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Minutes of SMC meeting held on Tuesday 1 July 2008

Minutes of the SMC Meeting held on Tuesday 01 July 2008
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Dr Ken Paterson (Chairman), Mrs Laura Ace, Professor James Barbour, Dr Keith Beard, Mrs Margo Biggs, Mr David Carson, Dr Sara Davies, Mr Tom Divers, Dr Jonathan Fox, Ms Susan Goldsmith,  Dr Chris Lush, Dr Frances Macdonald, Mr Alan McDonald, Dr John McElhinney, Ms Veronica Moffat,  Ms Aileen Muir, Mrs Pat Murray, Dr Anthony Ormerod, Mr Andrew Powrie-Smith, Mr Alistair Thorburn, Ms Angela Timoney, Mrs Sheila Tunstall-James

In Attendance: Mrs Marion Bennie (Items 1-8), Ms Ailsa Brown, Mr Scott Bryson, Mrs Alison Campbell, Ms Susan Downie, Mr Stephen Ferguson, Ms Sharon Hems (Items 1-8), Dr John Larkin,Mrs Anne Lee (Items 1-8), Mr Colin McAllister (Items 1-8), Mrs Laura McIver, Mrs Sandra McNaughton,Ms Rosie Murray,  Ms Alex Robertson, Mrs Maureen Stark, Dr Andrew Walker, Dr Matthew Walters

Apologies: Mr Colin Brown,  Dr Keith Brown, Professor John Cairns,  Dr David Crookes, Dr John Gemmill,Dr Barclay Goudie, Dr Jan Jones, Dr Harpreet Kohli, Dr Grace Lindsay, Mr Billy Malcolm, Professor Dilip, Nathwani, Dr Andrew Power, Dr Nick Reed, Dr Andrew Riley,  Dr Sandy Simpson, Dr Sarah Taylor, Mr Keith Thompson,  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 Mr Eddie MacDonald, General Manager of Stirling Community Healthcare Partnership (CHP), who was observing the meeting at the invitation of the Patient and Public Involvement Group (PAPIG) and Mrs Marion Bennie and Ms Sharon Hems who were presenting the SMC Evaluation Programme to the meeting.

A welcome was also extended to the following NDC Lead Assessors who were presenting submissions to the meeting: Dr John Larkin; Mrs Sandra McNaughton; Mr Scott Bryson; Mrs Alison Campbell; Dr Matthew Walters.
 
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 03 June 2008 were agreed as an accurate record.

4. Matters Arising From the Previous Minutes

There were no matters arising from the previous minutes.

Full Submissions

4.1 tenofovir disoproxil (as fumarate), 245 mg film-coated tablet (Viread?) Gilead Sciences No. (479/08)

4.1.1 The SMC advice for tenofovir disproxil fumarate (Viread), for the treatment of chronic hepatitis B in adults with compensated liver disease with evidence of active viral replication, persistently (at least 6 months) elevated serum alanine aminotransferase (ALT) levels or histological evidence of active inflammation and/or fibrosis (Knodell necroinflammatory score >4), will be posted on the SMC website on Monday, 07 July 2008.

4.2 fesoterodine fumarate 4mg and 8mg prolonged release tablets (Toviaz?) Pfizer Ltd (No. 480/08)

4.2.1 The SMC advice for fesoterodine fumarate (Toviaz), for treatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur in patients with overactive bladder syndrome, will be posted on the SMC website on Monday, 07 July 2008.

4.3 docetaxel 20 and 80mg concentrate and solvent for solution for infusion (Taxotere?) Sanofi-aventis No. (481/08)

4.3.1 The SMC advice for docetaxel (Taxotere), for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck in combination with cisplatin and 5-flourouracil, will be posted on the SMC website on Monday, 07 July 2008.

4.4 sorafenib, 200mg tablets (Nexavar?) Bayer Schering Pharma No.  (482/08)

4.4.1 The SMC advice for sorafenib (Nexavar), for the treatment of hepatocellular carcinoma, will be posted on the SMC website on Monday, 07 July 2008.

4.5 paricalcitol, capsules 1,2 and 4 micrograms (Zemplar?) Abbott Laboratories  No. (478/08)

4.5.1 The SMC advice for paricalcitol capsules (Zemplar), for the prevention and treatment of secondary hyperparathyroidism (SHPT) associated with chronic renal insufficiency (chronic kidney disease (CKD) stages 3 and 4) patients and chronic renal failure (CKD stage 5) patients on haemodialysis or peritoneal dialysis, will be posted on the SMC website on Monday, 07 July 2008.

Resubmission

4.6 paricalcitol, 5 micrograms/ml and 10 micrograms /ml solution for injection (Zemplar?) Abbott Laboratories No.  (288/06)

4.6.1 The SMC advice for paricalcitol solution for injection (Zemplar), for the prevention and treatment of secondary hyperparathyroidism in patients with chronic renal failure undergoing haemodialysis, will be posted on the SMC website on Monday, 07 July 2008.

