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SMC Minutes - Tuesday 6 April 2004

Minutes of Meeting
Held on Tuesday 6 April, 2004
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman); Dr Keith Beard; Mrs Marion Bennie; Mrs Barbara Black; Professor John Cairns; Mr John Glennie; Dr Barclay Goudie; Mrs Moira Howie; Dr Chris Lush; Professor Angus Mackay; Ms Angela Munday; Ms Wendy Nganasurian; Mr Chris Nicolson; Dr Ken Paterson; Ms Fiona Ramsay; Dr Philip Rutledge; Dr Sandy Simpson; Ms Angela Timoney; Ms Helen Tyrrell; Mr Derek Yuille; Mr Mike Wallace

In Attendance: Ms Joy Hosie; Mr Hector Mackenzie; Miss Rosie Murray

Apologies: Mr Jeff Ace; Professor James Barbour; Ms Chris Beech (New Member); Dr Corri Black; Professor Martin Brodie; Mrs Michelle Caldwell; Mr Tom Divers; Dr Peter Donnan (New Member); Dr John Haughney (New Member); Dr David Hood; Dr Harpreet Kohli; Ms Ali McAllister; Ms Laura McIver; Dr Marianne Nicholson; Ms Fiona Scott; Professor David Webb; Dr John Webster; Dr Lesley Wilkie

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting and apologies for absence were noted.   Ms Angela Munday, Chief Pharmacist, Argyll & Clyde and previous member of the New Drugs Committee and Mr John Glennie, Chief Executive, Borders NHS Trust were welcomed as new members.

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 (02.03.04)

3.1 The minutes of the meeting of 2 March, 2004, were agreed as an accurate record of the meeting with an amendment to 13.1.1. The last sentence should read:  Clarification will be sought regarding whether the directive applies only to those involved in joint working.

4 Matters Arising From the Previous Minutes

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

The paper which had previously 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, was subsequently approved through ABPI processes.   It has now been distributed to all members.

4.2 Relationship with SMC and NHS Quality Improvement Scotland

Discussions are still ongoing and confirmation regarding the budgetary allocation to SMC is to be agreed. Progress will be reported at the next SMC meeting.

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

Representatives of Roche Pharmaceuticals will attend the SMC meeting in June to present data in their possession regarding the implementation of outcomes on products assessed by SMC.

4.4 Declarations of Interest

The SMC Chairman has written to ADTC Chairs highlighting the recent guidance on the topic entitled 'A Common Understanding' - guidance on joint working between NHS Scotland and the Pharmaceutical Industry issued by the Scottish Executive HDL(2003)62.  He advised that the Scottish Medicines Consortium has standard procedures for dealing with declarations of interest and suggested it may be helpful for all ADTC's to adopt the SMC model as standard.

4.5 Experts

It was recognised that further work needs to be done regarding the use of clinical experts.  Nominated members of the committee have reviewed the current process and further discussions are taking place.  The outcome will be reported to the consortium in due course.

4.6 Medical Devices

Discussion took place about the remit of SMC in relation to medicines containing devices.  It was agreed that SMC would confine their involvement with such devices to those licensed as medicines by the MHRA/EMEA.  The Chairman confirmed that drug eluding stents will fall outwith this category.

4.7 Membership

SMC membership has been agreed and members received a formal letter of appointment/extension to their current term of service from the Chief Medical Officer at the Scottish Executive. It was agreed that Prof David Webb and Ms Angela Timoney would continue as Vice-Chairpersons of SMC. A proposed list of new NDC membership was tabled for review with the aim of replacing members transferred to SMC membership and recruiting additional members to reflect the increased workload. This was approved and new NDC membership will take immediate effect. The NDC Chairman will be stepping down from NDC and shadowing the SMC Chairman prior to his succession to the post later in the year. Dr Ken Paterson will succeed him as Chairman of NDC with Ms Marion Bennie as Vice-Chairperson.

The Chairman thanked all concerned for their hard work during the previous year.

4.8 SMC Manager Post

The advertisement for the SMC Manager post has been sent to NHS Scotland and ADTCs with a closing date of 21 April 2004.  The Chairman encouraged members to make the post known to any suitable candidates.

Full submissions

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

5.1.1 The recommendation for Duac' Once Daily Gel for the treatment of mild to moderate acne vulgaris, will be posted on the SMC website on Tuesday 13 April, 2004.

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

5.2.1 The recommendation for 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, will be posted on the SMC website on Tuesday 13 April, 2004.

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

5.3.1 The recommendation Macrogol 4000/PEG 4000 (Idrolax® 10 g), for the treatment of constipation in adults and children aged eight years and above, will be posted on the SMC website on Tuesday 13 April, 2004.

