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SMC Minutes - Tuesday, 1 August 2006

Minutes of the SMC Meeting held on Tuesday 1 August 2006
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Ms Laura Ace, Dr Keith Beard, Mrs Marion Bennie,
Mrs Barbara Black, Dr Keith Brown, Professor John Cairns, Mrs Michelle Caldwell, Dr David Crookes, Mr Tom Divers, Dr Peter Donnan, Mr Jim Eadie, Mr John Glennie, Dr Barclay Goudie
Dr John Haughney, Dr Jan Jones, Dr Grace Lindsay, Dr Chris Lush, Ms Angela Munday, Ms Wendy Nganasurian, Dr Ken Paterson, Ms Fiona Ramsay, Dr Nick Reed, Ms Angela Timoney, Ms Helen Tyrrell, Dr John Webster

In Attendance: Dr Jennifer  Armstrong, Ms Ailsa Brown, Dr Sara Davies, Mr Steven Fenocchi,
Mr Stephen Ferguson, Ms Sharon Hems, Dr Harpreet Kohli, Mrs Anne Lee, Ms Ailene Muir, Mr Colin McAllister, Mrs Laura McIver, Miss Rosie Murray, Mrs Maureen Stark

Apologies: Professor James Barbour, Ms Rosaleen Beattie, Mr Nick Brown, Mr John Glennie,
Mrs Hazel Illingworth, Dr Graham Lowe, Mrs Pat Murray, Ms Corinne O¡¦Dowd, Dr Andrew Power,
Dr Andrew Riley, Dr Philip Rutledge, Dr Sandy Simpson, Dr Sarah Taylor, Dr Andrew Walker,
Mr Mike Wallace, Mr Derek Yuille

1 Welcome and Apologies for Absence

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

1.2 Thanks were given to Ms Michele Caldwell and Mr Derek Yuille, whose terms of membership on SMC has ended for their invaluable contribution to SMC. Unfortunately,Derek was unable to attend his last meeting of SMC.

1.3 A welcome was extended to Mrs Ailsa Brown who has been appointed to a health economist post within NHS Quality Improvement Scotland (NHS QIS) with a major commitment to SMC. Ailsa will undertake SMC reviews and work on educational activities that will be made available to new and existing members of NDC and SMC.  Ailsa was previously employed by Greater Glasgow NHS Board and has been undertaking economic reviews for NDC for the last 3 years.

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 4 July 2006 were agreed as an accurate record.

4 Matters Arising From the Previous Minutes

Independent Review Panel

4.1 pregabalin (Lyrica)  Pfizer  (No. 157/05)  

The SMC advice for pregabalin (Lyrica), for the treatment of peripheral neuropathic pain, will be posted on the SMC website on Monday 7 August 2006.

Full Submissions

4.2 lanthanum carbonate (Fosrenol) Shire Pharmaceuticals Contract Ltd (No 286/06)

4.2.1 The SMC advice for lanthanum carbonate (Fosrenol), for the treatment of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD), will be withheld pending confirmation of launch.

4.3 fondaparinux sodium (Arixtra) VTE abdominal surgery GlaxoSmithKline (No 287/06)

4.3.1 The SMC advice for fondaparinux sodium (Arixtra), for the prevention of venous thromboembolic events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, will be posted on the SMC website on Monday 7 August 2006.

4.4 paricalcitol (Zemplar) Abbott (No 288/06)

4.4.1 The SMC advice for paricalcitol (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 7 August 2006.

4.5 rotigotine (Neupro) Schwarz Pharma (No 289/06)

4.5.1 The SMC advice for rotigotine (Neupro), for the treatment of the signs and symptoms of early-stage idiopathic Parkinson¡¦s disease as monotherapy (i.e.without levodopa), will be posted on the SMC website on Monday 7 August 2006.

4.6 pegaptanib sodium (Macugen) Pfizer Ltd (No 290/06)

4.6.1 The SMC advice for pegaptanib sodium (Macugen), for the treatment of neovascular (wet) age-related macular degeneration (AMD), will be posted on the SMC website on Monday 7 August 2006. A minor amendment has been made within the comparator section of the Detailed Advice Document (DAD) and the revised DAD will be reissued to ADTCs and NHS Boards on Friday 4 August.

4.6.2 There was discussion regarding whether pegaptanib sodium (Macugen) merited unique status.  The Chief Pharmaceutical Adviser to SMC presented a document which provided clarity about the licensed indication and use in Scotland and the group agreed that on review of this information pegaptanib should not be classified as unique. 

Abbreviated Submissions

4.7 ertapenem sodium (Invanz) paediatric Merck Sharp & Dohme (No.291/06)

4.7.1 The SMC advice for ertapenem sodium (Invanz) paediatric, for the treatment of intra-abdominal infections, will be posted on the SMC website on Monday 7 August 2006.

