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SMC Minutes - Tuesday, 5 September 2006

Minutes of the SMC Meeting held on Tuesday 5 September 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, Mr Dave Carson, Dr David Crookes,
Mr Tom Divers, Dr Peter Donnan, Mr Jim Eadie, Dr Jan Jones, Dr Chris Lush, Mr Billy Malcolm,
Dr Ken Paterson, Dr Andrew Power, Dr Nick Reed, Dr Philip Rutledge, Ms Angela Timoney,
Ms Helen Tyrrell, Mr Mike Wallace

In Attendance: Dr Jennifer  Armstrong, Ms Vicky Cairns, Ms Elaine Carnegie, Dr Sara Davies,
Mr Stephen Ferguson, Mrs Hazel Illingworth, Mrs Laura McIver, Dr James McLay, Miss Rosie Murray, Ms Corinne O'Dowd, Dr Libby Sillito, Mrs Maureen Stark

Apologies: Professor James Barbour, Ms Rosaleen Beattie, Mr Nick Brown, Mr Steven Fenocchi,
Mr John Glennie, Dr Barclay Goudie, Dr John Haughney, Dr Harpreet Kohli, Mrs Anne Lee,
Dr Grace Lindsay, Dr Graham Lowe, Mr Colin McAllister, Ms Angela Munday, Mrs Pat Murray, Ms Wendy Nganasurian, Ms Fiona Ramsay, Dr Andrew Riley, Dr Sandy Simpson, Dr Sarah Taylor,
Dr Andrew Walker, Dr John Webster

1 Welcome and Apologies for Absence

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

The Chairman gave a warm welcome to Mr Dave Carson, Director of Financial Performance Management, Tayside NHS Board and Mr Billy Malcolm, Specialist in Pharmaceutical Public Health, NHS Ayrshire & Arran, who were attending their first meeting of SMC.

The Chairman also welcomed the following who were observing the work of SMC:
Mrs Elaine Carnegie, Asthma UK Scotland.
Dr James McLay, Senior Lecturer and Consultant Physician, Member of the New Drugs Committee.
Dr Libby Sillito, Clinical Assessor, New drugs Committee.
Ms Vicky Cairns, Administrator, SMC Evaluation Team.  Recently appointed to replace Neetu Ram.

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 01 August 2006 were agreed as an accurate record.

4 Matters Arising From the Previous Minutes

4.1 SMC Meeting January 2007

The Chairman advised that the January meeting of SMC would be held on Tuesday, 9 January 2007.


Full Submissions

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

4.2.1 The SMC advice for duloxetine (Cymbalta), for the treatment of diabetic peripheral neuropathic pain (DPNP) in adults, will be posted on the SMC website on Monday, 11 September 2006.

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

4.3.1 The SMC advice for topiramate (Topamax), for the prophylaxis of migraine headache in adults, will be posted on the SMC website on Monday, 11 September 2006.

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

4.4.1 The SMC advice for insulin glulisine (Apidra), for the treatment of adult patients with diabetes mellitus, will be posted on the SMC website on Monday, 11 September 2006.

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

4.5.1 The SMC advice for ibandronic acid 3mg/3ml solution injection (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, 11 September 2006.

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

4.6.1 The SMC advice for 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, will be posted on the SMC website on Monday, 11 September 2006.

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

4.7.1 The SMC advice for nebivolol (Nebilet), for the treatment of stable mild and moderate chronic heart failure (CHF) in addition to standard therapies in elderly patients „d70 years, will be posted on the SMC website on Monday, 11 September 2006.

Resubmissions

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

4.8.1 The SMC advice for 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, will be posted on the SMC website on Monday, 11 September 2006.

An error in the numbering of the submission was highlighted, this has been revised and the DAD will be reissued to NHSScotland on Friday, 8 September, 2006.

Abbreviated Submissions

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

4.9.1 The SMC advice for etanercept (Enbrel), for the treatment of patients with rheumatoid arthritis, will be posted on the SMC website on Monday, 11 September 2006.

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

4.10.1 The SMC advice for budesonide 200mcg inhalation powder (Novolizer Budesonide), for the treatment of persistent asthma in adults and children over 6 years of age, will be posted on the SMC website on Monday, 11 September 2006.

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

4.11.1 The SMC advice for donepezil 5 & 10mg orodispersible (Aricept), for symptomatic treatment of mild to moderately severe Alzheimer's dementia, will be withheld pending confirmation of launch.

Deferred Advice

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

4.12.1 SMC reviewed a submission for etanercept (Enbrel) for the treatment of adults with severe ankylosing spondylitis who have had an inadequate response to conventional therapy, in August 2006, however advice was withheld pending confirmation of the product launch.  The product has now launched and SMC advice will be distributed to NHS Scotland on Friday 8 September 2006 and published on the SMC website on Monday, 11 September 2006.

