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SMC Minutes - Tuesday, 7 February 2006

Minutes of Meeting held on Tuesday, 7 February 2006
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Mrs Laura Ace, Professor James Barbour, Dr Keith Beard, Mrs Marion Bennie, Mrs Barbara Black, Dr Keith Brown, Professor John Cairns, Mrs Michelle Caldwell, Dr Carol Davidson, Mr Tom Divers, Dr Peter Donnan, Dr Barclay Goudie, Dr John Haughney, Dr David Hood, Mrs Moira Howie, Dr Jan Jones, Dr Harpreet Kohli, Ms Grace Lindsay, Dr Chris Lush, Mrs Angela Munday, Ms Wendy Nganasurian, Dr Marianne Nicolson, Mr Chris Nicholson, Dr Ken Paterson, Mrs Fiona Ramsay, Ms Angela Timoney, Mr Mike Wallace,
Dr John Webster, Mr Derek Yuille

In Attendance: Dr Jennifer Armstrong, Mr Nick Brown, Mr Dave Carson, Mr Jim Eadie, Dr Jonathan Fox, Mrs Hazel Illingworth, Mrs Anne Lee, Ms Lesley Michels, Miss Rosie Murray, Mr Samuel Oduro, Ms Neetu Ram, Mrs Maureen Stark, Mrs Emma Stoica

Apologies: Dr David Crookes, Ms Sara Davies, Mr John Glennie, Dr Graham Lowe, Mr Colin McAllister, Mrs Laura McIver, Mrs Pat Murray, Dr Andrew Riley, Dr Philip Rutledge, Dr Sandy Simpson, Mrs Helen Tyrrell, Dr Andrew Walker

1. Welcome and Apologies for Absence

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

1.2 Dr Carol Davidson, Director of Public Health, Ayrshire and Arran NHS Board, who will attend SMC for the next few months in place of Dr A Riley, was welcomed.

1.3 A welcome was extended to the following who were observing the work of the SMC:

  • Mr Nick Brown, Branch Head, Health Quality and Safety, Scottish Executive (SE).  Nick replaces Hector Mackenzie as SE representative on SMC
  • Mr Dave Carson, Head of Financial Performance Monitoring, Tayside Health Board, who will provide finance input to the horizon scanning initiative
  • Mr Jim Eadie, Director, ABPI Scotland
  • Dr Jonathan Fox, NDC member
  • Ms Lesley Michels, recently appointed member of Pharmacy Assessment Team
  • Mrs Hazel Illingworth and Mrs Emma Stoica, recently appointed SMC Co-ordinators
  • Dr Samuel Oduro and Ms Neetu Ram, recently appointed support staff to the SMC Evaluation Programme

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 - 4 January 2006

3.1 The minutes of the meeting held on 4 January 2006 were agreed as an accurate record with minor amendments noted.

4. Matters Arising From the Previous Minutes

Abbreviated Submission Process

The SMC Vice Chairman gave an update on the short-life working group which met before the SMC meeting to review the current process with regards to abbreviated submissions and improvements that could be made to the process.

Amendments to the process were agreed and it is hoped that the changes will provide increased structure and clarity to the process.   Revisions will be presented to the next meeting of SMC User Group Forum (to be held on 28 February 2006) in advance of implementation.

Prescription Medicine - Code of Practice Authority

A presentation was given by Mr Mike Wallace regarding the ABPI Code of Practice review.

Working Definitions for SMC

A paper prepared by Mr Mike Wallace, regarding working definitions for SMC, for terms such as marketing authorisation and product launch, was tabled for review.  This paper was designed to share with SMC how definitions are regarded within industry.  Members agreed that this is a helpful guide. Mr Wallace expressed thanks to members of industry who had assisted with refining the definitions.

Full Submissions

4.1 tramadol HCl/paracetamol (Tramacet)  Janssen-Cilag  (No. 236/06)

4.1.1 SMC advice for tramadol HCl/paracetamol (Tramacet), for the symptomatic treatment of moderate to severe pain will be posted on the SMC website on Monday 13 February, 2006.

