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Minutes of the SMC Meeting held on Tuesday 5 June 2007

Minutes of the SMC Meeting held on Tuesday 5 June 2007
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Mrs Marion Bennie, Mrs Barbara Black, Dr Keith Brown Dr David Crookes, Mr Tom Divers, Dr Barclay Goudie, Dr Jan Jones, Dr Graham Lowe
Dr Chris Lush, Dr Alan G MacDonald, Ms Aileen Muir, Ms Angela Munday, Mrs Wendy Nganasurian, Dr Ken Paterson, Dr Andrew Power, Ms Fiona Ramsaym, Dr Sarah Taylor, Mr Alistair Thorburn, Ms Angela Timoney, Mr Mike Wallace

In Attendance: Ms Ailsa Brown, Mr Scott Bryson, Ms A Campbell, Mr Stephen Ferguson, Mrs Hazel Illingworth, Mrs Anne Lee, Dr J McElhinney, Mrs Laura McIver, Ms C O’Dowd, Mr Samuel Oduro, Mrs Maureen Stark

Apologies: Mrs Laura Ace, Professor James Barbour, Dr Keith Beard, Mr Colin Brown, Professor John Cairns, Mr David Carson, Dr Sara Davies, Mr Jim Eadie, Mr Steven Fenocchi, Dr Jonathan Fox, Mr John Glennie, Dr Harpreet Kohli, Dr Grace Lindsay, Mr Colin McAllister, Mr Billy Malcolm, Mrs Pat Murray, Ms Rosie Murray, Professor Dilip Nathwani, Dr Nick Reed, Dr Andrew Riley,Dr Sandy Simpson, Dr Andrew Walker
 

1. Welcome and Apologies for Absence

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

The Chairman welcomed Samuel Oduro, Senior Analyst, NHS National Services Scotland, who is working with Mrs Marion Bennie on the evaluation programme.

The Chairman also welcomed Mr Scott Bryson, Dr John McElhinney, and Mrs Alison Campbell, NDC Members and indicated that they would be presenting submissions to SMC.

The Chairman offered his thanks for the invaluable contribution of Ms Angela Munday, a founder member of NDC, whose term of membership on SMC has expired. Angela had also attended her last meeting of PAPIG.

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

3.1 The minutes of the SMC meeting held on 01 May 2007 were agreed as an accurate record.

4. Matters Arising From the Previous Minutes

4.1 There were no matters arising from the previous minutes.

Full Submissions

4.1 darifenacin (Emselex) Ardana Bioscience (No. 377/07)

4.1.1 The SMC advice for darifenacin (Emselex), 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, 11 June 2007.

4.2 darunivir (Prezista) Tibotec (No. 378/07)

4.2.1 The SMC advice for darunivir (Prezista), co-administered with ritonavir in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus (HIV-1) infection in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor (PI), will be posted on the SMC website on Monday, 11 June 2007.

4.3 posaconazole (Noxafil) prophylaxis Schering-Plough (No. 379/07)

4.3.1 The SMC advice for posaconazole (Noxafil), for prophylaxis of invasive fungal infections in immunocompromised patients It is restricted to patients in whom there is a specific risk of Aspergillus infection or where fluconazole or itraconazole are not tolerated, will be posted on the SMC website on Monday, 11 June 2007.

4.4 enoxaparin (Clexane) Sanofi-Aventis (No. 380/07) 

4.4.1 The SMC advice for enoxaparin (Clexane), for the treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary Intervention (PCI), will be held in confidence until confirmation of product availability.

4.5 ranibizumab (Lucentis) Novartis Pharmaceuticals UK Ltd (No. 381/07)

4.5.1 The SMC advice for ranibizumab (Lucentis), for the treatment of neovascular (wet) age-related macular degeneration (AMD), will be posted on the SMC website on Monday, 11 June 2007.

Abbreviated Submissions

4.6 formoterol Easyhaler 12mcg per actuation inhalation powder Ranbaxy (UK) Ltd (No. 375/07)

4.6.1 The SMC advice for formoterol Easyhaler 12mcg per actuation inhalation powder, for the treatment of asthma in patients treated with inhaled corticosteroids and who also require a long-acting beta2-agonist in accordance with current treatment guidelines; and for relief of reversible airways obstruction in patients with chronic obstructive pulmonary disease (COPD) and requiring long-term bronchodilator therapy, will be posted on the SMC website on Monday, 11 June 2007.

Deferred Advice

4.7 esomeprazole (Nexium) AstraZeneca UK Ltd (No: 368/07)

This product was reviewed by SMC in April 2007 for patients in the age group 12-17 years inclusive, for the treatment of erosive reflux oesophagitis, the long-term management of patients with healed oesophagitis to prevent relapse, and the symptomatic treatment of gastro-oesophageal reflux disease. The product was withheld in confidence pending product availability, however, the company have advised that the product launched in May. The advice was distributed to NHSScotland on Friday, 4 May and will be published on the SMC website on Monday, 11 June 2007.

