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SMC Minutes - Tuesday 6 July 2004

Minutes of Meeting
Held on Tuesday 6 July, 2004
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman), Professor James Barbour, Mrs Marion Bennie,
Ms Chris Beech, Mrs Barbara Black, Professor John Cairns, Mrs Michelle Caldwell, Mr John Glennie, Dr John Haughney, Dr David Hood, Mrs Moira Howie, Ms Angela Munday, Ms Wendy Nganasurian, Dr Marianne Nicholson, Ms Fiona Ramsay, Dr Philip Rutledge, Ms Fiona Scott,
Dr Sandy Simpson, Ms Angela Timoney, Ms Helen Tyrrell, Mr Mike Wallace, Professor David Webb, Dr John Webster

In Attendance: Mr Michael Bews, Ms Joy Hosie, Mr Hector Mackenzie, Mr Rob Macphail, Ms Ali McAllister, Miss Rosie Murray, Dr David Steel

Apologies: Mr Jeff Ace, Dr Keith Beard, Dr Corri Blac, Professor Martin Brodie, Mr Tom Divers, Dr Peter Donnan, Dr Barclay Goudie, Dr Harpreet Kohli, Dr Chris Lush, Professor Angus Mackay,
Ms Laura McIver, Mr Chris Nicolson, Dr Ken Paterson, Dr Andrew Riley, Derek Yuille

1 Welcome and Apologies for Absence

1.1  The Chairman welcomed members to the meeting and apologies for absence were noted. 

Dr David Steel, Chief Executive, Mr Michael Bews, Director of Guidance and Standards, NHS Quality Improvement Scotland and Mr Paul Gibbons, working with NHS QIS regarding the Freedom of Information (Scotland) Act 2002, were  welcomed as observers.

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 (01.06.04)

3.1 The minutes of the meeting of 1 June, 2004, were agreed as an accurate record of the meeting with the following amendments noted:

10.3:    Change Zyprexa power to 'powder'
10.3.2  Change Zyprexa power to 'powder'

3.2 Purdah

3.2.1 Due to purdah a condensed version of the SMC minutes from the meeting held on 5 May meeting were posted on the SMC website in June. A full record of the minutes will be posted on the website on 12 July, 2004.

4 Matters Arising From the Previous Minutes

4.1 Relationship with SMC and NHS Quality Improvement Scotland

4.1.1 Dr David Steel, Chief Executive of NHS Quality Improvement Scotland, reported that he is pleased SMC are part of NHS QIS and progress has been made in developing a relationship which reflects the special status of SMC.  He advised that discussions are moving forward regarding the budgetary allocation and horizon scanning. Progress will be reported at the next SMC meeting. 

4.2 SMC Co-ordinator Post

4.2.1 Interviews for the SMC Co-ordinator are scheduled to take place on Thursday 15 July, 2004.

4.3 Pharmacy Assessment Team

4.3.1 he Pharmacy Assessment Team have relocated to Gyle Square.  It is recognised that the accommodation is unsuitable and discussions are underway to source alternative suitable accommodation.

4.4 Non-Submission of Products for Assessment

4.4.1 Correspondence from Mr Vincent Lawton, President of ABPI regarding the non-submission of data to SMC was tabled for review.  The Chairman briefed members regarding a meeting, which took place with APBI on 7 June, 2004, where this issue was addressed.  He reiterated that in the event of a company failing to submit a product to SMC for assessment, SMC will open channels of communication to determine the reasoning and hopefully achieve a resolution without the need to issue negative guidance.

4.5 Aripiprazole (Abilify TM):   Bristol-Myers Squibb Pharmaceuticals/Otsuka Pharmaceuticals  (No.95/04)

4.5.1 The SMC advice for Aripiprazole, for the treatment of schizophrenia, will be distributed to NHS Boards and ADTCs on Friday 9 July, 2004, and posted on the SMC website on Monday 9 August, 2004.  SMC reviewed the product in April and was awaiting confirmation of launch date prior to distribution of advice.

