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SMC Minutes - Tuesday 3 August 2004

Minutes of Meeting
Held on Tuesday 3 August, 2004
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman), Professor James Barbour, Mrs Marion Bennie, Professor Martin Brodie, Dr Keith Beard, Mrs Barbara Black, Dr Corri Black, Professor John Cairns, Mrs Michelle Caldwell, Mr Tom Divers, Dr Peter Donnan, Dr Barclay Goudie, Dr John Haughney, Mrs Moira Howie, Ms Angela Munday, Ms Wendy Nganasurian, Dr Ken Paterson, Ms Fiona Ramsay, Ms Helen Tyrrell, Mr Mike Wallace, Dr John Webster, Mr Derek Yuille

In Attendance: Ms Ailene Botfield, Professor Peter Davey, Mr Hector Mackenzie, Mr Rob MacPhail, Ms Ali McAllister, Ms Laura McIver, Miss Rosie Murray, Dr Dilip Nathwani

Apologies: Mr Jeff Ace, Ms Chris Beech, Mr John Glennie, Dr David Hood, Ms Joy Hosie, Dr Harpreet Kohli, Dr Chris Lush, Professor Angus Mackay, Dr Marianne Nicholson, Mr Chris Nicolson, Dr Andrew Riley, Dr Philip Rutledge, Ms Angela Timoney, Ms Fiona Scott, Dr Sandy Simpson, Professor David Webb

1 Welcome and Apologies for Absence

1.1  The Chairman welcomed members to the meeting and apologies for absence were noted.  Dr Dilip Nathwani, Chairman, and Professor Peter Davey, member of the Scottish Antimicrobial Prescribing Policy and Practice Group were welcomed as attendees.

2 Declarations of Interest

2.1 The Chairman reminded 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 (06.07.04)

3.1 The minutes of the meeting of 6 July, 2004, were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1 Relationship with SMC and NHS Quality Improvement Scotland

4.1.1 Discussions are moving forward regarding the budgetary allocation to SMC. Progress will be reported at the next SMC meeting. 

4.2 SMC Co-ordinator Post

4.2.1 Ms Maureen Stark, has been appointed to the post of SMC Co-ordinator and will commence work on 16 August, 2004. 

4.3 Scottish Antimicrobial Prescribing Policy and Practice Group

4.3.1 Following a request from the Scottish Executive, SMC set up a short-life working group with the remit of reviewing acute hospital antibiotic prescribing and practice and advising Health Boards and Area Drugs and Therapeutics Committees on standardising these matters across Scotland.   The group met on three occasions and have compiled a report for consideration by SMC.   Dr Dilip Nathwani, Chairman of the group outlined the remit of the group and presented their report to the Consortium.  Detailed discussion followed and the report was accepted in its entirety with minor amendments.   It was agreed to sent the revised report to Area Boards, ADTCs, CMO, NHSQiS and several bodies responsible for education of current and future prescribers.  This distribution would take place following any comments made by CMO on the document.

Dr Nathwani and his team were congratulated on producing such a clear, concise  and relevant report in the short time available to them.

4.4 Orphan Drug Group - SMC Statement

4.4.1 The SMC position statement regarding the requirements for orphan drug submissions to SMC was presented to NICE for comment.  NICE noted the content but made no further comment.  A revision has been made to the statement incorporating the EMEA definition of orphan medicines. The statement will be posted on the SMC website imminently.

4.5 Freedom of Information

4.5.1 Further to communication with Mr Dunion, Scottish Information Commissioner, requesting clarification of several areas in relation to SMC, a meeting has been scheduled for Monday 9 August, 2004.  Progress will be reported at the next SMC meeting.

4.6 Implementation of Unique Drugs Policy

4.6.1 A short life working group to make recommendations to Boards about which patients should receive Etanercept, at what stage in their illness and for how long the therapy should continue were there to be no satisfactory response is currently being set up.  It is anticipated the group will meet under the Chairmanship of Dr Keith Beard in early September.  Progress will be reported at a future meeting.

4.7 Change to order of SMC/NDC meetings

4.7.1 The ABPI representative advised that concern has been expressed within some companies regarding the planned change to scheduling of SMC/NDC meetings and the potential threat of delays in output from SMC arising from this.

