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Minutes of the SMC Meeting - Tuesday 3 July 2007

Minutes of the SMC Meeting held on Tuesday 3 July 2007 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, Mr Colin Brown, Professor John Cairns, Mr Tom Divers, Dr Jonathan Fox, Dr Barclay Goudie
Dr Jan Jones, Dr Harpreet Kohli, Dr Chris Lush, Ms Aileen Muir, Mrs Pat Murray, Mrs Wendy Nganasurian, Dr Andrew Power, Ms Fiona Ramsay, Dr Nick Reed, Dr Sandy Simpson, Mr Alistair Thorburn
Ms Angela Timoney, Mr Mike Wallace

In Attendance: Ms Ailsa Brown, Mr Scott Bryson, Ms Alison Campbell,Dr James Dear, Mr Stephen Ferguson, Mr Tom Haswell, Mrs Hazel Illingworth, Mrs Sheila Tunstall-James, Mrs Laura McIver
Ms Rosie Murray, Ms Alex Robertson,Dr Andrew Walker

Apologies: Professor James Barbour, Mrs Marion Bennie, Dr Keith Brown,Mr David Carson, Dr David Crookes, Dr Sara Davies, Mr Jim Eadie, Mr Steven Fenocchi, Mrs Anne Lee, Dr Grace Lindsay, Dr Graham Lowe, Dr Alan MacDonald, Mr Billy Malcolm, Mr Colin McAllister, Professor Dilip Nathwani,  Dr Ken Paterson, Dr Andrew Riley, Mrs Maureen Stark, Dr Sarah Taylor

1. Welcome and Apologies for Absence

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

The Chairman welcomed Ms Sheila Tunstall-James and Mr Tom Haswell, newly appointed public partners, and Dr James Dear, Specialist Registrar, Edinburgh who were observing the meeting.

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

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 05 June 2007 were agreed with a minor amendment to item 9.11.

4. Matters Arising From the Previous Minutes

There were no matters arising from the previous minutes.

Full Submissions

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

4.1.1 The SMC advice for 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, will be posted on the SMC website on Monday, 09 July 2007.

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

4.2.1 The SMC advice for 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, will be posted on the SMC website on Monday, 09 July 2007.

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

4.3.1 The SMC advice for sunitinib (Sutent), for the treatment of advanced and/or metastatic renal cell carcinoma (MRCC), will be posted on the SMC website on Monday, 09 July 2007.

4.4 imiquimod 5% cream (Aldara?) Meda Pharmaceuticals Ltd (No. 385/07)

4.4.1 The SMC advice for 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, will be posted on the SMC website on Monday, 09 July 2007.

RESUBMISSIONS

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

4.5.1 The SMC advice for 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), will be posted on the SMC website on Monday, 09 July 2007.

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

4.6.1 The SMC advice for bemiparin sodium INN (Zibor), for the prevention of thromboembolic events in patients undergoing orthopaedic surgery, will be posted on the SMC website on Monday 09 July 2007.

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

4.7.1 The SMC advice for bemiparin sodium INN (Zibor), for the treatment of established deep vein thrombosis, with or without pulmonary embolism, during the acute phase, will be posted on the SMC website on Monday, 09 July 2007.

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

4.8.1 The SMC advice for rotigotine (Neupro), for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e. without levodopa), will be posted on the SMC website on Monday, 09 July 2007.

Abbreviated Submissions

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

4.9.1 The SMC advice for (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, will be posted on the SMC website on Monday, 09 July 2007.

Non Submissions

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

4.10.1 The SMC advice for elotinib (Tarceva) in combination with gemcitabine for the treatment of patients with metastatic pancreatic cancer, will be posted on the SMC website on Monday, 09 July 2007.

4.11 trastuzumab (Herceptin) Roche Pharmaceuticals (No. 386/07)

4.11.1 The SMC advice for tratuzumab (Herceptin) in combination with an aromatase inhibitor for the treatment of metastatic breast cancer, will be posted on the SMC website on Monday, 09 July 2007.