4.8 salmeterol (Serevent Evohaler) GlaxoSmithKline (No.292/06)

4.8.1 The SMC advice for salmeterol (Serevent Evohaler), for the regular symptomatic treatment of reversible airways obstruction in patients with asthma, including those with nocturnal asthma or chronic obstructive pulmonary disease (COPD), and the prevention of exercise-induced asthma, will be posted on the SMC website on Monday 7 August 2006.

4.9 dorzolamide hydrochloride timolol maleate (COSOPT) Merck Sharp & Dohme (No.293/06)

4.9.1 The SMC advice for dorzolamide hydrochloride timolol maleate (COSOPT), for the treatment of elevated intra-ocular pressure (IOP) in patients with open-angle glaucoma or pseudo-exfoliative glaucoma when topical beta-blocker monotherapy is not sufficient, will be withheld pending confirmation of launch.

4.10 travoprost/timolol (DUOTRAV) Alcon Laboratories (UK) Ltd (No.294/06)

4.10.1 The SMC advice for travoprost/timolol (DUOTRAV), for decrease of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues, will be posted on the SMC website on Monday 7 August 2006.

The manufacturer have highlighted an error within product update which states ¡§travoprost 4%¡¨ when it should state travoprost concentration is 40 micrograms/ml or 0.004%. This has been amended and the revised product update will be reissued to ADTCs and NHS Boards on Friday 4 August.

4.11 100mg/losartan potassium/12.5mg hydrochlorothiazide (Cozaar-Comp 100/12.5) Merck, Sharp & Dohme Ltd  (No: 295/06) 

4.11.1 The SMC advice for 100mg/losartan potassium/12.5mg hydrochlorothiazide (Cozaar-Comp 100/12.5), for the treatment of hypertension in patients whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy, will be withheld pending confirmation of launch.

4.12 100mg/losartan potassium/25mg hydrochlorothiazide (Cozaar-Comp 100/25)  Merck, Sharp & Dohme Ltd  (No: 296/06) 

4.12.1 The SMC advice for 100mg/losartan potassium/25mg hydrochlorothiazide (Cozaar-Comp 100/25), for the treatment of essential hypertension in patients, whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy, will be posted on the SMC website on Monday 7 August 2006.

Non-Submissions

4.13 testosterone (Nebido) 1000mg/4ml, solution for injection Schering Health Care Ltd (No 308/06)

4.13.1 The SMC advice for testosterone (Nedido), for the treatment of male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests, will be posted on the SMC website on Monday 7 August 2006.

4.14 carbetocin (Pabal) Ferring Pharmaceuticals Ltd (No 309/06)

4.14.1 The SMC advice for carbetocin (Pabal), for the prevention of uterine atony and excessive bleeding following delivery of the infant by caesarean section under epidural or spinal anaesthesia, will be posted on the SMC website on Monday 7 August 2006.

4.15 rivastigmine (Exelon) Novartis (No 310/06)

4.15.1 The SMC advice for rivastigmine (Exelon), for the treatment of mild to moderately severe dementia in patients with idiopathic Parkinson¡¦s disease, will be posted on the SMC website on Monday 7 August 2006.

5 Appeals Update

5.1 Nothing to report.


6 PAPIG

6.1 The minutes of the meeting of 4 July, 2006, were reviewed.  It was noted that these are in draft format and will be ratified by PAPIG at their meeting in September, 2006. 

An update was provided regarding the number of patient interest group submissions received to date.  The Chairman stated that the statistics were encouraging and he was pleased to see the rise in PIG submissions. 

At present representatives of patient groups who have made a submission to SMC are invited to attend a meeting as an observer, the Chairman advised that it would also be appropriate to invite representatives of patient groups who have not yet made a PIG submission to SMC to give them an insight into the process.

It was reported that volunteers within the organisation are now to be referred to as Public Partners and should no longer to be referred to as ¡§lay reviewers¡¨. The new name of Public Partner was formally launched at the Public Partners Conference held in Stirling recently and was chosen as it best reflects the new and developing role of lay people working across all NHS Quality Improvement Scotland. 

7 New Drugs Committee: Chairman's report

7.1 NDC Representative, SMC User Group Forum

Ms Sheena Kerr, Principal Pharmacist, Medicines Information Service, Royal Infirmary of Edinburgh, has agreed to replace Dr Andrew Power as NDC representative on the SMC User Group Forum.

7.2 NDC Representative, Health Economic Sub Group

Dr Scott Bryson, Pharmaceutical Policy Adviser, Greater Glasgow NHS Board, has agreed to represent NDC on the Health Economic Sub Group.


