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SMC Minutes - Tuesday 9 January 2007

Minutes of the SMC Meeting held on Tuesday 09 January 2007
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Mrs Laura Ace, Professor James Barbour, Dr Keith Beard, Ms Rosaleen Beattie, Mrs Marion Bennie, Mrs Barbara Black, Dr Keith Brown, Professor John Cairns, Mr David Carson, Dr David Crookes, Mr Tom Divers, Dr Peter Donnan, Dr Barclay Goudie, Dr John Haughney, Dr Jan Jones, Dr Harpreet Kohli, Mr Billy Malcolm, Ms Angela Munday, Mrs Wendy Nganasurian, Dr Ken Paterson, Dr Andrew Power, Dr Nick Reed, Ms Fiona Ramsay, Dr Andrew Riley, Dr Philip Rutledge, Dr Sandy Simpson, Dr Sarah Taylor, Ms Angela Timoney, Ms Helen Tyrrell, Mr Mike Wallace

In Attendance: Ms Ailsa Brown, Dr Sara Davies, Mr Stephen Ferguson, Mrs Laura McIver, Ms Rosie Murray, Mrs Maureen Stark, Dr Andrew Walker

Apologies: Dr Jennifer Armstrong, Mr Nick Brown, Mr Jim Eadie, Mr Steven Fenocchi, Mr John Glennie, Mrs Hazel Illingworth, Mrs Anne Lee, Dr Grace Lindsay, Dr Graham Lowe, Dr Chris Lush, Mr Colin McAllister, Mrs Pat Murray, Dr John Webster

1 Welcome and Apologies for Absence

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

The Chairman advised that it was Ms Helen Tyrrell’s last attendance at the Scottish Medicines Consortium (SMC) as a lay representative member and thanked her for her invaluable contribution to the work of the Consortium.  Ms Tyrrell thanked the Chairman for the opportunity to be involved in SMC since it’s inception and indicated her willingness to continue to maintain links between SMC and Voluntary Health Scotland.

The Chairman advised that with the increasing use of complex statistical analyses in submissions, Dr Peter Donnan had agreed that his knowledge and skills could best be used in relation to the work of the New Drugs Committee (NDC), rather than SMC.   Dr Donnan was therefore attending his last SMC meeting before moving to join NDC.

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 December 2006 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

4.2 clofarabine (Evoltra)   Bioenvision  (No 327/06)

4.2.1 The SMC advice for clofarabine (Evoltra), for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients (≤ 21 years) who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response, will be posted on the SMC website on Monday, 15 January 2007.

4.3 lidocaine 5% plaster (Versatis)   Grunenthal GmbH  (No 334/06) 

4.3.1 The SMC advice for lidocaine 5% plaster (Versatis), for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia), will be withheld pending confirmation of launch.

4.4 ertapenem (Invanz) diabetic foot   Merck Sharp & Dohme  (No 335/06) 

4.4.1 The SMC advice for ertapenem (Invanz), for the treatment of diabetic foot infections of the skin and soft tissue when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required, will be posted on the SMC website on Monday, 15 January 2007.

4.5 varenicline 1mg tablets (Champix)   Pfizer  (No 336/06)  

4.5.1 The SMC advice for varenicline (Champix), for smoking cessation in adults, will be posted on the SMC website on Monday, 15 January 2007.

4.6 busulfan IV (Busilvex)   Pierre Fabre Ltd  (No 337/06)   

4.6.1 The SMC advice for busulfan IV (Busilvex), as part of a combination regimen for conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in paediatric patients and, in adult patients, when the combination is considered the best available option, will be posted on the SMC website on Monday, 15 January 2007.

RE-SUBMISSIONS

4.7 omalizumab (Xolair)   Novartis Pharmaceuticals UK Ltd  (No 259/06)

4.7.1 The SMC advice for omalizumab (Xolair), as add-on therapy to improve asthma control in adult and adolescent patients (12 years of age and above) with severe persistent allergic asthma, will be posted on the SMC website on Monday 15 January 2007.

Abbreviated Submissions

4.8 daptomycin (Cubicin) 500mg   Novartis Pharmaceuticals UK Ltd (No 338/06)

4.8.1 The SMC advice for daptomycin 500mg (Cubicin), for the treatment of complicated skin and soft-tissue infections in adults, will be posted on the SMC website on Monday, 15 January 2007.

5 Appeals Update

5.1 sorafenib 200mg tablets (Nexavar)   Bayer Plc  (No. 321/06)

Bayer Healthcare Ltd has indicated their intention to make a re-submission for sorafenib (Nexavar), for the treatment of patients with advanced renal cell carcinoma, when new data becomes available.

6. Patient and Public Involvement Group (PAPIG)

6.1 PAPIG Matters Arising

Mrs Nganasurian indicated that PAPIG had met earlier in the day and meeting notes would be available at the next meeting of SMC in February.

