You are here:

SMC Minutes: Tuesday 5 October 2010

Minutes of the SMC Meeting
held on Tuesday 05 October 2010
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: 
Professor Ken Paterson (Chairman), Mrs Laura Ace, Mrs Margo Biggs, Dr Keith Brown, Dr Jennifer Burns, Professor Scott Bryson, Mr Dave Carson, Dr David Dunlop, Dr John Gemmill, Dr Jacqui Howes, Dr Jan Jones, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Dr James McLay, Mrs Sandra McNaughton, Ms Aileen Muir, Dr Mercia Page, Dr Robert Peel, Dr Andrew Power, Mr Andrew Powrie-Smith, Mr Michael Pratt, Mrs Sheila Tunstall-James, Mr Keith Thompson, Dr Andrew Walker, Mr Alistair Thorburn

In Attendance:
Dr Rachel Baker, Dr Robert Bracchi, Mrs Corinne Booth, Ms Ailsa Brown, Dr Sara Davies, Miss Jaclyn Flood, Mrs Anne Lee, Ms Marie McHenery, Ms Rosie Murray, Ms Alex Robertson, Mrs Hazel Smith, Mrs Catherine Tait

Apologies:
Professor James Barbour, Dr Keith Beard, Mr Colin Brown, Mr Robert Calderwood, Dr Dominic Culligan, Ms Jane Davidson, Mrs Susan Downie, Mr Stephen Ferguson, Ms Veronica Moffat, Dr Jonathan Fox, Dr Barclay Goudie, Dr Chris Lush, Dr Paul McNamee, Dr Simon Maxwell, Professor Dilip Nathwani, Dr Anthony Ormerod, Dr Brian Robson, Mrs Maureen Stark, Dr Sarah Taylor, Ms Angela Timoney, Professor Tony Wells, Professor David Wray

1. Welcome and Apologies for Absence

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

A welcome was extended to the following individuals who were observing the meeting:

  • Dr Rachel Baker, Reader in Health Economics, Glasgow Caledonian University
  • Dr Robert Bracchi, GP in Abergavenny.  Chair of the New Drugs Assessment process of the All-Wales Medicines Strategy Group.
  • Mrs Hazel Smith, SMC Horizon Scanning Administrator.
  • Miss Jaclyn Flood, Senior Assistant Project Accountant, NHS Tayside.

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 (07 September 2010)

3.1 The minutes of the SMC meeting held on 07 September 2010 were accepted as an accurate record of the meeting.

4. Verbal Presentation from Mr Dave Carson on Budget Impact

4.1 SMC established a SLWG to review the relevant processes to enable consistency in the standard and presentation of budget impact (BI) information. The group, chaired by Dave Carson, has representatives from NHS finance, health economists, industry (AZ and Lundbeck), pharmacy, secretariat, and Excel expert.  The purpose of the group was to revise the guidance for BI, streamlining the process from HS to DAD, improving consistency and presentation and maximising the usefulness of BI.

There were a wide range of issues including:

  • PAS, biosimilars
  • Uncertainty
  • Diversity of drugs
  • Price and VAT
  • Patient numbers
  • NHS capacity and planning
  • ISD contacts

Discussion within the group quickly led to an Excel-based tool, designed to capture relevant data for a wide range of drugs and for multiple use and amendment by SMC, companies, regions, Boards and hospitals. Time has been taken over the design and detailed guidance notes to ensure a practical and acceptable tool for data entry, calculation, review by economists, clinical experts, finance, etc.  Importantly, it distinguishes between cash releasing savings and opportunity costs.

Phase 1 testing was performed of the first version in April 2010 by 18 companies on previously submitted drugs. Over 2/3rds were positive and detailed results were analysed leading to a final version which is being user tested at the moment with returns by 08 October.  The next steps are to put to the User Group Forum by end of October 2010 and implement from November 2010, for January 2011 SMC. The tool will be monitored with the aim of improving the template and will be reviewed after 1 year.

There is still work to do to re-design the existing Section 7 of submissions and what goes into the DAD BI section. The full template can also be circulated to members prior to meetings on request. 