8 Chairman's Business

8.1 Tacrolimus ointment 0.1% and 0.03% (Protopic)   Fujisawa  (No. 12/02)

8.1.1 Topical tacrolimus (Protopic) has recently undergone a European Safety Review in which it has been reported that it has been associated with reports of skin cancers, lymphomas and other cancers.  Elidel Cream should now only be used as a second line treatment for mild or moderate Atopic Dermatitis, in line with SMC Advice.

8.2 Freedom of Information

8.2.1 SMC have actioned a request under the Freedom of Information (Scotland) Act 2002 from Dr Chris Poole, Senior Research Pharmacist, Cardiff Research Consortium, Cardiff MediCentre, Heath Park, Cardiff, requesting the company submission and Detailed Advice Document (DAD) with regards to the resubmission for clostridium botulinum toxin A (Botox) for focal spasticity following stroke.   The information requested was sent to the enquirer on Friday 28 July, 2006.

8.3 Holyrood News:  Issue 47, July 2006

8.3.1 An article with regards to SMC, horizon scanning and Freedom of Information has been published in the July issue of Holyrood News.  The secretariat will circulate the relevant section of this document to SMC members for information.

8.4 Deferred Submissions Pending Launch

8.4.1 pioglitazone/metformin (Competact) Takeda UK (No. 252/06)

SMC reviewed pioglitazone/metformin (Competact), for the treatment of type 2 diabetes, as an abbreviated submission in April 2006.  Distribution of advice was withheld pending launch.  The product has now launched and advice will be distributed to NHSScotland on 4 August, 2006 and posted on the SMC website on 11 September, 2006.

8.4.2 inhaled insulin, 1mg and 3mg inhalation powder (Exubera)  Pfizer Ltd  No. 254/06

SMC reviewed inhaled insulin (Exubera), for the treatment of adult patients with type 2 diabetes mellitus, in April 2006.  Distribution of advice was withheld pending launch.  The product has now launched and advice will be distributed to NHSScotland on 4 August, 2006 and posted on the SMC website on 11 September, 2006.

8.5 SMC Meeting January 2007

8.5.1 Due to the New Year public holiday, SMC are unable to meet on the first Tuesday of the month as scheduled. The Chairman proposed that the meeting is either held on Wednesday 3 January, 2007 or to postpone the meeting by one week to Tuesday 9 January, 2007. He requested members advise the secretariat regarding their availability and preference to meet on either 3 or 9 January, 2007. The preferred option will be reported at the next meeting of SMC.

9 NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 duloxetine (Cymbalta) DPNP Eli Lilly and Company Ltd (No 285/06)

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

9.1.2 The NDC Lead Assessor provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company. A revised copy of the NDC draft Advice, economic checklist, economic recalculation based on the drug tariff and additional sensitivity analysis of the budget impact were tabled for review. A member of PAPIG presented a Patient Interest Group submission from Diabetes UK Scotland. Detailed discussion followed and the group agreed that duloxetine (Cymbalta), for the treatment of diabetic peripheral neuropathic pain (DPNP) in adults, should be accepted for restricted 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.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 August 2006.

9.2 topiramate (Topamax)  Janssen-Cilag Ltd  (No: 297/06)

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

9.2.2 The NDC Vice Chairman provided a detailed 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 Migraine Action Association. Detailed discussion followed and the group agreed that topiramate (Topamax), for the prophylaxis of migraine headache in adults, should be accepted for restricted 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.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 August 2006.

9.3 insulin glulisine (Apidra) Sanofi-Aventis (No: 298/06)

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

9.3.2 The SMC Vice Chairman provided a detailed 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 Diabetes UK Scotland.  Detailed discussion followed and the group agreed that insulin glulisine (Apidra), for the treatment of adult patients with diabetes mellitus, should be accepted for restricted 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.

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 August 2006.

9.4 carglumic acid (Carbaglu)  Orphan Europe (UK) Ltd  (No:  299/06)

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

9.4.2 The SMC Vice Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed to consider the advice further.  It was therefore decided to defer carglumic acid (Carbaglu) for the treatment of hyperammonaemia due to N-acetylglutamate synthase deficiency, for review at the September meeting of SMC.

9.5 ibandronic acid 3mg/3ml solution injection (Bonviva)  Roche/GSK  (No: 301/06) 

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

The NDC Vice Chairman 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 the National Osteoporosis Society.  Detailed discussion followed and the group agreed that ibandronic acid 3mg/3ml solution injection (Bonviva), for the treatment of osteoporosis in postmenopausal women in order to reduce the risk of vertebral fractures, should be accepted for restricted use within NHS Scotland. Assessors, in liaison with the secretariat, to make the appropriate amendments for review by the Chairman prior to distribution of the advice.

