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Minutes of the SMC Meeting held on Tuesday 06 March 2007

Present: Professor David Webb (Chairman), Dr Keith Beard,  Mrs Barbara Black, Dr Keith Brown,  Mr David Carson, Dr David Crookes, Mr Tom Divers, Mr Jim Eadie, Dr Barclay Goudie,, Dr Nick Reed, Ms Fiona Ramsay, Dr Sandy Simpson,Dr Sarah Taylor, Ms Angela Timoney, Mr Mike Wallace, Dr John Webster

In Attendance: Ms Ailsa Brown, Dr Sara Davies, Mr Steven Fenocchi, Mr Stephen Ferguson, Mrs Hazel Illingworth, Mrs Anne Lee,  Dr Trevor McGoldrick, Mrs Laura McIver, Ms Rosie Murray, Mrs Maureen Stark, Dr Andrew Walker

Apologies: Mrs Laura Ace, Dr Jennifer Armstrong, Professor James Barbour, Mrs Marion Bennie,  Professor John Cairns, Mr John Glennie, Dr Grace Lindsay, Dr Harpreet Kohli,  Mr Colin McAllister, Mrs Wendy Nganasurian, Dr Andrew Riley, Dr Philip Rutledge

1. Welcome and Apologies for Absence

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

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 06 February 2007 were agreed as an accurate record.

4 Matters Arising From the Previous Minutes

4.1 Statistical/Health Economic Training Day for SMC/NDC Members – 20 February 2007

Ms Ailsa Brown advised that the day had been very successful with good representation from both NDC and SMC.  The group are considering holding another training day with similar topics for those members who were unable to attend. Details will be given at a future meeting.

4.2 PAPIG Recruitment

The Chairman advised that the recruitment process was still ongoing and the Secretariat hope to have the work completed within the next two to three weeks.

Full Submissions

4.3 alglucosidase alfa (Myozyme) Gemzyme (No.352/07)

4.3.1 The SMC advice for alglucosidase alfa (Myozyme), for the treatment of Pompe disease (acid α-glucosidase deficiency), will be posted on the SMC website on Monday, 12 March 2007.

4.4 clostridium botulinum type A toxin haemagglutinin (Dysport) Ipsen Ltd (No.353/07)

4.4.1 The SMC advice for clostridium botulinum type A toxin (Dysport), for the treatment of focal spasticity, including arm symptoms associated with focal spasticity, in conjunction with physiotherapy, will be posted on the SMC website on Monday, 12 March 2007.

4.5 pioglitazone hydrochloride (Actos) triple therapy Takeda UK Ltd (No.354/07)

4.5.1 The SMC advice for pioglitazone (Actos), as triple therapy in combination with metformin and a sulphonylurea, for the treatment of patients with insufficient glycaemic control despite dual oral therapy and where patients are unable or unwilling to take insulin, will be posted on the SMC website on Monday, 12 March 2007.

4.6 buprenorphine/naloxone 4:1 ratio (Suboxone) Schering-Plough (No.355/07)

4.6.1 The SMC advice for buprenorphine/naloxone (Suboxone), for substitution treatment of opioid drug dependence, within a framework of medical, social and psychological treatment, will be posted on the SMC website on Monday, 12 March 2007.

4.7 parathyroid hormone (Preotact) Nycomed Ltd (No.356/07)

4.7.1 The SMC advice for parathyroid hormone (Preotact), for the treatment of osteoporosis in postmenopausal women at high risk of fractures, will be posted on the SMC website on Monday, 12 March 2007.

Re-submissions

4.8 ivabradine (Procoralan) Servier Laboratories Ltd (No.319/06)

4.8.1 The SMC advice for ivabradine (Procoralan), for the symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers, will be posted on the SMC website on Monday, 12 March 2007.

4.9 glyceryl trinitrate 0.4% rectal ointment (Rectogesic) Prostrakan (No.200/05)

4.9.1 The SMC advice for glyceryl trinitrate 0.4% rectal ointment (Rectogesic), for the relief of pain associated with chronic anal fissure, will be posted on the SMC website on Monday, 12 March 2007.

Abbreviated Submissions

4.10 calcium carbonate/colecalciferol (Natecal) Trinity Chiesi Ltd (No.348/07)  

4.10.1 The SMC advice for calcium carbonate/colecalciferol (Natecal), for correction of vitamin D and calcium deficiencies in the elderly, vitamin D and calcium supplementation as an adjunct to specific treatment for osteoporosis in patients where combined vitamin D and calcium deficiencies have been diagnosed or at a high risk of such deficiencies, will be withheld pending confirmation of launch.

4.11 formoterol fumarate dihydrate (Atimos Modulite) Trinity Chiesi Ltd (No.349/07)

4.11.1 The SMC advice for formoterol fumarate (Atimos Modulite), for the relief of reversible airways obstruction in patients with chronic obstructive pulmonary disease (COPD) requiring long-term bronchodilator therapy, will be withheld pending confirmation of launch.

4.12 amlodipine besylate/valsartan (Exforge) Novartis Pharmaceuticals UK Ltd (No.350/07)

4.12.1 The SMC advice for amlodipine/valsartan (Exforge), for patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy will be posted on the SMC website on Monday, 12 March 2007.