The Chairman advised that the revised timelines are designed to improve workload flow and allow greater time for company responses to NDC advice to be incorporated into SMC paperwork thereby giving all committee members a better opportunity to review all relevant information in advance of the meeting.  The aim is to facilitate better communication between companies and SMC.   There will be no delays to final output from SMC arising from this change which will occur during the New Year holiday when the standing meeting of SMC will not take place in January 2005.

FULL SUBMISSIONS

4.8 fulvestrant (Faslodex)  AstraZeneca UK Ltd  (No. 114/04)

4.8.1 SMC advice for fulvestrant (Faslodex), for the treatment of metastatic breast cancer, will be posted on the SMC website on Monday 9 August, 2004.

4.9 insulin determir (Levemir)  NovoNordisk  (No:  110/04)

4.9.1 SMC advice for insulin determir (Levemir), the treatment of diabetes mellitus, will be posted on the SMC website on Monday 9 August, 2004.

4.10 pioglitazone (Actos)  Takeda  (No. 115/04)

4.10.1 SMC advice for pioglitazone (Actos), for the treatment of diabetes mellitus, will be posted on the SMC website on Monday 9 August, 2004.

4.11 risperidone (Risperdal)  Janssen-Cilag  (No. 113/04)

4.11.1 SMC advice for risperidone (Risperdal), for the treatment of bipolar disorder, will be posted on the SMC website on Monday 9 August, 2004.

4.12 losartan (Cozaar)  Merck Sharp & Dohme  (No.112/04)

4.12.1 SMC advice for losartan (Cozaar), for the treatment of hypertension, will be posted on the SMC website on Monday 9 August 2004.

RE-SUBMISSION

4.13 rosiglitazone (Avandia)  GlaxoSmithKline  (No. 91/04)

4.13.1 SMC advice for rosiglitazone (Avandia), for the treatment of diabetes mellitus, will be posted on the SMC website on Monday 9 August, 2004.

INDEPENDENT REVIEW PANEL

4.14 pimecrolimus cream (Elidel):  Novartis  (No. 35/04)
 
4.14.1 SMC advice for pimecrolimus cream (Elidel), for signs and symptoms of mild-to-moderate atopic dermatitis, will be posted on the SMC website on Monday 9 August, 2004.

4.14.2 The Chairman noted that the NICE Final Appraisal Determination for this product.will appear shortly: http://www.nice.org.uk/pdf/P&T_FAD.pdf.  He indicated that whereas NICE guidance would normally supersede SMC advice in Scotland, as this particular product was reviewed within the same timeframe and from the same data set, NHS Boards in Scotland will, no doubt, take this into account in coming to their decision about the use of pimecrolimus cream in their area.

ABBREVIATED SUBMISSION

4.15 montelukast paediatric 4mg granules (Singulair®)  Merck Sharp & Dohme
(No. 111/04)

4.15.1 SMC advice for montelukast paediatric 4mg granules (Singulair®), for the treatment of asthma, will be posted on the SMC website on Monday 9 August, 2004.

4.16 estradot (Estradot Transdermal Patch)  Novartis  (No. 117/04)

4.16.1 SMC advice for estradot (Estradot Transdermal Patch), for the treatment of for the treatment of oestrogen only HRT patch, will be posted on the SMC website on Monday 9 August, 2004.

5 Appeals Update

5.1 infliximab (Remicade):  Schering Plough (No. 101/04)

5.1.1 Schering Plough has advised of their intention to resubmit following the SMC recommendation for infliximab (Remicade) in the treatment of ankylosing spondylitis.

6 Correspondence

6.1 ABPI Director General

6.1.1 The new Director General of ABPI has been named as Dr Richard Baker.  He succeeds Dr Trevor Jones who is retiring on 31 August, 2004.

6.2 Chief Executive - NHS Scotland

6.2.1 Mr Trevor Jones, CEO, NHS Scotland, has resigned from his post and will take up a new position within Avon and Somerset Health Authority in the near future.  The Chairman has written to Mr Jones on behalf of SMC thanking him for his support in the conception and development of the Consortium.

