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SMC Minutes - December 2007

Minutes of the SMC Meeting held on Tuesday 4 December 2007
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Mrs Laura Ace, Dr Keith Brown, Professor John Cairns, Mr David Carson, Dr David Crookes, Dr Jonathan Fox, Dr Barclay Goudie, Dr Harpreet Kohli, Dr Chris Lush
Mr Billy Malcolm, Ms Aileen Muir, Mrs Wendy Nganasurian, Dr Ken Paterson, Dr Andrew Power, Dr Nick Reed, Dr Sandy Simpson, Ms Angela Timoney, Mrs Sheila Tunstall-James, Mr Mike Wallace, Professor Tony Wells

In Attendance: Ms Ailsa Brown, Dr Sara Davies, Dr James Dear, Ms Susan Downie, Mr Steven Fenocchi, Mr Stephen Ferguson, Mr Craig Harrow, Mrs Hazel Illingworth, Mrs Anne Lee, Ms Corinne O’Dowd, Ms Rosie Murray, Dr Fiona Shrive Ms Jacqueline Sneddon, Mrs Maureen Stark, Dr Andrew Walker

Apologies: Professor James Barbour, Dr Keith Beard, Mrs Marion Bennie, Mr Colin Brown, Mr Tom Divers, Mr Jim Eadie, Dr Jan Jones, Dr Grace Lindsay, Dr Graham Lowe, Mr Colin McAllister, Dr Alan MacDonald, Mrs Laura McIver, Mrs Pat Murray, Professor Dilip Nathwani, Ms Fiona Ramsay, Dr Andrew Riley, Ms Alex Robertson, Dr Sarah Taylor, Mr Alistair Thorburn

1.Welcome and Apologies for Absence

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

The Chairman welcomed the following who were observing the meeting:

  • Jacqueline Sneddon, recently appointed Clinical Effectiveness Pharmacist, dealing with the ADTC, formulary and guidance in Fife.
  • Craig Harrow, SpR in Clinical Pharmacology and Therapeutics, Division of Cardiovascular & Medical Sciences, Gardner Institute, Western Infirmary, Glasgow.
  • Dr Fiona Shrive, Post-doctoral Fellow, University of Newcastle
  • Dr James Dear, Clinical Lecturer in Clinical Pharmacology and Therapeutics, University of Edinburgh.

Thank you and Goodbye

In his absence, the Chairman noted Mr Jim Eadie’s contribution to SMC.  He is leaving his post within ABPI and has attended his 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 November 2007 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 fondaparinux sodium, 2.5mg/0.5ml solution for injection, pre-filled syringe (Arixtra®) GlaxoSmithKline (No: 420/07)

4.1.1 The SMC advice for fondaparinux sodium (Arixtra), for the treatment of unstable angina or non-ST segment elevation myocardial infarction in patients for whom urgent (<120minutes) invasive management (PCI) is not indicated, will be posted on the SMC website on Monday, 10 December 2007.

4.1.2 The Chairman advised that further to comparator comments minor amendments have been made to the section entitled “Summary of Evidence on Comparative Efficacy”.  The revised DAD will be reissued to NHSScotland on Friday, 7 December 2007.

4.2 topotecan (Hycamtin) GlaxoSmithKline (No: 421/07)

4.2.1 The SMC advice for topotecan (Hycamtin®), in combination with cisplatin for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage IVB disease, will be posted on the SMC website on Monday, 10 December 2007.

4.3 esomeprazole (Nexium) Astrazeneca (No: 422/07)

4.3.1 The SMC advice for esomeprazole (Nexium®), for the treatment of Zollinger-Ellison Syndrome, will be posted on the SMC website on Monday, 10 December 2007.

4.4 sevelamer hydrochloride (Renegal) Genzyme  (No: 423/07)

4.4.1 The SMC advice for sevelamer (Renagel®), for control of hyperphosphataemia in adult patients receiving peritoneal dialysis, will be posted on the SMC website on Monday, 10 December 2007.

Non submissions

4.5 risedronate sodium (Actonel) Procter & Gamble Pharmaceuticals UK Ltd (No: 424/07)

4.5.1 The SMC advice for risedronate sodium (Actonel), for the treatment of osteoporosis in men at high risk fractures, will be posted on the SMC website on Monday, 10 December 2007.