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

4.13.1 SMC reviewed a submission 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, in August 2006, however advice was withheld pending confirmation of the product launch.  The product has now launched and SMC advice will be distributed to NHS Scotland on Friday 8 September 2006 and published on the SMC website on Monday, 11 September 2006.

Amended Advice

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

4.14.1 The Chairman advised that there had been a minor change to the ¡§Cost per Relevant Comparator¡¨ section within the Detailed Advice Document for inhaled insulin (Exubera) for  the treatment of adult patients with type 2 diabetes mellitus not adequately controlled with oral antidiabetic agents and requiring insulin therapy or for the treatment of adult patients with type 1 diabetes mellitus, in addition to long or intermediate acting subcutaneous insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns.

4.14.2 The revised advice will be reissued to NHS Scotland on Friday 8 September 2006 and posted on the SMC website on Monday, 11 September 2006.

5 Appeals Update

5.1 bortezomib (Velcade) 3.5mg powder for intravenous injection (No. 302/06)

Ortho Biotech have advised of their intention to make a resubmission for bortezomib (Velcade) 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.

6 PAPIG

The minutes of the meeting held earlier in the day will be available at the next meeting of SMC.  The PAPIG members thanked Elaine Carnegie from the Asthma Society for allowing a Patient Interest Group Submission from Asthma Society to be displayed on the SMC website as an example of good practice.

7 New Drugs Committee: Chairman's report

Nothing to report.

8 Chairman's Business

8.1 NDC Vice Chair

The Chairman advised that the Vice Chair of NDC intends to step down from her role of Vice Chair for 1 year to allow more time to work on the SMC Evaluation Programme.  Nominations for Vice Chair of NDC on a secondment basis are to be sent to the secretariat by the end of September.

8.2 SMC Executive Team Meeting 22 August 2006

The Chairman advised that the Executive Team held a meeting on Tuesday 22 August where the following items had been discussed:

Process for Reviewing Decisions

The Process for Reviewing Decisions document had been revised and has now been posted on the SMC website.

Template for Detailed Advice Document (DAD)

Minor revisions have been made to the template for the DAD, the most notable change being that the Comparators and Cost per treatment course and relevant comparators would now be sited at the end of the DAD, before the Additional Information Section.

Unique Status

The Executive Team have agreed that if an SMC member felt strongly that a product should have unique status then this should be discussed further at SMC.  For this to be given fair consideration by the SMC, he/she should give prior warning of five days to the SMC Administrative Team giving a justification of why they feel that the product should be given unique status.

8.3 SMC Website

Work is ongoing with the development of the SMC website and it is anticipated that the new site will be operational by mid-October.

8.4 NICE: Appraising Orphan Drugs

The Chairman explained that NICE had been invited by the Department of Health, to indicate how it might meet ministerial requests to appraise so-called ¡¥orphan drugs¡¦, the NICE response to this was circulated with the papers for information purposes. It was noted that Industry welcome the pragmatic approach adopted by SMC in this area.

8.5 SMC/ABPI Event

The Chairman advised that ABPI are hosting an event in collaboration with SMC on 17th November 2006 at the Scottish Health Service Centre at the Western General Hospital, Edinburgh.  The event will focus on horizon scanning, evaluation and how to make a good submission. Mr Jim Eadie explained that this is very much a collaborative venture and he hopes to circulate the programme to members by the end of September.

8.6 SMC Paperwork

The Chairman asked members if they were receiving their SMC papers two weekends in advance of the meetings or if they were experiencing any difficulties with receipt.  One member reported having difficulties. The secretariat will investigate.

9 NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 co-careldopa (Duodopa) intestinal gel Solvay Healthcare Ltd (No 316/06)

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

9.1.2 The NDC 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 co-careldopa (Duodopa), for treatment of advanced levodopa-responsive Parkinson¡¦s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results, 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.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 September 2006.

9.2 zoledronic acid (Aclasta) Novartis (No 317/06)

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

9.2.2 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 zoledronic acid (Aclasta), for the treatment of Paget¡¦s disease of bone, 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.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 September 2006.

9.3 ivabradine (Procoralan) Servier Laboratories Ltd (No 319/06)

9.3.1 There were no declarations of interest 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 the British Cardiac Patients Association. Detailed discussion followed and the group agreed that ivabradine (Procoralan), for the symptomatic treatment of chronic stable angina in patients with normal sinus rhythm, who have a contra-indication to or intolerance of beta-blockers, should not be recommended for use within the NHS in 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 8 September 2006.

9.4 entecavir (Baraclude) Bristol-Myers Squibb Pharmaceuticals Ltd (No 320/06)

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 that entecavir (Baraclude), for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease and evidence of active 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, 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 ADTCs and NHS Boards on Friday 8 September 2006.

9.5 sunitinib (Sutent) Pfizer Ltd (No 275/06)

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

9.5.2 The NDC Vice Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company. A revised Detailed Advice Document to reflect the final pricing together with the company comments were tabled for review. A member of PAPIG presented a Patient Interest Group submission from Sarcoma UK. Detailed discussion followed and the group agreed that sunitinib (Sutent), for the treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance, 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.

