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Minutes of the SMC Meeting - Tuesday 04 March 2008

Minutes of the SMC Meeting held on Tuesday 04 March 2008
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present:  Professor David Webb (Chairman), Mrs Laura Ace, Dr Keith Beard, Mrs Margo Biggs,
Mr Colin Brown, Dr Keith Brown, Professor John Cairns, Dr David Crookes, Dr Sara Davies,
Mr Tom Divers, Dr Barclay Goudie, Dr Jan Jones, Dr Harpreet Kohli, Dr Grace Lindsay, Dr Chris Lush, Dr Alan MacDonald, Dr John McElhinney, Mr Billy Malcolm, Ms Aileen Muir, Mrs Pat Murray, Mrs Wendy Nganasurian, Dr Ken Paterson, Dr Andrew Power, Dr Nick Reed, Dr Andrew Riley, Dr Sarah Taylor, Mr Keith Thompson, Ms Angela Timoney, Mrs Sheila Tunstall-James, Mr Mike Wallace.

In Attendance: Ms Ailsa Brown, Ms Susan Downie, Mr Stephen Ferguson, Mrs Hazel Illingworth,Mrs Laura McIver, Ms Rosie Murray, Mrs Maureen Stark.

Apologies: Professor James Barbour, Mr David Carson, Dr Jonathan Fox, Mrs Anne Lee, Dr Graham Lowe, Mr Colin McAllister, Professor Dilip Nathwani, Ms Fiona Ramsay, Ms Alex Robertson, Dr Sandy Simpson, Mr Alistair Thorburn, Dr Andrew Walker,Professor Tony Wells.

 

1. Welcome and Apologies for Absence

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

The Chairman extended a  welcome to the following observers at the meeting:

  • Dr Rod Taylor, Associate Professor in Health Service Research, University of Birmingham
    and a Director of the University’s HTA Group.
  • Ms Anna Zawada, whose role is to prepare and assess health technology reports,
    including the review of industry sponsors’ submissions, for the Polish Ministry of Health
    in relation to drug reimbursement.

1.2 Thank you and Goodbye

1.2.1 Mrs Wendy Nganasurian, an SMC Public Partner, founding member and Chair of SMC’s Public and Patient Involvement Group (PAPIG), attended her final meeting of SMC.

The Chairman applauded Wendy’s work in establishing the case for patient and public
involvement within SMC’s processes and for continuing to champion the cause for patients
and their carers over the past 6 years.  Statistics show that submissions from Patient
Interest Groups lead to a higher rate of positive advice and therefore have a notable
influence on SMC’s assessment process.  The Chairman expressed his sincere thanks for
her sterling work and offered his best wishes for the future.

1.2.2 Mr Mike Wallace, ABPI representative, Chairman of the SMC User Group Forum and founding member of SMC, also attended his final meeting.  The Chairman commended the very
significant role that Mike had played in the inception of SMC, working towards the establishment of a robust, collaborative working relationship between SMC and industry. 
Mike has continued to provide wise counsel and support to SMC and has proved himself
a worthy ambassador for ABPI.  The Chairman offered his best wishes for the future.

1.2.3 The Consortium thoroughly endorsed the Chairman’s comments.


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 February 2008 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 nilotinib 200mg capsules (Tasigna) Novartis Pharmaceuticals UK Limited (No. 440/08)                            

4.1.1 The SMC advice for nilotinib (Tasigna), for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib, will be withheld pending confirmation of licence and availability.


4.2 diclofenac, 75mg/2ml of solution for intravenous injection (Dyloject) Javelin Pharmaceuticals UK Ltd (No. 446/08)

4.2.1 The SMC advice for diclofenac (Dyloject), for the prevention of post-operative pain by intravenous injection, in supervised healthcare settings, will be posted on the SMC website on Monday, 10 March 2008.


4.3 zoledronic acid, 5mg solution for infusion (Aclasta) Novartis Pharmaceuticals UK Limited (No. 447/08)

4.3.1 The SMC advice for zoledronic acid (Aclasta), for the treatment of osteoporosis in post-menopausal women at increased risk of fractures, will be posted on the SMC website on Monday, 10 March 2008.


4.4 infliximab 100mg powder for concentrate for solution for Infusion, (Remicade) Schering-Plough (No. 448/08)

4.4.1 The SMC advice for infliximab (Remicade), for the treatment of severe, active Crohn’s disease, in paediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies, will be posted on the SMC website on Monday, 10 March 2008.


