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SMC Minutes - Tuesday, 1 April 2003

Present:

Professor David Lawson (Chairman); Dr Keith Beard; Mrs Marion Bennie; Professor Martin Brodie; Mrs Michelle Caldwell; Professor Karen Facey; Dr David Hood; Dr Chris Lush; Professor Angus Mackay; Mrs Chris McBeath; Ms Wendy Nganasurian; Dr Ken Paterson; Dr Sandy Simpson; Ms Angela Timoney; Ms Helen Tyrrell; Mr Mike Wallace; Professor David Webb; Dr Leslie Wilkie; Dr Derek Yuille

In Attendance:

Dr Corri Black; Ms Joy Hosie; Mr Rob MacPhail; Ms Ali McAllister; Mrs Jill Mitchell; Ms Rosie Murray

Apologies:

Mr Jeff Ace; Mr Tom Divers; Dr Barclay Goudie; Ms Moira Howie; Mr Hector Mackenzie; Mr Chris Nicholson; Dr Marianne Nicholson; Dr Brian Paice; Dr Keith Ridge; Dr Philip Rutledge; Mr Bill Scott; Ms Fiona Scott; Ms Pamela Warrington; Dr John Webster; Mr Hugh Whyte

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members 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 Minute of the Previous Meeting (04.03.03)

3.1 The minutes of the meeting of 4 March 2003 were agreed as an accurate record of the meeting. 

3.2 Agreement was reached when referring to competitors in final recommendations, to treat as a ┬┐class effect┬┐, whether singular or plural competitors.

4 Matters Arising From the Previous Minutes

During the period 1 April - 1 May 2003, NHS Scotland will enter a period of purdah. This covers the conduct of business during the Scottish Parliamentary elections during which no public announcements will be made. Therefore, final recommendations summaries which were due to be posted on the SMC website on 4 April 2003, will not be posted until 9 May 2003.

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

4.1.1 The recommendation for 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), will be posted on the SMC website on Friday 9 May, 2003.

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

4.2.1 The recommendation for Desogestrel (Cerazette), an oral contraceptive, will be posted on the SMC website on Friday 9 May, 2003.

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

4.3.1 The recommendation for Dutasteride (Avole), for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH), will be posted on the SMC website on Friday 9 May, 2003.

4.3.2 Minor change to wording within the final recommendation was noted.

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

4.4.1 The recommendation for Irbesartan (Aprovel), for the treatment of renal disease in patients with hypertension and type 2 diabetes mellitus, as part of an antihypertensive drug regime, will be posted on the SMC website on Friday 9 May, 2003.

4.5 Telmisartan + hydrochlorothiazide (MicardisPlus) (No. 39/03): Boehringer Ingelheim

4.5.1 The recommendation for Telmisartan + hydrochlorothiazide (MicardisPlus), for the treatment of hypertension, will be posted on the SMC website on Friday 9 May 2003.

4.5.2 Minor change to wording within the final recommendation was noted.

4.6 Cialis (Tadalafil) (No. 40/03): Lilly

4.6.1 The recommendation for Cialis (Tadalafil), for the treatment of erectile dysfunction, will be posted on the SMC website on Friday 9 May 2003.

4.6.2 A declaration of interest was noted for this product.

4.6.3 Minor change to wording within the section entitled 'Guidelines, protocols, audit and monitoring arrangements' was noted.

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

4.7.1 The recommendation for Risperdal Quicklet, for the treatment of acute and chronic schizophrenic psychoses, will be posted on the SMC website on Friday 9 May, 2003.

5 Appeals Update

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

5.1.1 At the request of the company a meeting has been scheduled to discuss the process and way forward.

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

5.2.1 At the request of the company a meeting has been scheduled to discuss the process and way forward.

6 Public Involvement

6.1 Documentation regarding the Patient Involvement Group including guidance for submissions and the submission template for patient interest groups is now available on the website.

7 New Drugs Committee Update (Update from NDC Chairman)

7.1 NDC Meeting - New Start Time

NDC meetings will now commence at 12.30 pm.

7.2 NDC/SMC Members

Members of the NDC assessment team will attend SMC meetings on a rotational basis to present the assessments. It was agreed that appropriate Health Authorities are to fund any travel expenses incurred.

7.3 Agenda Setting

The NDC Chairman highlighted the current shortfall in submissions. This is being addressed and further information is detailed in Section 10.1.

7.4 Olanzapine (Zyprexa)  Eli Lilly & Co Ltd No. 44/03

The NDC decision regarding Olanzapine (Zyprexa), for the treatment of moderate to severe manic episodes, was deferred and will be reviewed at the NDC meeting on 8 April.  The company have been requested to re-run the model to reflect Scottish practice.

