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SMC Minutes - Tuesday, 4 February 2003

Present:

Professor David Lawson (Chairman); Dr Keith Beard; Professor Martin Brodie; Professor Karen Facey; Dr Barclay Goudie; Mrs Chris McBeath; Mr Chris Nicholson; Dr Ken Paterson; Dr Philip Rutledge; Dr Sandy Simpson; Ms Angela Timoney; Ms Helen Tyrrell; Mr Mike Wallace; Professor David Webb; Dr Derek Yuille
 
In Attendance:

Ms Susan Donnelly; Ms Joy Hosie; Ms Moira Howie; Mr Rob MacPhail; Mrs Jill Mitchell; Ms Rosie Murray
 
Apologies:

Mr Jeff Ace; Mrs Marion Bennie; Dr Corri Black; Mrs Michelle Caldwell; Mr Tom Divers; Dr John Forbes; Dr David Hood; Dr Chris Lush; Professor Angus Mackay; Mr Hector Mackenzie; Ms Wendy Nganasurian; Dr Marianne Nicholson; Dr Brian Paice; Dr Keith Ridge; Mr Bill Scott; Ms Fiona Scott; Ms Pamela Warrington; Dr John Webster; Mr Hugh Whyte; 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 thanked members present for enduring the difficult weather conditions to attend the meeting, and expressed concern for those caught in severe snow en route to SMC. 

1.2 The Chairperson reminded members and attendees that they are bound by a confidentiality undertaking.

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 (03.12.02)

3.1 The minutes of the meeting of 3 December, 2002, were agreed as an accurate record of the meeting.

Clarity was sought regarding 6.1: Public Involvement. It was confirmed that where it stated, 'SMC would be proactive in contacting companies' this referred to pharmaceutical companies.

The Minutes of the meeting of 3 December, 2002, will be posted on the SMC website on Friday 7 February, 2003.

4 Matters Arising From the Previous Minutes

4.1 Detailed Recommendation Form

4.1.1 The NDC Chairman emphasised that consistence was required in the wording of recommendation categories. Some confusion had been noted in Lothian ADTC in this regard. In order to ensure a clear structure is in place to enable NHS Boards and ADTCs to implement guidance, it was agreed that standardisation of the first component of the recommendation defining a simple statement of the summary recommendation. This can be expanded and refined in the second paragraph as necessary.

4.1.2 The Chairman advised that discussions were ongoing regarding posting of the fuller recommendation document in the public domain once confidentiality issues can be clarified.

4.2 New Submission Form

4.2.1 The Consortium approved the revised submission form, launched at the Industry Training Day.  The form will be posted on the SMC website within the next 2/3  weeks.

4.3 New Indications/Formulations - Information to Pharmaceutical Companies

4.3.1 The Consortium accepted the redrafted 'Information for Pharmaceutical Companies' with a minor amendment regarding patient guidance. This will be posted on the SMC website on Friday 7 February, 2003.

4.4 Transdermal fentanyl (Durogesic) (No. 24/02): Janssen-Cilag

4.4.1 The Chairman advised that the recommendation for Transdermal fentanyl (Durogesic) offering a second line alternative for patients with intractable pain due to non malignant conditions which has been controlled by oral means, will be posted on the SMC website on Friday 7 February, 2003.

4.5 Voriconazole (Vfend) (No. 25/02): Pfizer

4.5.1 The Chairman advised that the recommendation for Voriconazole (Vfend) for the treatment of suspected or confirmed cases of invasive aspergillosis will be posted on the SMC website on Friday 7 February, 2003.

4.6 Imatinib CML (No. 26/02): Pharma Novartis

4.6.1 The Chairman advised that the recommendation for Imatinib CML for the first line treatment of patient with chronic myeloid leukaemia will be posted on the SMC website on Friday 7 February, 2003.

