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SMC Minutes - Tuesday, 7 March 2006

Minutes of the SMC Meeting held on Tuesday, 7 March 2006 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 Rosaleen, Beattie, Mrs Marion Bennie, Dr Keith Brown, Professor John Cairns, Mrs Michelle Caldwell, Dr David Crookes, Dr Carol Davidson, Mr Tom Divers, Dr Peter Donnan, Dr Barclay Goudie, Dr John Haughney,Dr David Hood, Mrs Moira Howie, Ms Grace Lindsay, Mrs Angela Munday, Ms Wendy Nganasurian, Dr Marianne Nicolson, Mr Chris Nicholson, Mrs Fiona Ramsay, Dr Philip Rutledge, Dr Sandy Simpson, Ms Angela Timoney, Mrs Helen Tyrrell, Mr Mike Wallace, Dr John Webster, Mr Derek Yuille

In Attendance: Ms Joanne Andrew, Dr Jennifer Armstrong, Dr Jennifer Burns, Miss Paula Carson, Ms Sara Davies, Mrs Hazel Illingworth, Ms Tracey Love, Mr Colin McAllister, Dr John McElhinney, Mrs Laura McIver, Miss Rosie Murray, Miss Corinne O’Dowd, Mr Bill Ramsay, Mrs Emma Stoica, Ms Jane Strathern, Dr Andrew Walker

Apologies: Mrs Laura Ace, Mrs Barbara Black, Mr Nick Brown, Mr John Glennie, Dr Harpreet Kohli, Mrs Anne Lee, Dr Graham Lowe, Dr Chris Lush, Mrs Pat Murray, Dr Ken Paterson, Dr Andrew Riley

1. Welcome and Apologies for Absence

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

1.2  A welcome was extended to the following who were observing the work of the SMC:

  • Ms Joanne Andrew, Oncology Horizon Scanning Pharmacist, Glasgow Royal Infirmary
  • Dr Rosaleen Beattie, Chair of Orkney Medicines Management Group
  • Dr Jennifer Burns, NDC member
  • Ms Paula Carson, SMC Administrator
  • Ms Tracy Love, Principal Pharmacist, Medicines Information, Ayrshire & Arran
  • Dr John McElhinney, NDC member
  • Ms Jane Strathern, Senior Solicitor, Central Legal Office

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 – 7 February 2006

3.1 The minutes of the meeting held on 7 February 2006 were agreed as an accurate record.

4. Matters Arising From the Previous Minutes

4.1 Non-submissions

4.1.1. Further to previous discussion with regards to the process for dealing with non-submissions, SMC will imminently issue “not recommended” advice to companies who have failed to make a submission to SMC within an agreed timescale.  A formal process has been put in place for prompting companies and following up of non-submissions.

Full Submissions

4.2  aprepitant (Emend)  Merck Sharp & Dohme  (No: 242/06) 

4.2.1 SMC advice for aprepitant (Emend), for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, will be posted on the SMC website on Monday 13 March 2006.

4.3  rasagiline 1mg (Azilect)  Lundbeck Ltd/Teva Pharmaceuticals Ltd  (No.  243/06)

4.3.1 SMC Advice for rasagiline 1mg (Azilect), for the treatment of idiopathic Parkinson’s disease as monotherapy (without levodopa), will be posted on the SMC website on Monday 13 March 2006.

4.4 rasagiline 1mg (Azilect)  Lundbeck Ltd/Teva Pharmaceuticals Ltd  (No.  255/06)

4.4.1 SMC Advice for rasagiline 1mg (Azilect), for the treatment of idiopathic Parkinson’s disease as adjunct therapy (with levodopa), will be posted on the SMC website on Monday 13 March 2006.

4.4.2 Following comments received from a comparator, minor amendments have been made to the Detailed Advice Document for rasagiline and this will be reissued to NHSScotland on Friday 10 March, 2006.

4.5 temozolomide 5, 20, 100 and 250mg capsules (Temodal) Schering-Plough UK Ltd (No. 244/06)

4.5.1 SMC Advice for temozolomide (Temodal), for the treatment of newly diagnosed glioblastoma multiforme (GBM), concomitantly with radiotherapy and subsequently as monotherapy treatment, will be posted on the SMC website on Monday 13 March 2006.

