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Minutes of SMC Meeting - Tuesday 2 June 2009

Minutes of the SMC Meeting held on Tuesday 2 June 2009
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: Professor Ken Paterson (Chairman), Mrs Laura Ace, Mrs Margo Biggs, Dr Keith Brown, Mr Scott Bryson, Mr Robert Calderwood, Dr Sara Davies, Dr Jonathan Fox, Dr John Gemmill, Dr Barclay Goudie, Dr Jan Jones, Dr Chris Lush, Dr Alan MacDonald, Dr Frances Macdonald, Ms Aileen Muir, Dr Robert Peel, Dr Andrew Power, Mr Andrew Powrie-Smith, Mr Mike Pratt, Dr Nick Reed, Mr Keith Thompson, Mr Alistair Thorburn, Ms Angela Timoney, Mrs Sheila Tunstall-James, Dr Andrew Walker, Dr Iain Wallace, Professor David Wray

In Attendance: Mrs Corinne Booth, Ms Ailsa Brown, Dr Gordon Forrest, Dr Michelle Gillies, Mrs Anne Lee, Ms Rosie Murray, Dr Sharon Pfleger, Ms Emma Riches, Ms Alex Robertson, Mrs Maureen Stark, Mrs Catherine Tait

Apologies: Professor James Barbour, Dr Keith Beard, Mr Colin Brown, Professor John Cairns, Mr Dave Carson, Dr David Crookes, Mr Stephen Ferguson, Dr Gail Gilbert, Ms Susan Goldsmith, Dr Simon Hurding, Dr Duncan McCormick, Dr John McElhinney, Dr Simon Maxwell, Ms Veronica Moffat, Professor Dilip Nathwani, Dr Anthony Ormerod, Dr Mercia Page, 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. 

1.2 A further welcome was extended to the following observers:

  • Dr Sharon Pfleger, Consultant in Pharmaceutical Public Health, NHS Highland
  • Dr Michelle Gillies, Clinical Lecturer in Public Health, NHS QIS
  • Dr Gordon Forrest, NDC Member and Lead Assessor presenting histrelin acetate (Vantas). 

Welcome (New Members)

  • Mr Scott Bryson, Pharmaceutical Policy Adviser, NHS GG&C, and previously an NDC Member
  • Mr Mike Pratt, Director of Pharmacy, Dumfries and Galloway Royal Infirmary
  • Dr Robert Peel, Consultant Nephrologist, Raigmore Hospital, Inverness
  • Dr Iain Wallace, Medical Director QIS

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 05 May 2009 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 rituximab (MabThera) Roche (No. 540/09)

4.1.1 The SMC advice for rituximab (MabThera), for first-line treatment of patients with chronic lymphocytic leukaemia (CLL) in combination with fludarabine and cyclophosphamide, will be published on the website on Monday 8 June 2009.

4.2 romiplostim (Nplate) Amgen (No. 553/09)

4.2.1 The SMC advice for romiplostim (Nplate), for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins), will be held in confidence pending confirmation of the product licence and availability.

Resubmissions

4.3 aripiprazole (Abilify) Bristol Myers Squibb Pharmaceuticals Ltd/Otsuka Pharmaceuticals (UK) (No. 498/08)

4.3.1 The SMC advice for aripiprazole (Abilify), for the treatment of moderate to severe manic episodes in bipolar I disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment, will be published on the website on Monday 8 June 2009.

4.4 pemetrexed (Alimta) Eli Lilly and Company Limited (No. 531/09)

4.4.1 The SMC advice for pemetrexed (Alimta), for the first-line treatment of patients with locally advanced or metastatic non- small cell lung cancer other than predominantly squamous cell histology, will be published on the website on Monday 8 June 2009.

Abbreviated Submissions

4.5 tadalafil (Cialis) Lilly UK (No. 554/09)

4.5.1 The SMC advice for tadalafil (Cialis), for regular once-daily administration in patients with erectile dysfunction responding to an on-demand regimen of tadalafil who anticipate frequent use (at least twice weekly), will be published on the website on Monday 8 June 2009.

4.6 terlipressin acetate (Glypressin  Solution) Ferring Pharmaceuticals Ltd (No. 555/09)

4.6.1 The SMC advice for terlipressin acetate (Glypressin  Solution), for the treatment of bleeding oesophageal varices in patients for whom terlipressin is an appropriate choice of therapy, was withheld pending product availability.  However the product is now available and SMC Advice will be issued to NHS Boards and ADTCs on Friday 05 June and posted on the website on Monday 13 July 2009.

Non Submission

4.7 sapropterin (Kuvan) Merck Serono  (No. 558/09)

4.7.1 The SMC advice for sapropterin (Kuvan), for the treatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with phenylketonuria (PKU) and for the treatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with tetrahydrobiopterin (BH4) deficiency, will be published on the website on Monday 8 June 2009.

Deferred Advice

4.8 enoxaparin pre-filled syringes (Clexane) Sanofi-aventis  (No. 380/07)

4.8.1 SMC reviewed enoxaparin pre-filled syringes (Clexane) in May 2007.  Advice was withheld pending market authorisation for a new indication, however, the product is now available and advice will be distributed to NHS Boards and ADTCs on Friday 5 June and published on the SMC website on Monday 13 July 2009.

