to minutes