4.6  lumiracoxib 100 mg tablets (Prexige)  Novartis  (No.  245/06)

4.6.1 SMC Advice for lumiracoxib (Prexige), for symptomatic relief in the treatment of osteoarthritis, will be posted on the SMC website on Monday 13 March 2006

Resubmissions

4.7  ropinirole (Adartrel)  GlaxoSmithKline  (No. 165/05) 

4.7.1 SMC Advice for ropinirole (Adartrel), for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome will be withheld pending confirmation of launch.

4.8  modafinil (Provigil)  Cephalon  (No.  63/03)

4.8.1 SMC Advice for modafinil (Provigil), for the treatment of excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome, will be posted on the SMC website on Monday 13 March 2006.

Abbreviated Submissions

4.9 somatropin (Genotropin)  Pfizer  (No. 240/06)  

4.9.1 SMC Advice for somatropin (Genotropin), for the treatment of growth disturbance in short children born small for gestational age (SGA), with a birth weight and/or length below -2 Standard Deviations, who failed to show catch-up growth (Height velocity SDS < 0 during the last year) by 4 years of age or later, will be posted on the SMC website on Monday 13 March 2006.

4.10  budesonide inhalation powder 100, 200, 400mcg (Budesonide Easyhaler)

4.10.1 SMC Advice for budesonide inhalation powder 100, 200, 400mcg (Budesonide Easyhaler), for the treatment of mild, moderate or severe persistent asthma in adults and children over 6 years of age, will be posted on the SMC website on Monday 13 March 2006

4.11 dorzolamide hydrochloride (Trusopt)  Merck Sharp and Dohme  (No. 238/06)

4.11.1 SMC Advice for dorzolamide hydrochloride (Trusopt), for the treatment of elevated ocular pressure in ocular hypertension, open-angle glaucoma and pseudo-exfoliative glaucoma will be withheld pending confirmation of launch.

5.  Appeals Update

5.1 buprenorphine transdermal patches (BuTrans)  Napp Pharmaceuticals

5.1.1 Napp have advised of their intention to make a resubmission to SMC for buprenorphine transdermal patches for the treatment of severe opioid responsive pain conditions which are not adequately responding to non-opioid analgesics.

6  PAPIG

6.1 The minutes of the meeting of 7 February, 2006 were available for review and information. 

7. New Drugs Committee: Chairman’s report

7.1 Nothing to report.

8. Evaluation Programme

8.1 The first meeting of the Reference Group of the Evaluation Team was held on 27 February 2006. The Chairman of the Reference Group gave an update and advised that the first meeting had been very successful with good participation from all.

9.  Chairman’s Business

9.1 Abbreviated Submission Process

9.1.1 An update on the short-life working group for the review of the current process with regards to abbreviated submissions was presented to the SMC User Group Forum meeting on 28 February 2006. Amendments to the process were agreed by SMC.  The revised documentation will be posted on the SMC website.

9.2 Membership

9.2.1 Rotation of membership is currently being reviewed.  Members who are due to leave the committee at the end of March 2006 have been informed, but some members have been asked to extend their membership until new members have been appointed. 

9.3 Teleconferencing Meeting with Andrew Dillon and Carol Longson, NICE

9.3.1 The Chairman and Vice Chairman of SMC discussed with Andrew Dillon and Carol Longson SMC Advice and the NICE Single Technology Appraisal (STA) programme. Both Groups have agreed to an ongoing dialogue.

9.4 Health Department Letter (HDL) regarding SMC Advice and NICE STA 

9.4.1 The Scottish Executive Health Department (SEHD) in conjunction with representatives of SMC have drawn together a HDL regarding the position with regards to SMC Advice and NICE STA.  It is anticipated that this will be issued shortly.

9.5 All Wales Medicines Strategy Group (AWMSG)

9.5.1 Professor Philip Routledge, Chairman of the AWMSG, met with the Chairman of SMC to discuss AWMSG and SMC working together. Further discussion regarding the principles that might underpin this are underway.

9.6 SMC Statement on Orphan Drugs

9.6.1 The SMC statement on orphan drugs has been revised and was presented to the SMC User Group Forum meeting on 28 February 2006. Amendments were noted and the revised statement will be posted on the SMC website.

9.7 Changes at the MHRA and CSM Scotland

The Chairman advised that the MHRA is instituting a new electronic way of storing and analysing Yellow Card data as from mid-April 2006. This has wide-ranging implications for the way in which the Regional Monitoring Centres established by the CSM operate. The CSM has been replaced by a new body, the CHM (Commission for Human Medicines). Not only will the organisational names change, but timescales imposed by legislation are likely to result in a need for all Yellow Cards to be collected in one location for electronic entry onto the MHRA databases within specified time frames.

