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SMC Minutes - Tuesday, 1 July 2003

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

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting. Apologies for absence were noted.
1.2 The Chairman advised that Mr Andrew Dillon, Chief Executive of NICE, has been awarded a CBE in the Birthday Honours List.  The Chairman will write to Mr Dillon to congratulate him on this honour.

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. 

3 Minute of the Previous Meeting (03.06.03)
3.1 The minutes of the meeting of 3 June, 2003 were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1 Frovatriptan (Migard): A.Menarini UK No. 49/03 The recommendation for Frovatriptan (Migard), for the treatment of migraine, will be posted on the SMC website on Friday 4 July, 2003. 

4.2 Methyl aminolevulinate (Metvix cream) - Actinic Keratoses: Galderma (UK) Ltd No. 50/03The recommendation for Methyl aminolevulinate (Metvix cream), for the treatment of actinic keratoses, will be posted on the SMC website on Friday 4 July, 2003.  

4.3 Methyl aminolevulinate (Metvix Cream) Basal Cell Carcinoma: Galderma (UK) Ltd  No. 51/03The recommendation for Methyl aminolevulinate (Metvix Cream), for the treatment of basal cell carcinoma, will be posted on the SMC website on Friday 4 July, 2003.  The Chairman wrote to the Chief Executive of Galderma regarding the quality of their submission for both indications and received an acknowledgement from the company.

4.4 Hydrofluoralkane Beclomethasone Diproprionate (Qvar) Paediatric Indication: 3M Health Care Ltd  No. 52/03 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.    
 

5 Appeals Update
5.1 Methyl aminolevulinate (Metvix cream) - Actinic Keratoses: Galderma (UK) Ltd No. 50/03 Methyl aminolevulinate (Metvix Cream) Basal Cell Carcinoma: Galderma (UK) Ltd  No. 51/03.  Galderma have advised of their intention to resubmit. 
5.2 Frovatriptan (Migard): A.Menarini UK No. 49/03.  A Menarini UK have advised of their intention to resubmit.
5.3 Zoledronic Acid (Zometa): Novartis No. 29/02.  Novartis have forwarded documentation to support their appeal against the SMC recommendation for Zoledronic Acid (Zometa). The timescale for review is yet to be confirmed.

6 Correspondence
6.1 There was no correspondence to note. 

7 Public Involvement Sub Group
7.1 A NHS QIS/ABPI Patient Involvement Group Training event has been proposed for later this year.  Details of event are still under discussion and will be confirmed in due course.

8 New Drugs Committee Update
8.1 Desogestrel (Cerazette)  The NDC Chairman advised that further to a meeting with family planning leaders within Lothian Primary Care NHS Trust, they wish to appeal the SMC advice with issues highlighted to be reviewed at NDC in July.   Detailed discussion followed and the group agreed that the route for clinicians to appeal would be to write formally to SMC, declaring any interests and stating the reasons why they feel SMC have come to the wrong decision.

9 NDC Assessment Reports

9.1 Adefovir dipivoxil 10mg (Hepsera 10mg) No. 54/03.  No 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 and the group agreed that Adefovir dipivoxil 10 mg (Hepsera 10mg), for the treatment of hepatitis B, 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 4 July, 2003.

9.2 Valdecoxib (Bextra): Pfizer Ltd No. 55/03.  Declarations of interest were recorded in relation to this product and 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 and the group agreed that Valdecoxib (Bextra), for the symptomatic relief of osteoarthritis and rheumatoid arthritis should  be recommended for general use within NHS Scotland. Minor amendments to wording were noted. The SMC advice will be issued to ADTCs and NHS Boards on 4 July, 2003.

9.3 Enfuvirtide (Fuzeon): Roche  No. 56/03.  A declaration of interest was recorded in relation to this product. The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified and the draft recommendation. Detailed discussion followed and the group agreed that Enfuvirtide (Fuzeon), for the treatment of HIV, should be recommended for restricted use within NHS Scotland. Minor amendments to wording were noted. The SMC advice will be issued to ADTCs and NHS Boards on 4 July, 2003.

9.4 Memantine (Ebixa): H. Lundbeck Ltd  No. 57/03.  No declarations of interest were recorded in relation to this product or comparator drugs.  The NDC Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and summary of comments received from the company and patient group submission from Alzheimer Scotland.  Detailed debate followed and the group agreed that the company had not provided a sensitivity analysis, the economic case had not been proven and on the evidence presented the associated gains appear to be marginal relative to the overall costs.  Therefore, Memantine (Ebixa), for the treatment Alzheimer's disease and other dementias, was 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 4 July, 2003.

9.5 Pimecrolimus (Elidel Cream 1%): Novartis Pharmaceuticals UK Limited No. 35/03 RESUBMISSION.  No declaration of interests were recorded in relation to this product or comparator drugs.The Chairman advised that Novartis had requested a deferment of the consideration of pimecrolimus in the light of substantial new information submitted to the secretariat only one working day prior to the meeting.  Some of this information had only just come into the company's possession.  A deferment was granted on this occasion.  The resubmission will be revisited as soon as practical.    

9.6 Avonex (Interferon beta 1a):  Biogen Ltd No: 58/03 ABBREVIATED SUBMISSION.  No declaration of interests were recorded in relation to this product or comparator drugs.Discussion followed and the group agreed that as Avonex (Interferon beta 1a), for the treatment of ambulatory patients with relapsing multiple sclerosis, will not be launched until September, in accordance with SMC process, the distribution of this recommendation will be withheld until launch.  Details of wording were discussed and will be revisited at the SMC meeting in August.

10 Forthcoming Submissions
10.1 A revised list of forthcoming submissions was reviewed.

11 ADTC Feedback
11.1 The ABPI representative commended the work of those involved in putting together the Lothian Prescribing Bulletin and hope that this can be reflected across Scotland.

12 SMC User Group Forum
12.1 The minutes of the SMC User Group Forum held on 10 June, 2003, were presented for information purposes.

13 Experts
13.1 The ABPI representative stated that there is concern within industry that the identity of experts used is not reflected within the recommendation document. Detailed discussion followed and it was agreed it would be acceptable to incorporate a summary of expert views within the document but not to specifically name experts.  This will be explored at NDC and comments fedback  to the User Group Forum.  

14 Any Other Business
14.1 Healthcare Planning Sub Group
A summary of the progress of the Healthcare Planning Sub Group was presented to the group.  The SMC approved a financial template that will be issued to Health Boards and ADTCs.   A Horizon Scanning Group will meet twice yearly and issue predictions of expensive products for the following six months to the SMC for onward distribution to Health Boards and ADTCs.
 
14.2 Evaluation Project
An update regarding the evaluation project was provided.  A formal report will be presented to SMC in September.

15 Date of Next Meeting
15.1 The date of the next meeting was confirmed as Tuesday 5 August, 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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