You are here:

SMC Minutes - Tuesday 3 May 2005

Minutes of Meeting held on Tuesday 3 May 2005
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Professor James Barbour, Dr Keith Beard, Ms Chris Beech, Dr Corri Black, Mrs Michelle Caldwell, Professor John Cairns, Mr Tom Divers, Dr Peter Donnan, Mr John Glennie, Dr Barclay Goudie, Dr John Haughney, Dr David Hood, Dr Jan Jones, Dr Harpreet Kohli, Mrs Angela Munday, Ms Wendy Nganasurian, Dr Marianne Nicholson, Dr Ken Paterson, Ms Fiona Ramsay, Dr Andrew Riley, Mrs Fiona Scott, Dr Sandy Simpson, Ms Helen Tyrrell, Mr Mike Wallace, Dr John Webster, Mr Derek Yuille

In Attendance: Dr Ross Camidge, Dr Sara Davies, Mr Steven Fenocchi, Mrs Laura McIver,
Miss Rosie Murray, Mrs Maureen Stark, Mr Brian West

Apologies: Mrs Barbara Black, Ms Sandra Blevings, Professor Martin Brodie, Mrs Moira Howie,
Dr Chris Lush, Mr Hector MacKenzie, Dr Philip Rutledge, Mr Chris Nicolson

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:

  • Dr Jennifer Burns, Consultant Geriatrician, Glasgow Royal Infirmary and New Drugs Committee Member
  • Dr Andrew Power, Head of Medicines Management, Greater Glasgow Primary Care Trust and New Drugs Committee Member 
  • Mr Brian West, Information and Development Officer, HIV Scotland

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 (05.04.05)

3.1 The minutes of the meeting of 5 April, 2005, were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1 Staffing

4.1.1 Laura McIver, currently seconded to SMC, has been appointed as Chief Pharmaceutical Adviser for SMC.  Anne Lee, currently working for the Medicines Information Centre at Glasgow Royal Infirmary has been appointed as Principal Pharmacist for Horizon Scanning.  Both will take up their posts in July 2005.

4.2 SMC Annual Report 2004

4.2.1 A copy of the SMC Annual Report 2004 was tabled for all members. The report will be distributed to NHS Scotland and the SMC expert panel within the next two weeks and also posted on the SMC website.  

4.3 Review of Membership

4.3.1 The SMC Executive team are currently reviewing nominations from ADTCs and are aware of current members' options.  It is anticipated that rotation of membership will be complete within the next couple of months.

FULL SUBMISSIONS

Paperwork

To reduce the volume of paperwork, the SMC Detailed Advice Documents from the previous SMC meeting will no longer be included in paperwork to SMC.  However, the DADs will remain on the SMC agenda and a verbal update on each will be given.  In the event that there has been a change to wording the DAD will be tabled for review.

Removal of Confidential Data from DAD

It was agreed that where confidential data has been removed from a submission a standard form of words will be used to reflect that data has been removed along with a timescale within which publication is anticipated.

4.4 liposomal cytabarine (Depocyte)  Napp Pharmaceuticals  (No: 164/05)

4.4.1 SMC advice for liposomal cytabarine (Depocyte), for the intrathecal treatment of lymphomatous meningitis, will be posted on the SMC website on Monday 9 May, 2005.

4.5 ropinirole (Adartrel)  GlaxoSmithKline  (No: 165/05)

4.5.1 SMC advice for ropinirole (Adartrel), for the treatment of idiopathic restless legs syndrome was withheld pending licence/launch.

4.6 oral beclometasone (Clipper)  Trinity-Chiesi  (No: 166/05)

4.6.1 SMC advice for oral beclometasone (Clipper), for the treatment of ulcerative colitis, was withheld pending licence/launch.
 
4.7 imiquimod 5% cream (Aldara)  3M Healthcare  (No: 167/05)

4.7.1 SMC advice for imiquimod 5% cream (Aldara), for small superficial basal cell carcinoma, will be posted on the SMC website on Monday 9 May, 2005. 

