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Minutes of the SMC Meeting - Tuesday 3 March 2009

Minutes of the SMC Meeting held on Tuesday 03 March 2009
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: Professor Ken Paterson (Chairman), Mrs Laura Ace, Professor James Barbour, Dr Keith Beard, Mrs Margo Biggs, Dr Keith Brown, Mr David Carson, Dr David Crookes, Dr Sara Davies, Mr Tom Divers, Dr Jonathan Fox, Dr John Gemmill, Ms Susan Goldsmith, Dr Jan Jones, Dr Frances Macdonald, Dr John McElhinney, Dr Simon Maxwell, Ms Veronica Moffat, Dr Andrew Power, Mr Andrew Powrie-Smith, Dr Nick Reed, Dr Sandy Simpson, Dr Sarah Taylor,Mr Keith Thompson, Mr Alistair Thorburn, Mrs Sheila Tunstall-James, Dr Andrew Walker.

In Attendance: Mrs Corinne Booth, Ms Ailsa Brown, Mr Stephen Ferguson, Mrs Anne Lee,
Ms Rosie Murray, Dr Mercia Page, Mrs Maureen Stark, Mrs Catherine Tait, Ms Diane Thomson,
Ms Lisa Wilson.

Apologies: Mr Colin Brown, Professor John Cairns, Dr Gail Gilbert, Dr Barclay Goudie,
Dr Grace Lindsay, Dr Chris Lush, Dr Alan MacDonald, Ms Aileen Muir, Professor Dilip Nathwani, Dr Anthony Ormerod, Ms Alex Robertson, Ms Angela Timoney,  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 welcome was extended to the following observers:

Dr Mercia Page. Dr Page will replace Dr Sandy Simpson from April 2009 as ABPI representative on SMC.  Dr Page is currently Director of Medical Affairs for Merck, Sharp and Dohme where her responsibilities include medical input into HTA assessments.

Ms Diane Thomson. Ms Thomson is employed with Wyeth and is an Industry representative on the User Group Forum (UGF).

Ms Lisa Wilson. Ms Wilson is an economic assessor for the New Drugs Committee.

1.3 The Chairman  thanked the  following  members of SMC who had completed their terms of appointment and were attending their final meeting:

Mr Tom Divers. The Chairman commended the very significant role that Tom has played as a founder member of SMC, providing wise counsel and support to the initiative.  Tom has continued to provide pragmatic advice and guidance to SMC during his seven years of membership and will be sorely missed around the table. The Chairman offered his best wishes for the future.
 
Dr Sandy Simpson. Sandy has been an ABPI member of SMC since August 2002 and during that time has helped foster good relations between SMC and the Pharmaceutical Industry. The Chairman thanked Sandy for his valuable contribution and wished him well in his future endeavours.

Dr Grace Lindsay.  Following a three year term of office Grace, unfortunately was unable to attend her final meeting.  The Chairman expressed his thanks and good wishes. 

1.4 The Chairman expressed his thanks and good wishes to Ruth Ford, SMC Administrator for Horizon Scanning, who left SMC on 20 February to take up a new position within the NHS. Ruth has strongly supported the work of SMC’s Horizon Scanning team since August 2005.  Emilia Pietka is acting Administrator for Horizon Scanning, until a permanent appointment is made. 

1.5 The NDC Chairman announced that the University of Glasgow recently granted the status of Honorary Professor in the Faculty of Medicine to Dr Ken Paterson, SMC Chair.  SMC congratulated Professor Paterson on his appointment.

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 03 February 2009 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 doripenem, 500mg powder for solution for infusion (Doribax®)  Janssen-Cilag  No.  (539/09)

4.1.1 The SMC advice for doripenem, (Doribax®) for the treatment of nosocomial pneumonia (including ventilator-associated pneumonia) in adults, will be published on the SMC website on Monday, 09 March 2009.

4.2 alitretinoin 10mg, 30mg capsules (Toctino®)  Basilea Pharmaceuticals Ltd  No.  (538/09)

4.2.1 The SMC advice for alitretinoin (Toctino®), for the treatment of adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids, will be published on the SMC website on Monday, 09 March 2009.

4.3 testosterone undecanoate, 1000mg/4ml oily solution for injection (Nebido®)  Bayer Schering Pharma No.  308/06) 

4.3.1 SMC advice for testosterone undecanoate, (Nebido®), as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests, will be published on the SMC website on Monday, 09 March 2009.

