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Minutes of the SMC Meeting held on Tuesday 07 July 2009

Minutes of the SMC Meeting
held on Tuesday 07 July 2009
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: Professor Ken Paterson (Chairman),Professor James Barbour, Dr Keith Beard,
Mrs Margo Biggs, Mr Colin Brown, Mr Scott Bryson, Dr David Crookes, Dr John Gemmill,
Ms Susan Goldsmith, Dr Barclay Goudie, Dr Jan Jones, Dr Frances Macdonald,
Dr John McElhinney, Dr Simon Maxwell, Ms Aileen Muir, Dr Mercia Page, Dr Robert Peel,
Dr Andrew Power, Mr Mike Pratt, Dr Nick Reed, Mr Keith Thompson, Mrs Sheila Tunstall-James,
Dr Andrew Walker.

In Attendance: Mrs Corinne Booth, Ms Ailsa Brown, Ms Rosie Murray, Ms Emma Riches,
Ms Alex Robertson, Mrs Maureen Stark, Mrs Catherine Tait.

Apologies: Mrs Laura Ace, Dr Keith Brown, Professor John Cairns, Mr Robert Calderwood,
Mr Dave Carson,Dr Sara Davies, Mr Stephen Ferguson, Dr Jonathan Fox, Dr Gail Gilbert,
Mrs Anne Lee, Dr Chris Lush, Dr Alan MacDonald, Ms Veronica Moffat, Professor Dilip Nathwani, Dr Anthony Ormerod, Mr Andrew Powrie-Smith, Dr Sarah Taylor, Mr Alistair Thorburn, Ms Angela Timoney, Dr Iain Wallace, Professor Tony Wells, Professor David Wray.

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 Ms Susan Douglas-Scott, Chief Executive of the Long Term Conditions Alliance Scotland (LTCAS), who was observing the meeting.
 
Dr Jennifer Burns, was welcomed to her first meeting of SMC as a new Member.  Dr Burns is a Consultant in medicine for the elderly and a previous long-standing member of the New Drugs Committee (NDC).

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 02 June 2009 were accepted as an accurate record of the meeting subject to a minor amendment to wording in item 6.1.

4. Matters Arising

Full Submissions

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

4.1.1 The SMC advice for histrelin acetate (VantasÒ), for the palliative treatment of advanced prostate cancer, will be issued to NHS Boards on Friday 10 July and published on the website on Monday 10 August 2009.  Distribution of advice was withheld in June 2009 pending confirmation of product availability. 

4.2  infliximab 100mg powder for concentrate for solution for infusion  (Remicade)  Schering-Plough Ltd (No. 374/07)

4.2.1 The SMC advice for infliximab (Remicade) 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, will be published on the website on Monday 13 July 2009.

Resubmission

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

4.3.1 The SMC advice for pegylated liposomal doxorubicin (Caelyx), in combination with  bortezomib, 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, will be published on the website on Monday 13 July 2009.

Deferred Advice

4.4 rotigotine, 1mg, 2mg and 3mg per 24 hours transdermal patch (NeuproÒ)  UCB Pharma Ltd  (No. 548/09) 

4.4 1 Rotigotine (Neupro) was reviewed by SMC in April 2009 and was accepted for use for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults, but the advice was withheld pending confirmation of product availability.  The product is now available and advice will be distributed to NHS Boards and ADTCs on Friday 10 July and published on the SMC website on Monday 10 August 2009.

Amended Advice

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

4.5.1 Enoxaparin (Clexane) was reviewed by SMC in May 2007 and accepted for use for the treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).  Advice was withheld pending product licence.  The product is now available and advice was distributed to NHS Boards and ADTCs on Friday 05 June 2009.  As a result of comparator comments, amendments have been made to the Advice and it will be reissued to NHS Scotland on Friday 3 July, 2009.and published on the SMC website on Monday 13 July 2009.  

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the previous meeting of PAPIG (02 June 2009)

Minutes of the previous meeting were noted.

6.2 Update on current PAPIG business

Mrs Tunstall - James reported that meetings had taken place with Dr Jacqui Sneddon, Project Lead for the Scottish Antimicrobial Prescribing Group, to discuss how best to engage with patients and the public at both national and local level, and with Ms Susan Douglas-Scott, Chief Executive  of the Long Term Conditions Alliance, which in collaboration with  PAPIG, is working to establish a Patient and Public Involvement Officer to increase and develop patient interest group submissions to SMC.
 
6.3 PAPIG Webpage

Mrs Tunstall – James expressed her thanks to the Secretariat Manager for making suggested improvements to the PAPIG webpage.

7. New Drugs Committee (NDC): Chairman’s Report

7.1 A Patient Access Scheme Assessment Group (PASAG) is currently being established under the auspices of National Services Scotland (NSS). The Group is charged with establishing and applying a national process for assessing Patient Access Schemes and their suitability for use in NHS Scotland.     Dr Jan Jones intimated that the first submissions containing a PAS have now been reviewed by the NDC.  

Where a manufacturer makes a submission with an associated PAS, SMC will consider the cost-effectiveness of the product both with and without the PAS.   Only once the PASAG has assessed the suitability of the PAS and accepted it for use in NHS Scotland will SMC issue advice which takes the PAS into account. 

Until the PASAG has established its process for assessing and accepting such schemes and has opined on the suitability of each PAS, SMC may delay consideration of some submissions for a short period of time.  Individual companies appear to wish to co-operate with SMC on this issue to ensure that robust PAS assessment processes are put in place.

Dr F Macdonald requested that whilst interim PASAG arrangements apply, the NDC Recommendation clearly indicates to the manufacturer whether the Recommendation is made with or without taking the PAS into consideration.