6.3 Welsh Medicines Partnership

6.3.1 A request has been received from The Welsh Medicines Partnership to adopt some of the format and questions of SMC documentation.  Members agreed to this request.

7 Patient and Public Involvement Group (PAPIG)

7.1 PAPIG met previous to SMC.  The minutes of the meeting will be available for review at the next SMC meeting. 

7.1.1 It was reported that the Patient Interest Group Guidance and Submission Template is currently being revised.  This will be approved through PAPIG and the revised version posted on the SMC website.
 
7.1.2 The Patient Interest Summary, which is a voluntary submission from the pharmaceutical company to assist patient interest groups who wish to make a submission, will be renamed 'Summary Information for Patients'.

7.1.3 A proposal for patient interest group members to observe at SMC was considered.  Due to confidentiality and indemnity issues this will be discussed with the Central Legal Office and the outcome reported at a future SMC meeting.
 
8 New Drugs Committee Update

8.1 Scottish Health Authority Forum

8.1.1 The NDC Chairman attended the Scottish Health Authority Forum to update members on the progress of SMC.  The feedback from the group was extremely positive. 

8.2 ABPI Membership of New Drugs Committee - Experience to Date

8.2.1 Nick Bruce and Keith Tolley, industry representatives on NDC, gave a presentation to ABPI member companies on 28 July, 2004, regarding their observations since joining the New Drugs Committee.  They will summarise the issues raised at the NDC meeting in September.

10 NDC Assessment Reports - Full Submissions

10.1 buprenorphine (Transtec matrix patches):  Napp Pharmaceuticals Limited  (No. 116/04)

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

10.1.2 The NDC Chairman 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 agreed that buprenorphine (Transtec matrix patches), for the treatment of severe pain, should not be recommended for use within NHS Scotland. Amendments to wording were noted.

10.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 6 August, 2004.
 
10.2 rabeprazole sodium (Pariet): Janssen-Cilag/Eisai (No. 118/04)

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

10.2.2 The NDC Chairman 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 agreed that rabeprazole sodium (Pariet), for on-demand treatment of gastro-oesophageal reflux disease, should be accepted 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 6 August, 2004.

10.3 duloxetine (Yentreve):  Eli Lilly and Co Ltd/ Boehringer Ingelheim  (No. 119/04) 

10.3.1 Declarations of interest were recorded in relation to this product/comparator drugs.  A member with a personal specific interest left the room for this part of the agenda.  

10.3.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and comments received from the company.  A member of PAPIG presented a Patient Interest Group Submission from Incontact.  Detailed discussion followed and the group made a recommendation regarding duloxetine (Yentreve), for the treatment of stress urinary incontinence.

10.3.3 As the licence for duloxetine (Yentreve) is yet to be confirmed, in accordance with SMC process, the distribution of this recommendation will be withheld until this time.  If however there are any changes to the licence the recommendation will be revisited. 

10.3.4 Members were particularly impressed with the high standard of presentation by Incontact, which made a significant contribution to the final recommendation.

10.4 atazanvir (Reyataz): Bristol-Myers Squibb Pharmaceuticals Limited  (No. 120/04)

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

10.4.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and comments received from the company. A member of PAPIG presented a Patient Interest Group Submission from HIV Scotland. Detailed discussion followed and the group agreed that atazanvir (Reyataz), for the treatment of HIV, 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 6 August, 2004.

10.5 valsartan/hydrochlorothiazide (Co-Diovan®): Novartis Pharmaceuticals  (No.  121/04) 

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

10.5.2 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 valsartan/hydrochlorothiazide (Co-Diovan®), for the treatment of essential hypertension, should be accepted 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 6 August, 2004.

11 Forthcoming Submissions
 
11.1 A revised list of forthcoming submissions was reviewed.

12 ADTC Feedback

12.1 The Chairman has written to the ADTC Chairmen to request that they directly encourage specialist practitioners to follow the advice issued from SMC and approved by ADTCs to ensure consistency of access to medicines within NHS Scotland.

13 Any Other Business

13.1 No other business was reported.

14 Date of Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 7 September, 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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