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Tuesday 06 November 2007

NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Professor James Barbour, Dr Keith Brown, Mr David Carson, Dr David Crookes, Mr Tom Divers, Dr Harpreet Kohli, Dr Chris Lush, Ms Aileen Muir, Mrs Pat Murray, Dr Alan MacDonald, Mrs Wendy Nganasurian, Dr Ken Paterson, Dr Andrew Power, Dr Nick Reed, Dr Andrew Riley, Dr Sandy Simpson, Mr Alistair Thorburn, Ms Angela Timoney, Mrs Sheila Tunstall-James, Mr Mike Wallace

In Attendance: Ms Lynne Anderson, Ms Ailsa Brown, Ms Rebecca Crosier, Mr Steven Fenocchi, Mr Stephen Ferguson, Ms Karen Harkness, Ms Claire James, Mrs Hazel Illingworth, Mrs Laura McIver, Ms Rosie Murray,  Dr Rupert Payne, Ms Jane Pearson, Mrs Maureen Stark, Dr Andrew Walker

Apologies: Mrs Laura Ace, Dr Keith Beard, Mrs Marion Bennie, Mr Colin Brown, Professor John Cairns, Dr Sara Davies, Mr Jim Eadie, Dr Jonathan Fox, Dr Barclay Goudie, Dr Jan Jones, Mrs Anne Lee, Dr Grace Lindsay, Dr Graham Lowe, Mr Colin McAllister, Mr Billy Malcolm, Professor Dilip Nathwani,  Ms Fiona Ramsay, Ms Alex Robertson, Dr Sarah Taylor, 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 welcomed the following observers to the meeting:

• Dr Rupert Payne, Clinical Lecturer, Clinical Pharmacology Unit, University of Edinburgh
• Rebecca Crosier Policy Officer, Breakthrough Breast Cancer
• Lynne Anderson, Karen Harkness and Claire James, pharmacists from NHS Tayside who will be studying the assessment process with a view to undertaking B checking work for NDC in future
• Jane Pearson, Formulary Pharmacist, Lothian

Congratulations

The Chairman congratulated Dr Keith Brown, who will succeed Professor Gordon Lowe as Chairman of SIGN.

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 02 October 2007 were agreed as an accurate record with an amendment to item 9.8.2 to read; rivastigmine transdermal patch (Exelon), for symptomatic treatment of moderately severe Alzheimer’s dementia only.

4. Matters Arising From the Previous Minutes

There were no matters arising from the previous minutes.

Full Submissions

4.1 erdosteine (Erdotin) Edmond Pharma Sr.l/Galen Ltd (No: 415/07)

4.1.1 The SMC advice for erdosteine (Erdotin), as an expectorant for the symptomatic treatment of acute exacerbations of chronic bronchitis in adults, will be posted on the SMC website on Monday, 12 November 2007.

4.2 rufinamide, 100mg, 200mg and 400mg Tablets (Inovelon) Eisai Ltd (No:  416/07)

4.2.1 The SMC advice for rufinamide, 100mg, 200mg and 400mg tablets (Inovelon), as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients four years and older, will be posted on the SMC website on Monday, 12 November 2007.

4.3 adalimumab (Humira) Abbott Laboratories Ltd (No: 417/07)

4.3.1 The SMC advice for adalimumab (Humira), for the treatment of severe, active Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies, will be posted on the SMC website on Monday, 12 November 2007.

4.4 epoetin delta (Dynepo) Shire Pharmaceuticals Ltd (No: 418/07)

4.4.1 The SMC advice for epoetin delta (Dynepo) for the treatment of anaemia in patients with chronic renal failure,, will be posted on the SMC website on Monday, 12 November 2007.

ABBREVIATED SUBMISSION

4.5 tiotropium (Spiriva-Respimat) Boehringer Ingelheim Ltd (No: 411/07) 

4.5.1 As maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease, was considered potentially inappropriate for consideration via the abbreviated submission process.

4.5.2 The Chairman advised that he had received a further clarification from the company, together with new data, and that the SMC advice for tiotropium (Spiriva-Respimat) as maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease, is that it should be accepted for restricted use within NHS Scotland. 

4.5.3 The advice will be issued to NHS Scotland on Friday, 9 November and posted on the SMC website on Monday, 10 December 2007.