8. Chairman’s Business

8.1 Re-assessment of deferred advice

SMC considered a theoretical situation where a significant period of time may have elapsed between SMC undertaking a review and receiving confirmation of the product licence and its availability to the market.    In addition to potential changes in pricing and changes in prescribing practice, new data, may also have become available in the intervening period.  It was agreed that, in conjunction with NHS Boards and the SMC User Group Forum, further consideration should be given to asking manufacturers to make a revised submission to SMC if an agreed period of time has elapsed between SMC review and publication of advice.

8.2 Freedom of Information Request. 

SMC received a request under the Freedom of Information (Scotland) Act 2002 for release of the SMC Detailed Advice Document for bexarotene capsules (Targretin) for the treatment of advanced cutaneous T-cell lymphoma which was reviewed by SMC in October 2002. The licence holder, Cephalon indicated that they had no objection to the release of the information and the request was met within the 20 working day timeframe (30 June 2009). 

8.3 NICE Single Technology Appraisal Guidance No. TA 171: Lenalidomide for the treatment of multiple myeloma (Issued 18 June 2009)

The NICE STA No. 171 summarises that lenalidomide (used together with dexamethasone) is recommended as a possible treatment for people with multiple myeloma who have already had at least two other treatments. The manufacturer of lenalidomide has agreed to cover the cost of the drug for people who stay on treatment for more than 26 cycles (normally a period of 2 years).

In May 2008, SMC published the following advice: lenalidomide (Revlimid) is not recommended for use within NHS Scotland in combination with dexamethasone for the treatment of multiple myeloma in patients who have received at least one prior therapy. Lenalidomide plus dexamethasone significantly increased the time to disease progression compared with dexamethasone alone in multiple myeloma patients who had been treated with at least one prior therapy. The manufacturer did not present a sufficiently robust case and in addition the manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC.  The licence holder has indicated their intention to resubmit.

NICE Single Technology Assessments (STAs) have no status in NHS Scotland.

8.4 NICE Single Technology Appraisal Guidance No. TA 172 – Cetuximab for the treatment of recurrent and/or metastatic squamous cell cancer of the head and neck (Issued 24 June 2009)
 
The NICE STA 172 summarises that cetuximab, in combination with platinum-based chemotherapy, is not recommended for people with recurrent and/or metastatic squamous cell cancer of the head and neck. Healthcare professionals should not stop prescribing cetuximab in combination with platinum-based chemotherapy for patients who are already receiving treatment.

In February 2009, following a non-submission, SMC published the following advice: In the absence of a submission from the holder of the marketing authorisation, cetuximab (Erbitux) is not recommended for use within NHSScotland for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.

NICE Single Technology Assessments (STAs) have no status in NHS Scotland.

8.5 Surge in SMC Submissions

SMC are anticipating a surge in submissions from manufacturers over the coming months.  For operational reasons, SMC may therefore have to prioritise and limit the number of submissions that can be assessed at any one meeting.  The SMC Secretariat is happy to discuss likely timelines for assessment with individual companies who may be in the process of preparing submissions.

8.6 Flu Pandemic

In line with other NHS organizations, SMC has drafted an action plan should staff absences increase along with infection rates.  In the event of a severe pandemic SMC priorities would be:

  • To prioritise the assessment of new medicines based on clinical need.
  • To consider  the need for  staff redeployment to other NHS Organisations

An early effect of reduced numbers of SMC staff and members, will be the ability of Leads/ Executive members to present submissions to SMC.  The Executive have requested that where possible, appropriate members of staff eg assessors or NDC/SMC members, make themselves available to present to SMC whenever shortfalls arise.  Under the circumstances, requests for help may be made at short notice.

9. NDC ASSESSMENT REPORTS

 FULL SUBMISSIONS

9.1 peginterferon alfa-2a (Pegasys) Roche Products Limited (No. 561/09)                   

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

9.1.2 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 peginterferon-alpha 2a (Pegasys), should be accepted for use in NHS Scotland, for the treatment of chronic hepatitis C in adult patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) alone or in combination therapy with ribavirin.  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 July 2009.

9.2 calcipotriol 50 mcg/g / betamethasone 500 mcg/g (Xamiol Gel®) LEO Pharma (No. 559/09)

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

9.2.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented patient interest group submissions from PSALV, and Skin Care Campaign Scotland.  Detailed discussion followed and the group agreed that calcipotriol / betamethasone (Xamiol Gel®), should be accepted for use in NHS Scotland, for the topical treatment of scalp psoriasis.  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 July 2009.

9.3 degarelix (Firmagon) Ferring Pharmaceuticals Limited (No. 560/09)                      

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

9.3.2 The NDC Co-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 degarelix (Firmagon), should not be recommended for use in NHS Scotland, for the treatment of adult male patients with advanced hormone-dependent prostate cancer.  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 July 2009.

RESUBMISSION

9.4 etravirine (Intelence) Tibotec / Janssen-Cilag Ltd (No. 530/09)                               

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

9.4.2 The NDC Chair 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 Waverly Care and HIV Scotland.  Detailed discussion followed and the group agreed that etravirine (IntelenceÒ), should be accepted for use in NHS Scotland, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients.  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 July 2009.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

11. SMC User Group Forum (UGF)
11.1 Nothing to report.

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

12.1 Prophylactic prescribing of aspirin

Tayside Medicines Advisory Group is currently considering the risks and benefits of prescribing aspirin for primary prevention of vascular events and asked whether any other Area Drug and Therapeutic Committees were undertaking similar evaluations.  None of the Members around the table were aware of such discussions but it was agreed that a note to ADTCs could be issued to explore further.

13. Any Other Business

13.1 No other business was raised.

14. Date of the Next Meeting

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