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SMC Minutes - Tuesday, 1 November 2005

Minutes of Meeting held on Tuesday 1 November 2005
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Professor James Barbour, Mrs Barbara Black, Dr Keith Brown, Dr David Crookes, Mr Tom Divers, Dr Peter Donnan, Dr Barclay Goudie, Dr John Haughney, Dr David Hood, Mrs Moira Howie, Dr Jan Jones, Dr Harpreet Kohli, Dr Grace Lindsay, Dr Chris Lush, Dr Graham Lowe, Mrs Angela Munday, Ms Wendy Nganasurian, Dr Marianne Nicholson, Dr Ken Paterson, Mrs Fiona Scott, Dr Sandy Simpson, Ms Helen Tyrrell, Mr Mike Wallace, Dr John Webster, Mr Derek Yuille

In Attendance: Dr Jennifer Armstrong, Ms Sara Davies, Ms Sharon Hems, Mrs Anne Lee, Mrs Laura McIver, Mr Patrick Maitland-Cullen, Miss Rosie Murray, Mr Andrew Power, Mrs Maureen Stark, Dr Andrew Walker

Apologies: Mrs Laura Ace, Dr Keith Beard, Mrs Michelle Caldwell, Professor John Cairns, Mr John Glennie, Mrs Pat Murray, Mr Chris Nicolson, Mrs Fiona Ramsay, Dr Andrew Riley, Dr Philip Rutledge, Ms Angela Timoney

1 Welcome and Apologies for Absence

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

1.2 Thanks was extended to Mrs Fiona Scott who is leaving the committee temporarily to commence a period of maternity leave.

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 04/10/05

3.1 The minutes of the meeting of 4 October, 2005, were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1 SMC Conference - 10 October 2005

4.1.1 The feedback from the SMC Conference has been positive and 250 delegates were in attendance. Presentations will be posted on the SMC website imminently and an evaluation summary will be presented at the next meeting. The Chairman advised that he was happy for members to use his slides when undertaking presentations at local meetings.

4.2 Meeting with CEOs - 12 October 2005

4.2.1 Members of the SMC Executive attended a meeting of the CEOs on 12 October, 2005.  Comments were positive and Kevin Woods, Chief Executive, of the NHS in Scotland, was supportive of the work of SMC. 

FULL SUBMISSIONS

4.3 cilostazol (Pletal)  Otsuka Pharmaceuticals UK Ltd  (No. 86/04)
  
4.3.1 SMC advice for cilostazol (Pletal), for the treatment of intermittent claudication, will be posted on the SMC website on Monday 7 November, 2005.

4.3.2 Processes are in place to meet with SIGN representatives on a regular basis to compare work programmes.

4.4 palonosetron (Aloxi) Cambridge Laboratories/ Helsinn Healthcare SA (No. 208/05) 
                                
4.4.1 SMC advice for palonosetron (Aloxi), for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, will be posted on the SMC website on Monday 7 November, 2005.

 
4.5 docetaxel (Taxotere) - Sanofi-Aventis (No. 209/05) 

4.5.1 SMC advice for docetaxel (Taxotere), for the treatment of patients with hormone refractory metastatic prostate cancer (mHRPC) will be posted on the SMC website on Monday 7 November, 2005.
 
4.6 exemestane (Aromasin)  Pfizer  (No. 210/05)

4.6.1 SMC advice for exemestane (Aromasin), for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy, will be posted on the SMC website on Monday 7 November, 2005.

4.7 etanercept (Enbrel) Wyeth  (No. 212/05)
                                           
4.7.1 SMC advice for etanercept (Enbrel), for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy, will be posted on the SMC website on Monday 7 November, 2005.
 
4.8 oxaliplatin (Eloxatin)  Sanofi-Aventis  (No. 211/05)            
    
4.8.1 SMC advice for oxaliplatin (Eloxatin), in combination with fluorouracil and folinic acid, for the adjuvant treatment of stage III (Dukes┬┐ C) colon cancer after complete resection of the primary tumour, will be posted on the SMC website on Monday 7 November, 2005.

RESUBMISSION

4.9 solifenacin (Vesicare)  Yamanouchi  (No. 129/04) 

4.9.1 SMC advice for solifenacin (Vesicare), for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome, will be posted on the SMC website on Monday 7 November, 2005.

ABBREVIATED SUBMISSION

4.10 alendronate sodium / colecalciferol  (Fosavance)  Merck Sharp & Dohme Ltd (No. 213/05)  

4.10.1 SMC advice for alendronate sodium/colecalciferol (Fosavance), for the treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency who require treatment with both alendronate and vitamin D and for whom once-weekly administration is appropriate, will be posted on the SMC website on Monday 7 November, 2005.