6.2 Patient Interest Group Observers at SMC

Mrs Nganasurian shared positive feedback received from a recent Observer at SMC.  In particular, the Observer considered that it had helped her to understand the complexities of SMC’s assessment process and perhaps helped her to understand that if a medicine has a high cost attached, it does not necessarily mean that patients can’t have it, providing it can be demonstrated that the benefits the medicine brings to patients is worth the high cost.

7 New Drugs Committee: Chairman’s report

7.1 Statistical/Health Economics Training Day for SMC/NDC Members

The NDC Chairman reminded members that a date had been set for the statistical/health economics training day for SMC/NDC Members, on Tuesday 20 February 2007, between 9:30am and 4:30pm, in Delta House Glasgow.  The focus of the day is to discuss topics that commonly arise in submissions and to outline current best practice in relation to these issues.  Members were advised to contact the Secretariat as soon as possible if they wished to attend.  Consideration will be given to repeating the event in the future if there is demand from members unable to attend on 20 February.

8. Chairman’s Business

8.1 Personal Declarations of Interest

Current guidance for NDC/SMC members, on what constitutes a conflict of interest and defines the nature of that interest, is largely slanted at financial and other beneficial, professional interests in the pharmaceutical industry.  The Chairman indicated that he was concerned that there were certain instances where a member could have a non-financial/professional interest, that currently fell outwith the guidance but one which could make that member less objective.  For example, a member could be in a position where they are considering advice for a medicine, and a close family member could potentially gain benefit from this medicine to treat a serious or life threatening illness.

Accordingly, draft changes have been made to the existing guidance to take account of such interests and to define how they should be handled in relation to SMC process.  The draft will be considered by the SMC Users Group and SMC membership, before being forwarded to the Central Legal Office for scrutiny.  It will then be brought to SMC for ratification and adoption.

8.2 Brainstorming Session on SMC’s Role, Remit and Process

The SMC Executive Team recently convened a group of representatives from SMC and NDC who were asked to consider how SMC works, if we should do things differently or do new things that might be more helpful to the Area Drug and Therapeutic Committees (ADTCs) for whom we act, and if there are ways we could work more efficiently or more effectively. These issues were to be considered in terms of SMC’s current position and where SMC might want to be in 3-5 years. Dr Barclay Goudie chaired the group.

A draft report has been prepared detailing the outputs from the group and recommendations.  A final report is expected to be made available to the Executive Team shortly and key actions will be considered by SMC in due course.

8.3 Membership

The annual review of SMC membership is underway.  The terms of appointment for several members are due to expire.  However, to maintain knowledge and consistency within the Consortium, it may be necessary to invite some members to extend their term.  The Secretariat will approach ADTCs for nominations where terms cannot be extended and replacement members are required.  Members were asked to bring potential nominees to the attention of their ADTC.

8.4 Good Practice on Managing the Introduction of New Healthcare Interventions and Links to NICE Technology Appraisal Guidance

A recent publication from the Department of Health - Good Practice on Managing the Introduction of New Healthcare Interventions and Links to NICE Technology Appraisal Guidance – was noted and in particular the positive comments about the usefulness of SMC advice as an early source of guidance on the use of new medicines in the UK.

8.5 New England journal of Medicines: 5 Year Follow-up of Patients Receiving Imatinib for Chronic Myeloid Leukaemia

The Chairman was pleased to note that the results of the 5-year follow-up of patients receiving imatinib for chronic myeloid leukaemia had confirmed the durability of treatment response and effectively endorsed SMC’s decision in 2002 to accept it for use and allow early access to the treatment for patients in Scotland.

8.6 Specialist Media Briefing on the Science of Health Economics

Both the SMC Chairman and Dr Andrew Walker will be speaking, and representing SMC, at a Specialist Media Briefing on the Science of Health Economics, at the Science Media Centre in London on 19 February 2007.

8.7 Therapeutics 2007 – Improving Clinical Effectiveness and Patient Safety

A meeting will be held at the Royal College of Physicians of Edinburgh on 23 February 2007, jointly between the College and the Royal Pharmaceutical Society in Scotland.  All SMC/NDC members are welcome to attend.

9 NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 rimonabant (Acomplia)   sanofi-aventis UK  (No. 341/07)

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

9.1.2 The SMC Vice Chair provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that rimonabant (Acomplia), as an adjunct to diet and exercise for the treatment of obese patients (body mass index (BMI) ≥30 kg/m2), or overweight patients (BMI >27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia, should not be recommend 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 ADTCs and NHS Boards on Friday, 12 January 2007.

9.2 pemetrexed (Alimta)   Eli Lilly and Company Limited  (No.342/07)

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 Vice Chairman provided a detailed 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 Roy Castle Lung Foundation. Detailed discussion followed and the group agreed that pemetrexed (Alimta), as monotherapy for second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, should not be recommend 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.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 12 January 2007.