4.4 oxycodone/naloxone 10mg/5mg and 20mg/10mg prolonged release tablets  (Targinact®) Napp Pharmaceuticals Ltd No. (541/09) 

4.4.1 The SMC advice for oxycodone/naloxone (Targinact®), for the treatment of severe pain which can be adequately managed only with opioid analgesics, will be published on the SMC website on Monday, 09 March 2009.

Resubmission

4.5 betaine anhydrous oral powder (Cystadane®) Orphan Europe (UK) Limited No.  (407/07)

4.5.1 The SMC advice for betaine Cystadane®), as adjunctive treatment of homocystinuria involving deficiencies or defects in cystathionine beta-synthase (CBS), 5,10-methylene-tetrahydrofolate reductase (MTHFR) or cobalamin cofactor metabolism (cbl), will be published on the SMC website on Monday, 09 March 2009.

Abbreviated Submissions

4.6 budesonide CFC-free inhaler 100 micrograms and 200 micrograms per actuation (Pulmicort®) AstraZeneca UK Ltd (No: 536/09)

4.6.1 The SMC advice for budesonide CFC-free inhaler (Pulmicort®), for the treatment of asthma, was initially withheld pending confirmation of product availability.  The company has now advised the product will be available in March.  Advice will therefore be published on the SMC website on Monday, 09 March 2009.

4.7 cladribine 2mg/ml solution for injection (LITAK®) LIPOMED GmbH  (No:537/09) 

4.7.1 The SMC advice for cladribine (LITAK®), for the treatment of hairy cell leukaemia, will be published on the SMC website on Monday, 09 March 2009.
 
Non Submission

4.8 cetuximab 5mg/ml solution for infusion (Erbitux®) Merck Serono  (No. 547/09)

The SMC advice for cetuximab (Erbitux®), 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, will be published on the SMC website on Monday, 09 March 2009.

Deferred Advice

4.9 Nothing to report.

Amended Advice

4.10 Nothing to report.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 The minutes of the PAPIG meeting held on 03 February 2009, were noted.

6.2 Mrs Tunstall-James reported fruitful ongoing discussions with the Long Term Conditions Alliance (Scotland) (LTCAS) on the establishment of a Patient and Public Involvement Officer.  SMC will be advised of developments in due course.

6.2 A training day for Patient Interest Groups is now planned for Thursday 21 May 2009, in Edinburgh.  A programme and invitations will be issued in early April.  The SMC Chair and Executive team have expressed strong support for the event and representatives will participate in the proceedings.

7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 NICE Methodology Changes - Implications for Scotland

NICE recently issued supplementary advice to the Institute’s Appraisal Committees, to be applied when they appraise treatments which may extend life, at the end of life.  The methodology changes have provoked questions for NHS Scotland therefore the Chief Medical Officer (CMO) requested that SMC describe factors which may modify a decision baed exclusively on cost-effectiveness. 

The SMC Executive prepared a draft list of modifiers and circulated them to members prior to the meeting.  A detailed discussion followed and SMC concluded that:

  • The modifiers should reflect SMC’s current decision making process.
  • In addition to their assessment of clinical and cost effectiveness, the SMC would consider other factors such as, but not limited to an agreed list of modifiers.
  • The modifiers should be flexible and allow a pragmatic approach, i.e. the SMC would also look at any other special issues which may be highlighted by the manufacturer, by clinical experts and/or Patient Interest Groups.  These special issues are usually very specific to the drug or disease under consideration and are thus not readily categorised.
  • The NDC will continue to consider the evidence base and provide a Recommendation to SMC based on that evidence.   It will be for SMC to outline their final decision for accepting a drug that is otherwise conventionally not cost-effective.
  • SMC would wish to preserve the existing orphan modifiers in addition to modifiers for drugs where the conventional criteria for cost-effectiveness are not met.   SMC will, in appropriate circumstances, accept a greater degree of uncertainty around the incremental cost effectiveness ratio (ICER) for Orphan and Ultra Orphan drugs.  For other types of drugs and treatments a conventional presentation of the ICER will be required together with reasons for the high ICER.
  • The modifiers should be reviewed one year after implementation.

The response to the CMO will include a list of modifiers agreed by SMC and reflecting Members’ views.