5 Appeals Update

5.1 glyceryl trinitrate 0.4% (Rectogesic Rectal Ointment)  ProStrakan Group plc (No: 200/05)

5.1.1 The company have advised of their intention to make a resubmission.

6 PAPIG

6.1 The minutes of the meeting of 6 September, 2005, were not available for review and will be considered at the next meeting of SMC.

It was highlighted that there are currently severe resource issues within the secretariat, which are having an impact on the work of PAPIG. 

The Chairman advised that staffing shortages, both within the administration and economics team, are currently being addressed and it is hoped that the situation will improve in the new year when new members of staff have been recruited. 

7 New Drugs Committee: Update

7.1 Nothing to report.

8 Chairman's Business

8.1 Observations on SMC from a Roche Perspective

8.1.1 Observations on SMC from a Roche Perspective were noted. The ABPI representative stated that this very positive statement reflects the general view from industry of SMC, with the exception of evaluation where there is a wish to see the results as soon as possible. It was noted that the first meeting of the Management Group will be in December and the first meeting of the reference group early in the new year, the outcome of which will be reported thereafter.

8.2 Media Broadcasts

8.2.1 Members of the SMC Executive team have been interviewed by ITN and Radio 4 regarding the process in Scotland developed by SMC for the review of newly licenced medicines and the comparison with rapid appraisal.

9 NDC ASSESSMENT REPORTS

DEFERRED SUBMISSION

9.1 calcipotriol/ betamethasone (Dovobet)  Leo Pharma  (No. 09/02)

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

9.1.2The NDC Vice Chairman provided a detailed overview of the assessment, the draft advice, expert comments, comments received from the company and Patient Interest Group submissions from Psoriasis Scotland Arthritis Link Volunteers (PSALV), the Psoriasis Association and Psoriatic Arthritis Liaison Scotland.  Detailed discussion followed and group agreed that calcipotriol/betamethasone (Dovobet), for the treatment of initial topical treatment of stable plaque psoriasis, should be accepted for restricted use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.  
 
9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 November, 2005.

FULL SUBMISSIONS

9.2 carmustine (Gliadel Implant)  Link Pharamceuticals Limited  (No: 215/05)

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 and a letter of support from the Brain Tumour Action Group.  Detailed discussion followed and the SMC agreed that carmustine (Gliadel Implant), for the treatment of newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation, 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.   

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 November, 2005.

9.3 zonisamide (Zonegran)  Eisai Ltd  (No: 216/05)

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

9.3.2 The NDC lead assessor provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company.  A member of PAPIG presented a patient interest group submission from Epilepsy Scotland.  Detailed discussion followed and the SMC agreed that zonisamide (Zonegran), as adjunctive therapy in the treatment of adult patients with partial seizures, should be accepted for restricted 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 4 November, 2005.

9.4 adalimumab (Humira)  Abbott Laboratories Ltd  (No:  218/05) 

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

9.4.2 The NDC lead assessor provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company. Detailed discussion followed and the SMC agreed that 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, 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.   

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 November, 2005.

 
9.5 iloprost trometamol (Ventavis)  Schering Healthcare  Ltd  (No:  219/05)                   

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. Detailed discussion followed and the SMC agreed that iloprost trometamol (Ventavis), for the treatment of patients with New York Heart Association Class III primary pulmonary hypertension, should be accepted for restricted use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

9.5.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 November, 2005.

9.6 erlotinib (Tarceva)  Roche  (No:  220/05)

9.6.1 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.

9.6.2 The NDC Vice Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company. A member of PAPIG presented a Patient Interest Group Submission from The Roy Castle Lung Cancer Foundation. Detailed discussion followed and the SMC agreed that 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, 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.   

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 November, 2005.

ABBREVIATED SUBMISSION

9.7 clarithromycin (ClaroSip 125mg/187.5mg/250mg)  Grunenthal Ltd (No: 217/05)

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

9.7.2 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Discussion followed and the SMC agreed that clarithromycin (ClaroSip 125mg/187.5mg/250mg), for the treatment of acute and chronic infections when caused by clarithromycin susceptible organisms, is not acceptable for review as an abbreviated submission. Although the budget impact is expected to be low, it is at a premium price with increased cost per treatment.  The secretariat will contact the company to request a full submission.

10 Forthcoming Submissions
 
10.1 A list of forthcoming submissions was reviewed.  

11 ADTC Feedback

11.1 Nothing to report.

12 Any Other Business

12.1 Trastuzumab (Herceptin)

12.1.1 An update was requested with regards to trastuzumab (Herceptin). The Chairman advised that a submission for this product 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.

12.2 Secretariat

12.2.1 The Chairman reiterated the resource pressures within the SMC secretariat and requested that members are considerate of this until a resolution is found and the secretariat is working to full complement.

13 Date of Next Meeting

The date of the next meeting was confirmed as Tuesday 6 December, 2005, 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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