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SMC Minutes - Tuesday 7 August 2007

Minutes of the SMC Meeting held on Tuesday 7 August 2007 NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Ms Angela Timoney (Chairman Pro tem), Mrs Laura Ace, Dr Keith Beard, Mrs Barbara Black, Professor John Cairns, Mr David Carson, Mr Tom Divers, Mr Jim Eadie, Dr Barclay Goudie, Dr Jan Jones, Dr Harpreet Kohli, Dr Graham Lowe, Dr Chris Lush, Mr Billy Malcolm, Ms Aileen Muir, Dr Alan MacDonald, Mrs Wendy Nganasurian, Dr Ken Paterson, Ms Fiona Ramsay, Dr Nick Reed, Dr Andrew Riley, Dr Sandy Simpson, Mrs Sheila Tunstall-James, Mr Mike Wallace, Professor Tony Wells

In Attendance: Ms Ailsa Brown, Ms Fiona Bruce, Mr Steven Fenocchi, Mr Stephen Ferguson, Mr Tony Gavin, Dr Lesley Holdsworth, Mrs Hazel Illingworth, Dr John Larkin, Mrs Anne Lee, Dr Kate McKean, Dr James McLay, Mr Mark Parsons, Ms Alex Robertson, Mrs Maureen Stark, Dr Andrew Walker, Ms Lisa Wilson

Apologies: Professor James Barbour, Mrs Marion Bennie, Mr Colin Brown, Dr Keith Brown, Dr David Crookes, Dr Sara Davies, Dr Jonathan Fox, Dr Grace Lindsay, Ms Rosie Murray, Mrs Pat Murray, Mr Colin McAllister, Mrs Laura McIver, Professor Dilip Nathwani,  Dr Andrew Power, Dr Sarah Taylor, Mr Alistair Thorburn, Professor David Webb

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:

  • Fiona Bruce, Head of Medicines Utilisation Unit, NHS Ayrshire and Arran.
  • Mr Tony Gavin, Chief Executive, Leukaemia Care.
  • Dr Lesley Holdswoth, recently appointed Head of Health Services Research and Assessment Unit, QIS.
  • Dr Kate McKean, Head of Pharmacy and Prescribing Support Unit, Queen's Park House, Victoria Infirmary.
  • Lisa Wilson, newly appointed health economist with QIS, who will eventually be doing some work for SMC.

The Chairman also welcomed:

  • Professor Tony Wells, Chief Executive, NHS Tayside, new member, attending his first meeting.
  • Ms Sheila Tunstall-James newly appointed public partner who was attending her fist meeting as a member of SMC.
  • Mr Mark Parsons, Dr John Larkin and Dr James McLay, NDC Members, and indicated that they would be presenting submissions to 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

3.1The minutes of the SMC meeting held on 03 July 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 pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg capsules (Lyrica) Pfizer Ltd (No. 389/07)

4.1.1 The SMC advice for pregabalin (Lyrica), for the treatment of central neuropathic pain in adults, will be posted on the SMC website on Monday, 13 August 2007.

4.2 clopidogrel 75mg tablets (Plavix) Sanofi-Aventis/Bristol Myers Squibb (No. 390/07)

4.2.1 The SMC advice for clopidogrel (Plavix), for patients with ST segment elevation acute myocardial infarction (MI), in combination with aspirin, in medically treated patients eligible for thrombolytic therapy, will be posted on the SMC website on Monday, 13 August 2007.

4.3 idursulfase 2mg/ml concentrate for solution for infusion (Elaprase) Shire HGT UK Ltd (No. 391/07)

4.3.1 The SMC advice for idursulfase (Elaprase), for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II MPS II), will be posted on the SMC website on Monday, 13 August 2007.

4.4 rotigotine 2mg/24hours, 4mg/24hours, 6mg/24 hours, 8mg/24 hours transdermal patch (Neupro) Schwarz Pharma (No. 392/07)

4.4.1 The SMC advice for rotigotine (Neupro), for the treatment of the signs and symptoms of advanced-stage idiopathic Parkinson’s disease in combination with levodopa; i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on-off” fluctuations), will be posted on the SMC website on Monday, 13 August 2007.