4.7.2 Further to competitor comments, minor amendments to wording were noted and will be advised to ADTCs and NHS Boards on Friday 6 May, 2005.

4.8 Tachosil  Nycomed UK Ltd  (No: 168/05)

4.8.1 SMC advice for Tachosil, for the management of haemostasis in liver surgery, will be posted on the SMC website on Monday 9 May, 2005. 

4.9 cinacalcet (Mimpara)  Amgen Ltd  (No: 169/05)

4.9.1 SMC advice for cinacalcet (Mimpara), for the treatment of secondary hyperparathyroidism in end stage renal disease, will be posted on the SMC website on Monday 9 May, 2005. 

4.10 adefovir dipivoxil (Hepsera)  Gilead Sciences: (No: 54/03) Re-submission

4.10.1 SMC advice for adefovir dipivoxil (Hepsera), for the treatment of Hepatitis B, will be posted on the SMC website on Monday 9 May, 2005. 

4.11 ibritumomab tiuxetan (Zevalin)  Schering HealthCare  (No: 171/05)

4.11.1 SMC advice for ibritumomab tiuxetan (Zevalin), for the treatment of rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin¿s lymphoma, will be posted on the SMC website on Monday 9 May, 2005. 

4.11.2 Further to company comments, minor amendments to wording were noted and will be advised to ADTCs and NHS Boards on Friday 6 May, 2005.
 

ABBREVIATED SUBMISSIONS

4.12 paracetamol IV infusion (Perfalgan)  Bristol Myers Squibb  (No:  172/05)

4.12.1 SMC advice for paracetamol IV infusion (Perfalgan) for the treatment of moderate pain and fever, will be posted on the SMC website on Monday 9 May, 2005. 

4.13 abacavir (Ziagen)  GlaxoSmithKline  (No: 174.05) 

4.13.1 SMC advice for abacavir (Ziagen) once-daily dosage for the treatment of HIV type 1, will be posted on the SMC website on Monday 9 May, 2005. 

4.14 abacavir lamivudine combination (Kivexa)  GlaxoSmithKline  (No: 175/05)

4.14.1 SMC advice for abacavir lamivudine combination (Kivexa) for the treatment of HIV type 1, will be posted on the SMC website on Monday 9 May, 2005. 

4.15 beclometasone dipropionate (Clenil Modulite)  Trinity-Chiesi Pharmaceuticals Ltd
(No: 177/05)
  

4.15.1 SMC advice for beclometasone dipropionate (Clenil Modulite) for the treatment of asthma, was withheld pending licence/launch.

5 Appeals Update

5.1 pegvisomant (Somavert): Pfizer  (No: 158/05)

5.1.1 The company has advised of their intention to make a resubmission.

5.2 anagrelide (Xagrid): Shire

5.2.1 The company has advised of their intention to make a resubmission.

5.3 cetuximab (Erbitux)  Merck Pharma  (No: 155/04)

5.3.1 A panel is currently being assembled for an IRP.  Once this is complete a date for the meeting will be set.

6 PAPIG

6.1 A powerpoint presentation regarding SMC and Patient and Public Involvement is now available.  Members wishing to use the presentation should contact the secretariat.  Voluntary Health Scotland has written an article for their Newsletter about SMC.  A copy will be circulated to all members.  The feedback from the first patient group representative observer at SMC has been very positive, as a consequence of this PAPIG have developed an action plan to ensure this is a beneficial experience for all future patient group representatives.  Full minutes of the PAPIG meeting held on 3 May, 2005, will be available for review at the next meeting of SMC.  

7 Freedom of Information

7.1 There were no new requests for information to report.

8 New Drug Committee: Update

8.1 There were no items to report.

9 Chairman's Business

9.1 Orphan Drugs

9.1.1 A meeting with the Scottish Executive to discuss orphan drugs will be held on 16 May, 2005.  The outcome will be reported at the next SMC meeting.