4.6 bevacizumab (Avastin) Roche Pharmaceuticals  (No: 425/07)

4.6.1 The SMC advice for bevacizumab (Avastin), in addition to platinum-based chemotherapy, for first-line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology, will be posted on the SMC website on Monday, 10 December 2007.

4.7 imatinib (Glivec) Novartis Pharmaceuticals UK Ltd (No: 426/07)

4.7.1 The SMC advice for imatinib (Glivec), for the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) as monotherapy, will be posted on the SMC website on Monday, 10 December 2007.

4.8 imatinib (Glivec) Novartis Pharmaceuticals UK Ltd (No: 427/07)

4.8.1 The SMC advice for imatinib (Glivec), for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (PH + ALL) in combination with chemotherapy, will be posted on the SMC website on Monday, 10 December 2007.

4.9 imatinib (Glivec) Novartis Pharmaceuticals UK Ltd (No: 428/07)

4.9.1 The SMC advice for imatinib (Glivec), for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet -derived growth factor receptor (PDGFR) gene re-arrangements, will be posted on the SMC website on Monday, 10 December 2007.

4.10 imatinib (Glivec) Novartis Pharmaceuticals UK Ltd (No: 429/07)

4.10.1 The SMC advice for imatinib (Glivec), for the treatment of adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement, will be posted on the SMC website on Monday, 10 December 2007.
 
4.11 imatinib (Glivec) Novartis Pharmaceuticals UK Ltd (No: 430/07)

4.11.1 The SMC advice for imatinib (Glivec), for the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery, will be posted on the SMC website on Monday, 10 December 2007.

4.12 fosamprenavir (Telzir) GlaxoSmithKline (No: 431/07)

4.12.1 The SMC advice for fosamprenavir (Telzir), for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adolescents and children of 6 years and above in combination with other antiretroviral medicinal products, will be posted on the SMC website on Monday, 10 December 2007.

4.13 eculizumab (Soliris) Alexion Pharma UK Ltd (No: 436/07)

4.13.1 The SMC advice for eculizumab (Soliris), for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH), will be posted on the SMC website on Monday, 10 December 2007.

Deferred Advice

4.14 beclometasone 100mcg, formoterol 6mcg metered dose inhaler (Fostair) Trinity Chiesi Pharmaceuticals Ltd (No. 373/07)

4.14.1 Beclometasone (Fostair), for the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short acting beta2-agonist; or patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.

4.14.2 This product was reviewed by SMC in April 2007; however the advice was withheld pending confirmation of the product licence and availability.  The product is now available. Minor amendments have been made to the advice box and the product name has changed from (Fostex Modulite) to (Fostair).  The revised advice will be sent to NHSScotland on Friday, 7 December 2007 and published on the SMC website on Monday, 14 January 2008.

4.15 calcium carbonate 1500 mg/colecalciferol 400 IU (Natecal) Trinity-Chiesi Ltd (No. 348/07)

4.15.1 Calcium carbonate (Natecal), for correction of vitamin D and calcium deficiencies in the elderly and for vitamin D and calcium supplementation as an adjunct to specific treatment for osteoporosis in patients where combined vitamin D and calcium deficiencies have been diagnosed or at high risk of such deficiencies.

4.15.2 This product was reviewed by SMC in February 2007; however, the advice was withheld pending confirmation of the product licence and availability. The product is now available and the advice will be sent to NHSScotland on Friday, 7 December 2007 and published on the SMC website on Monday, 14 January 2008.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 The Chairman of PAPIG advised that the interviews for the 2 new public partners had taken place and two of the candidates had been invited to join PAPIG, and one had already accepted the post.  It is anticipated that they will attend their first meeting of SMC as observers in February 2008.

7. New Drugs Committee Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 Media Update

The Chairman advised that Dr Paterson had participated in the BBC Politics Show on Sunday, 25 November.

BBC Ethics Programme

The Chairman advised that Ms Timoney participated in the BBC Ethics Programme on Thursday, 29 November, 2007. The programme will be broadcast on Radio Scotland on Monday, 14 January 2008.

8.2 Scottish Bid for HTAi Conference 2010

The Chairman advised that he has written to the HTAi Board to support the proposal for a Scottish bid for the HTAi conference in 2010, led by NHS QiS.  Between NHS QiS, SIGN, SMC and other organisations dedicated to health technology assessment in Scotland, there is substantial activity that would fully justify the bid for bringing HTAi in 2010 to Scotland. 

