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SMC Minutes - Tuesday, 6 December 2005

Minutes of Meeting held on Tuesday 6 December 2005
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Mrs Laura Ace, Dr Keith Beard, Mrs Barbara Black,
Professor John Cairns, Mrs Michelle Caldwell, Dr David Crookes, Dr Peter Donnan, Dr Barclay Goudie, Dr David Hood, Mrs Moira Howie, Dr Jan Jones, Dr Harpreet Kohli, Dr Graham Lowe,
Dr Chris Lush, Mrs Angela Munday, Mrs Pat Murray, Ms Wendy Nganasurian, Dr Marianne Nicholson, Mr Chris Nicolson, Dr Ken Paterson, Ms Fiona Ramsay, Dr Philip Rutledge, Ms Angela Timoney, Ms Helen Tyrrell, Mr Derek Yuille

In Attendance: Dr Jennifer Armstrong. Ms Sara Davies, Mrs Anne Lee, Mr Colin McAllister,
Mrs Laura McIver, Ms Sandra McNaughton, Miss Rosie Murray, Mrs Maureen Stark, Dr Andrew Walker

Apologies: Mrs Marion Bennie, Professor James Barbour, Mr Tom Divers, Mr John Glennie,
Dr John Haughney, Ms Grace Lindsay, Dr Andrew Riley, Dr Sandy Simpson, Mr Mike Wallace,
Dr John Webster

1 Welcome and Apologies for Absence

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

1.2 A welcome was extended to Ms Sandra McNaughton, NDC Member, who was observing the work of the SMC.

1.3 Mr Colin McAllister, Head of Communications, NHS Quality Improvement Scotland, was welcomed to the meeting.  Colin replaces Patrick Maitland-Cullen as communications representative to SMC.

1.4 Ms Angela Timoney was welcomed back to the committee.

2 Declarations of Interest

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

3 Minutes of the Previous Meeting 1 November 2005

3.11 The minutes of the meeting of 1 November, 2005, were agreed as an accurate record of the meeting.

3.1.1 It was noted that there has been a delay in posting the presentations from the SMC Conference on the website and this will be actioned urgently.

4 Matters Arising From the Previous Minutes

4.1 SMC Conference - Evaluation Feedback

4.1.1 The evaluation summary from the SMC Conference was presented for review.  The Chairman outlined comments regarding suggestions for future events and areas of improvement, although overall the views reflected were very positive.

4.2 Process for Consulting Clinical Experts

4.2.1 The new process for consulting clinical experts was presented for review.  It was agreed that this is an excellent step forward and following minor amendments and further discussions with regards to sub-specialist areas, the process will be implemented with immediate effect. The clinical expert working group were thanked for their input to this.

DEFERRED SUBMISSION

4.3 calcipotriol & bethamethasone (Dovobet)  Leo Pharmaceuticals  (No. 09/02)
  
4.3.1 SMC advice for calcipotriol & bethamethasone (Dovobet), for the initial topical treatment of stable plaque psoriasis, will be posted on the SMC website on Monday 12 December, 2005.

FULL SUBMISSIONS

4.4 carmustine (Gliadel)  Link Pharmaceuticals  (No. 215/05) 
                                
4.4.1 SMC advice for carmustine (Gliadel), for the treatment of newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation, will be posted on the SMC website on Monday 12 December, 2005.

4.5 zonisamide (Zonegran)  Eisai Ltd  (No. 216/05)

4.5.1 SMC advice for zonisamide (Zonegran), as adjunctive therapy in adult patients with partial seizures with or without secondary generalisation, will be posted on the SMC website on Monday 12 December, 2005.
 
4.6 adalimumab (Humira)  Abbott Laboratories  (No. 218/05)

4.6.1 SMC advice for adalimumab (Humira), for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate, will be posted on the SMC website on Monday 12 December, 2005.

4.7 iloprost trometamol (Ventavis)  Schering Healthcare  (No. 219/05)
                                           
4.7.1 SMC advice for iloprost trometamol (Ventavis), for the treatment of patients with New York Heart Association Class III primary pulmonary hypertension as a second-line treatment where bosentan is ineffective or is not tolerated, will be posted on the SMC website on Monday 12 December, 2005.
 
4.8 erlotinib (Tarceva)  Roche  (No. 220/05)  
    
4.8.1 SMC advice for erlotinib (Tarceva), for the treatment of patients with locally advanced or metastatic non small cell lung cancer, after failure of at least one prior chemotherapy regimen, will be posted on the SMC website on Monday 12 December, 2005.

4.8.2 Minor changes have been made to the Detailed Advice Document  (DAD) post SMC and therefore the DAD will be reissued to NHS Scotland on Friday 9 December, 2005.

5 Appeals Update

5.1 Nothing to report.

6 PAPIG

6.1 The minutes of the meetings of 6 September 2005 and 1 November 2005 were noted.

7 New Drugs Committee: Update

7.1 It was noted that there have been difficulties within the abbreviated submission process and this will be discussed further at the January meeting of SMC.