4.2 sildenafil citrate (Revatio)  Pfizer Ltd  (No. 235/06)

4.2.1 SMC advice for sildenafil citrate (Revatio), for the treatment of patients with pulmonary arterial hypertension classified as WHO functional class III, to improve exercise capacity will be withheld pending confirmation of launch.

4.3 buprenorphine (BuTrans transdermal patches)  Napp Pharmaceuticals   (No. 234/06)

4.3.1 SMC advice for buprenorphine (BuTrans transdermal patches), 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 13 February, 2006.

4.4 ibandronate (Bonviva)  Roche  (No. 228/05)

4.4.1 SMC advice for ibandronate (Bonviva), for the treatment of osteoporosis in postmenopausal women in order to reduce the risk of vertebral fractures, will be posted on the SMC website on Monday 13 February, 2006.  Further to discussion with the company there has been a minor amendment to the advice and this will be reissued to NHSScotland on Friday 10 February, 2006.

Resubmissions

4.5 nicotinic acid (Niaspan)  Merck Pharmaceuticals  (No. 93/04)

4.5.1 SMC advice for nicotinic acid (Niaspan), for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia, will be posted on the SMC website on Monday 13 February, 2006.

4.6 emtricitabine (Emtriva)  Gilead Sciences Ltd  (No. 105/04)

4.6.1 The SMC advice for emtricitabine (Emtriva), for the treatment of Human Immunodeficiency Virus (HIV-1) infected adults, in combination with other antiretroviral agents, will be posted on the SMC website on Monday 13 February, 2006.  Following comments from a comparator company, minor amendments have been made to the Detailed Advice Document (DAD) and the amended DAD will be reissued to NHSScotland on Friday 10 February, 2006.

Abbreviated Submissions

4.7 emtricitabine/tenofovir disoproxil (Truvada) Gilead Sciences Limited  (No.  237/06)

4.7.1 SMC advice for emtricitabin/tenofovir disoproxil (Truvada), for the treatment of Human Immunodeficiency Virus (HIV-1) infected adults, in combination with other antiretroviral medicinal products, will be posted on the SMC website on Monday 13 February, 2006.

4.8 clarithromycin 125 mg, 187.5 mg, 250 mg granules for oral suspension (ClaroSip) Grunenthal Ltd  (No. 217/05)

4.8.1 SMC advice for clarithromycin 125 mg, 187.5 mg, 250 mg granules for oral suspension (ClaroSip), for the treatment of acute and chronic infections caused by clarithromycin susceptible organisms, will be posted on the SMC website on Monday 13 February, 2006.

4.9 ibuprofen intravenous injection 5mg/ml (Pedea)  Orphan Europe (UK)  (No. 233/06)

4.9.1 SMC advice for ibuprofen intravenous injection 5mg/ml (Pedea), for the treatment of haemodynamically significant patent ductus arteriosus in pre-term newborn infants of less than 34 weeks gestational age, will be posted on the SMC website on Monday 13 February, 2006.

4.10 rabeprazole sodium (Pariet)  Eisai Ltd  (No. 232/06)

4.10.1 SMC advice for rabeprazole sodium (Pariet), for the treatment of Zollinger-Ellison syndrome, will be posted on the SMC website on Monday 13 February, 2006.

4.11 lanreotide (INN BAN) (Somatuline LA)  Ipsen Ltd  (No. 231/06)

4.11.1 SMC agreed that lanreotide (INN BAN) (Somatuline LA), for the treatment of thyrotrophic adenomas when the circulating level of thyroid stimulating hormone remains inappropriately high after surgery and/or radiotherapy, was not suitable for review as an abbreviated submission and a full submission has been requested from the company.

4.12 formoterol 12 micrograms metered dose inhaler (Atimos Modulite) Trinity Chiesi
(No. 239/06)

4.12.1 SMC advice for formoterol (Atimos Modulite), for the long-term symptomatic treatment of persistent, moderate to severe asthma in patients requiring regular bronchodilator therapy, in combination with long-term anti-inflammatory therapy, (inhaled and/or oral glucocorticoids), will be posted on the SMC website on Monday 13 February, 2006.

