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SMC Minutes - Tuesday 3 February 2004

Minutes of Meeting
Held on Tuesday 3 February, 2004
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; Ms Barbara Black; Professor Martin Brodie; Professor John Cairns; Mrs Michelle Caldwell; Dr Barclay Goudie; Dr David Hood; Ms Moira Howie; Dr Chris Lush; Mrs Laura McIver; Ms Wendy Nganasurian; Mr Chris Nicolson; Dr Ken Paterson; Dr Philip Rutledge; Ms Fiona Scott; Dr Sandy Simpson; Ms Angela Timoney; Ms Helen Tyrrell; Mr Derek Yuille; Mr Mike Wallace; Professor David Webb; Dr John Webster

In Attendance: Ms Corri Black; Ms Joy Hosie; Dr Harpreet Kohli; Mr Hector Mackenzie; Mr Rob MacPhail; Ms Ali McAllister; Mrs Jill Mitchell; Miss Rosie Murray

Apologies: Mr Tom Divers; Professor Angus Mackay; Mrs Chris McBeath; Dr Marianne Nicholson; Dr Brian Paice; Dr Leslie Wilkie

1 Welcome and Apologies for Absence
1.1 The Chairman welcomed members to the meeting and apologies for absence were noted.   Ms Laura McIver, Pharmacy Consultant, Forth Valley NHS Board, seconded from the Scottish Executive to attend both NDC and SMC until December, was welcomed to the meeting.  Dr Emelia Crighton, Specialist Registrar in Public Health Medicine, NHS QIS, was also welcomed as an observer.

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 Minutes of the Previous Meeting (06.01.04)
3.1 The minutes of the meeting of 6 January, 2004, were agreed as an accurate record of the meeting. 

4 Matters Arising From the Previous Minutes
4.1 Guidelines on the Release of Company Data (SMC Version)

4.1.1 The document, adapted to reflect the views of SMC, was reviewed.  The Chairman requested members feedback comments to the secretariat, after which the ABPI representative would present to ABPI for comments with a view to agreeing a joint position between SMC and ABPI similar to that between ABPI and NICE. 

4.2 Relationship with SMC and NHS Quality Improvement Scotland

4.2.1 Discussions are ongoing and it is anticipated the relationship with SMC and NHS QIS will be clarified and structures in place by 31 March, 2004.

4.3 Antibiotic Prescribing Group

4.3.1 The first meeting of the group is scheduled for Monday 9 February, 2004.  Progress will be reported to the consortium.

4.4 Evaluation Project

4.4.1 Work regarding the evaluation project is ongoing.  The Chairman highlighted correspondence received from a company offering assistance to conduct an evaluation of SMC processes.  He emphasised that the evaluation of SMC is to remain as is current under the aegis of the Department of Public Health, University of Aberdeen (Dr Corri Black).  He strongly discouraged collaboration of ADTCs with other commercial agencies. Members strongly supported this position.

4.5 Travoprost 40 mg/ml eye drops solution (Travatan):  Alcon Laboratories UK Ltd  (No. 60/04)

4.5.1 The recommendation for Travoprost 40 mg/ml eye drops solution (Travatan), for the decrease of elevated intraocular pressure in patients with ocular hypertension (OH) or Open-angle Glaucoma (OAG), will be posted on the SMC website on Monday, 9 February, 2004.

4.5.2 A minor change within the wording was noted.  This will be communicated to the company and NHS Boards/ADTCs on Friday 6 February, 2004.

4.6 Fluvastatin XL (Lescol XL): Novartis Pharmaceuticals (No. 76/04) 

4.6.1 The recommendation for Fluvastatin XL (Lescol XL), for the secondary prevention of coronary events after percutaneous coronary intervention, will be posted on the SMC website on Monday, 9 February, 2004.

4.7 Frovatriptan (MigardÒ):A. Menarini UK Resubmission

4.7.1 The recommendation for Frovatriptan (Migard), for the acute treatment of the headache phase of migraine attacks with or without aura, will be posted on the SMC website on Monday, 9 February, 2004.

5 Appeals Update

5.1 Pimecrolimus Cream (Elidel)  No. 35.03:  Novartis

5.1.1 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.

6 Correspondence

6.1 Correspondence from Trevor Jones, Director General, ABPI

6.1.1 The Chairman briefed members on correspondence received from Professor Trevor Jones, Director General, ABPI, following the SMC proposal that, after a suitable interval, persistent non-submission of data about a new medicine would trigger a negative recommendation.

6.2 Vaccines

6.2.1 Following correspondence from a company regarding the SMC guidelines regarding the review of vaccines, the Chairman recommended that this is outwith the remit of SMC as it is already well catered for by the advisory bodies. Members supported this position.  A statement to this effect will be placed on the SMC website.

6.3 Orphan Products

6.3.1 A document defining orphan products was tabled for review.  Several such products will come before SMC in the near future.

7 Patient and Public Involvement Group (PAPIG)

7.1 Feedback following the patient event 'Patient Power' Making a Difference, held on 23 January, 2004, has been extremely positive. Minutes from the last meeting of the group will be circulated within the next week.  Mr Mike Wallace, ABPI representative on SMC, has joined the group.  A paper detailing proposals for training of lay members will be presented to the next meeting of SMC for review.  An article for publication in the ¿popular press¿ detailing the work of PAPIG is being drafted. This will be presented to SMC for review and approval.  It has been recognised that Patient Interest Groups may benefit from more support than is currently given and proposals to address this will be considered.      