4.4.2 Further to comparator comments minor amendments have been made to the ‘Summary of Comparative Efficacy’ and ‘Cost of Relevant Comparators’ sections within the Detailed Advice Document. The SMC advice will be reissued to NHS Boards and ADTCs on Friday, 10 August 2007.

RESUBMISSIONS

4.5 liposomal cytarabine 50mg suspension for injection (DepoCyte) injection Napp Pharmaceuticals (No. 164/05)

4.5.1 The SMC advice for liposomal cytarabine (DepoCyte), for the Intrathecal treatment of lymphomatous meningitis, will be posted on the SMC website on Monday, 13 August 2007.

4.6 nebivolol tablets 5mg (Nebilet) A Menarini (No. 214/05)

4.6.1 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 >70 years, will be posted on the SMC website on Monday, 13 August 2007.

4.7 bortezomib 3.5mg vial of powder for solution for intravenous injection (Velcade) Ortho Biotech (No. 302/06)

4.7.1 The SMC advice for bortezomib (Velcade), as mono-therapy for the treatment of progressive multiple myeloma (MM) in patients who have received at least 1 prior therapy and who have already undergone or are unsuitable for bone marrow transplantation, will be posted on the SMC website on Monday, 13 August 2007.

ABBREVIATED SUBMISSION

4.8 insulin detemir 100 U/ml solution for injection via Innolet device ( Levemir in InnoLet) Novo Nordisk (No. 393/07)

4.8.1 The SMC advice for insulin detemir (Levemir InnoLet), for the treatment of diabetes mellitus in patients for whom insulin detemir is an appropriate choice of insulin and who have poor visual acuity, dexterity problems or learning or memory problems which necessitate nurse support for administration, will be posted on the SMC website on Monday, 13 August 2007.

Deferred Advice

4.9 vinorelbine 20mg and 30mg capsule (Navelbine) Pierre G Fabre Ltd No. 324/06)

4.9.1 vinorelbine (Navelbine), for the treatment of advanced breast cancer stage 3 and 4 relapsing after, or refractory to, an anthracycline-containing regimen, was considered by SMC in October 2006; however, the advice was withheld pending confirmation of the product licence and availability.  The product is now available and the advice will be issued to NHS Boards and ADTCs on Friday 10 August 2007 and published on the SMC website on Monday, 13 August 2007.

4.10 beclometasone dipropionate 5mg tablets (Clipper) Trinity Chiesi Pharmaceuticals (No. 166/05)

4.10.1 beclometasone (Clipper), for the treatment of mild to moderate ulcerative colitis in active phase as add-on therapy to 5-ASA containing drugs, was considered by SMC in April 2005; however, the advice was withheld pending confirmation of licence and availability.  The product is now available and the advice will be issued to NHS Boards and ADTCs on Friday, 10 August 2007 and published on the SMC website on Monday, 10 September 2007.

5. Appeals Update

5.1 Pfizer Ltd has advised of their intention to make a resubmission to SMC for sunitinib (sutent) for the treatment of advanced and/or metastatic renal cell carcinoma (MRCC).

5.2 Freedom of Information

The Vice-Chair advised that NHS Lothian has received an FOI request from a member of the public seeking details of a product that was reviewed by SMC.

6. Patient and Public Involvement Group (PAPIG)

6.1 The Chairman of PAPIG welcomed Mrs Sheila Tunstall-James, new public partner to her first official meeting of SMC.  She also advised that Mr Tom Haswell had decided to withdraw from SMC and PAPIG would start the recruitment process for two new members in September.

She also advised that 31 Patient Interest Group submissions had been made since January 2007.  Of those drugs assessed to date 68% of those, where a PIG submission had been made, were accepted/accepted restricted for use.  This is in comparison to 65% of the total number of drugs assessed, being accepted /accepted for restricted use.