8 Chairman's Business

8.1 Lord Patel

8.1.1 Lord Patel has decided to stand down as Chairman of NHS QIS, after nearly 7 years in office - first with CSBS and then with NHS QIS.  He has accepted an appointment as Chairman of the National Patient Safety Agency. The SMC Chairman has written to Lord Patel to thank him for his support to SMC.

8.2 SIGN Meeting

8.2.1 Representatives of SMC attended a meeting of the SIGN Council on 9 November, 2005 and the SMC Chairman gave a presentation regarding SMC and its processes. This was a constructive meeting and it is the intention of SMC to meet with SIGN on a regular basis. 

8.3 Meeting with the Medical Adviser for the National Specialist Commissioning Advisory Group (NSCAG) - 3 November, 2005

8.3.1 The Chairman met with Edmund Jessop, the Medical Adviser for the National Specialist Commissioning Advisory Group (NSCAG) of the Department of Health (DoH), to discuss enzyme replacement therapies (ERTs).  This was a useful meeting providing an insight into the planning and development of services.  The Scottish Executive representative will report progress of the group to SMC.

8.4 Advice to NHS Scotland regarding Status of Etanercept (Enbrel)

8.4.1 Following the SMC advice for etancercept (Enbrel), for the treatment of psoriatic arthritis, and subsequent advice for adalimumab (Humira), for the treatment of active and progressive psoriatic arthritis, the Chairman has written to NHS Boards and Area Drug and Therapeutic Committees (ADTCs) to advise that the ¿unique drug¿ status for etanercept has lapsed and to recommend that consideration is given to which of the two treatment options (either one or both) will be made available for patients with psoriatic arthritis. 

8.5 NICE Fast Track Appraisals

8.5.1 NICE and the Department of Health announced that NICE is launching a new, rapid process for assessing drugs and other treatments to sit alongside its standard processes. The Single Technology Appraisal (STA) process will be used initially to produce faster guidance on 'life-saving' drugs which have already been licensed and on new medicines close to when they first become available.

All Wales Medicines Strategy Group have confirmed that they will not proceed with the appraisals of a number of drugs that have been identified by NICE under the STA programme unless there is overwhelming evidence to the contrary that there would be additional benefit to NHS Wales.

The Chairman stated that SMC are delighted that NICE has recognised the importance of fast track assessments and that SMC wish to contribute to the consultation process.  He requested members feedback comments to the secretariat by Friday 16 December, 2005, for inclusion in a draft paper for discussion at the next meeting of SMC.

NHS QIS will comment on the Health Technology Assessment (HTA) process and the status of the STA.  

8.6 Staffing

8.6.1 Interviews for an additional SMC Co-ordinator took place on Monday 5 December, 2005 and it is anticipated that an appointment will be been made and in early in the New Year.

8.7 trastuzumab (Herceptin)

8.7.1 The Chairman reiterated the position with regards to Herception advising that a submission is awaited subject to licensing.  On confirmation of licensing plans, and subsequent receipt of an application from Roche, SMC will begin immediately their assessment process.

9 NDC Assessment Reports - Full Submissions

9.1 bevacizumab (Avastin)  Roche  (No. 221/05)

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

9.1.2 The NDC Vice Chairman provided a detailed overview of the assessment, the draft advice and expert comments.  Very substantial amounts of additional information were received from the company after NDC assessment.  In keeping with routine SMC process, this was not reviewed.

9.1.3 Detailed discussion followed and the group agreed that bevacizumab (Avastin), for first-line treatment of patients with metastatic carcinoma of the colon or rectum, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.  
 
9.1.4 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 December, 2005.

9.2 tipranavir (Aptivus)  Boehringer-Ingelheim  (No 226/05)

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

9.2.2 The NDC Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company.  A Patient Interest Group Submission from HIV Scotland was presented for review.  Detailed discussion followed and the group agreed that tipranavir (Aptivus), for the treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 December, 2005.

9.3 estradiol 1mg/drospirenone (Angeliq) Schering Healthcare  (Nos. 227/05)

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

9.3.2 The NDC Vice Chairman provided a detailed overview of the assessment, the draft advice and comments received from the company.  Detailed discussion followed and the group agreed that estradiol 1mg/drospirenone (Angeliq), for the prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or have contra-indications to, other medicinal products approved for the prevention of osteoporosis, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 December, 2005.

9.4 estradiol 1mg/drospirenone (Angeliq)  Schering Healthcare  (Nos. 230/05)

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

9.4.2 The NDC Vice Chairman provided a detailed overview of the assessment, the draft advice and comments received from the company.  Detailed discussion followed and the group agreed that estradiol 1mg/drospirenone (Angeliq), as hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women more than 1 year post-menopause, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 December, 2005.

9.5 ibandronate (Bonviva)  Roche  (No. 228/05) 

9.5.1 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.