5. Appeals Update

5.1 standardised allergen extract of grass pollen from Timothy (Phleum pratense) 75,000 SQ-T per oral lyophilisate (Grazax)  ALK-Abello Ltd (No: 367/07)

ALK-Abello Ltd has indicated their intention to make a resubmission for standardised allergen extract of grass pollen 75,000 per oral lyophilisate (Grazax), for the treatment of grass pollen induced rhinitis and conjunctivitis in adult patients with clinically relevant symptoms and diagnosed with a positive skin prick test and/or specific IgE test to grass pollen.

6. Patient and Public Involvement Group (PAPIG)

The Chairman of PAPIG advised that the minutes of their meeting held today would be available at the next meeting of SMC.

She advised that PAPIG has received to date 103 patient interest group submissions, 27 of which have been received in 2007. 

The Chairman was pleased to announce that two new Public Partners will be joining PAPIG and will attend their first meeting of SMC in July as observers and their first working meeting in August. 

She also advised that PAPIG needs a clinical replacement from SMC for Angela Munday. The Chairman of SMC advised that the Secretariat will circulate this request, asking for volunteers.

7. New Drugs Committee: Chairman’s report

Nothing to report.

8. Chairman’s Business

8.1 Meeting with CMO/Representatives of SIGN/NHS QIS 17 May

The Chairman advised that following a preliminary exchange of emails, senior representatives from NHS QIS (including SIGN) and SMC met with the CMO on 17th May 2007 to discuss joint working between SIGN and SMC.  This was an extremely constructive meeting, which identified a number of the key issues and actions necessary to ensure that SIGN and SMC provide consistent and evidence-based advice on medicines to the NHS in Scotland. The different remits of SIGN and SMC were recognised, as was the role of NHS QIS in considering the situations where a NICE MTA should supersede SMC advice in Scotland.

It was agreed that there should be early identification of areas where there are common workstreams underway and thus the potential for overlapping or conflicting advice. In these areas, there should be early sharing of recommendations and of the evidence on which they are based, including dialogue between the clinical experts used by each organisation.

There was also an agreement to set up a short-life working group, with an important focus on health economic issues, to identify any impediments to consistency between the two organisations and to ensure that these are addressed at the earliest opportunity. 

All of the parties at the meeting agreed to build on the existing good working relationship between SIGN and SMC, so as to strengthen the excellent work of both organisations.

8.2 SMC 2006 Annual Report

The Chairman advised that the SMC 2006 Annual Report has now been published and a copy has been sent to all members. Additional copies are available from the secretariat on request.

He thanked Rosie Murray and the Secretariat for their efforts in putting together the report.

8.3 BMA Board of Science – Evidence-Based Prescribing

The Chairman advised that this document had been circulated for information purposes.

8.4 Health Select Committee Visit

The Chairman advised that representatives of the Health Committee Select, House of Commons, London, have requested a meeting with representatives of SMC with regards to their enquiry into the work of NICE. The meeting is scheduled for 5 July, 2007.

8.5 SMC Response to the OFT Report

A copy of the draft response was tabled at the meeting.  The NDC Chairman thanked those members who had already sent comments and asked for any further comments to be emailed to the Secretariat.

8.6 NICE Decision to support bortezomib (Velcade) in risk sharing

The Chairman advised that it was the position of the Scottish Executive Health Department to make a decision on risk sharing schemes in Scotland.

8.7 SMC Advice

The Chairman advised that a manufacturer had included misleading information in their marketing material regarding the SMC resubmission process. 

The Chairman asked Industry representatives to remind companies that advice must be quoted in full at all times and information given should reflect SMC processes accurately.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 exenatide 5 or 10 micrograms, solution for injection, prefilled pen (Byetta) Eli Lilly and Company Limited (No. 376/07)

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

9.1.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and comments received from the company.  A member of PAPIG presented a Patient Interest Group Submission from Diabetes UK Scotland. Detailed discussion followed and the group agreed that exenatide (Byetta), for the treatment of type 2 diabetes mellitus in combination with metformin and/or sulphonylureas in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies, should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 8 June 2007.

9.2 montelukast 4mg and 5mg chewable tablets and 4mg granules (Singulair Paediatric) Merck Sharpe & Dohme Ltd (No. 383/07)

9.2.1 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.

9.2.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and comments received from the company.  A member of PAPIG presented a Patient Interest Group Submission from Asthma UK Scotland. Detailed discussion followed and the group agreed that montelukast (Singulair Paediatric), as an alternative treatment option to low-dose inhaled corticosteroids for patients, [children 2 to 14 years of age] with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids, should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 8 June 2007.

