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SMC Minutes - Tuesday 6 February 2007

Minutes of the SMC Meeting held on Tuesday 06 February 2007
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Ms Angela Timoney Chairman Pro tem, Professor James Barbour, Mrs Marion Bennie, Mrs Barbara Black, Dr Keith Brown, Professor John Cairns, Mr David Carson, Dr David Crookes, Mr Tom Divers,
Mr Jim Eadie, Dr Barclay Goudie, Dr John Haughney, Dr Jan Jones, Dr Harpreet Kohli, Mr Billy Malcolm,
Ms Angela Munday, Mrs Pat Murray, Mrs Wendy Nganasurian, Dr Ken Paterson, Dr Andrew Power,
Dr Nick Reed, Ms Fiona Ramsay, Dr Andrew Riley, Mr Mike Wallace, Dr John Webster

In Attendance: Dr Jennifer Armstrong, Mr Steven Fenocchi, Mr Stephen Ferguson, Mrs Hazel Illingworth,
Mrs Anne Lee, Mr Colin McAllister, Dr Trevor McGoldrick, Ms Mary McLean, Mr Ewan Morrison, Ms Rosie Murray, Ms Anne Paris, Mrs Maureen Stark, Dr Andrew Walker

Apologies: Mrs Laura Ace, Dr Keith Beard, Ms Ailsa Brown, Mr Nick Brown, Dr Sara Davies, Mr John Glennie, Dr Grace Lindsay, Dr Graham Lowe, Dr Chris Lush, Mrs Laura McIver, Dr Philip Rutledge, Dr Sandy Simpson, Dr Sarah Taylor, Professor David Webb

1 Welcome and Apologies for Absence

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

A warm welcome was given to the following who were observing the work of SMC:

Dr Trevor McGoldrick, Clinical Lecturer in Cancer Therapeutics, Clinical Pharmacology Unit, Centre for Cardiovascular Science, University of Edinburgh.

Mr Ewan Morrison, Lead Pharmacist, South East of Scotland Cancer Network, c/o Western General Hospital, Edinburgh

Ms Mary McLean, Regional Cancer Care Pharmacist, Western Infirmary, Glasgow

Ms Anne Paris, Diabetes UK

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 09 January 2007 were agreed with a minor amendment to item 11.1.

4 Matters Arising From the Previous Minutes

4.1 There were no matters arising from the previous minutes.

Full Submissions

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

4.2.1 The SMC advice for 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, will be posted on the SMC website on Monday, 12 February 2007.

4.2.2 The Vice-Chairman advised that further to comparator comments, minor amendments have been made to the Additional Information: Guidelines and Protocols section of the SMC DAD for rimonabant (Acomplia).  A revised copy of the DAD will be issued to NHS Boards and ADTCs on Friday 9 February 2007. 

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

4.3.1 The SMC advice for pemetrexed (Alimta), as monotherapy for second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, will be posted on the SMC website on Monday, 12 February 2007.

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

4.4.1 The SMC advice for sunitinib (Sutent), for the treatment of advanced and/or metastatic renal cell carcinoma after failure of interferon-alpha or interleukin-2 therapy, will be posted on the SMC website on Monday, 12 February 2007.

4.4.2 The Vice-Chairman advised that further to comparator comments, minor amendments have been made to the Summary of Clinical Effectiveness Issues section of the SMC DAD for sunitinib (Sutent).  A revised copy of the DAD will be issued to NHS Boards and ADTCs on Friday 9 February 2007. 

4.5 TachoSil® Nycomed (No. 344/07)

4.5.1 The SMC advice for TachoSil®, for supportive treatment in surgery for improvement of haemostasis where standard techniques are insufficient, will be posted on the SMC website on Monday, 12 February 2007.

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

4.6.1 The SMC advice for 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, will be posted on the SMC website on Monday, 12 February 2007.

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

4.7.1 The SMC advice for tacrolimus (Prograf), for the prophylaxis of transplant rejection in heart allograft patients will be posted on the SMC website on Monday 12 February 2007.

4.7.2 The Vice-Chairman advised that further to comparator comments, minor amendments have been made to the Dosing Information and Additional Information costs sections of the SMC DAD for tacrolimus (Prograf).  A revised copy of the DAD will be issued to NHS Boards and ADTCs on Friday, 9 February 2007. 