The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 August 2006.

9.6 bortezomib (Velcade) Ortho Biotech  (No:  302/06) 

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

9.6.2 The SMC Vice Chairman 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 the International Myeloma Foundation. Detailed discussion followed and the group agreed that bortezomib (Velcade), as mono-therapy for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation, should not be recommended for use within NHS Scotland.  Assessors, in liaison with the secretariat, to make the appropriate amendments for review by the Chairman prior to distribution of the advice.

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 August 2006.

9.7 nebivolol (Nebilet) A  Menarini Pharma Ltd  (No: 214/05)

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

9.7.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that nebivolol (Nebilet), for the treatment of stable mild and moderate chronic heart failure (CHF) in addition to standard therapies in elderly patients „d70 years, should not be recommended for use within NHS Scotland.  Assessors, in liaison with the secretariat, to make the appropriate amendments for review by the Chairman prior to distribution of the advice.

9.7.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 August 2006.

RESUBMISSIONS

9.8 tipranavir (Aptivus)  Boehringer Ingelheim Limited  (No: 226/05)

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

9.8.2 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 HIV Scotland which was provided with the original submission.  Detailed discussion followed and the group agreed that tipranavir (Aptivus), in combination with low dose ritonavir for the treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors, should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the secretariat, to make the appropriate amendments for review by the Chairman prior to distribution of the advice.

9.8.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 August 2006.

ABBREVIATED SUBMISSIONS

9.9 etanercept (Enbrel) (AS) Wyeth Pharmaceuticals (No:303/06)

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

9.9.2 The SMC Vice Chairman provided an overview of the assessment and draft summary of advice. Discussion followed and the group concluded their advice for etanercept (Enbrel) for the treatment of adults with severe ankylosing spondylitis who have had an inadequate response to conventional therapy.

9.9.3 The SMC advice will be withheld pending confirmation of launch.

9.10 etanercept (Enbrel) (PsA)  Wyeth Pharmaceuticals (No: 304/06)

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

9.10.2 The SMC Vice Chairman provided an overview of the assessment and the draft summary of advice.  Discussion followed and the group concluded their advice for etanercept (Enbrel) for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.

9.10.3 The SMC advice will be withheld pending confirmation of launch.

9.11 etanercept (Enbrel) (RA)  Wyeth Pharmaceuticals (No: 305/06)

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

9.11.2 The SMC Vice Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that etanercept (Enbrel), for the treatment of patients with rheumatoid arthritis, should be accepted 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.

9.11.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 August 2006.

9.12 budesonide 200mcg inhalation powder (Novolizer Budesonide) Meda Pharmaceuticals Ltd (No:306/06)

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

9.12.2 The SMC Vice Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that budesonide 200mcg inhalation powder (Novolizer Budesonide), for the treatment of persistent asthma in adults and children over 6 years of age, should be accepted 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.

9.12.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 August 2006.

9.13 donepezil 5 & 10mg orodispersible (Aricept)  Eisai Ltd  (No: 307/06)

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

9.13.2 The SMC Vice Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group concluded their advice for donepezil 5 & 10mg orodispersible (Aricept), for symptomatic treatment of mild to moderately severe Alzheimer's dementia.

9.13.3 The SMC advice will be withheld pending confirmation of launch.

10 SMC Evaluation

10.1 The Chief Pharmaceutical Adviser to SMC reported that the evaluation programme is progressing well and a progress report will be presented to SMC in September.

11 Forthcoming Submissions

11.1 A list of forthcoming submissions was noted.

12 ADTC Feedback

12.1 Dr John Webster requested clarity regarding the status of SMC advice for tacrolimus ointment 0.1% and 0.03% (Protopic) No. 12/02 and Pimecrolimus cream (Elidel„¥) (No. 35/03) in view of the NICE guidance. He highlighted the SMC advice for tacrolimus (Protopic) states that in order to facilitate future investigation of long-term effects of the use of tacrolimus ointment, a register of recipients should be established and maintained and he asked if this practice should be continued.

The Chairman confirmed that NHS Quality Improvement Scotland reviews NICE Multiple Technology Appraisals and decides whether the recommendations should apply in Scotland. Where NHS QIS decides that a Multiple Technology Appraisal (MTA) should apply in Scotland, the NICE guidance supersedes SMC advice.  He did, however, suggest that it would be good clinical practice to continue to audit the use of tacrolimus. 

13 Any Other Business

13.1 Preliminary Research on Patient Safety

An update was requested regarding SMC involvement in the preliminary proposal regarding patient safety in relation to drug administration and prescribing. The SMC Chairman advised that this will be discussed at a meeting with the CMO in October and the outcome will be reported at a future meeting of SMC. 

14 Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 5 September 2006 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.