Amended Advice

4.9 Nothing to report.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 PAPIG Update

Mrs Tunstall-James advised that PAPIG had met immediately prior to the SMC meeting and minutes would be available at July SMC. The main item to report on was the recent Seminar for Patient Interest Groups held on 21 May 2009.  Feedback received has been very positive and the purpose of the event was to provide an opportunity for patient groups to find out how the Scottish Medicines Consortium works and how they can get involved on behalf of patients and carers.  Mrs Tunstall-James expressed sincere thanks to the SMC Chairman, and Dr Andrew Power for participating in this worthwhile event.  She also expressed thanks to Mrs Maureen Stark and Mr Robert Sanders for organising this event.  The Chairman agreed that this was a very useful exercise to engage with Patient Interest Groups and thanked Mrs Tunstall-James and colleagues for organising this.

6.2 SMC Membership on PAPIG

The Chairman reminded members that there was still a vacancy for an NHS member on PAPIG, representing SMC.  Prior to the SMC meeting the Chairman had spoken to Mr Scott Bryson to invite him to join the PAPIG group. Mr Bryson has in the past taken a major lead in a Patient Interest Group and being a former NDC member brings an NDC as well as SMC view.  Mr Bryson accepted and the Chairman welcomed him to the group.

7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 SMC Submissions – Summer 2009

Due to staffing issues in the Pharmacy Review Team there are restrictions on the Horizon Scanning Report which is due to Boards in October. This may impact on SMC submissions and we are hopeful not to defer any drugs, but due to this situation we may have to involve securing additional input through sedondment opportunity or recruiting pharmacist input on a consultancy basis.  This will be updated at the July SMC Meeting.

8.2 Update on the use of Patient Access Schemes

A Letter has now been issued to Boards explaining the need for a national framework for the assessment of proposed Patient Access Schemes. A Patient Access Schemes Advisory Group (PASAG) will be established to assess proposed Patient Access Schemes.  The PASAG will have a national focus, functioning under the auspices of NHS National Services Scotland (NHS NSS), bringing together the key areas of expertise as required.  It will operate separately from the SMC and Scottish Ministers in order to maintain the integrity and independence of the assessment process of SMC, though clear lines of communication with SMC are of critical importance.  The PASAG will develop standard objective criteria against which schemes proposed by pharmaceutical companies will be assessed.  It will take some time to fully establish the PASAG but, as some manufacturers have already submitted PASs, an interim group is being set up now to handle them.

8.3 Feedback on the ADTC Seminar held on 12 May 2009

The Chairman advised that feedback received from the event has been very positive.  There will be further feedback from SMC on the outputs from the Seminar in due course.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 histrelin acetate, 50mg subcutaneous implant (Vantas)  Orion Pharma (UK) Ltd (No. 557/09)

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

9.1.2 The Lead Assessor provided an overview of the assessment, draft advice, expert comments and revised data/analyses. Detailed discussion followed and the group concluded their advice for histrelin acetate (Vantas), for palliative treatment of advanced prostate cancer. 

9.1.3 The SMC advice will be withheld pending confirmation of licence and product availability.
 
9.2 infliximab 100mg powder for concentrate for solution for infusion  (Remicade)  Schering-Plough Ltd (No. 374/07)

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

9.2.2 The NDC Chair provided an overview of the assessment, draft advice, updated expert comments, revised data/analyses and comments received from the company. Detailed discussion followed and the group agreed that infliximab 100mg powder for concentrate for solution for infusion  (Remicade), should not be recommended for use in NHS Scotland, for the treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contra-indications for such therapies.  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 5 June 2009.
 
RESUBMISSION

9.3 pegylated liposomal doxorubicin, 2mg/ml concentrate for solution for infusion (Caelyx) Schering Plough Ltd  (No. 503/08)

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

9.3.2 The NDC Vice Chair 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 Myeloma UK.  Detailed discussion followed and the group agreed that pegylated liposomal doxorubicin, 2mg/ml concentrate for solution for infusion (Caelyx), in combination with bortezomib, should not be recommended for use in NHS Scotland, 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 transplant.  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 5 June 2009.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

11. SMC User Group Forum (UGF)

11.1 The Minutes of the User Group Forum meeting, held on 28 April 2009 were noted.

11.2 Update on SMC User Group Form (UGF)

Dr Frances Macdonald provided a brief update on the SMC User Group and advised that questionnaires asking companies why they have chosen not to make a submission to SMC should be sent this week to a range of companies. The aim of this exercise is to understand the reasons behind company decisions for not submitting.  Feedback will be provided in due course.

12. Area Drug and Therapeutic Committees (ADTCs): Issues

12.1 A member enquired about a paediatric licence extension and the estimated Budget Impact.  This was noted as an issue and will be considered as part of a wider review of the process for paediatric licence extensions at a later date.

13. Presentation to SMC on Biosimilars

13.1 Presentation on Biosimilars

Professor Norman Lannigan, Lead Pharmacist, Acute Services, Mental Health Innovation, NHS GG & C was invited to give a presentation to SMC on Biosimilars.  He congratulated SMC on the setting up of a SLWG on Biosimilar products which has now been formed to determine a policy decision on the SMC submission requirements for biosimilar medicinal products.  The aim of this awareness session is to capture some of SMC views and comments in preparations for the SLWG report.

Following a very informative presentation there was extensive discussion about the issues raised and possible ways forward for SMC. The Chair thanked Professor Lannigan for this presentation and discussion which has been very helpful in preparing the ground for the report from the SLWG.

14. Any Other Business

14.1 No other business was raised.

15. Date of the Next Meeting

15.1 The date of the next meeting was confirmed as Tuesday 7 July 2009 at 12.30 pm (lunch from 12 noon),
in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.