The Chairman thanked Mr Carson for taking the lead on this Project and looked forward to seeing the inclusion of the template in SMC paperwork in January 2011.

5. Matters Arising

Full Submissions

5.1 lanthanum carbonate  (Fosrenol) Shire Pharmaceuticals Ltd (No. 640/10)

5.1.1 The SMC advice for lanthanum carbonate 500mg, 750mg, 1,000mg, chewable tablets (Fosrenol), as a phosphate binding agent for use in the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphate levels =1.78mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels.  Following comments from the manufacturer there have been minor changes to the Summary of Clinical Effectiveness issues section within the Detailed Advice Document and revised advice was reissued on Friday 08 October 2010, and will be published on the SMC website on Monday 11 October 2010. 

5.2 sevelamer carbonate (Renvela) 800mg film-coated tablets and 1.6 and 2.4g powder for oral suspension  Genzyme  (No. 641/10)

5.2.1 The SMC advice for sevelamer carbonate (Renvela) 800mg film-coated tablets and 1.6 and 2.4g powder for oral suspension, for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.  Distribution of advice was withheld pending confirmation of product availability but this is now available from 01 October 2010, therefore advice will be published on the SMC website on Monday 08 November 2010.

5.3 pemetrexed (Alimta) 100mg and 500mg powder for concentrate for solution for infusion  Eli Lilly and Company Limited  (No. 642/10)

5.3.1 The SMC advice for pemetrexed (Alimta) 100mg and 500mg powder for concentrate for solution for infusion, as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy, will be published on the SMC website on Monday 11 October 2010.

Resubmission

5.4 certolizumab pegol (Cimzia) 200 mg/ml solution for injection (prefilled syringe) UCB Pharma Ltd (No. 590/09)

5.4.1 The SMC advice for certolizumab pegol (Cimzia) 200 mg/ml solution for injection (prefilled syringe) UCB Pharma Ltd, in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease modifying anti-rheumatic drugs, including methotrexate, has been inadequate; and monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate, will be published on the SMC website on Monday 11 October 2010.

Abbreviated Submissions

5.5 ethinylestradiol 30mcg and levonorgestrel 150mcg  (Rigevidon) Consilient Health Limited (No. 646/10)

5.5.1 The SMC advice for ethinylestradiol 30mcg and levonorgestrel 150mcg (Rigevidon), for oral contraception, will be published on the SMC website on Monday 11 October 2010.

5.6 ethinylestradiol and gestodene (Millinette 20/75 and 30/75) Consilient Health Limited (No. 644/10)

5.6.1 The SMC advice for ethinylestradiol and gestodene (Millinette 20/75 and 30/75), for oral contraception, will be published on the SMC website on Monday 11 October 2010.

5.7 ethinylestradiol and desogestrel (Gedarel 20/150 and 30/150)  Consilient Health Limited  (No. 643/10)

5.7.1 The SMC advice for ethinylestradiol and desogestrel (Gedarel 20/150 and 30/150), for oral contraception, will be published on the SMC website on Monday 11 October 2010.

5.8 ethinylestradiol and levonorgestrel 3 (TriRegol) Consilient Health Limited (No. 645/10)

5.8.1 The SMC advice for ethinylestradiol and levonorgestrel 3 (TriRegol), for oral contraception, will be published on the SMC website on Monday 11 October 2010.

Deferred Advice

5.9 See above sevelamer carbonate (Renvela) 800mg film-coated tablets and 1.6 and 2.4g powder for oral suspension  Genzyme  (No. 641/10)

Amended Advice

5.10 Nothing to report.

6. Appeals Update

6.1 Nothing to report.

7. Patient and Public Involvement Group (PAPIG)

7.1 PAPIG Update

Mrs Tunstall-James advised that PAPIG had met immediately prior to the SMC.

Verbal Update  - Mrs Tunstall-James

PAPIG representatives attended the ABPI Training Day on 22 September 2010 which was a very enjoyable and worthwhile event.

