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SMC Minutes - Tuesday, 6 May 2003

Present: Professor David Lawson (Chairman); Mr Jeff Ace; Dr Keith Beard; Mrs Marion Bennie; Professor Martin Brodie; Mrs Michelle Caldwell; Dr Barclay Goudie; Dr David Hood; Ms Moira Howie; Professor Angus Mackay; Mr Chris Nicholson; Dr Marianne Nicholson; Dr Ken Paterson; Dr Philip Rutledge; Dr Sandy Simpson; Ms Angela Timoney; Ms Helen Tyrrell; Mr Mike Wallace; Dr John Webster; Dr Derek Yuille
 
In Attendance: Dr Corri Black; Ms Joy Hosie; Ms Janne Kampmann; Mr Hector Mackenzie; Mr Rob MacPhail; Ms Ali McAllister; Ms Rosie Murray
 
Apologies: Mr Tom Divers; Professor Karen Facey; Dr Chris Lush; Mrs Chris McBeath; Mrs Jill Mitchell; Ms Wendy Nganasurian; Dr Brian Paice; Dr Keith Ridge; Mr Bill Scott; Ms Fiona Scott; Ms Pamela Warrington; Professor David Webb; 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. Ms Janne Kampmann, newly appointed part time member of the pharmacy assessment team, was welcomed as an observer.

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 (01.04.03)

3.1 The minutes of the meeting of 1 April 2003 were agreed as an accurate record of the meeting with the following amendments noted:

  • Chris Nicholson was noted as being both present and was absent. Delete from present section.
  • No. 4.6.1.  Delete words: for the treatment of major depressive episodes.
  • Written comments from an absent committee member were noted.

4 Matters Arising From the Previous Minutes

4.1 Antibiotic Policy

Following on from the proposal and subsequent presentation at the last SMC meeting by Dr Peter Christie, Professor Lawson tabled a proposal to set up a short life working group to consider key issues regarding antibiotic prescribing policy.  Detailed discussion followed and the group agreed to support the concept in principle, but highlighted this was a departure from their normal procedures and should by no means establish a precedent for the future.

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

4.2.1 The recommendation for Docetaxel (Taxotere), for the treatment of non-small-cell lung cancer (NSCLC), will be posted on the SMC website on Friday 9 May, 2003. 

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

4.3.1 The recommendation for Calcitriol 3ug/g (Silkis Ointment), for the treatment of mild-moderate plaque psoriasis (psoriasis vulgaris), will be posted on the SMC website on Friday 9 May, 2003.

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

4.4.1 The recommendation for Rosuvastatin (CRESTOR), for the treatment of raised low-density-lipoprotein-cholesterol (LDL-C), will be posted on the SMC website on Friday 9 May, 2003.

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

4.5.1 The recommendation for Zoledronic Acid (Zometa), for the treatment of patients with breast cancer and multiple myeloma, will be posted on the SMC website on Friday 9 May, 2003.

4.6 Risedronate sodium (Actonel): Procter & Gamble/Aventis No. 46/03 - ABBREVIATED SUBMISSION

4.6.1 The recommendation for Risedronate sodium (Actonel), for prophylaxis and treatment of osteoporosis in postmenopausal women, will be posted on the SMC website on Friday 9 May, 2003.

5 Appeals Update

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

5.1.1 The Chairman met with representatives from Novartis who have subsequently advised of their intention to resubmit.

5.1.2 Professor Lawson expressed concern that although the recommendation would not be in the public domain until 9 May, 2003, confidentiality appears to have been breached with several clinicians aware of the SMC advice.  He urged members to ensure that confidentiality is maintained at all times.

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

5.2.1 The Chairman met with representatives from Organon who have subsequently advised of their intention to resubmit.

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

5.3.1 Novartis have advised of their intention to appeal the SMC recommendation for their resubmission.  They will meet with Professor Lawson in the near future to discuss the process and way forward.

6 Public Involvement Sub Group

6.1 Work regarding engaging with Patient Interest Groups is ongoing and progress will be reported at the next SMC meeting.