6 Appeals Update

6.1 Pimecrolimus Cream (Elidel)  No. 35.03:  Novartis

6.1.1 Novartis have previously advised of their intention to seek an independent review following the SMC recommendation for Pimecrolimus Cream (Elidel).  The IRP meeting will take place on 23 April, 2004 and their results presented to SMC in June for final decision. The Chairman advised that the preliminary review by NICE, of Tacrolimus and Pimecrolimus in the management of atopic eczema is now in the public domain.

7 Correspondence

7.1 Remit of SMC

7.1.1 Further to correspondence received from a company seeking clarification about the licensing and launch of products in relation to submissions to SMC, the Chairman confirmed that SMC would review products licensed from January 2002.  Products licensed previous to this date and launched after will not be considered.

8 Patient and Public Involvement Group (PAPIG)

8.1 The PAPIG met prior to the SMC meeting and a copy of the minutes will be distributed to members for review at the next meeting.  It was reported that an article written by the group regarding SMC has been accepted for publication in 'Scottish Homes and Country'.  It was noted that the FAQ document requires amendment to reflect the ministerial statement.

9 New Drugs Committee Update

9.1 Pharmaceutical assessor

9.1.1 Caroline Evans, member of the Pharmacy Assessment Team, has moved to another job.

10 NDC Assessment Reports - Full Submissions

10.1 Aripiprazole (Abilify TM):   Bristol-Myers Squibb Pharmaceuticals/Otsuka Pharmaceuticals  (No.95/04)

10.1.1 Members with an interest in relation to this product/comparator drugs left the room for this part of the agenda.

10.1.2 The SMC Vice Chair provided a detailed overview of the assessment, the key issues identified, draft recommendation and comments received from the company.  Detailed discussion followed and the group made a recommendation regarding Aripiprazole (Abilify), for the treatment of schizophrenia.

10.1.3 As an official launch date for Aripiprazole (Abilify) is yet to be confirmed, in accordance with SMC process, the distribution of this recommendation will be withheld until launch.  If however there are any changes in the pricing of this product between the present time and the actual launch date the recommendation will be revisited.

10.2 Temoporfin (Foscan®): Biolitec Pharma Ltd  (No.96/04)

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

10.2.2 The SMC Vice Chair 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 Temporfin (Foscan), for the palliative treatment of patients with head and neck cancer failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy, should not be recommended for use within NHS Scotland.  Amendments to wording were noted.

10.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 8 April, 2004.

10.3 Olanzapine (Zyprexa): Eli Lilly & Company Ltd  (No. 98/04)

10.3.1 Members with personal specific declarations of interest in relation to this product/comparator drugs left the meeting for this part of the agenda.

10.3.2 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 patient interest group submission. Detailed discussion followed and the group agreed that Olanzapine (Zyprexa) for the prevention of recurrence in patients with bipolar disorder, whose manic episode has responded to olanzapine treatment, should be accepted for use within NHS Scotland. Amendments to wording were noted.

10.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 8 April, 2004.

10.4 Budesonide / eformoterol dry powder inhaler (Symbicort® Turbohaler®):  AstraZeneca UK Ltd  (No. 97/04)

10.4.1 Declarations of interest were recorded in relation to this product/ comparator drugs.

10.4.2 The SMC Vice Chair 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 Budesonide/eformoterol dry powder inhaler (Symbicort Turbohaler) for the symptomatic treatment of patients with severe chronic obstructive pulmonary disease (COPD) (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators, should be accepted for use within NHS Scotland. Amendments to wording were noted.

10.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 8 April, 2004.

Resubmission

10.5 Botulinum toxin type A (Botox®):  Allergan Ltd (No. 80/03 (S Donnelly/P Davey/A Power  (No.80/03)

10.5.1 No declarations of interest were recorded in relation to this product/comparator drugs.

10.5.2 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 Botulinum, for the management of adults with post stroke spasticity of the hand and wrist, should not be recommended for use within NHS Scotland. Amendments to wording were noted.

10.5.3 The SMC advice will be issued to ADTCs and NHS Boards on 8 April, 2004.

11 Forthcoming Submissions

11.1 List of Forthcoming Submissions

11.1.1 A revised list of forthcoming submissions was reviewed.

12 ADTC Feedback

12.1 There was no business to report.

13 Any Other Business

13.1 All Wales Medicines Strategy Group

13.1.1 The Chairman reported on a recent visit to the All Wales Medicines Strategy group and their ADTC equivalents.

14 Date of Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 4 May, 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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