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Minutes of the SMC Meeting held on Tuesday 5 August 2008

Minutes of the SMC Meeting held on Tuesday 05 August 2008
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Ms Angela Timoney  (Chairman, Pro-tem), Mrs Laura Ace, Mrs Margo Biggs, Dr Keith Brown,
Professor John Cairns, Dr David Crookes, Dr Sara Davies, Dr Jonathan Fox, Ms Susan Goldsmith, Dr Barclay Goudie, Dr Jan Jones,Dr Harpreet Kohli, Dr Frances Macdonald, Dr Alan McDonald, Dr John McElhinney, Mr Billy Malcolm, Dr Simon Maxwell, Ms Aileen Muir, Mr Andrew Powrie-Smith, Dr Nick Reed, Dr Sandy Simpson,Mr Keith Thompson, Mr Alistair Thorburn, Mrs Sheila Tunstall-James

In Attendance: Ms Ailsa Brown, Mrs Anne Lee, Ms Rosie Murray, Dr Susan Myles,Mr Mark Parsons, Ms Emilia Pietka, Ms Marina Shannon, Mrs Maureen Stark, Ms Nathalie Vernaz, Dr Andrew Walker.

Apologies:
Professor James Barbour, Dr Keith Beard, Mr Colin Brown, Mr David Carson, Mr Tom Divers, Ms Susan Downie, Mr Stephen Ferguson, Dr John Gemmill, Dr Grace Lindsay, Dr Chris Lush, Mr Colin McAllister, Mrs Laura McIver, Ms Veronica Moffat, Mrs Pat Murray, Professor Dilip Nathwani,  Dr Anthony Ormerod, Dr Ken Paterson, Dr Andrew Power, Dr Andrew Riley, Ms Alex Robertson, Dr Sarah Taylor, Professor Tony Wells. 

1. Welcome and Apologies for Absence

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

The Chairman welcomed Dr Simon Maxwell, Associate Medical Director, Yellow Card Centre, Edinburgh Royal Infirmary, attending his first meeting as an SMC member. 

A welcome was also extended to Dr Susan Myles, a recently appointed Health Service Researcher/Health Economist with NHS QiS, who was observing the meeting; Ms Nathalie Vernaz, a Swiss PhD student who is on a 5 week placement with Professor Peter Davey, Health Informatics Centre, Dundee, observing the meeting; Ms Emilia Pietka, part-time SMC administrator, also observing the meeting; Ms Marina Shannon, and Mr Mark Parsons, NDC Members, who were presenting submissions to SMC; Ms Sharon Hems representing the SMC Evaluation Team.

1.2  Thank you and Goodbye

Following a three year term of office Mrs Pat Murray, Director of Pharmacy, NHS Lothian, regretfully submitted her apologies for her last meeting as a member of SMC.  In her absence, the Chairman thanked Mrs Murray for her input to SMC over the last three years.

Following his recent secondment to the Scottish Government Health Department, Dr Andrew Riley, Director of Public Health, NHS Borders, was unable to attend his last meeting of SMC, however he forwarded his apologies and best wishes. 

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 01 July 2008 were agreed as an accurate record, subject to an amendment to the attendance list.

4. Matters Arising From the Previous Minutes

4.1  SMC Response to the Evaluation Programme – Key Recommendations

The Chairman thanked members for comments received following the presentation of the SMC Evaluation Programme at the July meeting of SMC.  The Chair expressed her willingness to discuss the evaluation further with any members who were not able to attend the July meeting and further comments are welcome.

Discussion followed and a number of issues were raised for action and follow-up prior to the September SMC meeting. Members should pass any final comments to the SMC Secretariat by 19 August at the latest.

Full Submissions

4.2  pegylated interferon a 2b plus ribavirin (ViraferonPeg plus Rebetol) Schering-Plough UK and Ireland  (No. 488/08)  

4.2.1  The SMC advice for pegylated interferon a 2b plus ribavirin (ViraferonPeg plus Rebetol), 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, will be posted on the SMC website on Monday, 11 August 2008.

4.3  anti-human thymocyte immunoglobin (Thymoglobuline) Genzyme Therapeutics Ltd  (No.489/08)                                                                                                              

4.3.1  The SMC advice for anti-human thymocyte immunoglobin (Thymoglobuline), for prevention of graft rejection in renal transplantation, will be posted on the SMC website on Monday, 11 August 2008.

4.4  teriparatide (Forsteo) Eli Lilly and Company Limited  (No. 490/08)

4.4.1  The SMC advice for teriparatide (Forsteo), for the treatment of osteoporosis in men at increased risk of fracture, will be posted on the SMC website on Monday, 11 August 2008.

4.5  trabectedin (Yondelis) Pharma Mar S.A. (No. 452/08) 

4.5.1  The SMC advice for trabectedin (Yondelis), for the treatment of patients with advanced soft tissue sarcoma (STS) after failure of anthracyclines and ifosfamide or who are unsuited to receive these agents, will be posted on the SMC website on Monday, 11 August 2008.

Resubmissions

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

4.6.1  The SMC advice for lidocaine 5% medicated plaster (Versatis), for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia), will be posted on the SMC website on Monday, 11 August 2008.