8.3 ezetimibe simvastatin (Inegy) Merck Sharpe & Dohme/Schering-Plough Ltd UK (No. 182/05)

SMC issued advice for ezetimibe simvastatin (Inegy) in May 2005 advising that ezetimibe simvastatin (Inegy) for patients who have failed to achieve target cholesterol levels after titration and optimisation of statin monotherapy and where the combination of ezetimibe 10mg and simvastatin 20mg, 40mg or 80mg is appropriate, should be accepted for restricted use. This reflects advice on ezetimibe issued by the Scottish Medicines Consortium in September 2003 (61/03) and is based on the combined tablets being priced at approximately the same level as the individual ingredients.

The Chairman advised that following multiple technology appraisal (MTA) the National Institute for Health and Clinical Excellence (NICE) issued guidance in November 2007 to the NHS in England and Wales recommending the use of ezetimibe coadministered with initial statin therapy, as an option for the treatment of adults with primary (heterozygous-familial or non familial) hypercholesterolaemia who have been initiated on statin therapy (as per NICE guidance TA 94 in adults with non-familial hypercholesterolaemia)

Therefore, NICE guidance supersedes SMC advice.

8.4 Methadone hydrochloride (Eptadone oral solution 1mg/ml and 5mg/ml)

8.4.1 Methadone hydrochloride (Eptadone) for use as an analgesic in moderate to severe pain, was reviewed at the meeting of the New Drugs Committee (NDC) on Tuesday, 27 November 2007, but as this is a new strength of a branded generic product the product falls outwith the remit of SMC.  The NDC have therefore, not made a recommendation to SMC.

8.4.2 SMC will provide a statement to NHSScotland on this submission.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 vildagliptin 50mg and 100mg tablets (Galvus®)Novartis (No: 435/07)

9.1.1 Declarations of interest were recorded in relation to this product/comparator drugs.  A member with a personal specific interest left the meeting for this part of the agenda.
 
9.1.2 The NDC Vice-Chair provided an overview of the assessment, draft advice, and expert comments. Detailed discussion followed and the group concluded their advice for vildagliptin (Galvus), for the treatment of type 2 diabetes as dual oral therapy in combination with metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin.

9.1.3 The SMC advice will be withheld until confirmation of licence and availability.

RESUBMISSIONS

9.2 standardised allergen extract pollen from Timothy (Phleum Pratense) 75,000 SQ-T* per oral lyophisisate (Grazax) ALK-Abello Ltd (No: 367/07)

9.2.1 A declaration of interest was recorded in relation to this product/comparator drugs.  A member with a personal specific interest took no part in the discussion.

9.2.2 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 a patient interest group submission jointly from Education for Health and Allergy UK. Detailed discussion followed and the group agreed that standardised allergen extract of grass pollen 75,000 per oral lyophilisate (Grazax), for the treatment of grass pollen induced rhinitis and conjunctivitis in adult patients with clinically relevant symptoms and diagnosed with a positive skin prick test and/or specific IgE test to grass pollen, should not be recommended 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.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 7 December 2007.

ABBREVIATED SUBMISSIONS

9.3 latanoprost timolol eyedrops (Xalacom) Pfizer Ltd (No: 432/07)

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 and draft summary of advice. Discussion followed and the group agreed that latanoprost timolol eyedrops (Xalacom), for reduction of intraocular pressure in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues 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.

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 7 December 2007.

9.4 quetiapine 50mg, 200mg, 300mg and 400mg prolonged-release tablet (Seroquel XL) Astrazeneca UK Ltd (No: 433/07)

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

9.4.2 The NDC Chairman provided an overview of the assessment, draft summary of advice and comments received from the company. Discussion followed and the group concluded their advice for quetiapine (Seroquel XL), for the treatment of schizophrenia and manic episodes associated with bipolar disorder.

9.4.3 The SMC advice will be withheld until confirmation of licence and availability.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

11. SMC User Group Forum

11.1 The minutes of the meeting held on Tuesday, 30 October were noted.

12. ADTC Feedback

12.1 Electronic Support for Prescribing

The Chairman had recently written to Area Drug and Therapeutic Committees (ADTCs) requesting evidence regarding prescribing errors within their health board area.  The Chairman thanked everyone for their responses.

13. Any Other Business

13.1 European Commission, Health and Consumer Protection Directorate-General – Rare Diseases: Europe’s Challenge

The Chairman advised that SMC were considering a response to this document. 

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 08 January 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.