Mrs Margo Biggs and Dr Jan Jones will be attending an event in Berlin later on this month at a one-day conference with the focus on Patient Involvement.  Thanks were given to the Secretariat for support with arrangements for this event.

8. New Drugs Committee: Chairman’s Report

8.1 Nothing to report.

9. Chairman’s Business

9.1 Biosimilars Update

It is now one year since SMC introduced their policy statement in relation to biosimilar medicines which requires a full submission for all new biosimilar medicines that details a comparison with the biological reference product.

It was agreed that the policy position would be reviewed after 12 months with a view to determining the most appropriate submission route for biosimilar medicines, however, the SMC Executive feel that there have an insufficient number of biosimilar medicines through the assessment process to make a judgement and therefore it was agreed that the position will be reviewed in one further year, but brought forward if necessary.

9.2 Freedom of information (FOI) request

SMC has received a request under the Freedom of Information (Scotland) Act 2002 for a copy of the SMC Detailed Advice document for mometasone furoate (Asmanex twisthaler) which was reviewed by SMC in November, 2003.  This DAD is considered as commercial in confidence as the product was reviewed before the process for publication of the full DAD on the SMC website was instigated.

SMC is dealing with the request and will issue a response by 08 October 2010.

9.3 SMC Website

The redeveloped SMC website went live on Friday 1 October, 2010.  We hope to make more improvements over the coming months and the secretariat would be pleased to receive feedback from members.

9.4 Europe-wide suspension of marketing authorisation for Avandia, Avandamet and Avaglim (rosiglitazone)

On Thursday 23 September, 2010, The European Medicines Agency recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim. These medicines will stop being available in Europe within the next few months.

The SMC website has been updated to reflect the suspension of the MA.

9.5 NICE Publications

9.5.1 NICE (Multiple) Technology Appraisal Guidance No 200 – Peginterferon alfa and ribavirin for the treatment of chronic hepatitis C (part review of technology appraisal guidance 75 and 106) published 22 September, 2010.

SMC Advice:
peginterferon alfa-2a (Pegasys) SMC No 561/09  -  for the treatment of chronic hepatitis C in adult patients who have failed previous treatment with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, published August 2009.

pegylated interferon a 2b (ViraferonPeg) SMC No 488/08 - for the treatment of adult patients with chronic hepatitis C who have failed previous treatment with interferon alfa (pegylated or non-pegylated) and ribavirin combination therapy or interferon alfa (pegylated or non-pegylated) monotherapy, published August 2008.

NICE MTA guidance supersedes SMC advice. However, the recommendations are consistent.  

Detailed information in relation to the above is provided in the attached appendix.

10. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

10.1 glucosamine sulphate sodium chloride (Glusartel)  HFA Healthcare Limited (No. 647/10) 
 
10.1.1 There were no declarations of interest recorded in relation to this product/comparator drugs.

10.1.2 The NDC Vice-Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses, and comments received from the company.    Detailed discussion followed and the group agreed that glucosamine sulphate (Glusartel®), should not be recommended for use within NHS Scotland, as relief of symptoms in mild to moderate osteoarthritis (OA) of the knee.  In an active-comparator study, glucosamine sulphate 1,500mg once daily was superior to placebo in the treatment of symptoms associated with osteoarthritis of the knee.  The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 October 2010.

10.2 eculizumab (Soliris)  Alexion Pharma UK Ltd (No. 436/07)

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

10.2.2 The NDC Vice-Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses, and comments received from the company.  A member of PAPIG presented a patient interest group submission from Scottish PNH patient group.  Detailed discussion followed and the group agreed that eculizumab (Soliris®), should not be recommended for use within NHS Scotland, for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit of eculizumab in the treatment of patients with PNH is limited to patients with a history of transfusions.  In a controlled study in patients with transfusion-dependent PNH, eculizumab reduced the rate of haemolysis and improved anaemia compared to placebo.  Uncontrolled data suggest that eculizumab reduces the incidence of thrombosis in patients with PNH.  The manufacturer did not supply any economic analysis and therefore eculizumab cannot 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.

10.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 October 2010.

