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SMC Minutes - Tuesday 1 June 2004

Minutes of Meeting
Held on Tuesday 1 June, 2004
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman), Mr Jeff Ace, Dr Keith Beard, Ms Chris Beech, Mrs Barbara Black, Dr Corri Black, Professor John Cairns, Mrs Michelle Caldwell, Mr Tom Divers, Dr Peter Donnan, Dr Barclay Goudie, Dr John Haughney, Dr David Hood, Dr Chris Lush, Professor Angus Mackay, Ms Laura McIver, Ms Wendy Nganasurian, Mr Chris Nicolson, Dr Marianne Nicholson, Dr Ken Paterson, Dr Andrew Riley, Dr Philip Rutledge, Ms Angela Timoney, Ms Helen Tyrrell, Mr Mike Wallace

In Attendance: Ms Ailene Botfield, Mr Steven Fennochi, Ms Joy Hosie, Dr Harpreet Kohli, Mr Hector Mackenzie, Ms Ali McAllister, Miss Rosie Murray

Apologies: Professor James Barbour, Mrs Marion Bennie, Professor Martin Brodie, Mr John Glennie, Mrs Moira Howie, Ms Angela Munday, Ms Fiona Ramsay, Ms Fiona Scott, Dr Sandy Simpson, Mr Derek Yuille, Professor David Webb, Dr John Webster

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting and apologies for absence were noted.   Dr John Haughney, General Practitioner, Lanarkshire, was welcomed to his first meeting of SMC.  Ms Ailene Botfield, SMC secretariat, was welcomed as an observer.

2 Declarations of Interest

2.1 The Chairman requested members declare interests in the products to be discussed and the comparator drugs as noted on the assessment reports.

3 Minutes of the Previous Meeting (04.05.04)

3.1 The minutes of the meeting of 4 May, 2004, were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1 Relationship with SMC and NHS Quality Improvement Scotland

Discussions are moving forward regarding the budgetary allocation to SMC. Progress will be reported at the next SMC meeting.  Members were concerned at the slow progress in this area and asked that Dr David Steel be invited to attend the next meeting.

4.2 Experts

Discussions are ongoing regarding the use of clinical experts and how to improve feedback and define expertise.  Proposals will be taken forward over the next couple of months and the outcome reported at a future meeting.

4.3 Devices incorporating blood products

It was agreed that SMC would confine their involvement with such devices to those licensed as medicines by the MHRA/EMEA. 

4.4 SMC Manager

Rosie Murray has been appointed to the post of SMC Manager.  Recruitment is underway to fill the post of co-ordinator. 

FULL SUBMISSIONS

Purdah

During the period 20 May 2004 to 10 June, 2004, NHSScotland will enter a period of purdah which outlines the conduct of business during the European Parliamentary election during which no public announcements will be made. Therefore recommendation summaries for the products listed below will be published on the SMC website on Monday 12 July, 2004. 

4.5 methylphenidate (Equasym XL):  Celltech (No. 99/04)

4.5.1 As an official launch date for methylphenidate (Equasym XL, for the treatment of attention deficit/hyperactivity disorder (ADHD), is yet to be confirmed, in accordance with SMC process, the distribution of this recommendation will be withheld until launch. 

4.6 laronidase (Aldurazyme):  Genzyme Therapeutics (No: 100/04)

4.6.1 The recommendation for laronidase (Aldurazyme), the treatment of long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency) to treat the non-neurological manifestations of the disease, will be posted on the SMC website on Monday 12 July, 2004.

4.7 infliximab (Remicade):  Schering Plough  (No. 101/04)

4.7.1 The recommendation for infliximab (Remicade), for the treatment of severe ankylosing spondylitis, will be posted on the SMC website on Monday 12 July, 2004.

4.8 latanoprost (Xalatan):  Pfizer  (No. 102/04)

4.8.1 The recommendation for latanoprost (Xalatan), for the reduction of elevated intraocular pressure in patients with (primary) open angle glaucoma, will be posted on the SMC website on Monday 12 July, 2004.

4.9 quetiapine (Seroquel):  AstraZeneca  (No. 104/04)

4.9.1 The recommendation for quetiapine (Seroquel), for the treatment of manic episodes associated with bipolar disorder, will be posted on the SMC website on Monday 12 July, 2004.

ABBREVIATED SUBMISSION

4.10 movicol paediatric plain:  Norgine Ltd  (No. 103/04)

4.10.1 The summary recommendation for movicol paediatric plain, for the treatment of for the treatment of paediatric faecal impaction, will be posted on the SMC website on Monday 12 July, 2004.

5 Appeals Update

5.1 temoporfin (Foscan)  No.  96/04  Biolitec Pharma

5.1.1 Biolitec Pharma have advised of their intention to resubmit following the SMC recommendation for temoporfin (Foscan).

6 Correspondence

6.1 Non submission of product for assessment

6.1.1 A company notified SMC that they are considering not making a submission to SMC because of the small number of patients involved for their product.  The secretariat was asked to confirm the position with the company.

7 Patient and Public Involvement Group (PAPIG)

7.1 The Patient and Public Involvement Group met prior to SMC and agreed the following:

Patient Interest Group Submission Template:

  • Wording agreed for declaration of interest request.
  • Addition of check box signifying agreement to reference being made to submission in 5/6 page recommendation document.
  • Following agreement from company and patient group, a worked example of a PIG submission will be added to the SMC website.

Meeting arranged with SIGN in relation to patient and public involvement.

