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SMC Minutes - Tuesday, 4 March 2003

Present:

Professor David Lawson (Chairman); Mr Jeff Ace; Dr Keith Beard; Mrs Marion Bennie; Dr Corri Black; Professor Karen Facey; Dr Barclay Goudie; Dr David Hood; Dr Chris Lush; Professor Angus Mackay; Mr Hector Mackenzie; Mrs Chris McBeath; Ms Wendy Nganasurian; Mr Chris Nicholson; Dr Philip Rutledge; Ms Fiona Scott; Dr Sandy Simpson; Ms Angela Timoney; Ms Helen Tyrrell; Mr Mike Wallace; Professor David Webb; Dr John Webster; Dr Derek Yuille

In Attendance:

Ms Joy Hosie; Ms Moira Howie; Ms Ali McAllister; Mr Rob MacPhail; Mrs Jill Mitchell; Ms Rosie Murray

Apologies:

Professor Martin Brodie; Mr Tom Divers; Mrs Michelle Caldwell; Dr Marianne Nicholson; Dr Brian Paice; Dr Ken Paterson; Dr Keith Ridge; Mr Bill Scott; Ms Pamela Warrington; Mr Hugh Whyte; Dr Leslie Wilkie

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting. Ms Ali McAllister, SMC Administrator was welcomed as a member of the SMC secretariat. Apologies for absence were noted.

1.2 The Chairman advised that due to fixed commitments to teaching and increasing other responsibilities, Dr John Forbes had tendered his resignation as a member of the consortium. It was noted that a replacement health economist would be sought to fill this vacancy.

1.3 The Chairman advised there had been no further comments regarding the article on conflicts of interest which appeared in a Sunday Herald article on 23 February, 2003.

1.4 The Chairperson reminded members and attendees that they are bound by a confidentiality undertaking in relation to all SMC business.

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 (04.02.03)

3.1 The minutes of the meeting of 4 February, 2003, were agreed as an accurate record of the meeting with the following points clarified:

Item 6.1 - first sentence should read '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.'

Item 8.2.2 - last sentence should read '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 NHSScotland.'

Item 14.2 - clarification was sought regarding the wording of this statement and the Chairman confirmed that this was accurate.

4 Matters Arising From the Previous Minutes

4.1 Abbreviated Submission Form and Process

4.1.1 A draft template had been compiled and circulated to the members for comments. It was agreed that this document be amended to reflect minor points raised and published on the website thereafter.

4.1.2 It was agreed that submissions of this nature be incorporated into standard process and that these would be reviewed by NDC prior to final review by SMC.

4.2 Abbreviated Submission Form - Actonel

4.2.1 It was noted that the abbreviated submission in relation to Actonel would be submitted to NDC on 11 March 2003 in accordance with the agreed process.

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

4.3.1 The recommendation for Caspofungin acetate (Caspofungin), for the treatment of invasive aspergillosis, will be posted on the SMC website on Friday 7 March, 2003.

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

4.4.1 The recommendation for 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, will be posted on the SMC website on Friday 7 March, 2003.

4.4.2 It was noted that the final recommendation should incorporate wording 'high-risk of GI side-effects'. It was agreed that an amended recommendation would be issued to NHS Boards and ADTCs.

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

4.5.1 The recommendation for Bosentan (Tracleer), for the treatment of pulmonary arterial hypertension, will be posted on the SMC website on Friday 7 March, 2003.

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

4.6.1 The recommendation for Rituximab (MabThera), for the treatment of patients with CD20 positive diffuse large B-cell non-Hodgkin¿s lymphoma, in combination with CHOP chemotherapy, will be posted on the SMC website on Friday 7 March, 2003.

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

4.7.1 The recommendation for Capecitabine (Xeloda), for the treatment of metastatic breast cancer, will be posted on the SMC website on Friday 7 March, 2003.

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

4.8.1 The recommendation for Escitalopram (Cipralex), for the treatment of major depressive episodes, will be posted on the SMC website on Friday 7 March, 2003.

4.9 Drospirenone ethinylostradiol (Yasmin) (No 23/03): Schering

4.9.1 The recommendation for Drospirenone ethinylostradiol (Yasmin), a combined oral contraceptive pill, will be posted on the SMC website on Friday 7 March, 2003.

5 Appeals Update

5.1 The Chairman noted that a letter had been received from Pharmacia stating their intention to appeal the decision regarding the final recommendation on Parecoxib.