4.7  clobetasol propionate 0.05% shampoo (Etrivex®)  Galderma (UK) Limited (No. 434/07) 

4.7.1  The SMC advice for clobetasol propionate 0.05% shampoo (Etrivex®), for the treatment of moderate scalp psoriasis in adults, will be posted on the SMC website on Monday, 11 August 2008.

4.8  buprenorphine transdermal patch (BuTrans)  Napp Pharmaceuticals Ltd (No. 234/06)

4.8.1  The SMC advice for buprenorphine transdermal patch (BuTrans) for the treatment of severe opioid responsive pain conditions which are not adequately responding to non-opioid analgesics, will be posted on the SMC website on Monday, 11 August 2008.

Abbreviated Submission

4.9  sitagliptin /metformin (Janumet) Merck Sharp and Dohme Ltd (No. 492/08)        

4.9.1  The SMC advice for sitagliptin /metformin (Janumet), as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of sitagliptin and metformin, will be withheld pending confirmation of licence and availability.

Non Submissions

4.10  ibritumomab tiuxetan 1.6mg/ml (Zevalin)  Bayer plc (No. 499/08)

4.10.1  The SMC advice for ibritumomab tiuxetan (Zevalin) as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma, will be posted on the SMC website on Monday, 11 August 2008.

4.11  melatonin 2mg prolonged-release tablets (Circadin) Lundbeck Limited  (No. 500/08)

4.11.1  The SMC advice for melatonin prolonged-release tablets (Circadin), as monotherapy for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over, will be posted on the SMC website on Monday, 11 August 2008.

4.12  venlafaxine (Efexor XL)  Wyeth Pharmaceuticals (No. 501/08)

4.12.1  The SMC advice for venlafaxine extended release capsules (Efexor XL),  for the treatment of moderate to severe generalised social anxiety disorder / social phobia in adults, will be posted on the SMC website on Monday, 11 August 2008.

Amended Advice

4.13  ferric carboxymaltose, 100mg/2ml and 500mg/10ml solution for injection/infusion (Ferinject) Syner-Med (PP) Ltd No. 463/08

4.13.1  This product was reviewed by SMC in April 2008 and advice was circulated to NHSScotland on 06 June 2008, following confirmation that the product had been launched.  However, as a result of comparator comments, amendments have subsequently been made to the section entitled "Summary of Clinical Effectiveness Issues".  A revised copy of the Detailed Advice Document was forwarded to NHSScotland on 04 July and published on the SMC website on Monday 07 July 2008.

5. Appeals Update

5.1  buprenorphine transdermal patch (BuTrans)  Napp Pharmaceuticals Ltd (No. 234/06)

5.1.1  Napp Pharmaceuticals Ltd, have advised their intention to make a resubmission for buprenorphine transdermal patch (BuTrans), for the treatment of severe opiod responsive pain conditions, which are not adequately responding to non-opiod analgesics.

6. Patient and Public Involvement Group (PAPIG)

6.1  Mrs Tunstall-James advised that PAPIG had met immediately prior to the SMC and minutes would be available at September SMC.  The focus of the meeting was on how PAPIG work as a group and how they can continue to improve and develop their interaction with Patient Interest Groups.

7. New Drugs Committee: Chairman’s Report

7.1  Fellowship of the Royal Pharmaceutical Society of Great Britain

The Consortium congratulated Ms Angela Timoney on being awarded a Fellowship of the Royal Pharmaceutical Society of Great Britain for distinction in the profession and practice of pharmacy.

7.2  Statistical Training for Assessors, NDC and SMC Members

Professor Peter Donnan is providing two seminars on statistical analyses relative to health technology assessments, on 5 September and 2 October. Both sessions will be held in Delta House from 10.00 am to 3.00 pm and will include survival analysis, dealing with missing data, indirect comparisons and equivalence studies.  Members who wish to attend should contact Ms Ailsa Brown.

8. Chairman’s Business

8.1  Request for Information under the Freedom of Information (Scotland) Act (2002)

SMC  received a request  for information relating to the SMC review of botulinum neurotoxin type A (Xeomin), for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults. (No: 464/08).  SMC are currently considering the request and a response is due on 21 August 2008.

8.2  SMC Conference: 23 September 2008

Members were advised that if they wish to attend the SMC Conference on 23 September, completed registration forms should be submitted to the SMC Secretariat by 08 September 2008.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1  icatibant (Firazyr)   Jerini AG  (No:476/08)                                                                

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

9.1.2  The NDC Chair provided an overview of the assessment, draft advice, expert comments, and comments received from the company.  Detailed discussion followed and the group concluded their advice for icatibant (Firazyr), for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).

9.1.3  The SMC advice will be withheld pending confirmation of licence and product availability.

9.2  aripiprazole (Abilify)  Bristol Myers Squibb Pharmaceuticals Ltd  (No: 498//08)   

9.2.1  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.