10.3 oxycodone (Oxynorm)  50mg ml solution for injection or infusion
Napp Pharmaceuticals Limited  (No. 648/10)

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

10.3.2 The NDC Vice-Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses, and comments received from the company.  Detailed discussion followed and the group agreed that oxycodone hydrochloride 50mg/ml injection (OxyNorm®), should be accepted for restricted use within NHS Scotland, for the treatment of moderate to severe pain in patients with cancer.  SMC restriction: patients who have difficulty in tolerating morphine or diamorphine therapy and who require a high dose of oxycodone delivered via syringe pump which necessitates the daily preparation of an additional syringe pump if oxycodone 10mg/mL is used.  No new clinical or pharmacokinetic evidence has been presented for this higher strength formulation. Comparative evidence of analgesia achieved with parenteral administration is extrapolated from the lower strength 10mg/mL oxycodone formulation compared with morphine 10mg/mL. The economic case was made only for patients in a hospice or community setting who require a high dose of oxycodone which necessitates the daily preparation of an additional syringe pump. Care should be taken to minimise any risk of administration error with the introduction of this increased strength formulation.  Oxycodone 50mg/mL is also licensed for the treatment of moderate to severe post-operative pain and severe pain requiring the use of strong opioid.  The manufacturer’s submission  related only to use in moderate to severe pain in patients with cancer therefore SMC cannot recommend the use of oxycodone 50mg/mL injection in the treatment of non-cancer pain. Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 October 2010.

RESUBMISSIONS

10.4 eslicarbazepine (Zebinix) Eisai (No. 592/09)

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

10.4.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses, and comments received from the company.  Detailed discussion followed and the group agreed that eslicarbazepine acetate (Zebinix), should be accepted for restricted use within NHS Scotland, as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.  SMC restriction: patients with highly refractory epilepsy who have been heavily pre-treated and remain uncontrolled with existing anti-epileptic drugs.  Eslicarbazepine acetate reduces seizure frequency compared to placebo over a 12-week maintenance period.  Direct comparative data versus other anti-epileptic drugs are unavailable, particularly comparisons with other cheaper agents with a very similar mode of action.   This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of eslicarbazepine acetate. This SMC advice is contingent upon the continuing availability of the PAS in Scotland.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 October 2010.

10.5 trabectedin (Yondelis)  Pharma Mar S.A. Sociedad Unipersonal  (No. 452/08)

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

10.5.2 The NDC Vice-Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses, and comments received from the company.  A member of PAPIG presented a patient interest group submission from Sarcoma UK.  Detailed discussion followed and the group agreed that trabectedin (Yondelis®), should not be recommended for use within NHS Scotland, for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.  In a phase II randomised study in patients with advanced leiomyosarcoma and liposarcoma in which two trabectedin dose schedules were used, the licensed 3-weekly schedule was superior to the alternative one for the primary endpoint, time to progression.  The manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC and in addition, the manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.5.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 October 2010.

NON SUBMISSIONS

10.6 canakinumab (Ilaris®) 150 mg/ml, powder for solution for injection intended Novartis Pharmacuticals  SMC No. (658/10)

10.6.1 In the absence of a submission from the holder of the marketing authorisation,    canakinumab (Ilaris ®) 150 mg/ml, powder for solution for injection, should not be recommended for use within NHSScotland, for Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents and children aged 4 years and older with body weight above 15 kg. 

10.6.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 October 2010.

10.7 docetaxel (Taxotere ®) 20 mg/1ml and 80 mg/4ml and 160 mg/8ml concentrate for solution for infusion Sanofi Aventis SMC No. (659/10)

10.7.1 In the absence of a submission from the holder of the marketing authorisation, docetaxel (Taxotere ®) in combination with doxorubicin and cyclophosphamide,  should not be recommended for use within NHS Scotland, for adjuvant treatment of patients with operable node-negative breast cancer.

10.7.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 October 2010.

10.8 amifampridine (Firdapse ®) BioMarin SMC No. (660/10)

10.8.1 In the absence of a submission from the holder of the marketing authorisation, amifampridine (Firdapse®), should not be recommended for use within NHSScotland, for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults.