4.8 deferasirox (Exjade) Novartis Pharamceuticals UK Ltd (No. 347/07)

4.8.1 The SMC advice for deferasirox (Exjade), for the treatment of chronic iron overload associated with the treatment of rare acquired or inherited anaemias requiring recurrent blood transfusions, will be posted on the SMC website on Monday, 12 February 2007.

 Abbreviated Submissions

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

4.9.1 The SMC advice for 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), will be posted on the SMC website on Monday, 12 February 2007.

Deferred Advice

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

4.10.1 The Vice-Chairman advised that lidocaine 5% medicated plaster (Versatis) launched on 8 January 2007. This product was reviewed by SMC in December 2006 and was not recommended for use within NHS Scotland for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia). Advice will be sent to NHS Boards and ADTCs on Friday 9 February 2007 and published on the SMC website on Monday, 12 March 2007.

4.11 donepezil 5mg and 10mg orodispersible tablets (Aricept® Evess) Eisai Ltd No. (307/06)

4.11.1 The Vice-Chairman advised that donepezil 5mg and 10mg orodispersible tablets launched on 22 January 2007.  This product was reviewed by SMC in August 2006 and was accepted for use within NHS Scotland for the symptomatic treatment of mild to moderately severe Alzheimer’s dementia in patients for whom donepezil is appropriate and who have difficulty in swallowing solid oral dose formulations. It costs the same as standard formulations of donepezil. Advice will be sent to NHS Boards and ADTCs on Friday 9 February 2007 and published on the SMC website on Monday 12 February 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 The minutes of the meeting held on 9 January 2007 were noted.

6.2 Recruitment of New Members

The Chairman of PAPIG advised that they will now be looking to recruit three new members, and hope to have two in place by April 2007.  The posts will be advertised on the SMC website, through NHSQIS Public Involvement Unit, Scottish Health Council, SIGN and Voluntary Health Scotland.  She asked the members of SMC to bring these posts to the attention of anyone that they think would be interested.

7 New Drugs Committee: Chairman’s report

7.1 Nothing to report.

8 Chairman’s Business

8.1 Disparity between advice from SMC and SIGN

The Vice-Chairman advised that further to concern about how to manage differences in advice coming from SMC and SIGN, Professor Webb 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.

8.2 Declarations of Interest

The Vice-Chairman thanked members for their comments regarding revisions to the Declarations of Interest document.  Keith Beard had provided a copy of the recently revised MHRA Code of Practice and it eloquently addresses all the key issues.  It is proposed therefore that the MHRA guidance should be adopted and badged for SMC use. 

8.3 Commissioning Cancer Drugs and Services – Looking to the Future 12 March 2007 

Dr Ken Paterson will attend the conference which will explore the role played by each of the UK HTA bodies and specifically how their advice is considered by commissioners of healthcare.

8.4 Scottish Management of Antimicrobial Resistance  Action Plan (Scot MARAP).

The Vice-Chairman advised that representatives of SMC met with SEHD to discuss the Scottish Antimicrobial Action Plan.  This work builds on the Antimicrobial Resistance Strategy Action Plan (2002) and Antimicrobial Prescribing Policy (2005). The latter work was led by SMC. Scot MARAP recommends that SMC convene and oversee a new national antimicrobial group that will work with Health Protection Scotland, NES, ISD and NHSQIS in the implementation of the plan.

SMC have agreed in principle that SMC will take on the coordinating role for the new group, SMC has a track record in establishing effective communications and working relationships with NHS Boards, prescribers and pharmacists, it fits in with the broader local ADTC agenda and would clearly add value locally. Issues that need to be worked through are the additional resource required; clarity around roles and responsibilities of other organisations (ISD, HPS, NES, NHSQIS); changes required to the membership and workings of SMC. A consultation document from SEHD is expected and will be discussed at a future meeting.

 8.5 ADTC Seminar

The SMC evaluation team wish to propose a one day NHS Scotland ADTC seminar in May/June 2007 centered on the Evaluation programme.  The programme will comprise of three strands:

  • Evolution of ADTC- SMC: two way traffic - sharing an overview of changing functions and structures over time and exploring best practice now and in the future 
  • Sharing some initial output from the programme – etanercept (unique indication); not recommended drugs - impact/uptake across Scotland.
  • Engagement with stakeholders - to gather evidence on effectiveness  or not of engagement with ADTCS - similar exercise has been completed with Industry and Voluntary groups -

An update would be given at a future meeting of SMC.