4.5 daptomycin, 350mg and 500mg vials of powder for solution for infusion (Cubicin)  Novartis Pharmaceuticals UK Limited (No. 449/08)

4.5.1 The SMC advice for daptomycin (Cubicin), for the treatment of Staphylococcus aureus bacteraemia (SAB) when associated with right-sided infective endocarditis (RIE) or with complicated skin and soft-tissue infections (cSSTI) in adults, will be posted on the SMC website on Monday, 10 March 2008.


4.6 salmeterol/fluticasone 50/500 micrograms inhaler (Seretide 500 Accuhaler) GlaxoSmithKline  (No. 450/08)

4.6.1 The SMC advice for salmeterol/fluticasone (Seretide 500 Accuhaler), for the symptomatic treatment of patients with chronic obstructive airways disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% to <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy, will be posted on the SMC website on Monday, 10 March 2008.


Abbreviated Submissions

4.7 follitropin alfa 150 IU/ lutropin alfa 75 IU for solution for injection (Pergoveris) Merck Serono UK (No. 444/08)

4.7.1 The SMC advice for follitropin alpha 150 IU/ lutropin alpha75 IU for solution for injection (Pergoveris), for stimulation of follicular development in women with severe luteinising hormone (LH) and follicle-stimulating hormone (FSH) deficiency, will be posted on the SMC website on Monday, 10 March 2008.


4.8 mesalazine 1200mg gastro-resistant, prolonged release tablet (Mezavant XL) Shire Pharmaceuticals Limited (No. 445/08)

4.8.1 The SMC advice for mesalazine (Mezavant XL), for the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis, and for maintenance of remission, will be posted on the SMC website on Monday, 10 March 2008.


Non Submission

4.9 bevacizumab (Avastin) Roche Pharmaceuticals (No. 459/08)

4.9.1 The SMC advice for bevacizumab (Avastin), in combination with interferon alfa-2a for the first line treatment of patients with advanced and/or metastatic renal cell cancer, will be posted on the SMC website on Monday, 10 March 2008.


Deferred Advice

4.10 vildagliptin 50mg and 100mg tablets (Galvus?) Novartis No. (435/07)

4.10.1 vildagliptin (Galvus?) for the treatment of type 2 diabetes mellitus as dual oral therapy in combination with metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin was reviewed by SMC in December 2007, but was withheld pending confirmation of the product availability and licence. The product is now available.   SMC Advice will be sent to NHS Boards on Friday 7 March and published on the SMC website on Monday 7 April, 2008.


5. Appeals Update

5.1 Nothing to report.


6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of  the meeting held on Tuesday 05 February 2008

6.1.1 The minutes were noted.

6.2 Successor to the Chair of PAPIG

6.2.1 Mrs Sheila Tunstall-James will succeed Mrs Wendy Nganasurian as Chair of the Patient and Public Involvement Group.


7. New Drugs Committee: Chairman’s Report

7.1 Dr Jan Jones reported that she had led her first meeting as Chair of NDC.

7.2 Dr Ken Paterson, the outgoing NDC Chairman, provided details of his recent attendance at a joint NHS/ABPI/Voluntary Sector Parliamentary Reception.   The purpose of the event was to highlight successful partnerships between these bodies.  A poster outlining the relationship between SMC and the pharmaceutical industry drew a lot of interest and useful discussion with Ministers and MPs who attended.


8. Chairman’s Business


8.1 Request for information under the Freedom of Information (Scotland ) Act 2002

SMC received a request under the Freedom of Information (Scotland) Act 2002 for the health economic case for fondaparinux (Arixtra) for the prevention of venous thromboembolic events in patients undergoing major orthopaedic surgery.  This was reviewed by SMC in 2002. 
 
SMC are currently considering the request and the timeframe for response is 12 March, 2008. Board FOI Contacts have been advised.


8.2 Meeting with The Chief Medical Officer (CMO)

The Chairman and members of the Executive met with the CMO as part of their programme of regular review meetings.  The CMO continues to be very supportive of SMC and discussed a range of current key issues such as the  ScotMARAP implementation, drug safety Issues, orphan drugs, market access schemes, the SMC Evaluation Programme and exit strategies in clinical trials.

The agreement recently drawn up between SMC and SIGN will be published on the SMC website in the near future.

This was Professor Webb’s last meeting with the CMO as Chairman of SMC but at the CMO’s request he will remain involved in certain specific areas of work, such as exit strategies in clinical trials.


9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 lenalidomide (Revlimid)  Celgene Europe Ltd  (No. 441/08)                                           

9.1.1 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.

9.1.2 The NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses, a summary of patient information and comments received from the company.  A member of PAPIG presented a patient interest group submission from the Rarer Cancers Forum.  Detailed discussion followed and the group concluded their advice for lenalidomide (Revlimid), in combination with dexamethasone for the treatment of multiple myeloma in patients who have received at least one prior therapy.  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, 07 March 2008.


