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SMC Minutes - Tuesday, 3 June 2003

Present: Professor David Lawson (Chairman), Mr Jeff Ace, Dr Keith Beard, Mrs Marion Bennie, Professor Martin Brodie, Professor John Cairns, Professor Karen Facey, Dr Barclay Goudie, Dr David Hood, Dr Chris Lush, Professor Angus Mackay, Mrs Chris McBeath, Ms Wendy Nganasurian, Dr Ken Paterson, Dr Philip Rutledge, Ms Fiona Scott, Dr Sandy Simpson, Ms Angela Timoney, Mr Mike Wallace, Professor David Webb, Dr John Webster, Dr Derek Yuille
 
In Attendance: Dr Corri Black, Ms Joy Hosie, Mrs Jill Mitchell, Ms Rosie Murray, Mr Adrian Masson (NHS QIS)
 
Apologies: Mrs Michelle Caldwell, Mr Tom Divers, Ms Moira Howie, Mr Chris Nicholson, Dr Marianne Nicholson, Dr Brian Paice, Ms Helen Tyrrell, Dr Leslie Wilkie

1 Welcome and Apologies for Absence
  
1.1 The Chairman welcomed members to the meeting. Apologies for absence were noted. The Chairman welcomed a newly appointed member of the Consortium John Cairns, Professor in Health Economics, University of Aberdeen.  Mr Adrian Masson, Project Manager, NHS QIS, was welcomed as an observer.  The Chairman advised that due to other commitments Dr Keith Ridge has resigned from the consortium.  Mr Jeff Ace was congratulated on the recent birth of his baby daughter.

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.  He drew members attention to a recent volume of the BMJ regarding relationships between the professions and the pharmaceutical industry.

3 Minute of the Previous Meeting (06.05.03)

3.1 The minutes of the meeting of 6 May, 2003 were agreed as an accurate record of the meeting with the following amendment noted: 6.1.1: Change to Highland Acute Hospitals Trust.

4 Matters Arising From the Previous Minutes

4.1 Antibiotic Policy
A short life working group chaired by Dr Dilip Nathwani has been formed to discuss antibiotic policies.  The first meeting is scheduled for 25 June, 2003. 

4.2 Recommendations - Confidentiality
The Chairman will discuss issues regarding confidentiality of recommendations with the Central Legal Office and feedback at a future meeting.

4.3 Olanzapine (Zyprexa): Eli Lilly & Co Ltd No. 44/03 The recommendation for Olanzapine (Zyprexa), for the treatment of moderate to severe manic episodes, will be posted on the SMC website on Friday 6 June, 2003. 

4.4 Vardenafil (Levitra): GlaxoSmithKline/Bayer No. 47/03The recommendation for Vardenafil (Levitra), for the treatment of erectile dysfunction, will be posted on the SMC website on Friday 6 June, 2003. 

4.5 Biphasic Insulin Aspart 30 (NovoMix30): Novo Nordisk Ltd No. 06/02  RESUBMISSION The recommendation for Biphasic Insulin Aspart 30 (NovoMix30), for the treatment of diabetes, will be posted on the SMC website on Friday 6 June, 2003.  

4.6 Norelgestomin/ethinyl oestradiol transdermal patch (EVRA): Janssen-Cilag No. 48/03 The Chairman advised that at the time of the last meeting, SMC had failed to recognise that this product was yet to be launched.  In view of this unique situation there were two options:   Circulate SMC advice to NHS Boards and ADCTs in the usual manner. Regard SMC advice as preliminary and revisit following launch.  The committee agreed the latter option.  The Chairman emphasised that this would not set a precedent as, although in future such assessments could be reviewed by NDC pre-launch, they would not be considered by SMC until an official launch date has been confirmed.  Mechanisms have been set in place to ensure this from now on.

5 Appeals Update

5.1 Zoledronic Acid (Zometa): Novartis No. 29/02.  Novartis have advised of their intention to appeal the SMC recommendation following their resubmission. An independent review panel chaired by Dr John Webster will be set up to hear the appeal, the timescale of which has yet to be confirmed. 

6 Correspondence

Following a recent visit by the Chairman to Tayside, correspondence was reviewed about SMC output.  The main issues raised were proposals to grade recommendations in a manner similar to SIGN opinions and for wider availability of the full recommendation document.  After substantial discussions it was agreed that the Chairman would liaise with the Finance Sub Group to determine how best to address these issues.  A paper on the topic would be provided for a future meeting of SMC.  