The minutes of the meeting held on 5 June 2007 were noted.

6.2 Patient Interest Group Submission from MS Society Scotland in relation to the resubmission under consideration for natalizumab (Tysabri). 

The Vice-Chair advised that the MS Society had requested that SMC review their current process of not releasing advice to the Patient Interest Group until the advice is released into the public domain. The MS Society would wish to receive the advice at the same time as Health Boards and ADTCs to allow them to plan and manage their response to patients, press and public.

The members agreed to follow process and the advice for natalizumab will be sent to the MS Society at the same time as it is published on the SMC website.

7. New Drugs Committee Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 Scottish Medicines for Children Network

The Vice-Chair advised that following the formal requirement for pharmaceutical companies who submit new medicines for license to include a paediatric investigation plan in their submissions, the Chief Scientist has provided resources for a body to lead, encourage and co-ordinate activities of this kind in Scotland.  Professor Peter Helms, Department of Child Health, Royal Aberdeen Children’s Hospital, has been appointed Director of the Scottish Medicines for Children Network and Dr John Haughney past member of SMC has been appointed co-director.  Further details about the activities of the organisation can be found on their website www.scotmcn.org.

8.2 exenatide 5 or 10 micrograms, solution for injection, prefilled pen (Byetta) Eli Lilly and Company  No. 376/07

The Vice-Chair noted that it had been brought to the attention of the SMC Executive that there had been a breach of confidentiality with regards to the advice for exenatide (Byetta). It was noted that the breach of confidentiality did not come from Eli Lilly.  The advice was published on the SMC website on Monday, 9 July 2007.

8.3 NICE (Single) Technology Appraisal Guidance for Varenicline for smoking cessation

The Vice-Chair advised that NICE have published an STA for varenicline.  NHS QIS have reported that there is no material difference between the NICE STA and the SMC advice. 
SMC published advice on varenicline (Champix) in January 2007 and accepted for use within NHS Scotland for smoking cessation in adults. It should be used only as a component of a smoking cessation support programme. The benefits of an additional treatment course in those who have stopped smoking after the initial 12 weeks of therapy appear modest. Efficacy and safety in patients with significant co-morbidity are uncertain.

8.4 Nominations for NDC Chairman

The Vice-Chair advised that the secretariat has written to all members to invite nominations for NDC Chairman to replace Dr Paterson when he succeeds Professor Webb.  Please forward nominations to the secretariat by Friday 24 August, 2007.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 testosterone 300 microgram/24 hours  transdermal patch (Intrinsa TTP)  Proctor & Gamble pharmaceuticals UK Ltd  (No: 398/07)

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

9.1.2The NDC Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company. A member of PAPIG presented patient interest group submissions from the Hysterectomy Association, the Daisy Network Premature menopause Support Group and Women’s Health Concern. Detailed discussion followed and the group agreed that testosterone transdermal patch (Intrinsa TTP), for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy, 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 NHS Boards and ADTCs on Friday, 10 August 2007.

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

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

9.2.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and comments received from the company. 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 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, 10 August 2007.

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

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

9.3.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that levetiracetam (Keppra), as adjunctive therapy in the treatment of myclonic seizures in adults and adolescents from 12 years of age with Juvenile Mycoclonic Epilepsy, 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.

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 10 August 2007.

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

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

9.4.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and comments received from the company. 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 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, 10 August 2007.

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

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

9.5.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and comments received from the company. 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 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 NHS Boards and ADTCs on Friday, 10 August 2007.

9.6 pioglitazone 15mg, 30mg and 45mg tablets (Actos)  Takeda UK Ltd  (No:  399/07)

9.6.1 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.

9.6.2 The NDC Co Vice-Chair provided an overview of the assessment, draft advice, expert comments and comments received from the company. Additional sensitivity analysis dated July 2007 was tabled for review. Detailed discussion followed and the group agreed that pioglitazone (Actos), for use in combination with insulin in type 2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance, 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.
 
9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 10 August 2007.

