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Minutes of the SMC Meeting held on Tuesday 4 August 2009

Minutes of the SMC Meeting held on Tuesday 4 August 2009
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: Professor Ken Paterson (Chairman), Mrs Laura Ace, Dr Keith Beard, Mrs Margo Biggs, Dr Keith Brown, Mr Scott Bryson, Mr Robert Calderwood, Mr Dave Carson, Dr David Crookes, Dr Sara Davies, Dr Jonathan Fox, Dr Barclay Goudie, Dr Jan Jones, Dr Chris Lush, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Dr Simon Maxwell, Ms Aileen Muir, Dr Anthony Ormerod, Dr Mercia Page, Mr Andrew Powrie-Smith, Mr Mike Pratt, Dr Nick Reed, Mr Keith Thompson, Mr Alistair Thorburn, Ms Angela Timoney, Mrs Sheila Tunstall-James, Dr Andrew Walker, Professor David Wray

In Attendance: Mrs Corinne Booth, Ms Ailsa Brown, Ms Alison Clough, Dr Gordon Forrest, Mr Chris Hill, Mrs Anne Lee, Mr Ken Miller, Ms Emma Riches, Mr Craig Rore, Ms Marina Shannon, Mrs Maureen Stark, Mrs Catherine Tait

Apologies: Professor James Barbour, Mr Colin Brown, Dr Jennifer Burns, Professor John Cairns, Mr Stephen Ferguson,  Dr John Gemmil, Dr Gail Gilbert, Ms Susan Goldsmith, Ms Veronica Moffat, Ms Rosie Murray, Professor Dilip Nathwani, Dr Robert Peel, Dr Andrew Power, Ms Alex Robertson, Dr Sarah Taylor, Dr Iain Wallace, Professor Tony Wells

1.Welcome and Apologies for Absence

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

1.2 A further welcome was extended to the following observers:

  • Mr Chris Hill, Pfizer Industry rep on SMC User Group Forum (UGF)
  • Ms Alison Clough, Director, Value of Medicines, ABPI
  • Mr Ken Miller, Head of Communications, NHS Quality Improvement Scotland
  • Mr Craig Rore, NDC member and Lead Assessor, presenting a submission to SMC.
  • Mrs Marina Shannon, NDC member and Lead Assessor, presenting a submission 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 07 July 2009 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 peginterferon alfa-2a (Pegasys) Roche Products Limited (No. 561/09)

4.1.1 The SMC advice for peginterferon alfa-2a (Pegasys), for the treatment of chronic hepatitis C in adult patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) alone or in combination therapy with ribavirin, will be published on the website on Monday 10 August 2009.

4.2 calcipotriol 50 mcg/g / betamethasone 500 mcg/g (Xamiol Gel®) LEO Pharma (No. 559/09)

4.2.1 The SMC advice for calcipotriol 50 mcg/g / betamethasone 500 mcg/g (Xamiol Gel®), for the topical treatment of scalp psoriasis, will be published on the website on Monday 10 August 2009.

4.3 degarelix (Firmagon) Ferring Pharmaceuticals Limited (No. 560/09)

4.3.1 The SMC advice for degarelix (Firmagon), for the treatment of adult male patients with advanced hormone-dependent prostate cancer, will be published on the website on Monday 10 August 2009.

Resubmission

4.4 etravirine (Intelence) Tibotec / Janssen-Cilag Ltd (No. 530/09)

4.4.1  The SMC advice for etravirine (Intelence), in combination with a boosted protease inhibitor and other antiretroviral medicinal products, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, will be published on the website on Monday 10 August 2009.                            

4.5 Deferred Advice

Nothing to report.

4.6 Amended Advice

Nothing to report.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 PAPIG Update

Mrs Tunstall-James advised that PAPIG had met immediately prior to the SMC meeting and minutes would be available at September SMC. 

Mrs Tunstall-James expressed thanks to the SMC Executive Team for the opportunity to pilot some changes to the presentation of Patient Interest Group submissions at SMC, which will be trialled at SMC in September.  These will hopefully increase the impact of Patient Interest Group submissions and also clarify the respective roles of NDC and SMC.

7.New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 NICE Single Technology Appraisal Guidance No 173 – Tenofovir disoproxil for the treatment of chronic hepatitis B (Published 22 July 2009)

The NICE STA No. 173 summarises that tenofovir disoproxil is recommended as a possible treatment for people with chronic hepatitis B.

