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Minutes of the SMC Meeting held on Tuesday 8 January 2008

Minutes of the SMC Meeting held on Tuesday 08 January 2008
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Professor James Barbour, Dr Keith Beard, Dr Keith Brown, Professor John Cairns, Mr David Carson, Dr David Crookes, Mr Tom Divers, Dr Barclay Goudie, Dr Jan Jones,Dr Graham Lowe, Dr Chris Lush, Dr Alan MacDonald, Mr Billy Malcolm, Ms Aileen Muir, Dr Ken Paterson, Dr Andrew Power, Dr Nick Reed, Dr Sandy Simpson, Dr Sarah Taylor, Ms Angela Timoney, Mrs Sheila Tunstall-James, Mr Mike Wallace

In Attendance: Dr Maura Briscoe, Ms Ailsa Brown, Mr Gerard Collins, Dr Sara Davies, Mr Steven Fenocchi, Mr Stephen Ferguson, Mrs Laura McIver, Ms Rosie Murray, Ms Pauline O’Conner, Mrs Emma Riches, Mrs Maureen Stark, Mr Mark Timoney, Dr Matthew Walters

Apologies: Mrs Laura Ace, Mrs Marion Bennie, Mr Colin Brown, Dr Jonathan Fox, Mrs Hazel Illingworth, Dr Harpreet Kohli,  Mrs Anne Lee, Dr Grace Lindsay, Mr Colin McAllister, Dr John McElhinney, Mrs Pat Murray, Professor Dilip Nathwani, Mrs Wendy Nganasurian, Ms Fiona Ramsay, Dr Andrew Riley, Ms Alex Robertson, Dr Andrew Walker, Mr Alistair Thorburn, Professor Tony Wells

 1.Welcome and Apologies for Absence

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

Following an earlier introductory meeting with SMC, representatives from the Department of Health, Northern Ireland observed the meeting to help them better understand the SMC process:  

Dr Maura Briscoe, Senior Medical Officer and Director, Safety, Quality and Standards Directorate, Department of Health, Social Services and Public Safety, (DHSSPS), Northern Ireland
 
Mr Gerard Collins, Deputy Director, Head of Standards and Guidelines Unit, Department of Health, Social Services and Public Safety, (DHSSPS), Northern Ireland
 
Mr Mark Timoney, Senior Pharmaceutical Officer, Department of Health, Social Services and Public Safety, (DHSSPS), Northern Ireland
 
The Chairman also welcomed the following individuals, who were observing the meeting:

Trevor McGoldrick, Clinical Lecturer in Cancer Therapeutics, Clinical Pharmacology Unit, Centre for Cardiovascular Science, University of Edinburgh

Pauline O’Conner, Pharmacist (Cancer), supporting the SMC Horizon Scanning 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

3.1 The minutes of the SMC meeting held on 04 December 2007 were agreed as an accurate record.

4. Matters Arising From the Previous Minutes

Full Submissions

4.1 Vildagliptin 50mg and 100mg tablets (Galvus) Novartis (No. 435/07)

4.1.1 The SMC advice for vildagliptin (Galvus), for the treatment of type 2 diabetes mellitus (T2DM), will be withheld pending confirmation of licence and availability.

4.1.2 It was noted that the European CHMP have recently issued a positive opinion on approval of a lower 50mg daily dose of vildagliptin (Galvus) in this indication.

Resubmissions

4.2 standardised allergen extract of grass pollen from Timothy (Phleum Pratense) 75,000 SQ-T per oral lyophilisate (Grazax®)  ALK-Abell? Ltd  (No. 367/07)

4.2.1 The SMC advice for standardised allergen extract of grass pollen from Timothy (Phleum Pratense) 75,000 SQ-T per oral lyophilisate (Grazax), for the treatment of grass pollen induced rhinitis and conjunctivitis, will be posted on the SMC website on Monday, 14 January 2008.

Abbreviated Submissions

4.3 latanoprost, timolol eyedrops (Xalacom®) Pfizer Ltd (No. 432/07)

4.3.1 The SMC advice for latanoprost, timolol eyedrops (Xalacom), for reduction of raised intraocular pressure in patients with open angle glaucoma and ocular hypertension, will be posted on the SMC website on Monday, 14 January 2008.

