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Minutes of the SMC Meeting held on Tuesday 03 June 2008

Minutes of the SMC Meeting
held on Tuesday 03 June 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, Dr Keith Brown, Professor John Cairns, Dr David Crookes, Mr Tom Divers, Dr John Gemmill, Ms Susan Goldsmith, Dr Barclay Goudie, Dr Jan Jones, Dr Harpreet Kohli, Dr Chris Lush, Dr Frances Macdonald, Dr John McElhinney, Mr Billy Malcolm, Ms Veronica Moffat, Dr Anthony Ormerod, Dr Andrew Power, Mr Andrew Powrie-Smith, Dr Nick Reed, Dr Sarah Taylor, Mr Keith Thompson, Ms Angela Timoney

In Attendance: Ms Ailsa Brown, Dr Sara Davies, Ms Susan Downie, Mr Stephen Ferguson, Ms Sharon Hems, Mrs Hazel Illingworth, Mrs Anne Lee, Ms Rosie Murray, Mrs Maureen Stark, Dr Andrew Walker

Apologies:Mr Colin Brown, Mr David Carson, Dr Jonathan Fox, Dr Grace Lindsay, Mr Colin McAllister, Mr Alan McDonald, Mrs Laura McIver, Ms Aileen Muir, Mrs Pat Murray, Professor Dilip Nathwani, Ms Alex Robertson, Dr Andrew Riley, Dr Sandy Simpson, Mr Alistair Thorburn, Mrs Sheila Tunstall-James, 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 gave a warm welcome to Mr Andrew Powrie-Smith, Director, ABPI Scotland, who was attending his first meeting of SMC, he also welcomed Miss Sharon Hems, NDC member.
  • The Chairman also said thank you and goodbye to Mrs Hazel Illingworth who was attending her last meeting of 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 06 May 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 anidulafungin (Ecalta) Pfizer Ltd (No. 465/08)

4.1.1 The SMC advice for anidulafungin (Ecalta), for the treatment of invasive candidiasis in adult non-neutropenic patients, will be posted on the SMC website on Monday, 09 June 2008. 

4.2 dabigatran etexilate (Pradaxa)  Boehringer Ingelheim  (No. 466/08)

4.2.1 The SMC advice for dabigatran etexilate (Pradaxa), for the primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery, will be posted on the SMC website on Monday, 09 June 2008. 

4.3 epoetin zeta (Retacrit)  Hospira UK Ltd  (No. 46708)

4.3.1 The SMC advice for epoetin zeta (Retacrit), for the treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis and for treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis, will be posted on the SMC website on Monday, 09 June 2008. 

4.4 adalimumab (Humira)  Abbott Laboratories  (No. 468/08)

4.4.1 The SMC advice for adalimumab (Humira), for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA, will be posted on the SMC website on Monday, 09 June 2008. 

4.5 bevacizumab (Avastin)  Roche  (No. 469/08)

4.5.1 The SMC advice for bevacizumab (Avastin), for treatment of patients with metastatic carcinoma of the colon or rectum, in combination with fluoropyrimidine-based chemotherapy, will be posted on the SMC website on Monday, 09 June 2008. 

4.6 glucosamine (Alateris)  William Ransom & Son plc  (No. 471/08)

4.6.1 The SMC advice for glucosamine (Alateris), for the treatment of symptoms in mild to moderate osteoarthritis of the knee, will be posted on the SMC website on Monday, 09 June 2008. 

4.7 botulinum neurotoxin Type A (Xeomin)  Merz Pharma UK Ltd  (No. 464/08)

4.7.1 The SMC advice for botulinum neurotoxin Type A (Xeomin) for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults, will be posted on the SMC website on Monday, 09 June 2008. 

The Chairman advised that minor amendments have been made to the section entitled ‘Summary of comparative health economic evidence’, and following comparator comments, minor revisions have been made to the section entitled ‘Summary of clinical effectiveness issues’. The advice will be reissued to NHS Scotland on Friday, 06 June 2008 and published on the SMC website on Monday, 09 June 2008.