9.5.2 The NDC Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company.  A Patient Interest Group Submission from the National Osteoporosis Society was presented for review. Detailed discussion followed and the group agreed that a decision regarding ibandronate (Bonviva), for the treatment of osteoporosis in postmenopausal women in order to reduce the risk of vertebral fractures, will be made subject to confirmation of the license from the EMEA. Distribution of advice will be deferred pending confirmation.

RESUBMISSIONS

9.6 olopatadine (Opatanol)  Alcon Labs (UK) Ltd  (No. 59/03)

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

9.6.2 The SMC Vice Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that olopatadine (Opatanol), for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis, should be accepted for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 December, 2005

9.7 metformin HCl (Glucophage SR)  Merck Pharma Ltd  (No. 148/04)

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

9.7.2 The SMC Vice Chairman provided a detailed overview of the assessment, the draft advice and comments received from the company. A Patient Interest Group Submission from Diabetes UK was presented for review. Detailed discussion followed and the group agreed that metformin HCl (Glucophage SR), for the treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone do not result in adequate glycaemic control, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

9.7.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 December, 2005.

ABBREVIATED SUBMISSIONS

9.8 mesalazine (Asacol)  Procter and Gamble  (No. 222/05)

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

9.8.2 The NDC Chairman provided an overview of the assessment and draft summary of advice.  A Patient Interest Group Submission from the National Association for Colitis and Crohn's Disease was presented for review. Discussion followed and the group concluded their advice for mesalazine (Asacol), for the treatment of moderate acute exacerbations of ulcerative colitis.

9.8.3 The SMC advice will be withheld pending confirmation of launch.

9.9 mesalazine (Asacol)  Procter and Gamble  (No. 223/05)

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

9.9.2 The NDC Chairman provided an overview of the assessment and draft summary of advice.  A Patient Interest Group Submission from the National Association for Colitis and Crohn's Disease was presented for review. Discussion followed and the group concluded their advice for mesalazine (Asacol), for the treatment of mild acute exacerbations of ulcerative colitis.

9.9.3 The SMC advice will be withheld pending confirmation of launch.

9.10 mesalazine (Asacol)  Procter and Gamble  (No. 224/05)

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

9.10.2 The NDC Chairman provided an overview of the assessment and draft summary of advice.  A Patient Interest Group Submission from the National Association for Colitis and Crohn's Disease was presented for review. Discussion followed and the group concluded their advice for mesalazine (Asacol), for the maintenance of remission in ulcerative colitis and Crohn's ileo-colitis.

9.10.3 The SMC advice will be withheld pending confirmation of launch.

9.11 olmesartan (Olmetec Plus)  Sankyo Pharma UK Ltd  (No. 225/05)

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

9.11.2 The NDC Chairman provided an overview of the assessment, draft summary of advice and comments received from the company. Detailed discussion followed and the group concluded their discussion for olmesartan (Olmetec Plus), for the treatment of hypertension in patients whose blood pressure is not adequately controlled by olmesartan 20 mg monotherapy and for whom the addition of a thiazide diuretic is an appropriate next step.

9.11.3 The SMC advice will withheld pending confirmation of launch.

9.12 lansoprazole oro-dispersible tabs (Zoton Fas Tab)  Wyeth  (No. 229/05)

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

9.12.2 The NDC Chairman provided an overview of the assessment and draft summary of advice. Detailed discussion followed and the group agreed that lansoprazole oro-dispersible tabs (Zoton Fas Tab) for the eradication of Helicobacter pylori from the upper gastrointestinal tract in patients with ulcer-like dyspepsia in whom Helicobacter pylori infection has been demonstrated, should be accepted for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

9.12.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 December, 2005

10 SMC Evaluation Programme

10.1 An update regarding the remit and membership for the evaluation programme management and reference group was provided.  Progress of the group will be reported to SMC routinely.

11 Extrapolation of outcomes in long-term economic models

11.1 Dr Andrew Walker provided an overview of the extrapolation of outcomes in long-term economic models. 

12 Forthcoming Submissions

12.1 A list of forthcoming submissions was tabled for review.

13 ADTC Feedback

13.1 Centre for Change and Innovation (CCI)

13.1.1 NHS Ayrshire & Arran referred to the recently issued CCI guidelines for General Practice, which includes some references to named medicines. These may or may not be included within local formulary systems, and may or may not have SMC approval. It was noted that these guidelines are at the early stage of development and the impact on local formulary systems at this stage would be small, but the potential for conflict is of concern. SMC have contacted CCI who have agreed that they would refer to local formulary systems in future and not refer to specific named medicines to prevent any potential for conflict of national guidance.

14 Any Other Business

14.1 Dr Jan Jones

14.1.1 The Chairman thanked Dr Jan Jones, who was covering Marion Bennie's period of absence, for her invaluable contribution to SMC.

14.2 Paperwork for January SMC

14.2.1 The Chairman thanked members for their commitment all year and wished them a Happy Christmas.  Paperwork for the January meeting of SMC will be distributed to members on Friday 16 December, 2005.

15 Date of Next Meeting

15.1 The date of the next meeting was confirmed as Wednesday, 4 January 2006, 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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