Abbreviated Submission

4.7 vildagliptin 50mg / metformin hydrochloride 850mg film coated tablets and vildagliptin 50mg / metformin hydrochloride 1000mg film coated tablets (Eucreas? 50mg/850mg and 50mg/1000mg) Novartis Pharmaceuticals UK Limited (No: 477/08)

4.7.1 The SMC advice for vildagliptin/metformin (Eucreas), for the treatment of type 2 diabetes mellitus as dual oral therapy, in patients with insufficient glycaemic control despite their maximally tolerated dose of monotherapy with metformin, or who are already treated with the combination of vildagliptin amd metformin as separate tablets, will be posted on the SMC website on Monday, 07 July 2008.

5. Appeals Update

5.1 salmeterol/fluticasone 50/500 (Seretide), GlaxoSmithKline

GlaxoSmithKline have advised their intention to make a resubmission for salmeterol/fluticasone 50/500 (Seretide), for the symptomatic treatment of patients with chronic obstructive airways disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% to <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

6. Patient and Public Involvement Group (PAPIG)

6.1 The minutes of the meeting of the Patient and Public Involvement Group, held on 03 June 2008, were noted.

6.2 Mrs Laura McIver, SMC Chief Pharmaceutical Adviser, will attend the August meeting of PAPIG to discuss the impending publication of the SMC Evaluation programme in relation to patient and public involvement.

6.3 The PAPIG are currently developing Terms of Reference for group members. The Group is also preparing additional lay guidance for patients and members of the public on how the SMC conducts their assessments and the factors they consider in reaching their decisions.
 
6.4 As Mrs P Murray’s term of appointment to SMC and PAPIG will end in September, the Chairman sought nominations from SMC by 05 August 2008, for her replacement.

7. New Drugs Committee Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 Hospital Electronic Prescribing Systems

Work is in progress to establish an Hospital Electronic Prescribing and Administration (HEPMA) system in Scotland.  A Reference Group will be formed to evaluate individual hospital systems and champion the introduction of a national system.

It is intended that SMC’s links with Area Drug and Therapeutic Committees (ADTCs) will be drawn on, to provide experience, knowledge and support to the implementation network.  Nominations will be sought for the Reference Group and the Chair encouraged members to get involved.

8.2 Feedback from SMC presentation to the Verband Forschender Arzneimittelhersteller (VFA)

A delegation of four SMC representatives, led by the Chairman, was invited to speak to members of the German pharmaceutical industry about the work of SMC.  Their presentation was well received and whilst it highlighted variations and differing stages of development in the HTA systems applying across European countries, it provoked worthwhile discussion and information sharing.

8.3 Inquiry into the availability of cancer treatment drugs on the NHS: Public Petitions Committee Report

The Report from the Public Petitions Committee on the availability of cancer treatment drugs was noted, and in particular, the suggestion that further research into the use of Quality Adjusted Life Years (QALYs) in the health technology appraisal would be useful.  SMC acknowledged that this has a bearing on the work of the Consortium and would consider undertaking further research in the future.

8.4 Market Access Schemes: Update

Work is continuing in collaboration with industry, NHS QiS and the Scottish Government Health Department.  A report is anticipated later in the Summer.

8.5 NICE – Single Technology Appraisal (STA) Guidance

NICE issued STA guidance on 25 June with regards to adalimumab for the treatment of adults with psoriasis, cetuximab for the treatment of locally advanced squamous cell cancer of the head and neck and rimonabant for the treatment of overweight and obese adults.

adalimumab is recommended as a treatment option for adults with plaque psoriasis for whom anti-tumour necrosis factor (TNF) treatment is being considered and when specific criteria are met.

cetuximab in combination with radiotherapy is recommended as a treatment option only for patients with locally advanced squamous cell cancer of the head and neck whose Karnofsky performance status score is 90% or greater and for whom all forms of platinum-based chemotherapy treatment are contraindicated.
rimonabant, within its licensed indications, is recommended as an adjunct to diet and exercise for adults who are obese or overweight and who have had an inadequate response to, are intolerant1 of or are contraindicated to orlistat and sibutramine.

There is no material difference between the NICE STA and the SMC advice for adalimumab and cetuximab whilst there is a difference for rimonabant.