Abbreviated Submissions

4.8 perindopril arginine (Coversyl) Servier Laboratories Ltd  (No. 473/08)                                  

4.8.1 The SMC advice for perindopril arginine (Coversyl, for the treatment of essential hypertension, and the treatment of symptomatic heart failure, will be posted on the SMC website on Monday, 09 June 2008. 

4.9 perindopril arginine/ indapamine (Coversyl Plus) Servier Laboratories Ltd (No. 474/08)

4.9.1 The SMC advice for peridopril arginine/ indapamine (Coversyl Plus), for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on perindopril alone and for whom this combination is an appropriate choice of therapy, will be posted on the SMC website on Monday, 09 June 2008. 

Non Submissions

4.10 lidocaine 70mg / tetracaine 70mg (Rapydan 70mg/70mg medicated plaster) EUSA Pharma Europe Limited (No: 483/08)

4.10.1 The SMC advice for lidocaine (Rapydan 70mg/70mg medicated plaster), for surface anaesthesia of the skin in connection with needle puncture and in cases of superficial surgical procedures (such as excision of various skin lesions and punch biopsies) on normal skin in adults; surface anaesthesia of the skin in connection with needle puncture on normal intact skin in children from 3 years of age, will be posted on the SMC website on Monday, 09 June 2008.

4.11 loteprednol etabonate 0.5% 5mg/ml (Lotemax 0.5% Eye Drops, Suspension) Bausch & Lomb GmbH (No: 484/08)

4.11.1 The SMC advice for loteprednol (Lotemax 0.5% eye drops, suspension), for the treatment of post-operative inflammation following ocular surgery, will be posted on the SMC website on Monday, 09 June 2008.

4.12 bosentan 62.5mg, 125mg (Tracleer) Actelion Pharmaceuticals UK (No: 485/08)

4.12.1 The SMC advice for bosentan (Tracleer), to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease, will be posted on the SMC website on Monday, 09 June 2008.

4.13 panitumumab 20mg/ml concentrate  for solution for infusion (Vectibix) Amgen Ltd
(No: 486/08)

4.13.1 The SMC advice for panitumumab (Vectibix), as monotherapy for the treatment of patients with EGFR expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS after failure of flouropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens, will be posted on the SMC website on Monday, 09 June 2008.

4.14 teriparatide (Forsteo) Eli Lilly & Company Ltd (No. 487/08)

4.14.1 The SMC advice for teriparatide (Forsteo), for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk of fracture, will be posted on the SMC website on Monday, 09 June 2008.

Deferred Advice

4.15 ferric carboxymaltose, 100mg/2ml and 500mg/10ml solution for injection/infusion (Ferinject)

for the treatment of iron deficiency when oral preparations are ineffective or cannot be used.

4.15.1 The Chairman advised that this product was reviewed by SMC in April 2008, and the advice was withheld pending confirmation of the product availability.  The product is now available and the advice will be issued to NHS Scotland on Friday, 06 June 2008 and issued on the SMC website on Monday 07 July 2008.

Amended Advice

4.16 lenalidomide, 5mg,10mg,15mg and 25mg capsules (Revlimid) No 441/08

in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.

4.16.1 The Chairman advised that amendments have been made to the section entitled ‘Summary of clinical effectiveness issues.  The advice was posted on the SMC website on Monday, 12 May 2008 and will be reissued to NHSScotland on Friday 06 June 2008.

5. Appeals Update

5.1 lenalidomide, 5mg,10mg,15mg and 25mg capsules (Revlimid) No 441/08

The Chairman advised that Celgene Europe Limited have advised of their intention to make a resubmission to SMC for lenalidomide (Revlimid), in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.

5.2 ferric carboxymaltose, 100mg/2ml and 500mg/10ml solution for injection/infusion (Ferinject)

The Chairman advised that Syner-Med (PP) Ltd has advised of their intention to make a resubmission to SMC for Ferric carboxymaltose (Ferinject), for the treatment of iron deficiency when oral preparations are ineffective or cannot be used.