4.6 Licensing/Launch Status

4.6.1 The Chairman advised that SMC are still holding distribution of 2 products pending licensing/launch status.  Advice will be circulated to NHS Boards and ADTCs when this had been confirmed.

4.7

4.7.1 Changes to order of SMC/NDC meeting

The proposal to change the order of SMC/NDC meetings was accepted by NDC.  Therefore NDC meetings will be moved to the last Tuesday of each month and SMC remain the first Tuesday of each month.  In order to facilitate transition the January 2005 meeting of the SMC will be cancelled and the new schedule of meetings for 2005 commence with the first meeting of NDC on 25 January, 2005.  The secretariat will distribute a list of meeting dates for 2005 to members.

FULL SUBMISSIONS

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

4.8.1 SMC advice for valdecoxib (Bextra), for the treatment of primary dysmenorrhoea, will be posted on the SMC website on Monday 12 July 2004.

4.9 emtricitabine (Emtriva)  Gilead Sciences Ltd  (No.105/04)

4.9.1 SMC advice for emtricitabine (Emtriva), the treatment of HIV, will be posted on the SMC website on Monday 12 July 2004.

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

4.10.1 SMC advice for olanzapine IM (Zyprexa powder for solution for injection), for the treatment of acute agitation in schizophrenia or acute mania, will be posted on the SMC website on Monday 12 July, 2004.

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

4.11.1 SMC advice for etanercept (Enbrel), for the treatment of psoriatic arthritis (PsA), will be posted on the SMC website on Monday 12 July, 2004.

4.11.2 SMC regards etanercept (Enbrel) as falling within the category of a ¿unique¿ drug for the treatment of psoriatic arthropathy, as described in the NHS HDL (2003) 60 and believe it should be made available uniformly across Scotland.  Boards should proceed to adopt this guidance.  SMC will set up a working group to make recommendations to Boards regarding which patients should receive this drug, at what stage in their illness and for how long the therapy should continue were there to be no satisfactory response.  It is hoped that such a protocol for the use of this drug in the approved indication will be adopted uniformly throughout the service thus facilitating the audit of the outcomes (Appendix 1).

ABBREVIATED SUBMISSIONS

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

4.12.1 SMC advice for seretide 50 evohaler (Salmeterol xinafoate 25mcg/fluticasone propionate 50mcg), for the treatment of asthma, will be posted on the SMC website on Monday 12 July, 2004.

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

4.13.1 SMC advice for decapeptyl SR 11.25mg (as Triptorelin acetate), for the treatment of  advanced prostate cancer, will be posted on the SMC website on Monday 12 July, 2004.

4.14 Antibiotic Sub Group

4.14.1 Following on from discussions regarding prescribing policies for antimicrobials across Scotland, SMC set up a short-life working group with the remit to review hospital antibiotic prescribing and advise Health Boards whether there is a useful role for SMC in addressing clearly defined aspects of this area which are not being addressed by other relevant bodies. 

The Chairman reported that the group have now met on three occasions and have compiled a report for review and consideration by SMC.   The Chairman requested members review the report and feedback comments to the secretariat for further consideration at the SMC meeting in August. 
  
5 Appeals Update

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

5.1.1 Genzyme Therapeutics has advised of their intention to resubmit following the SMC recommendation for laronidase (Aldurazyme).

6 Correspondence

6.1 Review of Access to Yellow Card Scheme

6.1.1 Representatives from SMC have provided comments regarding the report that has now gone out for publication.   Their contributions have been gratefully acknowledged by the Review Panel set up by the DoH to advise on the Yellow Card Reporting Scheme.

7 Patient and Public Involvement Group (PAPIG)

7.1 Minutes from the last meeting held on 1 June, 2004, were presented for information.   It was noted that there is now a section within the Patient Interest Group Submission to record declarations of interest.  A meeting with SIGN to discuss issues regarding patient and public involvement is scheduled for 27 July, 2004.  Members of PAPIG attended a study day hosted by Eli Lilly entitled 'Campaigning for Success'.  It was highlighted that only one patient group in attendance at the event had made a submission to SMC and the secretariat will correspond with patient interest groups to encourage submissions.  