The NDC Lead Assessor provided an overview of the assessment, draft advice, expert 9.2.2  comments, and comments received from the company.  Detailed discussion followed and the group agreed that aripiprazole (Abilify), for the treatment of moderate to severe manic episodes in bipolar I disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment, should be not be recommended for use in NHSScotland.  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 NHS Boards and ADTCs on Friday, 08 August 2008.

9.3  alemtuzumab (MabCampath)  Bayer plc/Bayer Schering Pharma  (No: 494/08)      

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

9.3.2  The NDC Chair 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 Rarer Cancers Forum and the Chronic Lymphocytic Leukaemia Support Association.  Detailed discussion followed and the group agreed that alemtuzumab (MabCampath) for the treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate, should be accepted for   restricted use in NHSScotland.  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 NHS Boards and ADTCs on Friday, 08 August 2008.

9.4  micafungin (Mycamine)  Astellas Pharma Ltd  (No: 497/08) 

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

9.4.2  The NDC 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 micafungin (Mycamine) for the treatment of invasive candidiasis, should be accepted for restricted use in NHSScotland.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.4.3  Micafungin (Mycamine) is not recommended for use within NHS Scotland for the treatment of oesophageal candidiasis in adult, elderly, and adolescent (=16 years of age) patients for whom intravenous therapy is appropriate. The manufacturer did not supply any economic analysis and therefore the cost effectiveness could not be assessed.

9.4.4  Micafungin (Mycamine)  is not recommended for use within NHS Scotland for prophylaxis of Candida infection in adults, elderly, and children (including neonates) undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. The manufacturer did not supply any economic analysis and therefore the cost effectiveness could not be assessed.

9.4.5  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 August 2008.

9.5  rituximab (MabThera)  Roche  (No: 493/08) 

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 NDC Lead Assessor provided an overview of the assessment, draft advice, and expert comments.  Detailed discussion followed and the group agreed that rituximab (MabThera), for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy, should be accepted for restricted use in NHSScotland.  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 NHS Boards and ADTCs on Friday, 08 August 2008.

RESUBMISSION

9.6  pemetrexed (Alimta)  Eli Lilly and Company Limited  (No:342/07)   

9.6.1  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.

9.6.2  The NDC Vice Chair provided an overview of the assessment, draft summary of advice, expert comments, revised data/analyses and comments received from the company.   A member of PAPIG presented a patient interest group submission from the Roy Castle Lung Cancer Foundation.  Discussion followed and the group agreed that pemetrexed (Alimta), as monotherapy for the second-line treatment of patients with locally advanced or metastatic non- small cell lung cancer other than predominantly squamous cell histology, should be accepted for restricted use in NHSScotland.  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 NHS Boards and ADTCs on Friday, 08 August 2008.

ABBREVIATED SUBMISSIONS

9.7  ropinirole prolonged release (Requip XL)  GlaxoSmithKline  (No. 491/08)

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

9.7.2  The NDC Chair provided an overview of the assessment, draft summary of advice, and expert comments.  Discussion followed and the agreed that ropinorole prolonged release (RequipXL), for the treatment of idiopathic Parkinson’s disease, who are already taking ropinorole immediate release tablets and in whom adequate symptomatic control has been established, should be accepted for  use in NHSScotland.  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 NHS Boards and ADTCs on Friday, 08 August 2008.

10. Forthcoming Submissions

10.1  A list of forthcoming submissions was tabled and noted.

11. SMC User Group Forum (UGF)

11.1  SMC User Group Forum – Meeting held on Tuesday 29 July 2008

Minutes of the SMC User Group Forum held on Tuesday 29 July 2008 will be available to SMC for information at September SMC.

11.2  Analyses of SMC’s decisions

Dr Frances MacDonald advised that for the benefit of both SMC and Industry, the UGF is conducting an analysis of SMC’s decisions, as published on the website.   In collaboration with Dr Andrew Walker they aim to inform discussion as to the reasons why SMC accept or do not recommend.

11.3  SMC User Group Forum – Invitation to members to observe an SMC meeting.

The SMC User Group Forum accepted and welcomed SMC’s invitation to individual members, to observe an SMC meeting.

12. Feedback from Area Drug and Therapeutic Committees ( ADTCs)

12.1  Temsirolimus (Torisel)

Temsirolimus received a marketing authorisation from the EMEA in November 2007. The manufacturer has not yet made the drug commercially available to the UK market however SMC understand that it is providing temsirolimus, free of charge, on a named-patient basis.

NICE is currently conducting a Multiple Technology Appraisal (MTA) for renal cell cancer and temsirolimus will be assessed as part of the MTA. NICE is expected to report in January 2009. Notwithstanding this, SMC has been pursuing a submission according to normal process but the manufacturer has recently advised that, in light of the small number of eligible patients in Scotland, they do not intend to make a submission.
 
SMC would normally issue a non-recommendation based on a non-submission however, it is only possible for SMC to do so when the product becomes commercially available. SMC therefore asked that ADTCs and local cancer networks make clinicians aware that temsirolimus has not been assessed by SMC.

The ADTC for NHS Grampian highlighted the difficulty this situation has caused prescribers in their area, due to the additional administration costs associated with prescriptions provided free of charge.

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, 02 September 2008 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.