4.4 quetiapine 50mg, 200mg, 300mg and 400mg prolonged release tablet (Seroquel SR)  AstraZeneca UK Ltd  (No. 433/07)

4.4.1 The SMC advice for quetiapine (Seroquel SR), for the treatment of schizophrenia and manic episodes associated with bipolar disorder, will be withheld pending confirmation of licence and availability.

Deferred Advice

4.5 mesalazine modified release tablets 800mg (Asacol) Procter and Gamble Pharmaceuticals UK Ltd  (No. 222/05)

4.5.1 Mesalazine modified release tablets 800mg (Asacol) for the treatment of moderate acute exacerbations of ulcerative colitis up to a maximum dose of 4.8g daily.

4.5.2 This product was reviewed by SMC in December 2005 and the advice was withheld pending confirmation of licence and availability.  The product is now available and the advice will be sent to NHS Scotland on Friday, 11 January 2008 and posted on the SMC website on Monday, 11 February 2008.

4.6 mesalazine modified release tablets 800mg (Asacol) Procter and Gamble Pharmaceuticals UK Ltd (No. 223/05)

4.6.1 Mesalazine modified release tablets 800mg (Asacol) for the treatment of mild acute exacerbations of ulcerative colitis.

4.6.2 This product was reviewed by SMC in December 2005 and the advice was withheld pending confirmation of licence and availability.  The product is now available and the advice will be sent to NHS Scotland on Friday, 11 January 2008 and posted on the SMC website on Monday, 11 February 2008.

4.7 mesalazine modified release tablet 800mg (Asacol) Procter and Gamble Pharmaceuticals UK Ltd (No. 224/05)

4.7.1 Mesalazine modified release tablet 800mg (Asacol) for the maintenance of remission in ulcerative colitis and Crohn’s ileo-colitis.

4.7.2 This product was reviewed by SMC in December 2005 and the advice was withheld pending confirmation of licence and availability.  The product is now available and the advice will be sent to NHS Scotland on Friday, 11 January 2008 and posted on the SMC website on Monday, 11 February 2008.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 The Appointment of New Public Partners

Mr Keith Thompson and Mrs Margo Biggs have accepted appointments to SMC as Public Partner members.   They will observe their first meeting of SMC in February 2008.

7. New Drugs Committee Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 SMC Briefing Note

The first SMC Briefing Note was published on the SMC website on Monday 10 December 2007.  The briefing note is prepared by medical writers in conjunction with SMC and aims to make the first steps towards simplifying information for the media, patients and healthcare professionals on SMC advice and how SMC reach their conclusions.

8.2 ABPI Representation on SMC

Mr Mike Wallace, a founding member of SMC, has been instrumental in fostering   positive and constructive working relationships between the pharmaceutical industry and SMC.  Whilst SMC will be very sorry to lose him, Mr Wallace will be stepping down in March 2008 and ABPI are in the process of appointing his successor.   It is anticipated that the appointee will officially join SMC in April 2008.

8.3 New Years Honours List

In recognition of his singular contributions to health care, sustained over many years and culminating in his vital role in the genesis and subsequent successful leadership of NHS Quality Improvement Scotland, Dr David Steel has been awarded an OBE in the New Years Honours List.  The Chairman extended his formal congratulations to Dr Steel on behalf of SMC.

9. NDC ASSESSMENT REPORTS

Full Submissions

9.1 telbivudine 600mg film-coated tablets (Sebivo) Novartis Pharmaceuticals UK Limited (No: 438/08)

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

9.1.2 The lead assessor provided an overview of the assessment, draft advice, and expert comments.  Detailed discussion followed and the group agreed that telbivudine 600mg film-coated tablets (Sebivo), for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase levels and histological evidence of active inflammation and/or fibrosis 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.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on 11 January 2008.

9.2 fondaparinux sodium 2.5mg/0.5ml pre-filled syringe for injection (Arixtra) GlaxoSmithKline (No: 439/08)

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

9.2.2 The NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, and comments received.  Detailed discussion followed and the group agreed that fondaparinux sodium 2.5mg/0.5ml pre-filled syringe for injection (Arixtra) for the treatment of  ST segment elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy 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.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on 11 January 2008.