9.3 sunitinib 12.5mg, 25mg, 50mg capsules (Sutent) Pfizer Ltd (No. 384/07)

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

9.3.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and comments received from the company. A member of PAPIG presented Patient Interest Group Submissions from Kidney Cancer UK and the James Whale Fund for Kidney Cancer. Detailed discussion followed and the group agreed that sunitinib (Sutent), for the treatment of advanced and/or metastatic renal cell carcinoma (MRCC), should not be recommended for use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 8 June 2007.

9.4 imiquimod 5% cream (Aldara) Meda Pharmaceuticals Ltd (No. 385/07)

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

9.4.2 The NDC Co Vice-Chair provided an overview of the assessment, draft advice, expert comments and comments received from the company, updated clinical expert responses were tabled for review. Detailed discussion followed and the group agreed that imiquimod 5% cream (Aldara), for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate, should not be recommended for use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 8 June 2007.

RESUBMISSIONS

9.5 ibritumomab tiuxetan (Zevalin) Schering Health Care Ltd (No. 171/05)

9.5.1 A declaration of interest was 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 an overview of the assessment, draft advice, expert comments and comments received from the company. A member of PAPIG presented Patient Interest Group Submissions from the Lymphoma Association and Leukaemia Care. Detailed discussion followed and the group agreed that ibritumomab tiuxetan (Zevalin), for the preparation of a radiopharmaceutical incorporating Yttrium 90 [90Y] for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL), should not be recommended for use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.5.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 8 June 2007.

9.6 bemiparin 3500 IU in 0.2ml injection for sub-cutaneous administration (Zibor) Pan Quimca Farmaceutica S.A. (No. 204/05)

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

9.6.2 The NDC Co Vice-Chair provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that bemiparin sodium INN (Zibor), for the prevention of thromboembolic events in patients undergoing orthopaedic surgery, should not be recommended for use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 8 June 2007.

9.7. bemiparin 25,000 IU/ml injection for sub-cutaneous administration (Zibor) Pan Quimca Farmaceutica S.A. (No. 206/05)

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

9.7.2 The NDC Co Vice-Chair provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that bemiparin sodium INN (Zibor), for the treatment of established deep vein thrombosis, with or without pulmonary embolism, during the acute phase, should not be recommended for use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.7.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 8 June 2007.

9.8 rotigotine 2mg/24 hours, 4mg/24 hours, 6mg/24 hours, 8mg/24 hours transdermal patch (Neupro) Schwarz Pharma (No. 289/06)

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

9.8.2 The NDC Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company. A member of PAPIG presented a Patient Interest Group Submission from the Parkinson’s Disease Society. Detailed discussion followed and the group agreed that rotigotine (Neupro), for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e. without levodopa), should be accepted for use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.8.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 8 June 2007.

ABBREVIATED SUBMISSIONS

9.9 methylphenidate prolonged release capsule (Medikinet XL) Flynn Pharma Ltd (No. 388/07)

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

9.9.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that methylphenidate prolonged-release capsule (Medikinet XL®) as part of a comprehensive treatment programme for attention deficit hyperactivity disorder (ADHD) in children over 6 years of age when remedial measures alone prove insufficient, should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.9.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 8 June 2007.

NON SUBMISSIONS

9.10 erlotinib (Tarceva) Roche Pharmaceuticals (No. 382/07)

9.10.1 In the absence of a submission from the holder of the marketing authorisation, elotinib (Tarceva) in combination with gemcitabine for the treatment of patients with metastatic pancreatic cancer, should not be recommended for use within NHS Scotland.

9.10.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 8 June 2007.
 
9.11 trastuzumab (Herceptin) Roche Pharmaceuticals (No. 386/07)

9.11.1 In the absence of a submission from the holder of the marketing authorisation, tratuzumab (Herceptin) in combination with an aromatase inhibitor for the treatment of metastatic breast cancer, should not be recommended for use within NHS Scotland.

9.11.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 8 June 2007.

9.12 bevacizumab (Avastin) Roche Pharmaceuticals (No. 387/07)

9.12.1 In the absence of a submission from the holder of the marketing authorisation, bevacizumab (Avastin) in combination with paclitaxel for first-line treatment of patients with metastatic breast cancer, should not be recommended for use within NHS Scotland.

9.12.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 8 June 2007.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

11. ADTC Feedback

Nothing to report.

12. SMC User Group Forum

The Minutes of the meeting held on 24 April 2007 were noted. The Chairman of the User Group Forum thanked Mrs Laura McIver for chairing the meeting in his absence.

13. Any Other Business

The Chairman advised that he is nearing the end of his three years in office as Chairman and he intends to stand down in April/May of 2008. He asked members to send nominations for the new Chairman to the Secretariat before the next meeting.  An update will be given at a future meeting of SMC.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 03 July 2007 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.