10.8.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 October 2010

11. Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled and noted. 

12 SMC User Group Forum (UGF)

12.1 Minutes from meeting on 27 July 2010 in paperwork for review. 

12.2 Verbal Update from Dr Frances Macdonald

APBI Training Day for industry took place on 22 September 2010.  It was very useful for industry to be updated on the work of SMC and thanks were given to all involved in relation to Budget Impact, PASAG and PAPIG which were very informative. 

13. SMC Meeting Dates 2011

13.1 Please note change to January meeting date which is on 11 January 2011.

14. Area Drug & Therapeutics Committee (ADTC) Issues

14.1 Nothing to report.

15. Any Other Business

15.1 No other business was noted.

16. Date of the Next Meeting

16.1 The date of the next meeting was confirmed as Tuesday 02 November 2010 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

APPENDIX

NICE Publications

Minutes of the SMC Meeting 05 October 2010

NICE (Multiple) Technology Appraisal Guidance No 200 – Peginterferon alfa and ribavirin for the treatment of chronic hepatitis C (part review of technology appraisal guidance 75 and 106)

Summary of NICE MTA

  • NICE technology appraisal guidance 75 (TA75) 'Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C' (which covers moderate to severe hepatitis C)
  • NICE technology appraisal guidance 106 (TA106) 'Peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis C'.

This appraisal addresses extensions to the marketing authorisations for peginterferon alfa-2a and peginterferon alfa-2b. This guidance updates and replaces:

  • section 1.2, bullet 3 only, of TA75
  • section 1.4 of TA75 for adults who are eligible for shortened courses of combination therapy (as described in section 1.2 of the current guidance)
  • section 1.7, bullet 1 only, of TA75
  • sections 1.4 and 1.5 of TA106.

All other recommendations in TA75 and TA106 still stand.

NICE recommends peginterferon alfa (2a or 2b) plus ribavirin as a possible treatment for people with chronic hepatitis C:

  • who have been treated previously with peginterferon alfa (2a or 2b) plus ribavirin, or with peginterferon alfa monotherapy, but their hepatitis C didn't improve, or improved but then got worse again or
  • who also have an HIV infection.

NICE also recommends short courses of treatment with peginterferon alfa (2a or 2b) plus ribavirin for people whose hepatitis C has greatly improved within 4 weeks of starting treatment and who are suitable for short treatment courses . Whether a person is suitable for a short treatment course will depend on a number of factors.

SMC Advice

SMC issued advice to NHSScotland on the use of peginterferon alfa-2a for Hepatitis C in 2009 (561/09), and on peginterferon alfa-2b for Hepatitis C in 2008 (488/08).

SMC published advice for peginterferon alfa-2a (Pegasys) in August 2009.

peginterferon alfa-2a (Pegasys) is accepted for use within NHS Scotland in combination
with ribavirin for the treatment of chronic hepatitis C in adult patients who have failed previous treatment with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin.Non-responders to previous hepatitis C treatment, predominantly with virus genotype 1,achieved sustained viral responses of 8% and 15% following 48 weeks and 72 weeks of combination treatment respectively.The manufacturer did not provide comparative clinical or cost-effectiveness data versuspeginterferon alfa-2b.

SMC published advice for pegylated interferon a 2b (ViraferonPeg) in August 2008

pegylated interferon a 2b (ViraferonPeg) in combination with ribavirin (Rebetol) is accepted within NHS Scotland for the treatment of adult patients with chronic hepatitis C who have failed previous treatment with interferon alfa (pegylated or non-pegylated) and ribavirin combination therapy or interferon alfa (pegylated or non-pegylated) monotherapy. A sustained virologic response rate of 23% was achieved in a single arm study where relapsed or non-responding patients were treated with peginterferon a 2b and ribavirin. Re-treatment was more cost-effective with patients who had previously responded but relapsed compared to patients who did not respond to initial therapy.

The Scottish Intercollegiate Guidelines Network (SIGN) published a guideline on the management of Hepatitis C in 2006 (SIGN 92).

NICE MTA guidance supersedes SMC advice. However, the recommendations are consistent.