9 NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

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

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

9.1.2 The NDC Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  Additional questions posed to the manufacturer post NDC were tabled for review. A member of PAPIG presented a Patient Interest Group Submission from the Association of Glycogen Storage Disease (UK). Detailed discussion followed and the group agreed that alglucosidase alfa (Myozyme), for the treatment of Pompe disease (acid α-glucosidase deficiency), 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 ADTCs and NHS Boards on Friday, 9 February 2007.

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

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

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 clostridium botulinum type A toxin (Dysport), for the treatment of focal spasticity, including arm symptoms associated with focal spasticity, in conjunction with physiotherapy, 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.

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

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

9.3.1 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.

9.3.2 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 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, 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 February 2007.

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

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

9.4.2 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 for Sign Post Forth Valley. Detailed discussion followed and the group agreed that buprenorphine/naloxone (Suboxone), for substitution treatment of opioid drug dependence, within a framework of medical, social and psychological treatment, 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 ADTCs and NHS Boards on Friday, 9 February 2007.

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

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

9.5.2 The NDC Chairman provided a detailed overview of the assessment, draft advice and expert comments. A member of PAPIG presented a Patient Interest Group Submission from the National Osteoporosis Society. Detailed discussion followed and the group agreed that parathyroid hormone (Preotact), for the treatment of osteoporosis in postmenopausal women at high risk of fractures, 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.

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

RE-SUBMISSIONS

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

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

9.6.2 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 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, 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, 9 February 2007.

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

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

9.7.2 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 glyceryl trinitrate 0.4% rectal ointment (Rectogesic), for the relief of pain associated with chronic anal fissure, 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 ADTCs and NHS Boards on Friday, 9 February 2007.

ABBREVIATED SUBMISSIONS

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

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 concluded their 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,

9.8.3 The SMC advice will be withheld pending confirmation of launch.

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

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 concluded their 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.

9.9.3 The SMC advice will be withheld pending confirmation of launch.

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

9.10.1 Declarations of Interest were recorded in relation to this product/comparator drugs. A member with a personal specific interest took no part in the discussion.

9.10.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that amlodipine/valsartan (Exforge), for patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy should be accepted for use within NHS Scotland.  Assessors in liaison with the Secretariat to make the appropriate amendments prior to distribution of the advice.

9.10.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 9 February 2007

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

9.11.1 Declarations of interest were recorded in relation to this product/comparator drugs. A member with a personal specific interest took no part in the discussion.

9.11.2 The NDC Chairman provided an overview of the assessment and the draft advice. Discussion followed and the group concluded their advice for valsartan 320mg (Diovan), for the treatment of hypertension.

9.11.3 The SMC advice will be withheld pending confirmation of launch.

10 Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

11 ADTC Feedback

11.1 Nothing to report.

 12 SMC User Group Forum

12.1 The Chairman of the User Group Forum advised that discussions had taken place on the release of the economic checklist to companies.  This was welcomed by Industry and they hoped that the checklist would be available immediately after the NDC meetings. The possibility of setting up scoping meetings between SMC and companies to make sure that the correct comparator was being used was also discussed.

The minutes of the meeting held on 9 January 2007 would be available at the SMC meeting in March.

13 Any Other Business

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

Dr Andrew Walker asked those members who would be attending the training day on 20 February to email any economic questions they have to Ailsa Brown or himself.

13.2 Disparity between advice from SMC and SIGN

A member of SMC referred to item 8.1 and asked if the information received from the Chief Medical Officer had been shared with SIGN and the ADTCs.

The Vice-Chairman advised that the information had not been circulated to the ADTCs or to SIGN but she would discuss this further at the next Executive Team meeting.

13.3 Orphan Drug indication -Review of Modifiers

A member requested that the modifiers used by SMC when considering submissions for medicines with orphan drug status should be reviewed.

The Vice-Chairman committed to having a review of the modifiers and agreed to discuss this further with the SMC Executive Team.

14 Date of the Next Meeting

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