5. Appeals Update

5.1 Pregabalin (Lyrica)

Pfizer have submitted additional information for pregabalin (Lyrica) for the treatment of peripheral neuropathic pain for review by IRP.  A panel is currently being sourced and it is anticipated the review will take place in May/June 2006.

6. PAPIG

6.1 A verbal update was given regarding the PAPIG meeting held prior to the SMC meeting. A note will be available at the next SMC meeting.

6.1.1 A verbal update was provided regarding the response made by PAPIG to the NHS QIS consultation ¿Refreshing the NHS QIS patient and public partnership - a Reform Agenda¿ and to the NICE STA consultation document.

6.1.2 Thanks were expressed to Moira Howie who attended her last PAPIG meeting. As Mrs Howie is due to leave SMC in April 2006, it was suggested that her replacement take her place on PAPIG. An invitation was extended to other SMC members to join PAPIG. 

6.2 SMC Evaluation

6.2.1 The NDC Vice Chairman gave an update on the progress with regards to the evaluation program. It was noted that appointments have been made to the Evaluation Team and nominations from ABPI have been announced. 

6.2.2 A request was made to consider bringing forward the timelines with regards to specification of some areas of the work. 

7. New Drugs Committee: Chairman's report

7.1 Nothing to report.

8. Chairman's Business

8.1 NICE Consultation on STA Process

8.1.1 The Chairman reported that the SMC response to the NICE STA Consultation had been revised in line with discussions at the January meeting of SMC and forwarded to NICE for review. The Secretariat will circulate the SMC response to all SMC members for information.

8.2 Non-submissions

8.2.1 A report outlining the current position with regards to non-submissions was tabled for review.  It is anticipated that SMC will issue a number of 'not recommended' statements to companies who have failed to make a submission to SMC following request within a specific timeframe.

8.3 SMC/NDC Membership

8.3.1 Rotation of membership is currently under review. Members who are due to leave the committee at the end of March 2006 will be informed, but may be asked to extend their membership if new members are not available to commence in April 2006.

8.4 beclometasine dispropionate (Clenil Modulite)

8.4.1 Beclometasine dispropionate (Clenil Modulite) for the prophylactic management of mild, moderate or severe asthma in adults or children, was considered by SMC in April 2005 but advice was withheld pending launch.  Further to confirmation from the company regarding launch in mid January, advice was distributed to NHSScotland on 6 January, 2006 and was due for publication on the SMC website on Monday 13 February, 2006. The company has now advised that the product is not going to be launched in the foreseeable future. The secretariat will write to NHSScotland advising of this.

9. NDC Assessment Reports - Full Submissions

9.1 aprepitant (Emend)  Merck Sharp & Dohme  (No: 242/06)

9.1.1 Declarations of interest were recorded in relation to this product/comparator drugs. A member with a personal specific interest left the room for this part of the agenda.

9.1.2 The NDC Vice Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments from the company.  Detailed discussion followed and the group agreed that aprepitant (Emend), for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, should not be recommended for use within NHS Scotland.  Assessors, in liaison with the secretariat, are 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 10 February, 2006.

9.2 rasagiline 1mg (Azilect)  Lundbeck Ltd/Teva Pharmaceuticals Ltd  (No.  243/06)

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

9.2.2 The NDC 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 Parkinson's Disease Society for the UK. Detailed discussion followed and the group agreed that rasagiline 1mg (Azilect), for the treatment of idiopathic Parkinson's disease as monotherapy (without levodopa), should not be recommended for use within NHS Scotland.  Assessors, in liaison with the secretariat, are 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 10 February, 2006.