5.3 anidulafungin (Ecalta)  Pfizer Ltd (No. 465/08)

The Chairman advised that Pfizer Ltd has advised of their intention to make a resubmission to SMC for anidulafungin (Ecalta), for the treatment of invasive candidiasis in adult non-neutropenic patients.

6. Patient and Public Involvement Group (PAPIG)

6.1 The Chairman of PAPIG advised that the group had met earlier in the day and the minutes of that meeting would be available at the next meeting of SMC.

7. New Drugs Committee Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 Policy Seminar on Pharmaceutical Governance – 14 May 2008

The Chairman advised that he had presented a presentation regarding SMC at the Department of Geography and Sociology, University of Strathclyde as part of a policy seminar on pharmaceutical governance looking at issues such as marketing, licensing and prescription advice.

8.2 Meeting with Dr Jill Sanders, Director of CADTH (Canadian Agency for Drugs and Technologies in Health – 19 May 2008

The Chairman advised that representatives of SMC attended a seminar held for Dr Jill Sanders, the Director of CADTH which provided information about the history and development of CADTH, organisation and structure, its role in the Canadian healthcare system and lessons learned.

8.3 Meeting with Professor Sawicki, Director of IQWiG (Institute for Quality and Efficiency in Health Care) – 27 May, Cologne

The Chairman advised that he met with Professor Sawicki, Director of IQWiG to discuss all aspects of SMC, and comparisons with IQWiG and other cognate bodies such as NICE.  He found the meeting most useful and the information gathered will help with his presentation to the VFA on 19 June 2008.

8.4 SMC Conference – 23 September, 2008, Royal College of Physicians, Edinburgh

The Chairman advised that SMC are hosting a conference on 23 September, 2008.  The main focus of the event is to launch the evaluation outputs.  The programme will be distributed this week.

8.5 Proposed Visit to ADTCs

The Chairman advised that he and Professor Dilip Nathwani will visit a number of the ADTCs over the coming months to provide an update regarding SMC and ScotMARAP.

8.6 Freedom of Information Request

The Chairman advised that SMC has received a request from a member of the public in relation to the SMC review of sunitinib (Sutent), for the treatment of advanced and/or metastatic renal cell carcinoma. The request is being considered and the deadline for response is 19 June 2008.

8.7 SMC Annual Report

The Chairman advised that the SMC Annual Report for 2007 had been published.  Copies were tabled at the meeting and he advised the members that if they wished additional copies to advise the Secretariat accordingly.

8.8 NICE Multiple Technology Appraisal Guidance

The Chairman advised that NICE issued MTA guidance on 28 May with regards to adalimumab, etanercept and infliximab for ankylosing spondylitis and has recommended adalimumab or etanercept as possible treatment for people with severe ankylosing spondylitis.  Infliximab is not recommended for ankylosing spondylitis.

SMC Advice

  • adalimumab 40mg pre-filled syringe (Humira) (SMC No. 300/06)

Following a full submission SMC issued advice for adalimumab (Humira), in December 2006 and accepted for restricted use for the treatment of adults with severe active ankylosing spondylitis who have an inadequate response to conventional therapy. It is restricted to use in accordance with the British Society for Rheumatology (BSR) guidelines of July 2004. Adalimumab improves signs, symptoms, physical function and quality of life in patients with severe active ankylosing spondylitis. It reduces spinal inflammation, but there is no radiological evidence that it decreases joint damage. An economic evaluation demonstrated that it is a cost-effective treatment option when used in tumour necrosis factor (TNF)- antagonist naïve patients in accordance with the BSR guidelines and where clear and rigorous stopping rules are applied.

  • etanercept (Enbrel) SMC No. 212/05

Followng a full submission SMC published advice for etanercept (Enbrel), in November 2005 and accepted for restricted use for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. It is restricted to use in accordance with the British Society for Rheumatology (BSR) guidelines of July 2004.  Etanercept improves signs and symptoms, physical function and quality of life in patients with severe active ankylosing spondylitis. It reduces acute spinal inflammation, but there is no radiological evidence that it decreases joint damage. An economic evaluation, including an assumption that etanercept reduces disease progression, demonstrated that it is a costeffective treatment option when used in accordance with the BSR guidelines and where clear and rigorous stopping rules are applied.