7.4.1 The APBI representative will discuss the issue of ensuring that appropriate data is presented to SMC at the next SMC User Group Forum.

8 Abbreviated Submissions

8.1 Risedronate sodium (Actonel®)  (No. 46/03)

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

8.1.2 The abbreviated submission for this medicine was considered. Risedronate sodium (Actonel), for prophylaxis and treatment of osteoporosis in postmenopausal women, was recommended for general use within NHS Scotland.

8.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 April 2003.

9 NDC Assessment Reports

9.1 Docetaxel (Taxotere) (No. 42/03): Aventis

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

9.1.2 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 Docetaxel (Taxotere), for the treatment of non-small-cell lung cancer (NSCLC), should be recommended for restricted use within NHS Scotland, with minor amendments to economic analysis and final recommendation.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 April, 2003.

9.2 Calcitriol 3ug/g (Silkis Ointment) (No. 43/03): Gladerma UK Ltd

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

9.2.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified and the draft recommendation. Detailed discussion followed and the group agreed that Calcitriol 3ug/g (Silkis Ointment), for the treatment of mild-moderate plaque psoriasis (psoriasis vulgaris), should be recommended for general use within NHS Scotland, with minor amendments to wording.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 April, 2003.


9.3 Rosuvastatin (CRESTOR) (No. 45/03):  Astra Zeneca UK Ltd

9.3.1 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.

9.3.2 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 Rosuvastatin (CRESTOR), for the treatment of low-density-lipoprotein-cholesterol (LDL-C), should be recommended for general use within NHS Scotland, with minor amendments to wording.

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 April, 2003.

9.4 Zoledronic Acid (Zometa) (No. 29/02): Novartis RESUBMISSION

9.4.1 A declaration of interest was recorded in relation to this product and comparator drugs.

9.4.2 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 Zoledronic Acid (Zometa) should be restricted to prescribing by oncologists for patients with breast cancer and multiple myeloma. It provides an alternative to other bisphosphonates licensed for prevention of skeletal related events. It has a broader range of indications than other bisphosphonates available and has shown some efficacy in patients with prostate cancer and NSCLC and other solid tumours. The quality of the economic evidence provided is insufficient to demonstrate that the use of this product for these indications is cost effective.

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 April 2003.

10 Forthcoming Submissions

10.1 List of Forthcoming Submissions

10.1.1 A revised list of forthcoming submissions was reviewed.

10.1.2 Concern was voiced in regard to the reduced numbers of company submissions. The secretariat will contact companies directly to request submissions and will advise that should they not be forthcoming within a specified timescale that ADTCs and NHS Boards will be advised of negative recommendation.

11 User Group Forum

11.1 The minutes of the SMC User Group Forum were presented for information.

  • The ABPI representative advised that further work has been agreed in regard to the guidance to experts and this is currently being taken forward.
  • Further work is required on non-technical submissions.
  • It is anticipated that the next Industry Training Day will take place in October/November.

12 Evaluation Project

12.1 Dr Corri Black provided a brief introduction to the group and presented a paper regarding a proposal for the evaluation of the SMC processes and impact to-date. Comments/questions were directed to Dr Black and included:

  • Interest in SMC from the perspective of 'before' and 'after' and whether it has made a marked difference since its inception.
  • Suggestion that the role of Public Involvement be incorporated as part of the baseline to the evaluation.
  • Advised that interaction with Audit Scotland would be advantageous.

12.2 The Chairman requested that full co-operation by individuals from ADTCs be given as this would be of great assistance to the evaluation process.

13 Antibiotic Policy

13.1 Dr Peter Christie of the Scottish Executive provided a brief introduction to the group and proposed that SMC facilitate the development of a working group to:

  • Collate and examine current practice across Scotland in terms of antibiotic prescribing policies.
  • Construct a 'good practice' model with appropriate consultation, and delivery of the model to ADTCs by December 2003.

13.2 General discussion followed and it was agreed that the Chairman would engage in further dialogue with Dr Christie, in the first instance. Following this, a paper will be provided to the committee, and the outcome be reported to Dr Christie at the next scheduled SMC meeting.

14 Any Other Business

14.1 The Chairman of the User Group Forum has been requested to provide a paper on pricing. It is hoped that this will be tabled for discussion at a future SMC meeting.

14.2 The Chairman notified committee members that the SMC meeting scheduled for June might be cancelled due to few submissions being received. The position will be clarified at the SMC meeting on 6 May 2003.

15 Date of Next Meeting

15.1 The date of the next meeting was confirmed as Tuesday 6 May, 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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