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

4.12.1 The SMC advice for bevacizumab (Avastin) in combination with paclitaxel for first-line treatment of patients with metastatic breast cancer, will be posted on the SMC website on Monday 09 July 2007.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 The Chairman of PAPIG advised that the group had had an extra-ordinary meeting earlier in the day to discuss the SMC evaluation report.  She also advised that Pat Murray had agreed to join PAPIG as the new SMC representative.

In addition, she read out a statement from the Royal National Institute of the Blind saying how the whole process of submitting a patient interest group submission to SMC had been a professional and positive experience.

7. New Drugs Committee Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 SMC Response to the OFT Report

A copy of the final response was circulated for information and the Chairman thanked all those who had contributed to the report.  He explained that the review is still ongoing and SMC anticipated seeing a response from government within the next 2 or 3 months.

8.2 Nominations for new Chairman of SMC

The Chairman advised that all of the nominations received were in support of Dr Ken Paterson succeeding him as Chairman. He intimated that he was personally delighted with the decision and thought that Dr Paterson was an excellent choice as Chairman of SMC.  This nomination will be forwarded to the Chief Executives in due course.

8.3 Revised/New Documents on SMC Website

The Chairman advised that the following revised/new documents had been posted on the SMC website:

SMC Statement on Orphan Drugs - Minor revisions have been made to the SMC Statement on Orphan Drugs.
Guidance on Submission Criteria - This document has been developed to provide more comprehensive guidance on the submission criteria.
SMC Policy on Meetings with Manufacturers - This document has been developed to provide manufacturers with guidance regarding the SMC Policy on meeting with manufacturers.

The Chairman asked for any comments regarding any of these documents to be sent to the Secretariat.  He explained that these were final draft versions subject to review by the SMC User Group Forum.

8.4 Meeting with Chief Medical Officer/Chief Pharmaceutical Officer 19 June 2007

The Chairman advised that the meeting had been very helpful and constructive. The annual budget was discussed together with the need for more Scottish Health Economists.

8.5 Short Life Working Group on Consistent Advice – 4 July 2007

The Chairman advised that representatives of SMC/SIGN and NHS QIS will convene on 4 July to discuss issues with regards to consistent advice from all three bodies across NHS Scotland. It is anticipated that the group will identify key issues and recommendations. The Chairman to report back at a future meeting of SMC.

8.6 Health Select Committee Visit – 5 July 2007

Representatives of the Health Select Committee, House of Commons, London, have requested a meeting with representatives of SMC with regards to SMC and their enquiry into the work of NICE. The Chairman to report back at a future meeting of SMC.

8.7 Drug and Therapeutic Bulletin – A View on New Drugs for Macular Degeneration

The Chairman highlighted an article in the Drug and Therapeutic Bulletin regarding new drugs for macular degeneration.

 9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg capsules (Lyrica) Pfizer Ltd (No. 389/07)

9.1.1 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.

9.1.2 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 pregabalin (Lyrica), for the treatment of central neuropathic pain in adults, 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.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 July 2007.

9.2 clopidogrel 75mg tablets (Plavix) Sanofi-Aventis/Bristol Myers Squibb (No. 390/07)

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 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 clopidogrel (Plavix), for patients with ST segment elevation acute myocardial infarction (MI), in combination with aspirin, in medically treated patients eligible for thrombolytic therapy, 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, 06 July 2007.

9.3 idursulfase 2mg/ml concentrate for solution for infusion (Elaprase) Shire HGT UK Ltd (No. 391/07)

9.3.1 A declaration of interest was recorded in relation to this product/comparator drugs. The Chief Executive of Greater Glasgow Health Board declared a non personal-specific interest in this product and it was agreed that he should leave the meeting for this part of the agenda.

9.3.2 The NDC Co-Vice Chair 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 Society for Mucopolysaccharide Diseases. Detailed discussion followed and the group agreed that idursulfase (Elaprase), for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II MPS II), 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, 06 July 2007

9.4 rotigotine 2mg/24hours, 4mg/24hours, 6mg/24 hours, 8mg/24 hours transdermal patch (Neupro) Schwarz Pharma (No. 392/07)

9.4.1 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.