4.7 Parecoxib (Dynastat injection) (No. 27/02): Pharmacia

4.7.1 The Chairman advised that the recommendation for Parecoxib (Dynastat injection) for the treatment of post operative pain will be posted on the SMC website on Friday 7 February, 2003.

4.8 FemSeven Conti (No. 28/02): Merck Pharmaceuticals

4.8.1 The Chairman advised that the recommendation for FemSeven Conti offering an alternative continuous combined hormone replacement therapy (HRT) for the treatment of oestrogen deficiency symptoms in postmenopausal women will be posted on the SMC website on Friday 7 February, 2003.

4.9 Zoledronic acid (Zometa) (No. 29/02): Novartis

4.9.1 The Chairman advised that the recommendation for Zoledronic acid (Zometa) for the prevention of skeletal related events in patients with advanced malignancies involving bone will be posted on the SMC website on Friday 7 February, 2003.

5 Appeals Update

5.1 No appeals were noted.

6 Public Involvement

6.1 The Patient Involvement Group had met with Patient Interest Groups on 3 December, 2002, and welcomed the opportunity to become involved in the SMC process. Three organisations agreed to the proposed protocol for public involvement in SMC processes and will report back as soon as possible. It was suggested that it would be useful to run a Patient Group Education Day focusing on the evolution of medicines. The Chairman supported the concept. Should ABPI (Scotland) wish to run such an event, SMC would be supportive, however should the proposal be that SMC itself run such an event, he advised that this should be undertaken in collaboration with NHS Quality Improvement Scotland. The Chairman requested that a written update regarding the progress of the Patient Involvement Group be available at a future meeting.

7 New Drugs Committee Update (Update from NDC Chairman)

7.1 Expert Involvement

A list of experts is being developed, with 105 acceptances to date.  Further acceptances are expected and an update will be presented to SMC in March. If an individual clinician wishes to form part of the expert panel their details should be forwarded to the secretariat for consideration.  Expert details are not incorporated in the annual report, but it is hoped that when complete, details of the expert panel will be put on the SMC website although further discussion with the CLO and individual experts is required before this can be implemented.

7.2 Health Economic Sub Group Meeting

The Health Economic Sub Group met on 10 December, 2002. Issues regarding quality assurance implications for health economics, expert involvement, input from assessors regarding company responses and information on whether NICE is undertaking Technology Appraisal Guidance on a particular product were discussed.

8 NDC Recommendation Reports

8.1 Drospirenone ethinylostradiol (Yasmin): Schering (No. 23/03)

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

8.1.2 Due to an error made during assessment the NDC assessment team who completed the initial assessment reassessed the data. The Chairman welcomed the Pharmacy Assessor to present the assessment.

8.1.3 The pharmacy assessor provided a detailed overview of the assessment, the key issues identified and draft recommendation. Detailed discussion followed and amendments were noted in relation to the recommendation document. Drospirenone ethinylostradiol (Yasmin) a new combined oral contraceptive pill was not recommended for use within NHS Scotland.

8.1.4 The SMC advice will be issued to ADTCs and NHS Boards on 7 February, 2003.

8.2 Caspofungin acetate (Caspofungin) (No. 30/03): Merck Sharp & Dohme Ltd

8.2.1 Declarations of interest were recorded in relation to this product and the comparator drugs.

8.2.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation and summary of comments received from the company. Detailed discussion followed. It was agreed that the submission was of poor quality and provided little indication of health gains or cost-effectiveness for this preparation. The group agreed, on the basis of the evidence presented to the committee, that Caspofungin acetate (Caspofungin) for the treatment of invasive aspergillosis should not be recommended for use within NHS Scotland.

8.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 February, 2003.

8.3 Etoricoxib (Arcoxia) (No. 31/03): Merck Sharp & Dohme Ltd

8.3.1 Declarations of interest were recorded in relation to this product and the comparator drugs.

8.3.2 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 Etoricoxib (Arcoxia) for the treatment of symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA) and the pain and signs of inflammation associated with acute gouty arthritis should be recommended for restricted use within NHS Scotland.