In July 2008, SMC published the following advice: tenofovir (Viread®) is accepted for use within NHS Scotland for the treatment of chronic hepatitis B in adults with compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.  Tenofovir has been shown to be significantly more effective than another nucleoside reverse transcriptase inhibitor in achieving a complete composite response (virological plus histological response) in a greater proportion of patients with chronic hepatitis B infection with HBeAg positive and HBeAg negative disease.

Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

8.2 NICE Single Technology Appraisal Guidance No 174 – Rituximab for the first-line treatment of chronic lymphocytic leukaemia (Pulbished 22 July 2009)

The NICE STA No. 174 summarises that rituximab is recommended as a possible first treatment for people with chronic lymphocytic leukaemia who are able to take fludarabine in combination with cyclophosphamide.  Rituximab should only be used in combination with fludarabine and cyclophosphamide.   Rituximab is not recommended in combination with any other chemotherapy agents as a first treatment for chronic lymphocytic leukaemia.

In July 2009, SMC published the following advice: rituximab (MabThera®) is accepted for restricted use within NHS Scotland for first-line treatment of patients with chronic lymphocytic leukaemia (CLL) in combination with fludarabine and cyclophosphamide.  Rituximab in combination with fludarabine and cyclophosphamide resulted in significantly longer progression free survival than fludarabine and cyclophosphamide alone. The patient population in the pivotal clinical study had an Eastern Cooperative Oncology Group Performance Status of 0 or 1 and was a younger population than that generally seen in practice. Evidence in patients over 70 years of age is limited. Rituximab is restricted to use by specialists in haematology and haemato-oncology.

Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

8.3 Office of Life Sciences Blueprint

The Office Life Sciences (OLS) which was part of the Department of Trade and Industry is now under the Department of Business Innovation and Skills (BIS) and has been created to address key issues affecting the pharmaceutical, medical biotech and devices sectors.

The OLS have came up with a number of recommendations on innovative medicines suggesting HTA’s are not required.  One proposal will be for the  Government, with the National Institute for Clinical Excellence (NICE), to introduce an ”Innovation Pass”, making selected innovative medicines available on the NHS for a time-limited period. The Pass will be piloted in 2010/2011, with a budget of £25 million. 

SMC will discuss the issue of the Scottish response at the CMO meeting on 11 August 2009.

8.4 Kennedy Report NICE Assessment Value of Medicines

The Kennedy Report is independent and commissioned by National Institute for Clinical Excellence (NICE) to assess the value of NICE assessments.  Sir Ian Kennedy is of the view that:

  • Cost utility analysis remains the way forward for NICE
  • More explicit valuing of innovation may be appropriate 
  • Innovation needs to be a ‘step-change’ and to be tangible

SMC to discuss this at the CMO meeting on 11 August 2009.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 darunavir, 400mg tablets (Prezista)  Tibotec, a division of Janssen-Cilag Ltd (No: 566/09)

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

9.1.2 The NDC Chair provided an overview of the assessment, draft advice and expert comments.  A member of PAPIG presented patient interest group submissions from HIV Scotland and Waverly Care.  Detailed discussion followed and the group agreed that darunavir, 400mg tablets (Prezista), should be accepted for use in NHS Scotland, for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral therapy (ART) naïve adults. 

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday 07 August 2009.

9.2 prasugrel 5mg and 10mg tablets (Efient) Daiichi-Sankyo/Eli Lilly and Company Limited (No: 562/09)

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

9.2.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments, revised data/analyses and company comments.  Detailed discussion followed and the group agreed that prasugrel 5mg and 10mg tablets (Efient), should be accepted for restricted use in NHS Scotland, for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention, restricted to patients who are eligible to receive the 10mg dose.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday 07 August 2009.

9.3 mecasermin, 10mg/mL solution for injection (Increlex) Ipsen Limited (No: 563/09)

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

9.3.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and company comments.  Detailed discussion followed and the group agreed that mecasermin, 10mg/mL solution for injection (Increlex), should be accepted for use in NHS Scotland, for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency (primary IGFD). 

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday 07 August 2009.

9.4 ranolazine, 375mg, 500mg and 750mg prolonged-release tablets (Ranexa) A Menarini Pharma UK SRL (No: 565/09)

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

9.4.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and company comments.  Detailed discussion followed and the group agreed that ranolazine, 375mg, 500mg and 750mg prolonged-release tablets (Ranexa), should be not recommended for use in NHS Scotland, as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists). 

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday 07 August 2009.