4.13 valsartan (Diovan) Novartis Pharmaceuticals UK Ltd (No.351/07)

4.13.1 The SMC advice for valsartan 320mg (Diovan), for the treatment of hypertension, will be withheld pending confirmation of launch.

Deferred Advice

4.14 lanthanum carbonate 250, 500, 750, 1000mg chewable tablets (Fosrenol) Shire Pharmaceuticals Contract Ltd No. (286/06)

4.14.1 The Chairman advised that lanthanum carbonate (Fosrenol) launched on 19 February 2007.  This product was reviewed by SMC in July 2006 and was accepted for restricted use as a phosphate-binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis. Lanthanum carbonate is as effective as calcium carbonate in reducing phosphate to target levels. It is restricted to use as a second-line agent in patients where a non-aluminium, non-calcium phosphate binder is required.  Advice will be sent to NHS Boards and ADTCs on Friday, 9 March 2007, and posted on the SMC website on Monday, 7 May 2007.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 Nothing to report.

7. New Drugs Committee: Chairman’s report

7.1 Nothing to report

8. Chairman’s Business

8.1 NICE STA and SMC Decisions

The Chairman advised that further to a meeting held on Friday, 2 March 2007, there has been agreement that the current position with regards to SMC advice and NICE STAs will be upheld for a further period of 2 years.  The HDL will be renewed before it is due to expire at the end of March 2007.

8.2 The Pharmaceutical Price Regulation Scheme - Office of Fair Trading Market Study Report

The Chairman advised that the Office of Fair Trading recently published a market report regarding the UK Pharmaceutical Price Regulation Scheme.  This has been circulated to all members of SMC and NDC.  The Chairman asked members to note the following quote contained within the Executive Summary.

"Under any value-based reform, the credibility of the institution carrying out the cost effectiveness assessment is key.  Institutions need to work well and to be seen to work well.  They therefore need to be competent and credible in the eyes of key stakeholders.  While individual views inevitably differ, it is clear that the bodies that carry out health technology assessments in the UK, particularly NICE and SMC are among the most respected in the world.  We believe that they should play a central role in any value-based pricing scheme and have set out some options for how this might work in the medium and long term."

The Chairman advised that SMC will be preparing a response to the report and asked members who would like to contribute to contact him through the secretariat.
 
8.3 Disparity between advice from SMC and SIGN

The Chairman advised that he had written to the CMO to seek further guidance.  The CMO recognised that it is difficult to be absolutely rigid about this rule, but has advised that where there is a clash between SIGN and SMC advice, SMC advice should take precedence.   With CMO’s approval, the communication between the Chair of SMC and the CMO has been distributed to SMC and NDC members and will be sent to ADTCs.

8.4 SMC Website

The Chairman advised that after a lengthy delay due to technical difficulties, coupled with the website developers being unable to meet anticipated deadlines within the project, the new SMC website is now live. There are still improvements to be made to the site and work is ongoing, specifically within the work programme and the Public Involvement section.
He advised that the secretariat would be pleased to receive comments from members regarding improvements and all suggestions would be considered.

8.5 Pre-election Period

The pre-election period commences on 2 April, 2007. Therefore, SMC advice due to be published on the SMC website on 10 April, 2007 will be withheld until 7 May, 2007.

8.6 Report: Scottish Market Understanding Initiative – Overcoming the barriers to market access for patients in Scotland

The Chairman asked Jim Eadie to talk to the report, which had been prepared by the ABPI Scotland Market Understanding Initiative (SMUI).  The report, which is apparently the first in a series, was designed to provide a starting point for a detailed analysis of the current facilitators and barriers for patient access to medicines in Scotland. Vigorous discussion took place and concerns were expressed about a number of aspects of the report. In particular, it emerged that the SMUI report was an opinion piece, representing the views of ABPI, not an evidence-based report on Scottish prescribing practice.

Jim Eadie agreed to pass back the views of SMC to the Chairman of SMUI, Allan Walker, and assured SMC that no further such reports would be published independent, or in advance of, the Evaluation Project to which ABPI is a partner. The Chairman, on behalf of SMC, agreed to work with the SMC Executive to prepare and convey a full critique of the report to ADTCs and NHS Boards.

8.7 Membership

The Chairman thanked members who are due to leave the committee and have advised of their willingness to remain for another term. He also thanked those who have agreed to stay until a replacement has been sourced.  Nominations have been received from ADTCs for new SMC and NDC members.  These are currently being considered by the SMC Executive and members will be notified as soon as possible regarding the decision with regards to retention of current members.  

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 infliximab 100mg powder for intravenous infusion (Remicade) Schering-Plough UK Ltd (No.318/06)

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

9.1.2 The SMC Vice-Chair provided an overview of the assessment, draft advice, expert comments and comments received from the company. Responses to additional expert questions were tabled for review. Detailed discussion followed and the group agreed that infliximab (Remicade), for the treatment of severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporine, methotrexate or psoralen ultraviolet A (PUVA), 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 ADTCs and NHS Boards on Friday, 9 March 2007.