7 Public Involvement Sub Group

7.1 Progress regarding the patient friendly submission for Norelgestomin/ethinyl oestradiol transdermal patch (EVRA) was reported.  Dr Robert Donnelly, who provided the patient friendly submission for EVRA has been invited to attend the Public Involvement Sub Group Meeting on 5 August, 2003.     The group aim to pilot patient friendly submissions for 6 months and report back to SMC regarding the patient and User Group perspectives.  It was also reported that the alert system notifying subscribers of updates with a link to the appropriate web page would be running by mid June.  The work programme/product list will be categorised on the website from the end of July.A NHS QIS/ABPI Patient Involvement Group Training event is planned for later this year, details to be confirmed. The Chairman thanked Ms Nganasurian and congratulated her on the progress of the Public Involvement Group.

8 Pricing Paper

The ABPI representative provided an informative succinct presentation regarding medicines pricing in the UK.  Discussion followed and the group agreed that this had been a most useful exercise.

9 New Drugs Committee Update

9.1 There was no update from NDC on this occasion.

10 Abbreviated Submissions

10.1 There were no abbreviated submissions from NDC for assessment.

11 NDC Assessment Report

11.1 Frovatriptan (Migard): A.Menarini UK No. 49/03 Declarations of interest were recorded in relation to this product and comparator drugs. The SMC Vice Chairperson 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 as the company provided no suitable analysis to demonstrate cost effectiveness of their product, Frovatriptan (Migard) for the treatment of migraine, it should not be recommended for use within NHS Scotland. Minor amendments to wording were noted. The SMC advice will be issued to ADTCs and NHS Boards on Friday 6 June, 2003.

11.2 Methyl aminolevulinate (Metvix cream) - Actinic Keratoses: Galderma (UK) Ltd No. 50/03No declarations of interest were recorded in relation to this product or comparator drugs.  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.  The group agreed as no economic information was presented to substantiate company claims, methyl aminolevulinate (Metvix cream), for the treatment of actinic keratosis, should not be recommended for use within NHS Scotland.  Minor amendments to wording were noted.  The SMC advice will be issued to ADTCs and NHS Boards on 6 June, 2003.

11.3 Methyl aminolevulinate (Metvix Cream) Basal Cell Carcinoma: Galderma (UK) Ltd  No. 51/03No declarations of interest were recorded in relation to this product or comparator drugs. 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.  The group agreed as the company failed to produce an economic evaluation of their product, methyl aminolevulinate (Metvix cream) for the treatment of superficial and/or nodular basal cell carcinoma should not be recommended for use within NHS Scotland. Minor amendments to wording were noted. The SMC advice will be issued to ADTCs and NHS Boards on 6 June, 2003.

11.4 Hydrofluorolkane Beclomethasone Diproprionate (Qvar) Paediatric Indication: 3M Health Care Ltd  No. 52/03A declaration of interest was recorded in relation to this product.  A member with a personal specific interest left the room for this part of the agenda.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 made a recommendation regarding Hydrofluorolkane Beclomethasone Diproprionate (Qvar) for the treatment of asthma.  As an official launch date for Hydrofluorolkane Beclomethasone Diproprionate (Qvar) 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. 

12 Forthcoming Submissions

12.1 List of Forthcoming SubmissionsA revised list of forthcoming submissions was reviewed. The secretariat will circulate the list to ADTCs for information.

13 ADTC Feedback

Professor Webb reported that Lothian Area Drugs & therapeutics Committee had received an appeal about the SMC decision for Cerazette. 

14 Rotation of Members 

The secretariat will circulate a proforma to committee members at the end of the week requesting views regarding future commitment to SMC.  The Chairman stated that specialty and geographical location would be of paramount importance when appointing new members for the session beginning in 2004.

15 Any Other Business

15.2 Audit Scotland
The Chairman reported on a meeting with representatives of Audit Scotland who indicated that they would be happy to review SMC on a one off basis but would not be reviewing our systems on a regular basis, as they had no funding or remit so to do.  Evaluation ProcessThe results of Dr Black¿s pilot evaluation project are anticipated within the next few months.  Discussions will then take place regarding a regular system of audit.   

16 Date of Next Meeting

The date of the next meeting was confirmed as Tuesday 1 July, 2003, at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland Headquarters, Delta House, 50 West Nile Street, Glasgow G1 2NP.

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