4.6 ciclesonide 80mcg, 160mcg inhaler (Alvesco®) Altana pharma Ltd (No: 412/07) 

4.6.1 The SMC advice for ciclesonide 80mcg, 160mcg inhaler (Alvesco®), at high doses (up to 640mcg daily for up to 12 weeks) to control persistent asthma, will be posted on the SMC website on Monday, 12 November 2007.

4.7 conjugated estrogen 0.3mg tablet (Premarin®)  Wyeth Pharmaceuticals(No: 413/07)

4.7.1 The SMC advice for conjugated estrogen 0.3mg tablet (Premarin®), as hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women, will be posted on the SMC website on Monday, 12 November 2007.

4.8 rivastigmine 4.6mg/24h and 9.5mg/24h transdermal patch (Exelon®)  Novartis Pharmaceuticals UK Limited (No: 414/07)

4.8.1 The SMC advice for rivastigmine 4.6mg/24h and 9.5mg/24h transdermal patch (Exelon®), for symptomatic treatment of moderately severe Alzheimer’s dementia, will be posted on the SMC website on Monday, 12 November 2007.

Non-Submission
4.9 dexrazoxane (Cardioxane)  Novartis Pharmaceuticals Ltd  (No: 419/07)

4.9.1 The SMC advice for dexrazoxane (Cardioxane), for the prevention of chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin use in advanced and/or metastatic cancer patients after previous anthracycline containing treatment, will be posted on the SMC website on Monday, 12 November 2007.

5. Appeals Update

5.1 Nothing to report

6. Patient and Public Involvement Group (PAPIG)

6.1 The minutes of the meeting held on 02 October were noted.

7. New Drugs Committee Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 Meeting with Department of Health, Northern Ireland 9 October 2007

The Chairman advised that this had been an excellent meeting.  The representatives of Northern Ireland will be attending the NDC meeting in November 2007 and the SMC meeting in January 2008 to help them better understand the SMC process.

8.2 Meeting with Chief Medical Officer (CMO), 18 October 2007

The Chairman advised that this had been a helpful meeting and the CMO had been very supportive of SMC.  The CMO had been notified that Dr Paterson had been proposed as the next Chair of SMC, from April 2008.  CMO will take this to the Chief Executives for approval. 

The Chairman also advised that Mrs Marion Bennie would be stepping down as vice-chair of NDC in January 2008 and Dr Andy Power and Ms Aileen Muir would become official vice-chairs of NDC.

8.3 Meeting with ABPI Representatives regarding Risk Sharing, 31 October 2007

The Chairman advised that this had been a very constructive meeting.  ABPI are working on presenting several scenarios to put to the CMO.

8.4 Consistent SIGN and SMC Advice on New Medicines for NHS Scotland

The paper was tabled at the meeting for information.  The Chairman thanked Laura McIver and Sara Twaddle for their hard work in putting the paper together.

8.5 E-mail alerts from NHS QIS

Representatives of ADTCs advised that they would like to continue to receive the NHS QIS e-mail alerts when NICE STA are published. 

8.6 Compassionate Supply of Drugs

The Chairman referred to the supply of an orphan drug in the event of a patient receiving compassionate supply of a drug awaiting SMC approval.  SMC agreed that it was good practice for a patient on existing therapy to be continued until a decision had been sought and received and, therefore, that the company should continue to supply the product until SMC have concluded their deliberations.

8.7 Press Release – Genzyme and NHS National Commissioning Group form a £7 million Partnership to support world class commissioning for rare diseases.

The Chairman advised that the NHS National Commissioning Group and Genzyme have announced that they have joined together in a £7m partnership to support a specialised system of care for patients with Lysosomal Storage Disorders. This item will be brought back to SMC for discussion at a future meeting.

8.8 European Association for Clinical Pharmacology and Therapeutics - Assessing the Cost-Effectiveness of New Medicines: The Scottish Approach

The Chairman advised that this article had been written by representatives of SMC and presented by him to the 8th congress of the European Association for Clinical Pharmacology and Therapeutics.  The paper was tabled for information purposes.