8 Orphan Drug Group

8.1 In view of the proposed number of orphan drugs expected to be submitted to SMC for assessment and following discussions at the SMC User Group Forum, it was agreed to form an Orphan Drug Group to establish criteria regarding the requirements for orphan drug submissions to SMC and identify any barriers in complying with the requirements for completion of the SMC product assessment form.  Notes of the meeting of the group held on 1 June, 2004, were presented for review and a position statement regarding orphan drugs was presented for approval. This statement will be posted on the SMC website in due course.

9 New Drugs Committee Update

9.1 SMC User Group Forum - Membership

9.1.1 Dr Richard Brown volunteered to replace Angela Munday on the SMC User Group Forum.

9.2 Changes to monthly order of SMC/NDC meetings

9.2.1 The proposal to change the NDC meetings to the last Tuesday of each month was agreed.

10 NDC Assessment Reports

RE-SUBMISSION

10.1 rosiglitazone (Avandia)  GlaxoSmithKline  (No. 91/04)

10.1.1 Declarations of interest were recorded in relation to this product/comparator drugs. Members with a personal specific interest left the room for this part of the agenda.
 
10.1.2 The SMC Vice Chair provided a detailed overview of the assessment, the key issues identified, draft recommendation and comments received from the company. A member of PAPIG presented a Patient Interest Group Submission from Diabetes UK.  Detailed discussion followed and the group agreed that rosiglitazone (Avandia) for the treatment of diabetes mellitus, should be accepted for restricted use within NHS Scotland. Amendments to wording were noted.

10.1.3 SMC advice will be issued to ADTCs and NHS Boards on 9 July, 2004.

FULL SUBMISSIONS

10.2 fulvestrant (Faslodex)  AstraZeneca UK Ltd  (No. 114/04)

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

10.2.2 The NDC 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 fulvestrant (Faslodex), for the treatment of metastatic breast cancer, should not be recommended for use within NHS Scotland. Amendments to wording were noted.

10.2.3 SMC advice will be issued to ADTCs and NHS Boards on 9 July, 2004.
 
10.3 insulin determir (Levemir)  NovoNordisk  (No:  110/04)

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 insulin determir (Levemir), for the treatment of diabetes mellitus, should be accepted for restricted use within NHS Scotland. Amendments to wording were noted.

10.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 9 July, 2004.

10.4 pioglitazone (Actos)  Takeda  (No. 115/04)

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

10.4.2 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 pioglitazone (Actos) for the treatment of diabetes mellitus, should not be recommended 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 9 July, 2004.

10.5 risperidone (Risperdal)  Janssen-Cilag  (No. 113/04)

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

10.5.2 The NDC 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 risperidone (Risperdal), for the treatment of bipolar disorder, should be accepted for use within NHS Scotland.  Amendments to wording were noted.

10.5.3 The SMC advice will be issued to ADTCs and NHS Boards on 9 July, 2004.

10.6 losartan (Cozaar)  Merck Sharp & Dohme  (No.112/04)

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

10.6.2 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 losartan (Cozaar), for the treatment of hypertensive patients with left ventricular hypertrophy, 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 9 July, 2004.

INDEPENDENT REVIEW PANEL

10.7 pimecrolimus cream (Elidel):  Novartis  (No. 35/03)
 
10.7.1 Declarations of interest were recorded in relation to this product/comparator drugs.  

10.7.2 Dr Marianne Nicholson, who chaired the IRP, provided background information regarding the SMC process and how Elidel had reached the stage of review by an Independent Review Panel.  Details regarding the previous submissions to SMC were highlighted. It was made clear by the consultant dermatologist members of the panel that they felt there was a clear and real requirement for an additional therapy to treat AD.  In their opinion, Elidel was that option.  A tabled letter from the British Association of Dermatologists supported this position.  The dermatologists present felt that there had been inadequate consultation with specialists regarding the potential role for Elidel.  However all agreed that the long-term effects of administering a topical immunomodulator are not yet established.  The consultant dermatologists commented that the evaluation of the evidence available to the SMC made their conclusion inevitable.  They expressed concern that there is not a means by which this drug may be made available for use until the relevant studies have been undertaken.  It was noted that if a clinician decided that the clinical need for Elidel was clear, individual prescriptions could be written for exceptional patients. 