9.2 azelaic acid 15% Gel (Finacea) Valeant Pharmaceuticals Ltd (No.359/07)

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

9.2.2 The SMC 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 azelaic acid 15% Gel (Finacea), for the topical treatment of papulopustular rosacea, 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.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 9 March 2007.

9.3 sitaxentan 100mg tablets (Thelin®) Encysive (UK) Ltd (No.360/07)

9.3.1 The Chairman declared a conflict of Interest and the Vice-Chair assumed control of the meeting for this agenda item.

9.3.2 The NDC Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that sitaxentan (Thelin®), for the treatment of patients with pulmonary arterial hypertension classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease, 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.

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 9 March 2007.

9.4 dexrazoxone 500mg for infusion (Savene ™) TopoTarget A/S (No.361/07)

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

9.4.2 The NDC Vice-Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that dexrazoxone (Savene ™), for the treatment of anthracycline extravasation, 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 ADTCs and NHS Boards on Friday, 9 March 2007.

9.5 budesonide/formoterol100/6, 200/6 turbohaler (Symbicort) AstraZeneca UK Ltd (No.362/07)

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 revised section of the economic checklist reflecting additional data received from the manufacturer was tabled for review. A member of PAPIG presented a Patient Interest Group Submission from Asthma UK Scotland and British Lung Foundation Scotland. Detailed discussion followed and the group concluded their advice for budesonide/formoterol (Symbicort), for the regular and relief treatment of asthma where use of a combination (inhaled corticosteroid and long-acting beta2-agonist) is appropriate.

9.5.3 The SMC advice will be held in confidence until confirmation of licence and launch

RE-SUBMISSIONS

9.6 buprenorphine transdermal patches 5,10 and 20 microgram/hour new 7-day formulation (BuTrans) Napp Pharmaceuticals Ltd (No.234/06)

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 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 Pain Association Scotland and Pain Concern. Detailed discussion followed and the group agreed that buprenorphine transdermal patches (BuTrans), for the treatment of severe osteoarthritis pain in elderly patients (aged 65 years and over), whose pain is not adequately controlled by non-opioid analgesics, or for whom other analgesics are not suitable, 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 ADTCs and NHS Boards on Friday, 9 March 2007.

ABBREVIATED SUBMISSIONS

9.7 desmopressin 240 micrograms oral lyophilisate (Desmomelt) Ferring Pharmaceuticals Ltd  (No: 357/07)

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

9.7.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that desmopressin (Desmomelt), for the treatment of primary nocturnal enuresis, 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.

9.7.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 9 March 2007.

9.8 desmopressin 60, 120 and 240 micrograms oral lyophilisate (DDAVP Melt) Ferring Pharmaceuticals Ltd (No. 358/07)

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 desmopressin (DDAVP Melt), for the treatment of vasopressin-sensitive cranial diabetes insipidus and in the treatment of post-hypophysectomy polyuria/polydipsia, 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, 9 March 2007.

NON SUBMISSIONS

9.9 Infliximab100 mg powder for intravenous infusion (Remicade) (No. 374/07)  

9.9.1 In the absence of a submission from the holder of the marketing authorisation, infliximab (Remicade) for the treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies, should not be recommended for use within NHS Scotland.

9.9.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 March 2007

10.Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

11. ADTC Feedback

11.1 SMC Presentations to Local Areas

The Chairman advised that there are some clinicians within Health Boards who are not clear on SMC’s role and differences between the work of NICE, SIGN and QIS.  The team is working on providing a generic presentation that members could use when doing presentations to local areas, and further educational activities of this sort were encouraged at NHS Board and hospital level, to raise awareness of the work of SMC.

11.2 NICE review of Ineffective Treatments

The Chairman advised that NICE will be looking at ineffective treatments that may not improve patient care, or may not represent good value for money. This work will include disinvestment and he asked members of ADTCs to bring any ideas on this to SMC, and share them with SEHD through Sara Davies.

11.3 Brainstorming Session

In December 2006 the SMC Executive convened a group consisting of representatives of SMC and NDC who were asked to consider how SMC works, if it should do things differently or do new things that might be more helpful to the ADTCs for whom it acts and if there are ways of working more efficiently or more effectively. These issues were to be considered in terms of the current position and where SMC might want to be in 3-5 years.

The group considered that SMC is a valued resource to NHSiS, with robust processes, which provide high quality advice to Health Boards regarding the role of new drugs.  SMC’s major challenges are now to ensure implementation of its advice and adapt to changing circumstances while retaining its existing strengths.  Several recommendations had emerged and were presented to the SMC Executive for consideration.

The Chairman advised the members of the recommendations and asked for any comments.  Discussion followed and it was agreed that all of the recommendations would be implemented.

11.4 Greater Glasgow & Clyde ADTC

A member advised that Martin Brodie has stepped down as Chairman of the ADTC in Greater Glasgow & Clyde. Once an appointment is made SMC will be informed.

12. SMC User Group Forum

12.1 The minutes of the meeting held on 30 January, 2007 were noted.

13. Any Other Business

13.1 No other business was noted.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 3 April 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.