9.4.2 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 rotigotine (Neupro), for the treatment of the signs and symptoms of advanced idiopathic Parkinson’s disease in combination with levodopa; i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on-off” fluctuations), 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.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 July 2007.

RESUBMISSIONS

9.5 liposomal cytarabine 50mg suspension for injection (DepoCyte) injection Napp Pharmaceuticals (No. 164/05)

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

9.5.2 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 the Lymphoma Association. Detailed discussion followed and the group agreed that liposomal cytarabine (DepoCyte), for the Intrathecal treatment of lymphomatous meningitis, 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, 06 July 2007.

9.6 nebivolol tablets 5mg (Nebilet) A Menarini (No. 214/05)

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 nebivolol (Nebilet), for the treatment of stable mild and moderate chronic heart failure (CHF) in addition to standard therapies in elderly patients >70 years, 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.

9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 July 2007.

9.7 bortezomib 3.5mg vial of powder for solution for intravenous injection (Velcade) Ortho Biotech (No. 302/06)

9.7.1 A declaration of interest was recorded in relation to this product/comparator drugs.

9.7.2 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 Myeloma UK. Detailed discussion followed and the group agreed that bortezomib (Velcade), as mono-therapy for the treatment of progressive multiple myeloma (MM) in patients who have received at least 1 prior therapy and who have already undergone or are unsuitable for bone marrow transplantation, 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, 06 July 2007.

ABBREVIATED SUBMISSIONS

9.8 insulin detemir 100 U/ml solution for injection via Innolet device (Levemir in InnoLet) Novo Nordisk (No. 393/07)

9.8.1 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.

9.8.2 This product was submitted to SMC as a full submission.  However, after careful consideration of the licence, it was agreed that this should have been reviewed as an abbreviated submission and SMC agreed to process the submission as such.

9.8.3 The NDC Co-Vice Chair provided an overview of the assessment, draft summary of advice, expert comments and comments received from the company.  Discussion followed and the group agreed that insulin detemir (Levemir InnoLet), for the treatment of diabetes mellitus in patients for whom insulin detemir is an appropriate choice of insulin and who have poor visual acuity, dexterity problems, 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.

9.8.4 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 July 2007.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

11. ADTC Feedback

Nothing to report.

12. Any Other Business

12.1 Cost Sharing Schemes

The Chairman advised that he had written to Mike Wallace asking him to take the issue of risk sharing schemes to ABPI to come up with proposals for the range of cost or risk sharing schemes that might be brought to SMC, considering the options that might be used to monitor them, and the practicalities for NHS Scotland associated with recovering the costs of such schemes.

The Chairman asked if a small number of representatives from SMC and industry might get together and take this forward.  Mike Wallace agreed to facilitate this through a discussion under Chatham House rules.  Interested parties from SMC should give their names to the Secretariat for consideration.

12.2 Lay version of Detailed Advice Document

A member asked if there had been any further progress with this.  Laura McIver advised that the document is in the final stages and the medical writers would welcome some input from PAPIG.  The final document should be ready for the SMC meeting in August 2007.
 
12.3 Membership Lists

A member asked the Secretariat to circulate an updated contact list of all members to the new members of SMC.

12.4 Evaluation Programme

Laura McIver asked for volunteers from SMC and NDC to join the reference group to look at the criteria that should be used in assessing if SMC advice is being implemented.

Volunteers to contact the Secretariat.

12.5 Pharmacy Recruitment

The Chairman advised that the pharmacy assessment team are finding it difficult to sustain 8 full submissions each month.  There is a 0.5 WTE vacancy outstanding but it is not possible to recruit to this position at present due to the redeployment policy with NSS.

13. Date of the Next Meeting

13.1 The date of the next meeting was confirmed as Tuesday, 07 August 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.