It is not absolute clear yet what the implications are for the monitoring centre for Scotland, based in Edinburgh, although there is concern that new developments do not impair their ability to provide the SMC with any information they may require on products they have approved for Scottish use. The committee agreed that safety issues are not the responsibility of SMC, but that data on Scottish yellow cards should be easily accessible to appropriate bodies in Scotland and that the focus of CSM Scotland, its impact on supporting submission of yellow cards, its role in pharmacovigilance, is not compromised with any new arrangements.
 
9.8 SMC Website

9.8.1 The SMC website is currently being redeveloped and it is anticipated that the new website will be operational by April 2006.

9.9 User Group Forum

9.9.1 The SMC UGF meeting was held on 28 February 2006. Minutes will be available at the April meeting of SMC. 

10. NDC Assessment Reports

Full Submissions

10.1 sodium oxybate (Xyrem)  UCB Pharma Ltd (No. 246/06)

10.1.1 No declarations of interest were recorded in relation to this product/comparator drugs.

10.1.2 The NDC Lead Assessor provided a detailed overview of the assessment, draft advice, expert comments and comments from the company. Marketing details for Xyrem Responder programme was tabled. A member of PAPIG presented a Patient Interest Group submission from UK Association of Narcoleptics (UKAN) 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, are to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 10 March, 2006.

10.2 pramipexole (Mirapexin)  Boehringer Ingelheim (No. 247/06)

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

10.2.2 The NDC Vice 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 Ekbom Support Group (ESG) which was tabled at the meeting. Detailed discussion followed and the group concluded their advice for pramipexole (Mirapexin), for the treatment of moderate to severe restless legs syndrome.

10.2.3 The SMC advice to ADTCs and NHS Boards will be withheld pending confirmation of launch.

10.3 daptomycin (Cubicin) Chiron Corporation Ltd (No. 248/06) 

10.3.1 Declarations of interest were recorded in relation to this product/comparator drugs. Members with personal specific interests left the room for this part of the meeting.

10.3.2 The NDC Lead Assessor provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company. A revised submission showing amendment to the economic section and a revised economic checklist were tabled. Detailed discussion followed and the group agreed that daptomycin (Cubicin), for the treatment of complicated skin and soft tissue infections in adults 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.

10.3.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 10 March, 2006.

10.4 ciclesonide (Alvesco) Paediatric  Altana Pharma Ltd (No. 249/06)

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

10.4.2 The SMC Vice Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company. SPC 80, Adult and Adolescent and SPC 160, Adult and Adolescent were tabled. A member of PAPIG presented a Patient Interest Group Submission from Asthma UK Scotland. Detailed discussion followed and the group concluded their advice for ciclesonide (Alvesco), for prophylactic treatment of persistent asthma in children and adolescents (aged 6–17 years).

10.4.3 The SMC advice to ADTCs and NHS Boards will be withheld pending confirmation of launch.

Resubmissions

10.5 cinacalcet (Mimpara)  Amgen Ltd (No. 169/05) 

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

10.5.2  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 cinacalcet (Mimpara), for the treatment of secondary hyperparathyroidism (SHPT) in patients with end stage renal disease ESRD (stage 5 chronic kidney disease) on haemodialysis and peritoneal dialysis, 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. 

10.5.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 10 March, 2006.

10.6 glyceryl trinitrate 0.4% (Rectogesic Rectal Ointment)  ProStrakan Group (No. 200/05) 

10.6.1 No declarations of interest were recorded in relation to this product/comparator drugs. 

10.6.2 The NDC Vice Chairman provided an overview of the assessment, the draft advice, expert comments from the original review and the resubmission and comments received from the company. Detailed discussion followed and the group agreed that glyceryl trinitrate 0.4% ointment (Rectogesic), for the relief of pain due to 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. 

10.6.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 10 March, 2006.

11 Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled for review.

12 ADTC Feedback

12.1 There was nothing to report

13 Any Other Business

13.1 NICE – Social Value Judgements, Principles for the development of NICE guidance

13.1.1 A member of PAPIG provided a overview of the PAPIG response to the above document. The paper will be circulated to members of SMC for review and further discussion at the April meeting of SMC. 

13.2 Moira Howie

The Chairman thanked Moira Howie who was attending her last meeting of SMC.  Moira was involved with the initial set up of SMC and her contribution to the committee has been invaluable.

14 Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 4 April, 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.