8.9 NHS QIS Annual Report

The Chairman advised that the report had been released.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 fondaparinux sodium, 2.5mg/0.5ml solution for injection, pre-filled syringe (Arixtra)  GlaxoSmithKline (No: 420/07)

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

9.1.2 The NDC 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 fondaparinux sodium, 2.5mg/0.5ml solution for injection, pre-filled syringe (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, 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.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 November 2007.

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

9.2.1 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.

9.2.2 The NDC 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 topotecan (Hycamtin), in combination with cisplatin for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage IVB disease, 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 NHS Boards and ADTCs on Friday, 09 November 2007.

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

9.3.1 A declaration of interest was 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 and comments received from the company.  A revised draft  of the NDC advice was tabled for review. Detailed discussion followed and the group agreed that esomeprazole (Nexium), for the treatment of Zollinger-Ellison Syndrome, 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, 09 November 2007.

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

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 from the company. Detailed discussion followed the group agreed that sevelamer (Renagel), for control of hyperphosphataemia in adult patients receiving peritoneal dialysis, 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.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 November 2007.

Non-Submission

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

9.5.1 In the absence of a submission from the holder of the marketing authorisation, risedronate sodium (Actonel), for the treatment of osteoporosis in men at high risk of fractures, should not be recommended for use within NHS Scotland.

9.5.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 November 2007.

9.6 bevacizumab (Avastin) Roche Pharmaceuticals (No. 425/07)

9.6.1 In the absence of a submission from the holder of the marketing authorisation, 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, should not be recommended for use within NHS Scotland.

9.6.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday 09 November 2007.

9.7 Imatinib (Glivec) Novartis Pharmaceuticals UK Ltd (No. 426/07)

9.7.1 In the absence of a submission from the holder of the marketing authorisation, imatinib (Glivec), for the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) as monotherapy, should not be recommended for use within NHS Scotland.

9.7.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday 09 November 2007.

9.8 Imatinib (Glivec) Novartis Pharmaceuticals UK Ltd (No. 427/07)

9.8.1 In the absence of a submission from the holder of the marketing authorisation, imatinib (Glivec), for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) in combination with chemotherapy, should not be recommended for use within NHS Scotland.

9.8.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday 09 November 2007.

9.9 Imatinib (Glivec) Novartis Pharmaceuticals UK Ltd (No. 428/07)

9.9.1 In the absence of a submission from the holder of the marketing authorisation, 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, should not be recommended for use within NHS Scotland.

9.9.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday 09 November 2007.

9.10 Imatinib (Glivec) Novartis Pharmaceuticals UK Ltd (No. 429/07)

9.10.1 In the absence of a submission from the holder of the marketing authorisation, imatinib (Glivec), for the treatment of adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement, should not be recommended for use within NHS Scotland.

9.10.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday 09 November 2007.

9.11 Imatinib (Glivec) Novartis Pharmaceuticals UK Ltd (No. 430/07)

9.11.1 In the absence of a submission from the holder of the marketing authorisation, 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, should not be recommended for use within NHS Scotland.

9.11.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday 09 November 2007.

9.12 fosamprenavir (Telzir) GlaxoSmithkline (No. 431/07)

9.12.1 In the absence of a submission from the holder of the marketing authorisation, fosamprenavir (Telzir), in combination with low dose ritonavir 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, should not be recommended for use within NHS Scotland.

9.12.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday 09 November 2007.

9.13 eculizumab (Soliris) Alexion Pharma UK Ltd (No. 436/07)

9.13.1 In the absence of a submission from the holder of the marketing authorisation, eculizumab (Soliris), for the treatment of patients with proxysmal nocturnal haemoglobinuria (PNH), should not be recommended for use within NHS Scotland.

9.13.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday 09 November 2007.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

11. SMC User Group Forum

The UGF Chairman advised that the minutes of the meeting held on 30 October 2007 would be available at the next meeting of SMC.

He advised that he had managed to secure an invitation for Anne Lee to join the UK Horizon Scanning Group.

He advised that the Short Life Working Group on Abbreviated Submissions are investigating extending the criteria to include paediatric indications, and are looking at the criteria for low budget impacts and orphan drugs.

He also apologised and advised that the Industry/SMC master class on 23 November would not now be going ahead and will be arranged for another date next year.

12. ADTC Feedback

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, 04 December 2007 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.