8.2 Symposium for Competent Authorities in Pharmaceutical Licensing, Assessment, Pricing and Reimbursement: 26 – 27 February 2009, Vancouver

The SMC Chair and Vice-Chair, were invited to attend a symposium for agencies who are responsible for decisions related to the assessment of pharmaceuticals across all four hurdles.  The event was hosted by the University of British Columbia, Centre for Health Services and Policy Research with delegates attending from Australia, Canada, England (NICE), France, Germany, Mexico, Netherlands, New Zealand, Norway and the USA.

The objective of the meeting was to exchange information and explore mechanisms for international co-operation among those facing common pharmaceutical policy challenges.

The Chairman considered it a valuable experience in terms of information sharing and the discussion that took place.  The different countries present expressed remarkable commonality in the issues they faced.  

It was also pleasing to note that delegates had a high regard for SMC and its process.  Delegates acknowledged the speed of SMC’s assessment process but they placed even greater importance on SMC‘s detailed advice documents.  Where many countries are restricted in the amount of data they are able to publish, SMC Advice provides the detail of SMC’s thinking that leads to the final advice.

8.3 SMC Membership

The annual rotation of Members is progressing.  New members have been identified and invitations extended however appointments will finally be made by the Chief Medical Officer (CMO) following ratification by the NHS Chief Executives Group.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 fluticasone furoate (Avamys)  GlaxoSmithKline  (No. 544/09)

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

9.1.2 The NDC Vice-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 fluticasone furoate (Avamys), should be accepted for use in NHS Scotland, for the treatment of symptoms of allergic rhinitis in adults, adolescents (12 years and over) and children (6 to 11 years).  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, 06 March 2009.

9.2 topotecan hydrochloride (Hycamtin) 0.25mg and 1mg hard capsules  GlaxoSmithKline  (No. 545/09)  

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

9.2.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses, a summary of information for patients and comments received from the company.  Detailed discussion followed and the group agreed that topotecan hydrochloride (Hycamtin), should be accepted for  restricted use in NHS Scotland, as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.  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, 06 March 2009.

9.3 cetuximab (Erbitux)  Merck Serono Ltd  (No. 543/09) 

9.3.1 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.

9.3.2 The NDC 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 Beating Bowel Cancer and Bowel Cancer UK. Detailed discussion followed and the group agreed that cetuximab (Erbitux), should not be recommended for use in NHS Scotland, for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer in combination with chemotherapy.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 March 2009.

9.4 micronised progesterone (Utrogestan)  Ferring Pharmaceuticals  Ltd  (No. 542/09)

9.4.1 There were no declarations of interest 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.  Detailed discussion followed and the group agreed that micronised progesterone (Utrogestan), should not be recommended for use in NHS Scotland, for adjunctive use with oestrogen in post-menopausal women with an intact uterus (HRT).  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, 06 March 2009.

ABBREVIATED SUBMISSION

9.5 brinzolomide 10mg/ml eye drops, suspension (Azopt)  Alcon Laboratories (UK) Limited  (No. 546/09)

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

9.5.2 The NDC Chair provided an overview of the assessment and draft advice.  Detailed discussion followed and the group agreed that brinzolomide (Azopt), should be accepted for use in NHS Scotland, to decrease elevated intraocular pressure in ocular hypertension and open-angle glaucoma as monotherapy in patients unresponsive to beta-blockers or in patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues.  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, 06 March 2009.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted.  Of particular note was the drop in submissions received for consideration by SMC in June 2009.  A smaller than normal agenda may offer an opportunity for Members to consider other strategic issues at the meeting.  Members should pass suggested topics for discussion to Rosie Murray.  

11. SMC User Group Forum (UGF)

11.1 The minutes of the User Group Forum meeting, held on 27 January 2009, were noted.

11.2 Dr Frances Macdonald highlighted the main issues under consideration by the UGF, i.e Patient Access Schemes, Budget Impact, Biosimilars and reasons for non-submissions.  It was suggested that some of these topics could be considered at SMC in June.

12. Feedback from Area Drug and Therapeutic Committees (ADTCs)

12.1 Mr Alistair Thorburn intimated the sad passing of Dr David Matthews, Chair of the NHS Lanarkshire, ADTC. The Chair expressed his condolences, Dr Matthews was well known to him and a huge supporter of SMC. He will be sorely missed.

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, 07 April 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.