Listed below is SMC advice:
 
adalimumab 40mg solution for injection (Humira) is accepted for restricted use within NHS Scotland for treatment of chronic plaque psoriasis in adult patients who failed to respond to or have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or PUVA.  Its use should be restricted to patients with severe disease as defined by a total Psoriasis Area Severity Index (PASI) score of _10 and a Dermatology Life Quality Index (DLQI) of >10. Adalimumab improves both signs and symptoms of psoriasis and quality of life compared to placebo and an active non-biological comparator. The manufacturer presented a sufficiently robust economic case to gain acceptance by the SMC for patients with severe disease who achieve a PASI 75 response from baseline at 16 weeks. Continuation of therapy beyond 16 weeks should be carefully reconsidered in patients not responding within this time period.
 
cetuximab (Erbitux) is accepted for restricted use within NHS Scotland in combination with radiation therapy for the treatment of patients with locally advanced squamous cell cancer of the head and neck. It is restricted to patients who are not appropriate for or unable to tolerate chemo-radiotherapy and who are of good performance status with no evidence of distant metastases. It is also restricted to use by specialists in the management of head and neck cancer.

rimonabant (Acomplia) is not recommended for use within NHS Scotland 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 an associated risk factor or risk factors such as type 2 diabetes or dyslipidaemia. Rimonabant was associated with a reduction in mean weight of about 4-5kg over that with placebo. However, this weight was generally regained within one year of stopping treatment. The economic case has not been demonstrated. The licence holder has indicated their decision to resubmit.

Please note, NICE STAs have no status in Scotland.

8.6 SMC Evaluation Programme
 
Mrs Marion Bennie,  Chief Pharmaceutical Adviser to National Services Scotland (NSS), presented the findings of the two year programme of independent evaluation carried out on the work of SMC (April 2006 – March 2008).

The data collection, analyses and interpretation aspects of the evaluation are complete and a report on the uptake of SMC Advice and SMC’s engagement with its key stakeholders is in preparation.

It is proposed that the output from the SMC Evaluation Programme will be formally communicated at the SMC Conference on 23 September 2008, in the Royal College of Physicians, Edinburgh.  In the intervening period, SMC will consider the outcomes and respond to the report at the conference. 
 
9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

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

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

9.1.2 The NDC Vice Chair provided an overview of the assessment, draft advice, and expert comments.   Detailed discussion followed and the group agreed that 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, should be accepted for use in 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 NHS Boards and ADTCs on Friday, 04 July 2008.

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

9.2.1 There were no declarations of interest 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, tabled expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that anti-human thymocyte immunoglobin (Thymoglobuline), for prevention of graft rejection in renal transplantation, should not be recommended for use in 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 NHS Boards and ADTCs on Friday, 04 July 2008.

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

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

9.3.2 The NDC Lead Assessor 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 the National Osteoporosis Society.  Detailed discussion followed and the group agreed that teriparatide (Forsteo), for the treatment of osteoporosis in men at increased risk of fracture, should not be recommended for use in 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 NHS Boards and ADTCs on Friday, 04 July 2008.

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

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 revised data/analyses.  A member of PAPIG presented a patient interest group submission from Sarcoma UK.  Detailed discussion followed and the group agreed that 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, should not be recommended for use in 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 NHS Boards and ADTCs on Friday, 04 July 2008.

Resubmissions

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

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

9.5.2 The NDC Lead Assessor 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 Concern.  Detailed discussion followed and the group agreed that lidocaine 5% medicated plaster (Versatis), for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia), should be accepted for restricted use in 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 NHS Boards and ADTCs on Friday, 04 July 2008.

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

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

9.6.2 The NDC Lead Assessor 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 Psoriasis Scotland Arthritis Link Volunteers (PSALV).  Detailed discussion followed and the group agreed that clobetasol propionate 0.05% shampoo (Etrivex®), for the treatment of moderate scalp psoriasis in adults, should be accepted use in 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 NHS Boards and ADTCs on Friday, 04 July 2008.

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

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

9.7.2 The NDC Vice 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 Pain Concern and the Pain Association Scotland.  Detailed discussion followed and the group agreed that buprenorphine transdermal patch (BuTrans) for the treatment of severe opioid responsive pain conditions which are not adequately responding to non-opioid analgesics, should not be recommended for use in 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 NHS Boards and ADTCs on Friday, 04 July 2008.

Abbreviated Submission

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

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

9.8.2 The NDC Vice Chair provided an overview of the assessment, and draft summary of advice.  Discussion followed and the group concluded their 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.

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

Non Submissions

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

9.9.1 In the absence of a submission from the holder of the marketing authorisation, ibritumomab tiuxetan (Zevalin) as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma, should not be recommended for use within NHS Scotland.

9.9.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 July 2008.

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

9.10.1 In the absence of a submission from the holder of the marketing authorisation, 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, should not be recommended for use within NHS Scotland.

9.10.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 July 2008.

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

9.11.1 In the absence of a submission from the holder of the marketing authorisation, venlafaxine extended release capsules (Efexor XL),  for the treatment of moderate to severe generalised social anxiety disorder / social phobia in adults, should not be recommended for use within NHS Scotland.

9.11.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 July 2008.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted.

11. SMC User Group Forum

Dr Frances MacDonald advised that, following their recent appointments to SMC, she and Andrew Powrie-Smith were having an introductory meeting with  ABPI  members of the User Group Forum to discuss and familiarise themselves with current SMC issues.

12. ADTC Feedback

12.1 Nothing to report.

13. Any Other Business

No other business was noted.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 05 August 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.