9.5.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 September 2006.

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

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

9.6.2 The NDC Chairman provided an overview of the draft advice. Discussion followed and the group agreed that carglumic acid (Carbaglu) for the treatment of hyperammonaemia due to N-acetylglutamate synthase deficiency, 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.

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 September 2006.

ABBREVIATED SUBMISSIONS

9.7 levetiracetam (Keppra) IV formulation UCB Pharma Ltd  (No 311/06)

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

9.7.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. 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 adults and children from 4 years of age with epilepsy, 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.
 

9.7.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 September 2006.

9.8 bimatoprost 0.03%/timolol 0.5% (Ganfort) Allergan Ltd (No 312/06)

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

9.8.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that bimatoprost 0.03%/timolol 0.5% (Ganfort), for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues and for whom this combination offers an appropriate choice, 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.

9.8.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 September 2006.

9.9 etoricoxib (Arcoxia) Merck Sharpe & Dohme Ltd (No 313/06)

9.9.1 A declaration of interest was 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 etoricoxib (Arcoxia), for the symptomatic relief of osteoarthritis, rheumatoid arthritis and the pain and signs of inflammation associated with gouty arthritis, in patients for whom the use of etoricoxib is appropriate, taking account of current advice on the place in therapy for specific inhibitors of cyclo-oxygenase-2 (COX-2), 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.

9.9.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 September 2006.

9.10 tobramycin nebulising solution (Bramitob 300mg/4ml Nebuliser Solution) Trinity Chiesi Pharmaceuticals Ltd  (No 314/06)

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

9.10.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice.  Discussion followed and the group concluded their advice for tobramycin nebulising solution (Bramitob), for the long-term management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis aged 6 years and older.

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

9.11 lercanidipine (Zanidip) 20mg Recordati Pharmaceuticals (No 315/06)

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

9.11.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice.  Discussion followed and the group agreed that lercanidipine (Zanidip), for the treatment of mild to moderate essential hypertension in patients for whom this is an appropriate antihypertensive agent, 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 8 September 2006.

9.12 choriogonadotropin alfa (Ovitrelle) Serono (No 263/06)

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

9.12.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice.  Discussion followed and the group agreed that choriogonadotropin alfa (Ovitrelle), for use in women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation, 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 8 September 2006.

9.12.4 The SMC issued ¡§Not Recommended¡¨ statements for choriogonadotropin alf (Ovitrelle) and this product was identified as a non-submission, i.e. a submission was not made to SMC within a specified timeframe and therefore a ¡§Not Recommended¡¨ statement was issued on Friday, 7 April 2006. The current advice supersedes the previous ¡§Not Recommended¡¨.

9.13 choriogonadotropin alfa (Ovitrelle) Serono (No 264/06)

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

9.13.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that choriogonadotropin alfa (Ovitrelle), for the treatment of oligo-ovulatory women, 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.

9.13.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 September 2006.

9.13.4 The SMC issued ¡§Not Recommended¡¨ statements for choriogonadotropin alf (Ovitrelle) and this product was identified as a non-submission, i.e. a submission was not made to SMC within a specified timeframe and therefore a ¡§Not Recommended¡¨ statement was issued on Friday, 7 April 2006. The current advice supersedes the previous ¡§Not Recommended¡¨.

10 SMC Evaluation

10.1 Impact and effectiveness of SMC advice in NHS Scotland

Laura McIver referred to the High Level Summary document and explained that elements 1 and 3 had been the main focus of activity to date.

Laura explained that the evaluation group would be focusing on methodology, data collection and its integrity. The classification exercise was crucial in breaking down the 207 drugs that SMC reviewed within the time period from January 2002 to December 2005. The classification has allowed grouping of drugs into primary or secondary use; cancer drugs, antibiotics, not recommended medicines, and budget impact.  She advised that the group are at the stage of consulting with the reference group regarding the validation, interpretation and presentation of the initial data collection with regards to not recommended advice and may need help from clinical experts with this stage of the work.

Secondary care drugs are more challenging, and the group have consulted with clinical specialists around the integrity of the data in antibiotics and cancer in order to prioritise the drugs for which to request the data on.  The group have established a collaborative network with Hospital Services to agree a programme for the data collection. This data request will place a significant demand on the service and needs to be managed well to keep the service on board. A similar network for industry needs to be established. She advised that the group were making good progress on all areas of element 1.

The work regarding the Patient and Public Involvement Group (PAPIG) is progressing to timelines, the initial interviews with SMC members, the questionnaire to patient interest groups and 16 follow up interviews have been completed.  Updates will be provided at future meetings.

11 Forthcoming Submissions

11.1 A list of forthcoming submissions was noted.

12 ADTC Feedback

Nothing to report

13 Any Other Business

No other business was reported.

14 Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 3 October 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.