  • etanercept 50mg subcutaneous injection (Enbrel) SMC No. 303/06

Following an abbreviated submission, SMC published advice in September 2006 for etanercept 50mg subcutaneous injection (Enbrel), and accepted for restricted use for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. It is restricted to use in accordance with the British Society for Rheumatology (BSR) guidelines of July 2004.  Etanercept improves signs and symptoms, physical function and quality of life in patients with severe active ankylosing spondylitis. It reduces acute spinal inflammation, but there is no radiological evidence that it decreases joint damage. It is a cost-effective treatment option when used in accordance with the BSR guidelines and where clear and rigorous stopping rules are applied. The 50mg formulation facilitates once weekly administration of etanercept at no additional cost over the existing 25mg formulation that is administered twice weekly.

  • Infliximab (Remicade) SMC No. 101/04

Following a resubmission SMC published advice for infliximab 100mg vial of powder for intravenous infusion (Remicade), in October 2004 and accepted for restricted use within NHS Scotland for the treatment of ankylosing spondylitis in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy. Infliximab has demonstrated improvements in signs and symptoms, quality of life and physical functioning and also reductions in spinal inflammation activity. As yet the magnitude of any effect on disease prognosis is unclear the treatment provides value for money only where clear and rigorous stopping rules are followed. It is restricted to use in accordance with British Society of Rheumatology (BSR) guidelines of July 2004.

8.9 Market Access Schemes

The Chairman advised that the Scottish Government Health Department has asked SMC to take the lead on market access schemes and bring together a group of people from industry, SMC and the wider NHS to discuss the practicalities of these schemes.  He will update at the next meeting of SMC.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

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

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

9.1.2 The NDC Chairman provided an overview of the assessment, draft advice and expert comments. Detailed discussion followed and the group agreed that 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), should be accepted for use within NHS Scotland.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 June 2008.

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

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

9.2.2 The NDC Co-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 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, should be accepted for restricted use within NHS Scotland.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 June 2008.

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

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

9.3.2 The NDC 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 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, should be accepted for restricted use within NHS Scotland.

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 June 2008.

9.4 sorafenib 200mg tablets (Nexavar) Bayer Schering Pharma (No. 482/08)

9.4.1 A declaration of interest was 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 comments received from the company. A member of PAPIG presented patient interest group submissions from the Rarer Cancers Forum and Hepatitis B Foundation UK. Detailed discussion followed and the group agreed that sorafenib (Nexavar), for the treatment of hepatocellular carcinoma, should not be recommended for use within NHS Scotland. 

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 June 2008.

9.5 paricalcitol capsules 1,2 and 4 micrograms (Zemplar) Abbot Laboratories (No. 478/08)

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

9.5.2 The NDC Co-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 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, should not be recommended for use within NHS Scotland. 

9.5.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 June 2008.

RESUBMISSIONS

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

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

9.6.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice, expert comments and comments received from the company. Discussion followed and the group agreed that paricalcitol solution for injection (Zemplar), for the prevention and treatment of secondary hyperparathyroidism in patients with chronic renal failure undergoing haemodialysis, should not be recommended for use within NHS Scotland.

9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 June 2008.

ABBREVIATED SUBMISSIONS

9.7 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)

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

9.7.2 The NDC Chairman provided an overview of the assessment and draft summary of advice. Discussion followed and the group agreed that vildagliptin.metformin (Eucreas), for the treatment of type 2 diabetes mellitus as dual oral therapy, 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, should be accepted for restricted use within NHS Scotland. 

9.7.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 June 2008.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted.

11. SMC User Group Forum

11.1 Nothing to report.
 
12. ADTC Feedback

12.1 Nothing to report.

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, 01 July 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.