8.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 February, 2003.

8.4 Rituximab (MabThera) (No. 33/03): Roche

8.4.1 Declarations of interest were recorded in relation to this product and the comparator drugs.

8.4.2 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 amendments were noted in relation to the recommendation document. The group agreed that Rituximab (MabThera) for the treatment of patients with CD20 positive diffuse large B-cell non-Hodgkin¿s lymphoma, in combination with CHOP chemotherapy, should be recommended for restricted use within NHS Scotland.

8.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 February, 2003.

8.5 Bosentan (Tracleer) (No. 32/03): Actelion Pharmaceuticals UK Ltd

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

8.5.2 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 amendments were noted in relation to the recommendation document. The group agreed that Bosentan (Tracleer) for the treatment of pulmonary arterial hypertension should be recommended for restricted use within NHS Scotland.

8.5.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 February, 2003.

8.6 Capecitabine (Xeloda) (No. 34/03): Roche

8.6.1 Declarations of interest were recorded in relation to this product and the comparator drugs.

8.6.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and summary of comments received from the company. Draft NICE guidance due to be published in spring 2003 after the consultation period was completed was noted. The group agreed that Capecitabine (Xeloda) for the treatment of metastatic breast cancer should be recommended for restricted use within NHS Scotland.

8.6.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 February, 2003.

8.7 Escitalopram (Cipralex) (No. 17/02): Lundbeck - RESUBMISSION

8.7.1 Declarations of interest were recorded in relation to this product and the comparator drugs.

8.7.2 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. The group agreed that Escitalopram (Cipralex) for the treatment of major depressive episodes should be recommended for restricted use within NHS Scotland.

8.7.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 February, 2003.

9 Forthcoming Submissions

9.1 List of Forthcoming Submissions

9.1.1 A revised list of forthcoming submissions was reviewed.

10 User Group Forum

10.1 Minutes from the User Group Forum were reviewed. The ABPI representative advised that industry welcomed the developments and dialogue with SMC.

11 Industry Training Day - 14 January, 2003

11.1 The ABPI representative provided an update on the industry Training Day and advised that feedback had been extremely positive.  A list of action points was reviewed and members were encouraged to identify issues not highlighted which they wish to be addressed in future meetings.

12 SMC Open Day - 13 February, 2003

12.1 Response to the SMC Open Day has been positive with 140 registrations to date.  Dr Armstrong, Chief Medical Officer will chair the morning session and Lord Patel, Chairman, NHS Quality Improvement Scotland, the afternoon session.  The SMC Annual Report will be available on the day and distributed to those members not attending after the event.

13 Health Care Planning - SMC Sub Group

13.1 A SMC Sub Group to look at health care planning has been set up and the first meeting will take place on Tuesday 4 March, 2003.  Details of this meeting will be reported to SMC in March.

14 Any Other Business

14.1 Risendronate sodium (Actonel)

Declarations of interest were recorded in relation to this product and the comparator drugs.

Following a suggestion that a statement should be issued to ADTCs and NHS Boards providing details of those products that do not require full SMC assessment, it was agreed that it is necessary to define a robust process for dealing with such products. The draft document ¿Information to Pharmaceutical Companies¿ had outlined such an approach. It was agreed that a draft template be presented to SMC in March, using this product as an example.

14.2 NHS Quality Improvement Scotland

The Chairman reported that further to discussions with the Chairman and Chief Executive of NHS Quality Improvement Scotland, SMC could become a stand alone sub group of NHS Quality Improvement Scotland with no direct reporting responsibility to the Board. SMC would retain its unique character as a body constituted from all the Health Boards in Scotland and reporting directly to them. Further details of progress in this area will be reported at future meetings. The Chairman stated that Lord Patel voiced his strong support for the SMC and NDC and congratulated members on their hard work to date.

15 Date of Next Meeting

15.1 The date of the next meeting was confirmed as Tuesday 4 March, 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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