Wording agreed regarding letter of encouragement to patient groups who have not made a submission to SMC.

A full minute of the meeting will be available for review at the next SMC meeting.
 
8 Changes to monthly order of SMC/NDC meetings

8.1 A proposal was put forward regarding changing the order of SMC/NDC meetings.  Members were asked to consider the implications and feedback comments to the secretariat.  The proposal will be presented to NDC for comment and a decision made by SMC thereafter.

9 New Drugs Committee Update

9.1 Feedback to ABPI

9.1.1 The industry representatives on NDC have been invited to feedback to ABPI their observations of their experience as industry members of NDC.  Views will be shared with the committee.

10 NDC Assessment Reports - Full Submissions

10.1 valdecoxib (Bextra):  Pfizer  (No.89/04)

10.1.1 Declarations of interest were recorded in relation to this product/comparator drugs. 

10.1.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation.  Detailed discussion followed and the group agreed that valdecoxib (Bextra), for the treatment of primary dysmenorrhoea, should not be recommended for use within NHS Scotland.  Amendments to wording were noted.

10.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 June, 2004.
 
10.2 emtricitabine (Emtriva)  Gilead Sciences Ltd  (No.105/04)

10.2.1 No declarations of interest were recorded in relation to this product/comparator drugs. 

10.2.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and comments received from the company.  A member of PAPIG presented the patient interest group submission.  Detailed discussion followed and the group agreed that emtricitabine (Emtriva), for the treatment of HIV, should not be recommended for use within NHS Scotland.  Amendments to wording were noted.

10.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 June, 2004.

10.3 olanzapine IM (Zyprexa powder for solution for injection):  Eli Lily & Company Ltd  (No.106.04)

10.3.1 Declarations of interest were recorded in relation to this product/comparator drugs.

10.3.2 The SMC Vice Chair provided a detailed overview of the assessment, the key issues identified, draft recommendation and comments received from the company.  Detailed discussion followed and the group agreed that olanzapine IM (Zyprexa powder for solution for injection) for the treatment of acute agitation in schizophrenia or acute mania, should be accepted for use within NHS Scotland. Amendments to wording were noted.

10.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 June, 2004.

10.4 etanercept (Enbrel):  Wyeth Pharmaceuticals  (No. 107/04)

10.4.1 Declarations of interest were recorded in relation to this product/comparator drugs.  

10.4.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and comments received from the company. A member of PAPIG presented patient interest group submissions.  Detailed discussion followed and the group agreed that etanercept (Enbrel), for the treatment of psoriatic arthritis (PsA), should be accepted for use within NHS Scotland.  Amendments to wording were noted.

10.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 June, 2004.

INDEPENDENT REVIEW PANEL

10.5 pimecrolimus cream (Elidel):  Novartis  (No. 35/04)

10.5.1 The Chairman thanked Dr Nicholson for chairing the IRP meeting for pimecrolimus cream (Elidel).  He stated that as a consequence of a delay in receiving paperwork from the Independent Review Panel, SMC were given insufficient time to adequately review the findings.  It was felt inappropriate to consider as a tabled paper with inadequate time to review in detail and therefore was deferred to the SMC Meeting on 6 July, 2004. 

ABBREVIATED SUBMISSIONS

10.6 Seretide 50 Evohaler (Salmeterol xinafoate 25mcg/fluticasone propionate 50mcg):  GlaxoSmithKline/UK Pharma  (No. 108/04)

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

10.6.2 The SMC Vice Chair provided an overview of the assessment, the key issues identified and the draft summary recommendation. Discussion followed and the group agreed that Seretide 50 Evohaler (Salmeterol xinafoate 25mcg/fluticasone propionate 50mcg), for the treatment of asthma, should be accepted for use within NHS Scotland. Amendments to wording were noted.

10.6.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 June, 2004. 

10.7 decapeptyl SR 11.25mg (as Triptorelin acetate):  Ipsen Ltd  (No. 109/04)

10.7.1 No declarations of interest were recorded in relation to this product/ comparator drugs.

10.7.2 The SMC Vice Chair provided an overview of the assessment, the key issues identified and the draft summary recommendation. Discussion followed and the group agreed that decapeptyl SR 11.25mg (as Triptorelin acetate), for the treatment of advanced prostate cancer, should be accepted for use within NHS Scotland. Amendments to wording were noted.

10.7.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 June, 2004. 

11 Forthcoming Submissions

11.1 List of Forthcoming Submissions

11.1.1 A revised list of forthcoming submissions was reviewed.  

12 ADTC Feedback

12.1 Consultant Contracts

12.1.1 The Chairman requested members to advise him of any difficulties encountered with their commitment to SMC as a result of the new consultant contract which he would then take up with the Chief Medical Officer.

13 SMC User Group Forum

13.1 The Minutes of the SMC User Group were presented for information.  Progress has been made in a number of areas, the most significant being the development of a sub group to bring forward the publication of the 5/6 page recommendation document on the public domain.

14 Audits into the Implementation of SMC and NICE Guidance for Roche Reviewed Drugs


14.1 Paul Catchpole, Healthcare Management Director and John Melville, Managing Director, Roche Products Limited, gave an informative presentation outlining methodology, assumptions and limitations of their review of the implementation of SMC and NICE guidance for Roche reviewed products. 

15 Any Other Business

15.1 No other business was reported.

16 Date of Next Meeting

16.1 The date of the next meeting was confirmed as Tuesday 6 July, 2004, at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

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