6 Public Involvement

6.1 A summary paper was presented on the progress of the Patient Involvement Group and issues which were on-going. It was agreed that following member comments, the guidance for submissions and the submission template for patient interest groups be published on the website. It was noted that the Q&A document would require updating to reflect consistent terminology.

7 New Drugs Committee Update (Update from NDC Chairman)

7.1 Expert Involvement

It was stated that the list of available experts was increasing and that a favourable response had been received. It was noted that there had been some queries regarding the completion of the confidentiality statement. The confidentiality statement issued to experts was the standard statement that all members had been requested to complete to ensure the confidentiality of the SMC process. It was noted that the secretariat would write to the experts clarifying issues raised.

7.2 NDC/SMC Meeting Timings

NDC Chairman had noted the variation in start times of the NDC and SMC and requested that the NDC meetings be aligned with the SMC and commence at 12.30pm. This was agreed.

7.3 NDC/SMC Members

It was noted that there were three members who link between the NDC and the SMC and that these nominated people present the assessments of the NDC to the SMC. The Chairman proposed that members of the assessment team be able to attend SMC meetings if required.

8 NDC Recommendation Reports

8.1 Pimecrolimus cream (Elidel) (No. 35/03): Novartis

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

8.1.2 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 Pimecrolimus cream (Elidel), for the treatment of signs and symptoms and intermittent long term treatment for prevention of progression to flares of mild to moderate atopic dermatitis (eczema), should not be recommended for use within NHS Scotland.

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

8.2 Desogestrel (Cerazette) (No. 36/03): Organon

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

8.2.2 The NDC Chairman 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 Desogestrel (Cerazette), an oral contraceptive, 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 March, 2003.

8.3 Dutasteride (Avole) (No. 37/03): GlaxoSmithKline UK Ltd

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

8.3.2 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 Dutasteride (Avole), for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH), 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 March, 2003.

8.4 Irbesartan (Aprovel) (No. 38/03): Sanofi Synthelabo & Bristol Myers Squibb

8.4.1 No declarations of interest were recorded in relation to this product and comparator drugs.

8.4.2 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 Irbesartan (Aprovel), for the treatment of renal disease in patients with hypertension and type 2 diabetes mellitus, as part of an antihypertensive drug regime, 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 March, 2003.

8.5 MicardisPlus (No. 39/03): Boehringer Ingelheim

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 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 MicardisPlus, for the treatment of hypertension, should be recommended for use within NHS Scotland.

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

8.6 Cialis (Tadalafil) (No. 40/03): Lilly - NDC 110203 (9)

8.6.1 Declarations of interest were recorded in relation to this product and the comparator drugs. Members with a personal specific interest in this product/company or in a competitor product left the room for this part of the agenda.

8.6.2 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 Cialis (Tadalafil), for the treatment of erectile dysfunction, should be recommended for use within NHS Scotland under the conditions of schedule 11.

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

8.7 Risperdal Quicklet (No. 41/03): Janssen-Cilag Ltd

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

8.7.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and summary of comments received from the company. The group agreed that Risperdal Quicklet, for the treatment of acute and chronic schizophrenic psychoses, should be recommended for use within NHS Scotland.

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

9 Forthcoming Submissions

9.1 List of Forthcoming Submissions

9.1.1 A revised list of forthcoming submissions was reviewed.

10 SMC Open Day - Feedback

The Chairman noted that feedback on the event had been positive.

11 Health Care Planning - SMC Sub Group

11.1 A short-life working group had met to discuss the level of information that SMC were issuing to NHS Boards. The group had concluded two action points. Firstly, it was noted the information was not standardised and that a standard format for this would be of assistance. It was agreed that a dataset of required information be drafted and piloted with two of the NHS Boards. Secondly, the horizon scanning information requirements of NHS Boards was identified as an information requirement and it was agreed that this be devolved to NDC for further discussion. Further updates regarding process would be made to SMC in due course.

12 Any Other Business

12.1 Competitor Input to Submissions

It was noted that a request had been received from a competitor company in relation to having an input to SMC assessments. It was noted that there seemed to be some confusion within industry regarding the role of NICE and the role of SMC. It was agreed that submissions from competitor companies would not be accepted by SMC.

13 Date of Next Meeting

13.1 The date of the next meeting was confirmed as Tuesday 1 April, 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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