ABBREVIATED SUBMISSIONS

9.5 fosamprenavir 50mg/ml oral suspension and 700mg film-coated tablet (Telzir) GlaxoSmithKline UK Ltd (No: 431/07)

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

9.5.2 The NDC Chair provided an overview of the assessment and a draft summary of advice.  Detailed discussion followed and the group agreed that fosamprenavir 50mg/ml oral suspension and 700mg film-coated tablet (Telzir), should be accepted for use in NHS Scotland,  for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adolescents and children of six years and above in combination with other antiretroviral medicinal products. 

9.5.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday 07 August 2009.

9.6 lamivudine/zidovudine fixed-dose combination (Combivir) GlaxoSmithKline UK Ltd (No: 569/09)

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

9.6.2 The NDC Chair provided an overview of the assessment and a draft summary of advice.  Detailed discussion followed and the group agreed that lamivudine/zidovudine fixed-dose combination (Combivir), should be accepted for use in NHS Scotland, for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) in paediatric patients weighing 14kg to 30kg.  This combination is listed in the British National Formulary for Children for the treatment of HIV infection.

9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday 07 August 2009.

9.7 etanercept (Enbrel) Wyeth Pharmaceuticals  (No: 570/09)

9.7.1 Declarations of interest were recorded in relation to this product/comparator drugs. A member with personal specific interest left the meeting for this part of the agenda.

9.7.2 The NDC Chair provided an overview of the assessment and a draft summary of advice.  Detailed discussion followed and the group agreed that etanercept (Enbrel), should be restricted for use in NHS Scotland,  for the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 8 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. 

9.7.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday 07 August 2009.

9.8 brinzolamide/timolol eye drops, suspension (Azarga) Alcon Laboratories (UK) Ltd (No: 568/09)

9.8.1 A member with personal specific interest left the meeting for this part of the agenda.

9.8.2 The NDC Chair provided an overview of the assessment and a draft summary of advice.  Detailed discussion followed and the group agreed that brinzolamide/timolol eye drops, suspension (Azarga), should be accepted for use in NHS Scotland,  for the decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. 

9.8.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday 07 August 2009.

9.9 droperidol 2.5mg/ml solution for injection (Xomolix) ProStrakan Ltd (No: 567/09)

9.9.1 Declarations of interest were recorded in relation to this product/comparator drugs.  A member with personal specific interest left the meeting for this part of the agenda.

9.9.2 SMC discussed the new preparation of droperidol 2.5mg/ml solution for injection (Xomolix), which has now been re-introduced by a different manufacturer (Prostrakan), at a lower dose and indicated for the prevention and treatment of  PONV in adults, and as a second line treatment in children and adolescents.   After full consideration of the circumstances (and in line with previous SMC practice) SMC has concluded that droperidol (Xomolix) is outwith SMC remit.

9.9.3 This information will be issued to NHS Boards and ADTCs on Friday 07 August 2009.

NON SUBMISSION

9.10 etoricoxib (Arcoxia) Merck Sharpe and Dohme (No: 576/09)

9.10.1 Declarations of interest were recorded in relation to this product/comparator drugs.  A member with personal specific interest left the meeting for this part of the agenda.

9.10.2 Etoricoxib (Arcoxia) is not recommended for use within NHS Scotland for the treatment of ankylosing spondylitis. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication.  As a result we cannot recommend its use within NHS Scotland.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

11. SMC User Group Forum (UGF)

11.1 The Minutes of the User Group Forum meeting, held on 28 July 2009 will be available at September SMC.

11.2 Update on SMC User Group Form (UGF)

Dr Frances Macdonald provided a brief update on the SMC User Group who had met on 28 July 2009.  The SLWG who are working on the Budget Impact template have advised more work is required than was originally anticipated.  The BI template had been developed initially with chronic therapies in mind and will now need to be adapted to encompass other disease areas and treatment types.
  
12. Area Drug and Therapeutic Committees (ADTCs): Issues

12.1 Sodium oxybate for cataplexy – exceptional prescribing – Lothian ADTC

Correspondence has been received from Lothian ADTC advising that sodium oxybate, for the treatment of cataplexy in adult patients with narcolepsy, has been approved for use by the Lothian Exceptional Cases Panel on several occasions. 

SMC reviewed sodium oxybate on two occasions, firstly in March 2006 and then following a resubmission in August 2007 and it was not recommended as the manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC.  SMC would be willing to review another resubmission if UCB Pharma wished to put one forward.  SMC have noted Lothian’s position and thanked them for bringing this to our attention.

13. Any Other Business

13.1 No other business was raised.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 01 September 2009 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.