9.2 Recommendations for Good Antimicrobial Practice in Acute Hospitals

9.2.1 Dilip Nathwani presented the report at a meeting of the Chief Executive Officers on 13 April, 2005. This was well received by those present and the SEHD will now distribute the report as an HDL.  SEHD have advised that they will make reference to SMC's critically important role in producing this document.

9.3 Insulin detemir (Levemir) (No: 138/04)

9.3.1 Insulin determir (Levemir), for the treatment of children and adolescents with diabetes mellitus, was reviewed by SMC in November 2004, but advice was withheld pending confirmation of licence.  The licence has now been received and advice will be distributed to ADTCs and NHS Boards on Friday 6 May, 2005, and posted on the SMC website on Monday 13 June, 2005.

9.4 Resignations from SMC

9.4.1 The Chairman expressed thanks to Professor Angus MacKay and Mr Jeff Ace who have both resigned from SMC.  Mr Ace has taken up a new post as Director of Health Services. Professor MacKay has stepped down due to other commitments but has advised that he is happy to provide a link to MHRA.

10 NDC Assessment Reports - Full Submissions

10.1 strontium ranelate (Protelos)  Servier Laboratories Ltd  (No: 178/05)

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

10.1.2 The acting NDC vice Chairman advised that further to the NDC draft advice the company had sought clarification regarding the restriction.  The information provided to the company was misleading and company comments and information provided was based on this information.  SMC have therefore agreed to defer assessment of the submission.  Strontium ranelate (protelos) will therefore be reviewed by NDC at their meeting in on 31 May, 2005 and by SMC on 5 July, 2005.
 
10.2 vinorelbine oral (Navelbine oral)  Pierre Fabre Ltd  (No: 179/05)

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

10.2.2 The acting NDC vice Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company.  Detailed discussion followed and group agreed that vinorelbine oral (Navelbine oral), for the treatment of non-small-cell lung cancer, should be accepted for restricted use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice. 

10.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 6 May, 2005.

10.3 modafinil (Provigil)  Cephalon UK Ltd (No. 183/05)

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

10.3.2 The NDC Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company.  Detailed discussion followed and group agreed that modafinil (Provigil), for the treatment of excessive sleepiness associated with shift work disorder, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice. 

10.3.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 6 May, 2005.

RESUBMISSIONS

10.4 modafinil (Provigil)  Cephalon UK Ltd  (No. 63/03)

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

10.4.2 The NDC Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company.  Detailed discussion followed and group agreed that modafinil (Provigil), for the treatment of excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice. 

10.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 6 May, 2005.

ABBREVIATED SUBMISSIONS

10.5.1 rosiglitazone maleate (AvandiaTriple Therapy)  GlaxoSmithKline  (No: 181/05) 

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

10.5.3 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Discussion followed and the group agreed that rosiglitazone maleate (Avandia Triple Therapy) as triple oral therapy in combination with metformin and a sulphonylurea in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy and where patients are unable or unwilling to take insulin, should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.
 
10.5.4 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 6 May, 2005.

10.6.1 ezetimibe/simvastatin (Inegy)  Merck Sharp Dohme - Schering  Plough Ltd  (No. 182/05) 

10.6.2 Declarations of interest were recorded in relation to this product/comparator drugs.
 
10.6.3 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Discussion followed and the group agreed that ezetimibe/simvastatin (Inegy) for the treatment of 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 within NHS Scotland.  Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.

10.6.4 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 6 May, 2005.

11 Forthcoming Submissions
 
11.1 A revised list of forthcoming submissions was reviewed.  

11.2 The secretariat are currently identifying companies who have not made a submission to SMC and will be contacting them accordingly.

12 ADTC Feedback

12.1 Clarification was made regarding the status of the DAD sent to NHS Boards and ADTCs and subsequent feedback.  The Chairman stated that this is intended as a final document, sent in advance to assist with planning before publication.  However, SMC would be happy to receive feedback regarding any major issues of relevance.

13 Any Other Business

13.1 There were no other items for discussion.

14 Date of Next Meeting

The date of the next meeting was confirmed as Tuesday 7 June, 2005, at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

Back to minutes