9.3 rasagiline 1mg (Azilect)  Lundbeck Ltd/Teva Pharmaceuticals Ltd  (No.  255/06)

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

9.3.2 The NDC 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 Parkinson's Disease Society for the UK. Detailed discussion followed and the group agreed that rasagiline 1mg (Azilect), for the treatment of idiopathic Parkinson's disease as adjunct therapy (with levodopa), should not be recommended for use within NHS Scotland.  Assessors, in liaison with the secretariat, are 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 10 February, 2006.

9.4 temozolomide 5, 20, 100 and 250mg capsules (Temodal)  Schering-Plough UK Ltd (No. 244/06)

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

9.4.2 The NDC Lead Assessor provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that temozolomide (Temodal), for the treatment of newly diagnosed glioblastoma multiforme (GBM), concomitantly with radiotherapy and subsequently as monotherapy treatment, should not be recommended for use within NHS Scotland.  Assessors, in liaison with the secretariat, are to make appropriate amendments for review by the Chairman prior to distribution of the advice. 

9.4.3The SMC advice will be issued to ADTCs and NHS Boards on Friday 10 February, 2006.

9.5 lumiracoxib 100 mg tablets (Prexige)  Novartis  (No.  245/06)

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

9.5.2 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 that lumiracoxib (Prexige), for symptomatic relief in the treatment of osteoarthritis, should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the secretariat, are 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 ADTCs and NHS Boards on Friday 10 February, 2006.

Resubmissions

9.6 ropinirole (Adartrel)  GlaxoSmithKline  (No. 165/05)

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

9.6.2 The NDC Vice Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company. A Patient Interest Group submission from Ekbom Support Group which was received with the original submission was reconsidered. Detailed discussion followed and the group concluded their advice for ropinirole (Adartrel), for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome.

9.6.3 The SMC advice to ADTCs and NHS Boards will be withheld pending confirmation of launch.

9.7 modafinil (Provigil)  Cephalon  (No.  63/03)

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

9.7.2 The NDC Chairman provided an overview of the assessment, the draft advice, expert comments from the original review and the resubmission and comments received from the company. Detailed discussion followed and the group agreed that modafinil (Provigil), for the treatment of excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome, should not be recommended for use within NHS Scotland.  Assessors, in liaison with the secretariat, are 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 ADTCs and NHS Boards on Friday 10 February, 2006.

Abbreviated Submissions

9.8 somatropin (Genotropin)  Pfizer  (No. 240/06) 

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

9.8.2 The NDC Chairman provided an overview of the assessment and draft summary of advice. Discussion followed and the group agreed that somatropin (genotropin), for the treatment of growth disturbance in short children born small for gestational age (SGA), with a birth weight and/or length below -2 Standard Deviations, who failed to show catch-up growth (Height velocity SDS < 0 during the last year) by 4 years of age or later, should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the secretariat, are to make 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 10 February, 2006.

9.9 budesonide inhalation powder 100, 200, 400mcg (Budesonide Easyhaler)

9.9.1 No declarations of interest were recorded in relation to this product/comparator drugs.

9.9.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that budesonide inhalation powder 100, 200, 400mcg (Budesonide Easyhaler), for the treatment of mild, moderate or severe 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, are to make appropriate amendments for review by the Chairman prior to distribution of the advice. 

9.9.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 10 February, 2006.

9.10 dorzolamide hydrochloride (Trusopt)  Merck Sharp and Dohme  (No. 238/06)

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

9.10.2 The NDC Chairman provided an overview of the assessment and draft summary of advice. Discussion followed and the group concluded their advice for dorzolamide hydrochloride (Trusopt), for the treatment of elevated ocular pressure in ocular hypertension, open-angle glaucoma and pseudo-exfoliative glaucoma.

9.10.3 The SMC advice to ADTCs and NHS Boards will be withheld pending confirmation of launch.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled for review.

11. ADTC Feedback

11.1 It was reported that the ADTCs of Glasgow and Argyll and Clyde are involved in merger discussions.  This is likely to be a phased process, the outcome of which will be reported in due course.

12. Any Other Business

12.1 No other business was reported.

13. Date of Next Meeting

13.1 The date of the next meeting was confirmed as Tuesday, 7 March, 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.

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