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SMC Minutes - Tuesday, 5 August 2003

Minutes of Meeting
Held on Tuesday 5 August, 2003
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

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

1 Welcome and Apologies for Absence
  
1.1 The Chairman welcomed members to the meeting. Mrs Barbara Black, lay representative, who has been co-opted to SMC to attend meetings to support Wendy Nganasurian, was also welcomed to the meeting. Apologies for absence were noted.

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 Minutes of the Previous Meeting (01.07.03)

3.1 The minutes of the meeting of 1 July, 2003 were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1 Avonex (Interferon beta 1a):  Biogen Ltd    No: 58/03  ABBREVIATED SUBMISSION
A declaration of interest was recorded in relation to a comparator product.  Minor amendments to wording were noted.  As an official launch date is yet to be confirmed for Avonex (Interferon beta 1a), 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.    The Chairman requested members note a change to policy whereby abbreviated submissions will no longer always be recommended for general use, but can be categorised for either restricted or general use.

4.2 Pimecrolimus (Elidel Cream 1%): Novartis Pharmaceuticals UK Limited No. 35/03 RESUBMISSION
The resubmission for Pimecrolimus (Elidel Cream 1%), for the treatment of mild to moderate atopic dermatitis, will now be reviewed by SMC in October.  

4.3 Adefovir dipivoxil 10mg (Hepsera 10mg) Gilead Sciences International Limited No. 54/03
Minor amendments were made to the wording within the final recommendation.  The company, NHS Boards and ADTCs will be notified accordingly.  The recommendation for Adefovir dipivoxil 10mg (Hepsera 10mg), for the treatment of chronic hepatitis B, will be posted on the SMC website on Monday 11 August, 2003. 

4.4 Valdecoxib (Bextra): Pfizer Ltd   No. 55/03
Minor amendments were made to the wording within the final recommendation.  The company, NHS Boards and ADTCs will be notified accordingly.  The recommendation for Valdecoxib (Bextra), for the treatment of osteoarthritis and rheumatoid arthritis, will be posted on the SMC website on Monday 11 August, 2003. 

4.5 Enfuvirtide (Fuzeon): Roche   No. 56/03
The recommendation for Enfuviritide (Fuzeon), for the treatment of HIV-1 infected patients, will be posted on the SMC website on Monday 11 August, 2003. 

4.6 Memantine (Ebixa): H. Lundbeck Ltd  No. 57/03
Minor amendments were made to the wording within the final recommendation.  The company, NHS Boards and ADTCs will be notified accordingly. The recommendation for Memantine (Ebixa), for the treatment of moderately severe to severe Alzheimer's disease, will be posted on the SMC website on Monday 11 August, 2003. 

4.7 Press Releases
The Chairman advised that future press releases would be made on Monday and not Friday as is the current practice.

5 Appeals Update

5.1 Zoledronic Acid (Zometa): Novartis No. 29/02
A date for the appeal hearing is to be confirmed, but is likely to be late October.  Progress will be reported at future meetings.

5.2 Memantine (Ebixa): Lundbeck Ltd  No. 57/03. 
Lundbeck have advised of their intention to resubmit.

6 Correspondence

6.1 There was no correspondence to note. 

7 Public Involvement Sub Group

7.1 The e-mail alert system has been incorporated in the overall re-development of the SMC website.  The work programme/product list is being BNF categorised.  The site is in the final stages of construction.  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 There was no update to report.

9 NDC Assessment Reports
 
9.1 Olopatadine 1 mg/ml Eye Drops (Opatanol 0.1% w/v Eye Drops)  No. 59/03
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 Olopatadine 1mg/ml eye drops (Opatanol 0.1% w/v eye drops), for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis, 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 8 August, 2003.

9.2 Norelgestromin-ethinyloestradiol (EVRA)  No. 48/03 
Declarations of interest were recorded in relation to this product and comparator drugs.  A member with an interest in a competitor product left the room for this part of the agenda.The SMC Vice Chairperson 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 Norelgestromin-ethinyloestradiol (EVRA), a combined transdermal contraceptive, 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 8 August, 2003.

9.3 Perindopril/Indapamide (Coversyl Plus) No. 64/03  
Declaration of interest was recorded in relation to this product and comparator drugs. Members with a personal specific interest left the room for this part of the agenda.  The SMC Vice Chairperson 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 Perindopril/Indapamide (Coversyl Plus), for the treatment of hypertension, 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 8 August, 2003.

9.4 Ezetimibe (Ezetrol) No. 61/03
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 Ezetimibe (Ezetrol), a lipid lowering agent, 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 8 August, 2003.

9.5 Travatan 40 mg/ml eye drops solution (Travoprost)  No. 60/03 ABBREVIATED SUBMISSION
No declaration of interests were recorded in relation to this product or comparator drugs.The NDC Vice Chairman provided an overview of the assessment and draft summary recommendation.  Detailed discussion followed and the group agreed that Travatan 40 mg/ml eye drops solution (Travoprost), for the first line treatment of raised intra-ocular pressure in open-glaucoma and ocular hypertension, was not suitable as an abbreviated submission.  The secretariat was requested to contact the company to request a full submission for this product, concentrating on the issues of budget impact and cost effectiveness.     

9.6 Valcyte (Valganciclovir) in Solid Organ Transplantation  No. 62/03 ABBREVIATED SUBMISSION
A declaration of interest was recorded in relation to this product.The SMC Vice Chairperson provided an overview of the assessment and draft summary recommendation.  Detailed discussion followed and the group agreed that Valcyte (Valganciclovir), for the induction and maintenance treatment of cytomegalovirus (CMV) retitinis in patients with AIDS, 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 8 August, 2003.

9.7 Desogestrel (Cerazette) No. 36/03 RESUBMISSION
A member with an interest in a competitor product left the room for this part of the agenda.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. Correspondence from family planning leaders within Lothian Primary Care NHS Trust was highlighted.  Detailed discussion followed and comments received from absent members were taken into consideration.  The group agreed that Desogestrel (Cerazette), a progestogen-only contraceptive pill, 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 8 August, 2003.

10 Forthcoming Submissions

10.1 List of Forthcoming SubmissionsA revised list of forthcoming submissions was reviewed.

11 ADTC Feedback

11.1 There was no feedback to report.

12 Any Other Business

12.1 There was no other business to report.

13 Date of Next Meeting

13.1 The date of the next meeting was confirmed as Tuesday 2 September, 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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