8. New Drugs Committee Update

8.1 Darbepoetin Alfa (Aranesp):  Amgen (No. 94/04)  Abbreviated Submission

8.1.1 The NDC Chairman reported that an abbreviated submission for Darbepoetin Alfa (Aranesp), for the treatment of anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy was not appropriate in this instance and that a full submission should be requested. 

8.2 Experts

8.2.1 It is recognised that work still needs to be done regarding the use of experts.  The current list is under review and nominations are welcomed.

9. NDC Assessment Reports - Full Submissions

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

9.1.1 A member with a personal specific interest left the room for this part of the agenda. 

9.1.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified and the draft recommendation.  Detailed discussion followed and the group agreed that 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, should not be recommended for use within NHS Scotland.  Amendments to wording were noted.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 6 February, 2004.

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

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

9.2.2 The SMC Vice Chairperson 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 Alteplase (rt-PA) (Actilyse), for the treatment of acute ischaemic stroke, should be accepted for restricted use within NHS Scotland.  Amendments to wording were noted.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 6 February, 2004.

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

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

9.3.2 The NDC 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 Clopidogrel (Plavix), for the prevention of atherothrombotic events in acute coronary syndrome (without ST-segment elevation) in combination with aspirin, should be accepted for restricted use within NHS Scotland.   Amendments to wording were noted.

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 6 February, 2004.

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

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

9.4.2 The NDC 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 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, should be accepted for restricted use within NHS Scotland.  Amendments to wording were noted.

9.4.3The SMC advice will be issued to ADTCs and NHS Boards on 6 February, 2004.

9.5 Rosiglitazone Monotherapy (Avandia): GlaxoSmithKline  (No. 91/04)

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

9.5.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation, summary of comments received from the company and submission of evidence from patient interest group.  Detailed discussion followed and the group agreed that Rosiglitazone Monotherapy (Avandia), monotherapy for type 2 diabetes mellitus patients for whom metformin is inappropriate, should not be recommended for use within NHS Scotland. Amendments to wording were noted.

9.5.3 The SMC advice will be issued to ADTCs and NHS Boards on 6 February, 2004.

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

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

9.6.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation, summary of comments received from the company and submission of evidence from patient interest group.  Detailed discussion followed and the group agreed that 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, should be accepted for use within NHS Scotland.  Amendments to wording were noted.

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on 6 February, 2004.

10 Forthcoming Submissions

10.1 List of Forthcoming Submissions

10.1.1 A revised list of forthcoming submissions was reviewed.

11 ADTC Feedback

11.1 Lothian ADTC reported the following issues:

11.1.1 · Critical Appraisal

There are concerns regarding the loss of local opportunity to gain skills on critical appraisal and the opportunity to work with the pharmacy assessment team would be welcomed.  The Chairman stated that proposals for a secondment to the team would be considered favourably from any Health Board area.

11.2 · Full Recommendation Document

11.2.1 It would be hugely beneficial to have the 6/7 page full recommendation and budget impact information available on the website.  The SMC Chairman reported that discussions regarding this are ongoing and he hoped this would be achieved within the coming year.

12 Update on NICE Opinions

12.1 A document detailing the opinion concluded on products following review by both SMC and NICE was tabled for information.  It was noted that two products, reviewed by SMC, would receive NICE opinion in the current phase.

13 Any Other Business

13.1 Article from Pharmacoepidemiology and Drug Safety

13.1.1 An article, co-authored by a member of SMC, entitled 'Do doctors rely on pharmaceutical industry funding to attend conferences and do they perceive that this creates a bias in their drug selection? Results from a questionnaire survey' was presented for information.

13.2 Developing a network to carry out simplified clinical trials

13.2.1 Following a meeting with the Chief Medical Officer and Chief Scientist for Scotland to explore the ways of taking forward the concepts of using the strengths of NHS Scotland to carry out simplified, large scale, prospective, randomised, blinded-endpoint clinical trials, the NDC Chairman presented a paper outlining the proposals.    It was suggested that the specific and generic issues should be separated and a group under the aegis of the SMC should examine the concept of a Scotland wide research network capable of delivering high quality and inexpensive studies in part, but not exclusively, funded by the pharmaceutical industry.  Detailed debate followed and members determined this was an exciting concept of which they approved.  They suggested it would be inappropriate for SMC to lead and agreed that the Chief Scientists Office should direct the project, with observers from SMC to support the development. Progress will be reported to SMC in due course.

13.3 Company Visits

13.3.1 The Chairman highlighted recent requests from individual companies for representatives of SMC to make presentations regarding process and methodology.  Further to discussions with the Scottish Office and the Central Legal Office, it was deemed appropriate for a representative of SMC to make a presentation at the expense of the company and to be accompanied by a member of the secretariat at the expense of NHS QIS.  The Chairman advised that two such company visits have been made as indicated below.  He requested that members liaise with companies regarding SMC activities via the secretariat.  Such visits could only be undertaken when resources permit.  

Visit to Novartis, 15.12.03:  Dr Andrew Walker/Mrs Jill Mitchell

Visit to  Merck, 26.01.04:    Dr Andrew Walker/Mrs Jill Mitchell

14 Date of Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 2 March, 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.

 

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