10.7.3 Detailed discussion followed and the group agreed that pimecrolimus cream (Elidel), for the treatment of signs and symptoms of mild-to-moderate atopic dermatitis, should not be recommended for use within NHS Scotland. Amendments to wording were noted.  

10.7.4 The SMC advice will be issued to ADTCs and NHS Boards on 9 July, 2004.

ABBREVIATED SUBMISSIONS

10.8 montelukast paediatric 4mg granules (Singulair)  Merck Sharp & Dohme
(No. 111/04)

10.8.1 Declarations of interest were recorded in relation to this product/ comparator drugs.
 
10.8.2 The NDC Vice Chair provided an overview of the assessment, the key issues identified and the draft summary recommendation. Discussion followed and the group agreed that montelukast paediatric 4mg granules (Singulair), for the treatment of asthma, should be accepted for use within NHS Scotland. Amendments to wording were noted.

10.8.3 The SMC advice will be issued to ADTCs and NHS Boards on 9 July, 2004.

10.9 estradot (Estradot Transdermal Patch)  Novartis  (No. 117/04)

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

10.9.2 The NDC Vice Chair provided an overview of the assessment, the key issues identified and the draft summary recommendation. Discussion followed and the group agreed that estradot (Estradot Transdermal Patch) Novartis, for the treatment of oestrogen only HRT patch, should be accepted for use within NHS Scotland. Amendments to wording were noted.

10.9.3 The SMC advice will be issued to ADTCs and NHS Boards on Monday 9 July, 2004.

11 Forthcoming Submissions
 
11.1 A revised list of forthcoming submissions was reviewed.     It was noted that there was an increase in submission rates that would require an increase in output from SMC over the coming months.   In this respect the Chairman was happy to announce the appointment of a further part-time pharmacy assessor to cope with the additional workload.

12 ADTC Feedback

12.1 Prescribing of Medicines Not Recommended by SMC

12.1.1 A report produced by the Common Services Agency detailing the prescribing of medicines not recommended by SMC was tabled for review.  Members emphasised that it is important to look at trends and that it would be useful for the information to include defined dates and be linked to indication were possible.   

13 Any Other Business

13.1 SMC/OHE Seminar

13.1.1 A joint seminar between the SMC economic reviewers and industry economists organised by the Office of Health Economics was held on 29 June.  Feedback from the event has been very positive.

13.2 Company Visits

13.2.1 The Chairman highlighted recent visits from representatives of SMC to make presentations regarding process and methodology. 

Visit to Eli Lilly, 26.05.04: Dr A Walker/Ms A Timoney/Ms R Murray
Visit to Lundbeck 18.06.04: Dr A Walker/Dr K Paterson

13.3 Freedom of Information Act

13.3.1 The Chairman briefed members on Freedom of Information Act (Scotland) 2002 which comes into force on 1 January, 2005.  A working group has been set up to address the implications for SMC.  Progress will be reported at a future meeting.

14 Date of Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 3 August, 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.

 

Appendix 1

Scottish Medicines Consortium

9 July 2004

SCOTTISH MEDICINES CONSORTIUM STATEMENT
etanercept (Enbrel®) No. 107/04

Etanercept (Enbrel) for the treatment of psoriatic arthropathy is regarded by the Scottish Medicines Consortium (SMC) as currently falling within the category of a unique treatment for this indication as described in the NHS HDL (2003) 60.

SMC believe that as such it should be made available uniformly across Scotland.   Boards are advised to proceed with this as soon as practical.

SMC will set up a working group to make recommendations to Boards about which patients should receive this drug, at what stage in their illness and for how long the therapy should continue were there to be no satisfactory response. 

It is likely that we will recommend a protocol for the use of this drug in the approved indication to be adopted uniformly throughout the service thus facilitating audit of the outcomes. 

D H LAWSON
CHAIRMAN

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