9.2 paliperidone prolonged-release tablets (INVEGA)  Janssen-Cilag  (No. 453/08)            

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

9.2.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that paliperidone prolonged-release tablets (INVEGA), for the treatment of schizophrenia, should not be recommended for use in 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, 07 March 2008.


9.3 nelarabine (Atriance)  GlaxoSmithKline UK  (No. 454/08)                                               

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

9.3.2 The NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, and a summary of patient information received from the company.  A member of PAPIG presented patient interest group submissions from the Rarer Cancers Forum and the Lymphoma Association.  Detailed discussion followed and the group agreed that nelarabine (Atriance) for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to, or relapsed following treatment, with at least two chemotherapy regimens, should be accepted for restricted use in 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, 07 March 2008.


9.4 methoxy polyethylene glycol-epoetin beta (Mircera)  Roche  (No. 455/08)                     

9.4.1 Declarations of interest were recorded in relation to this product/comparator drugs.
 
9.4.2 The NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.   Detailed discussion followed and the group agreed that methoxy polyethylene glycol-epoetin beta (Mircera), for the treatment of anaemia associated with chronic kidney disease, should be accepted for use in 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, 07 March 2008.


9.5 maraviroc (Celsentri)  Pfizer Ltd  (No. 458/08)                                                                 

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

9.5.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, and comments received from the company.  Detailed discussion followed and the group agreed that maraviroc (Celsentri), in combination with other antiretroviral medicinal products, for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable, should not be recommended for use in 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, 07 March 2008.


ABBREVIATED SUBMISSIONS

9.6 efavirenz, emtricitabine, tenofovir disoproxil fumarate (Atripla)  Bristol Myers Squibb /Gilead Sciences/Merck Sharp & Dohme Ltd  (No. 442/08)                                                         

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

9.6.2 The NDC Chair provided an overview of the assessment, and a draft summary of advice. Discussion followed and the group agreed that efavirenz, emtricitabine, tenofovir disoproxil fumarate (Atripla), for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months, should be accepted for use in 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, 07 March 2008.


9.7 insulin glargine (Lantus SoloStar)  Sanofi-aventis  (No. 456/08) 
                                 
9.7.1 A declaration of interest was recorded in relation to this product/comparator drugs.

9.7.2 The NDC Chair provided an overview of the assessment, and a draft summary of advice.  Discussion followed and the group agreed that insulin glargine (Lantus SoloStar), for the treatment of adults, adolescents and children of 6 years and above with diabetes mellitus, where treatment with insulin is required, should be accepted for restricted use in 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, 07 March 2008.


9.8 insulin glulisine (Apidra SoloStar)  Sanofi-aventis  (No. 457/08)                                   

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

9.8.2 The NDC Chair provided an overview of the assessment, and a draft summary of advice.  Discussion followed and the group agreed that that insulin glulisine (Apidra SoloStar), for the treatment of adult patients with diabetes mellitus in whom treatment with this insulin analogue is appropriate and in whom the use of a pre-filled pen offers advantages over a pen and cartridge device, should be accepted for restricted use in 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, 07 March 2008.


NON SUBMISSION

9.9 retapamulin (Altargo) GlaxoSmithKline UK (No. 472/08)

9.9.1 In the absence of a submission from the holder of the marketing authorisation, retapamulin (Altargo) for the short term treatment of the following superficial skin infections: Impetigo and infected small lacerations abrasions, or sutured wounds, should not be recommended for use within NHS Scotland.

9.9.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 07 March 2008.


10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted.


11.SMC User Group Forum

11.1 Minutes of  the meeting held on Tuesday 29 January 2008

11.1.1 The minutes were noted.


12. ADTC Feedback

12.1 There was nothing to report.


13. Any Other Business

13.1 Professor David Webb’s last meeting as Chairman of SMC

Dr Ken Paterson, on behalf of the Consortium, paid tribute to Professor David Webb as he closed his final meeting as Chairman of the Scottish Medicines Consortium.

Professor Webb has been involved since the inception of SMC, moving on first to Chair the New Drugs Committee before taking the Chair of SMC over the last three years.  During that time he has invested a huge amount of time and effort in establishing and developing the work and reputation of the Consortium and has proved to be a skilful and inclusive Chairman.  Dr Paterson wished him well in all his future endeavours.

Professor Webb thanked members for providing the opportunity to work with them.  He reflected on Professor David H Lawson’s visionary approach that led to the establishment of SMC and marvelled at the tremendous progress that has been made in the last eight to nine years. He found his Chairmanship to be an exciting and enjoyable experience and commended his successor, Dr Ken Paterson, to the Consortium.


14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 01 April 2008 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.