9.7 abatacept 250mg powder for concentrate for solution (Orencia)  Bristol Myers Squibb Pharmaceuticals Ltd  (No: 400/07)

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, expert comments and comments received from the company. A member of PAPIG presented a patient interest group submission from the National Rheumatoid Arthritis Society. Detailed discussion followed and the group agreed that abatacept (Orencia), in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease-modifying anti-rheumatic drugs (DMARDS) including at least one tumour necrosis factor (TNF) inhibitor, 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.

9.7.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 10 August 2007.

9.8 capecitabine150mg and 500mg tablets (Xeloda)  Roche  (No: 401/07)

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

9.8.2 The NDC Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that capecitabine (Xeloda), for first line treatment of patients with advanced gastric cancer in combination with a platinum based chemotherapy regimen, 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 NHS Boards and ADTCs on Friday, 10 August 2007.

RESUBMISSIONS

9.9 sodium oxybate 500mg/ml oral solution (Xyrem)  UCB Pharma Limited (No: 246/06)

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

9.9.2 The NDC Lead Assessor 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 from UK Association of Narcoleptics. Detailed discussion followed and the group agreed that sodium oxybate (Xyrem), for the treatment of cataplexy in adult patients with narcolepsy, 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.

9.9.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 10 August 2007.

9.10 natalizumab (Tysabri) Biogen Idec Ltd  (No: 329/06)

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

9.10.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and comments received from the company. A manufacturer’s response to economic questions dated 26 July 2007, was tabled for review. A member of PAPIG presented a patient interest Group Submission from MS Society Scotland. Detailed discussion followed and the group agreed that natalizumab (Tysabri), as single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups; patients with high disease activity despite treatment with beta-interferon and in patients with rapidly evolving severe RRMS, 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.

9.10.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 10 August 2007.

ABBREVIATED SUBMISSIONS

9.11 tacrolimus 0.5mg, 1mg, 5mg prolonged release capsule)  (Advagraf) Astella Pharma Ltd  (No: 402/07)

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

9.11.2 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Discussion followed and the group agreed that tacrolimus (Advagraf), for prophylaxis of transplant rejection in adult kidney or liver allograft recipients; and treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients, 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 NHS Boards and ADTCs on Friday, 10 August 2007.

9.12 risperidone 3mg, 4mg orodispersible tablets (Risperdal Quicklet)  Janssen-Cilag (No: 403/07)

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

9.12.2 The NDC Chairman provided an overview of the assessment and draft summary of advice. Discussion followed and the group agreed that risperidone (Risperdal Quicklet), for the treatment of acute and chronic schizophrenia and similar psychosis and treatment of mania in bipolar disorder, 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.

9.12.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 10 August 2007.

NON SUBMISSIONS

9.13 celecoxib (Celebrex) Pfizer Ltd (No. 410/07)

9.13.1 In the absence of a submission from the holder of the marketing authorisation, celecoxib (Celebrex) for the treatment of ankylosing spondylitis, 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, 10 August 2007.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

11. SMC User Group Forum

The Chairman of the User Group Forum advised that the group had met on 31 July 2007 and the minutes would be available at the next meeting of SMC.

He advised that ABPI are currently planning two events; a master class for HTA Specialists and industry in November 2007 and a high level meeting for NHS and Industry on HTAs and Horizon Scanning.

Comparator Products
He advised that there would be a change to process regarding comparator products; companies will have the right to see the Detailed Advice Document (DAD) at the same time as the manufacturer if they are mentioned at all within the DAD.

Revised/New Documents on SMC Website
The Chairman advised that the following document had been reviewed and agreed by the User Group Forum:
• SMC Statement on Orphan Drugs
• Guidance on Submission Criteria
• SMC Policy on Meetings with Manufacturers

Working Group
The Chairman advised that a working group consisting of members from Industry and SMC would be looking to identify a set of rules to reduce the workload of products with a limited budget impact.

12. ADTC Feedback

Nothing to report

13. Any Other Business

No other business was noted.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 04 September 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.