9.3 nilotinib 200mg capsules (Tasigna) Novartis Pharmaceuticals UK Limited (No: 440/08)

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

9.3.2 The NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments and detailed discussion followed. However, the group wished to consider the advice further.  It was therefore agreed that it would be necessary to defer a decision on nilotinib (Tasigna), for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic  myelogenous leukaemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib,

RESUBMISSIONS

9.4 glyceryl trinitrate 0.4% rectal ointment (Rectogesic) ProStrakan (No: 200/05)

9.4.1 There were no declarations of interest 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.  Detailed discussion followed and the group agreed that glyceryl trinitrate (Rectogesic), for relief of pain associated with anal fissure 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.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on 11 January 2008.

9.5 pemetrexed 500mg powder for solution for intravenous infusion (Alimta) Eli Lilly and Company Limited (No: 342/07)

9.5.1 There was a declaration of interest 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 Vice Chair provided an overview of the assessment, draft advice, expert comments, and comments received.  A member of PAPIG presented a patient interest group submission from the Roy Castle Lung Cancer Foundation Detailed discussion followed and the group agreed that pemetrexed (Alimta), as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior 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.

9.5.3 The SMC advice will be issued to NHS Boards and ADTCs on 11 January 2008.

9.6 levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) UCB Pharma Limited  (No: 394/07)

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

9.6.2 The NDC Chairman provided an overview of the assessment, draft advice, and expert comments.  Detailed discussion followed and the group agreed that levetiracetam (Keppra), as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in children from 4 years of age with epilepsy 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.

9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on 11 January 2008.

9.7 levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) UCB Pharma Limited  (No: 395/07)

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

9.7.2 The NDC Chairman provided an overview of the assessment, draft advice, and expert comments.  Detailed discussion followed and the group agreed that levetiracetam (Keppra), as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy 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.

9.7.3 The SMC advice will be issued to NHS Boards and ADTCs on 11 January 2008.

9.8 levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) UCB Pharma Limited  (No: 396/07)

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

9.8.2 The NDC Chairman provided an overview of the assessment, draft advice, and expert comments.  Detailed discussion followed and the group agreed that levetiracetam (Keppra), as adjunctive therapy in the treatment of primary generalised tonic clonic seizures in adults and adolescents from 12 years of age with generalised idiopathic epilepsy 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.

9.8.3 The SMC advice will be issued to NHS Boards and ADTCs on 11 January 2008.

9.9 levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra) UCB Pharma Limited  (No: 397/07)

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

9.9.2 The NDC Chairman provided an overview of the assessment, draft advice, and expert comments.  Detailed discussion followed and the group agreed that levetiracetam (Keppra), as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy 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.

9.9.3 The SMC advice will be issued to NHS Boards and ADTCs on 11 January 2008.

ABBREVIATED SUBMISSIONS

9.10 clobetasol propionate 0.05% shampoo (Etrivex)  Galderma (UK) Limited (No: 434/07)

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

9.10.2 The NDC Chairman provided an overview of the assessment, draft summary of advice and comments. Discussion followed and the group agreed that clobetasol propionate 0.05% shampoo (Etrivex) for the topical treatment of moderate scalp psoriasis in adults 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.

9.10.3 The SMC advice will be issued to NHS Boards and ADTCs on 11 January 2008.

10.NON-SUBMISSIONS

10.1 colesevelam 625mg film coated tablets (Cholestagel)  Genzyme Therapeutics (No: 451/08)

10.1.1 In the absence of a submission from the holder of the marketing authorisation, colesevelam (Cholestagel), for the treatment of primary hypercholesterolaemia, co-administered with HMG-CoA reductase inhibitor (statin), as adjunctive therapy to diet to provide an additive reduction in LDL-cholesterol levels in patients not adequately controlled with a statin alone; as adjunctive therapy to diet for reduction of elevated total and LDL-cholesterol in patients with isolated primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated, should not be recommended for use within NHS Scotland.

10.1.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 11 January 2008.

10.2 trabectedin (Yondelis) 0.25mg powder for concentrate for solution for infusion  Pharma Mar, SA  (No: 452/08)

10.2.1 In the absence of a submission from the holder of the marketing authorisation, trabectedin (Yondelis), for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents, should not be recommended for use within NHS Scotland.

10.2.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 11 January 2008.

11. Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled and noted.

12. SMC User Group Forum

12.1 Nothing to report.

13. ADTC Feedback

13.1 Nothing to report.

14. Any Other Business

14.1 Nothing to report.

15. Date of the Next Meeting

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