6.1.1 Professor Lawson advised that Wendy Nganasurian, Lay Representative, has been appointed Non Executive Director at Highland Acute Hospitals Trust and will therefore be able to join SMC for alternate meetings only. Members congratulated Ms Nganasurian on her new appointment.

6.2 Patient Friendly Submission - Norelgestomin/ethinyl oestradiol transdermal patch (EVRA)

6.2.1 Janssen-Cilag have developed a patient friendly submission which provides an industry perspective on their product EVRA. The group agreed this is an excellent initiative and would be useful to adapt and use as a template for all products.  It was emphasised that the information provided to patient groups from companies is independent of SMC. The Chairman suggested Dr Donnelly be invited to the next Patient Group Meeting in June to discuss issues with the Patient Involvement Group.

7 New Drugs Committee Update (Update from NDC Vice Chairman)

7.1 Healthcare Planning Sub Group

7.1.1 A healthcare planning sub group has been formed with responsibility for investigating the SMC information to Health Boards and ADTC's and its ultimate budget impact as part of a horizon scanning exercise.

7.2 Health Economic Sub Group

7.2.1 The Health Economic Sub Group met recently.  It was agreed that all health economics working would be checked independently for accuracy and the checklist initialled to indicate completion.  The health economists will ensure a system for doing this.

8 Abbreviated Submissions

8.1 There were no abbreviated submissions put forward for assessment.

9 NDC Assessment Reports

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

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

9.1.2 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 Olanzapine (Zyprexa), for the treatment of moderate to severe manic episodes, should be recommended for restricted use within NHS Scotland, with minor amendments to wording.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 May, 2003.

9.2 Vardenafil (Levitra): GlaxoSmithKline/Bayer  No. 47/03

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

9.2.2 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 Vardenafil (Levitra), for the treatment of erectile dysfunction, 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 Friday 9 May, 2003.

9.3 Norelgestomin/ethinyl oestradiol transdermal patch (EVRA): Janssen-Cilag No. 48/03

9.3.1 It was noted that this product was not yet launched and therefore the decision will be deferred until a later meeting.

9.4 Biphasic Insulin Aspart 30 (NovoMix30): Novo Nordisk Ltd  No. 06/02 RESUBMISSION

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

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 Biphasic Insulin Aspart 30 (NovoMix30), for the treatment of diabetes, should be recommended for use within NHS Scotland, with minor amendments to wording. 

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 May, 2003.

10 Forthcoming Submissions

10.1 List of Forthcoming Submissions

10.1.1 A revised list of forthcoming submissions was reviewed. It is anticipated that there will be an increase in submissions in future months.

11 Rotation of Members

11.1 The Chairman advised that the existing membership would continue until the end of the year, but the original proposal for half of the committee to be replaced at the end of the year would not be practical.  He suggested a third of members rotate annually over the next 3 years.  The Chairman will write to committee members asking for their views on future commitment to SMC.  He added that specialty and geographical location would be of paramount importance when electing new members.

12 Any Other Business

12.1 Paediatric Prescribing

12.1.1 A paper regarding paediatric prescribing from Grampian NHS Trust was presented for information. The Chairman advised that this area is subject to intensive discussions at national level.  It is not therefore for comment by SMC at present.

12.2 Correspondence from Dr J Webster

12.2.1 Correspondence regarding a leak of confidentiality in the intervening period between recommendations being issued to NHS Boards and the public domain was noted.  It was agreed this is a problem difficult to control outwith SMC.  The ABPI representative suggested this issue is taken forward by the SMC User Group Forum.  ADTC representatives were asked to discuss this matter with their local committees and to feedback suggestions to the secretariat for discussion at the SMC User Group Forum on 10 June, 2003.

12.3 SMC Submissions

12.3.1 It has been agreed that in view of the new submission form and detailed economic guidance, submissions will be dealt with as presented to avoid delay with assessments.   It is unlikely companies will be given additional time to present further economic data which has sometimes been the case in the past.  Cases will however be dealt with sensitively.

12.4 ADTC Feedback

12.4.1 It was agreed that this would be a standing Agenda item to enable ADTC representatives to feedback issues of interest or concern to the consortium.

13 Date of Next Meeting

13.1 The date of the next meeting was confirmed as Tuesday 3 June, 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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