9.3 sunitinib (Sutent)   Pfizer Ltd  (No.343/07)

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

9.3.2 The SMC Vice Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that sunitinib (Sutent), for the treatment of advanced and/or metastatic renal cell carcinoma after failure of interferon-alpha or interleukin-2 therapy, should not be recommend 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 ADTCs and NHS Boards on Friday, 12 January 2007.

9.4 TachoSil® Nycomed (No. 344/07)

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

9.4.2 The NDC Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that TachoSil®, for supportive treatment in surgery for improvement of haemostasis where standard techniques are insufficient, 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.

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 12 January 2007.

9.5 interferon beta-1b (Betaferon)   Schering Health Care Ltd  (No.345/07)

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 SMC Vice Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that interferon beta-1b (Betaferon), for the treatment of patients with a single demyelinating event with an active inflammatory process, severe enough to warrant treatment with intravenous corticosteroids, where alternative diagnoses are excluded and who are determined to be at high risk of developing clinically definite multiple sclerosis, should not be recommend 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 ADTCs and NHS Boards on Friday, 12 January 2007.

9.6 tacrolimus (Prograf)   Astellas Pharma Ltd  (No.346/07)

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

9.6.2 The NDC Vice Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that tacrolimus (Prograf), for the prophylaxis of transplant rejection in heart allograft patients, 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.

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 12 January 2007.

9.7 deferasirox (Exjade)   Novartis Pharmaceuticals UK Ltd  (No.347/07)

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

9.7.2 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 Sickle Cell Society and from the United Kingdom Thalassaemia Society.  Detailed discussion followed and the group agreed that deferasirox (Exjade), for the treatment of, chronic iron overload associated with the treatment of rare acquired or inherited anaemias requiring recurrent blood transfusions 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.

9.7.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 12 January 2007.

ABBREVIATED SUBMISSIONS

9.8 propiverine hydrochloride (Detrunorm XL) Amdipharm PLC (No. 340/07)

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 and the draft summary of advice. Discussion followed and the group agreed that propiverine hydrochloride (Detrunorm XL), for the treatment of urinary incontinence, as well as urgency and frequency in patients who have idiopathic detrusor overactivity (overactive bladder), 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 ADTCs and NHS Boards on Friday, 12 January 2007.

10 Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

11 ADTC Feedback

11.1 SIGN Guidelines for Peripheral Arterial Disease

In a letter to the Chairman of SIGN, copied to key clinical personnel in NHS Lothian, the Chief Executive and Medical Adviser for NHS QiS and the SMC Chairman, Lothian Formulary Committee raised the issue of conflicting advice from SMC and SIGN on the use of cilostazol for the treatment of intermittent claudication.  SMC has not recommended cilostazol for use however recently issued SIGN Guidelines for Peripheral Arterial Disease advocates its use and gives the medicine a Grade A Recommendation.  Lothian ADTC are unsure which advice/ guidance takes precedence and are therefore unsure whether or not cilostazol should properly be included in their Formulary.

The Chairman welcomed the opportunity to discuss the principle which highlighted the differences in SMC and SIGN assessments.  SMC considers both the clinical and cost effectiveness of the treatment whereas SIGN considers only clinical effectiveness, hence the possibility that the two pieces of advice may differ as they have in the case of cilostazol.  The Chairman stressed that SMC and SIGN do liaise with each other however the differences in remit between the two organisations has led to concern amongst the SMC Executive that the two bodies can make different recommendations in Scotland without some guidelines on the primacy of advice.

Members of the Consortium representing other ADTCs indicated that in their areas a decision had been made not to include cilostazol in their formulary based on SMC advice that it is not cost effective.

A representative of Lothian Formulary Committee was advised by the Consortium to refer the matter to the Chief Medical Officer (CMO) for clarification and guidance.  Dr Sarah Davies, SEHD, acknowledged the points made in the discussion.

12 Any Other Business

12.1 Redevelopment of the SMC Website

Following a series of delays and problems, a member of the Consortium asked the Chairman if he could give the SMC an indication of when real progress on the redevelopment of the SMC Website could be expected.   SMC were advised that the delays were due to problems with the Contractor, and were largely outwith SMC control, however strenuous efforts were being made by the SMC Secretariat and Communications Officers to have the new site operational in March.  SMC gave approval to seek further funding to address the issues, if required.

A PAPIG member indicated that a delay until March would impinge on a forthcoming recruitment campaign for new lay members however it was agreed that interim arrangements could be made using the existing website.

12.2 SMC Budget for 2007/08

Following an enquiry on progress towards the establishment of the SMC Budget for 2007/08 the Chairman advised that there had been a slight delay but meetings had now been scheduled to progress the matter and secure the budget within the shortest possible timescale.

13 Date of the Next Meeting

The date of the next meeting was confirmed as Tuesday, 6 February 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.