You are here:

Minutes of the SMC Meeting - Tuesday 5 May 2009

Minutes of the SMC Meeting held on Tuesday 5 May 2009
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: Professor Ken Paterson (Chairman), Mrs Laura Ace, Dr Keith Beard, Mrs Margo Biggs, Dr Keith Brown, Professor John Cairns, Mr David Carson, Dr David Crookes, Dr Jonathan Fox,  Dr John Gemmill, Dr Barclay Goudie, Dr Chris Lush, Dr Alan MacDonald, Dr Frances Macdonald,  Dr John McElhinney, Dr Simon Maxwell, Dr Mercia Page, Dr Andrew Power, Mr Andrew Powrie-Smith, Dr Nick Reed, Mr Keith Thompson, Mr Alistair Thorburn, Ms Angela Timoney, Professor David Wray.

In Attendance: Dr Baird-Gunning, Ms Ailsa Brown, Mr Stephen Ferguson, Dr Gordon Forrest, Mrs Anne Lee, Ms Rosie Murray, Ms Emma Riches, Ms Alex Robertson, Mr Craig Rore, Mrs Maureen Stark

Apologies: Professor James Barbour, Mrs Corinne Booth, Mr Colin Brown, Mr Scott Bryson, Mr Robert Calderwood, Dr Sara Davies, Ms Susan Goldsmith, Dr Jan Jones, Ms Veronica Moffat,  Ms Aileen Muir, Professor Dilip Nathwani, Dr Anthony Ormerod, Mrs Catherine Tait, Dr Sarah Taylor, Mrs Sheila Tunstall-James, Professor Tony Wells, Dr Andrew Walker,Dr Iain Wallace.
 
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 Gordon Forrest, General Practitioner and NDC Member.
  • Mr Craig Rore, Lead Pharmacist, Grampian Medicines Information Centre and NDC Member

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 07 April 2009 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 rotigotine, 1mg,2mg, 3mg per 24 hours transdermal patch (Neupro®) (No. 548/09)  UCB Pharma Ltd

4.1.1 The SMC advice for rotigotine transdermal patch (Neupro®), for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults, will be held in confidence pending confirmation of the product licence and availability.

4.2 quetiapine, 25mg, 100mg, 200mg, 300mg tablets (Seroquel®) No. (549/09) AstraZeneca
 
4.2.1 The SMC advice for quetiapine (Seroquel®), for the treatment of major depressive episodes in the framework of bipolar disorder, will be held in confidence pending confirmation of the product licence and availability.

4.3 Caffeine base 5mg/ml solution for injection  (No.550/09) Viridian Pharma Ltd

4.3.1 The SMC advice for caffeine base 5mg/ml solution for injection, for the treatment of apnoea of prematurity, will be published on the SMC website on Monday 11 May 2009.

Resubmission

4.4 pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg and 300mg capsules (Lyrica®)  (No. 157/05)  Pfizer Ltd

4.4.1 The SMC advice for pregabalin (Lyrica®), for the treatment of peripheral neuropathic pain in adults, will be published on the SMC website on Monday 11 May 2009.

Abbreviated Submissions

4.5 caspofungin 50mg and 70mg powder for concentrate for solution for infusion (Cancidas®) (No. 551/09) Merck Sharp & Dohme Ltd

4.5.1 The SMC advice for caspofungin (Cancidas®), as empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropenic paediatric patients (12 months to 17 years) , will be published on the SMC website on Monday 11 May 2009.

4.6 caspofungin 50mg and 70mg powder for concentrate for solution for infusion (Cancidas®) (No. 552/09) Merck Sharp & Dohme Ltd

4.6.1 The SMC advice for caspofungin (Cancidas®), for the treatment of invasive candidiasis in paediatric patients (12 months to 17 years), will be published on the SMC website on Monday 11 May 2009.

Non Submission

4.7 paclitaxel (Abraxane®) (No. 556/09) Abraxis BioScience Limited

4.7.1 The SMC advice for paclitaxel (Abraxane®), for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline containing therapy is not indicated, will be published on the SMC website on Monday 11 May 2009.

5. Appeals Update

5.1 extended release morphine sulphate, epidural,  for injection 10mg/ml (10mg, 15mg and 20mg) (Depodur®) Flynn Pharma Ltd (No. 528/09)

In January 2009, SMC did not recommend extended release morphine sulphate, epidural, for injection (Depodur®) for the relief of post-operative pain following major orthopaedic, abdominal or pelvic surgery.  Flynn Pharma has indicated their intention to resubmit.

6. Patient and Public Involvement Group (PAPIG)

6.1 The minutes of the PAPIG meeting held on 07 April 2009, were tabled and noted.

6.2 Mrs Margo Biggs highlighted the key issues discussed at the meeting as follows:

  • The establishment of a Patient and Public Involvement Officer is PAPIG’s main priority at present and whilst progress is being made in collaboration with the Long Term Conditions Alliance Scotland, the key issue at present is the ability to secure immediate and continuing funding for the post.  The funding issue has been raised with the SMC Executive for consideration and prioritisation in what will be a challenging round of budget negotiations.
  • PAPIG are offering a Seminar for Patient Interest Groups (which will be held on 21 May 2009).  Invitations have been sent to some 160 groups and the event is being publicised on various websites.  The full day event will 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.  It will be take the form of presentations, discussions and workshops, with input from PAPIG, SMC, industry and a patient group.
  • Development of the PAPIG page of the SMC website is ongoing, led by Keith Thompson in collaboration with Rosie Murray.
  • The group are currently widening PAPIG’s Terms of Reference into a Role and Remit document to encompass the full workings of the group.
  • PAPIG noted the Cabinet Secretary for Health and Wellbeing’s recent statement on changes designed to improve patient access to new medicines.
  • Following the recent Public Petitions Committee into access on cancer medicines, the Scottish Government Health Directorate (SGHD) is developing a patient friendly description of the ‘end to end’ process for managing new medicines. PAPIG has accepted an invitation from SGHD to review and comment on the draft version.

7. New Drugs Committee: Chairman’s Report

7.1 The NDC Co-Vice Chair reported on a seminar, on ‘Probabilistic Sensitivity Analyses’, which was presented to the NDC meeting by Dr Andrew Walker and Ms Ailsa Brown.  The presentation was very informative and helpful.  The SMC Chairman suggested that the seminar would be helpful for SMC members also and a suitable date will be identified for it to take place.

8.Chairman’s Business

8.1 Update on the use of Patient Access Schemes

Mrs Anne Lee provided a brief verbal update on progress.

8.2 Modifiers

SMC has prepared a policy statement that stipulates the factors, other than cost-effectiveness, that can be considered in the assessment of a new drug.  These factors are otherwise known as ‘modifiers’.  The Policy statement has now been approved by the Cabinet Secretary for Health and Wellbeing and published on the SMC website.  The modifiers are effective from 05 May 2009.

8.3 efalizumab (Raptiva®) 125 mg as powder and solvent for 100 mg/ml injection SMC No. (146/04)  Genentech, in partnership with Serono. Developed by XOMA.

In January 2005, SMC issued advice for efalizumab (Raptiva®) for the treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or have a contra-indication to, or are intolerant to other systemic therapies, including ciclosporin, methotrexate and PUVA (photochemotherapy).  SMC did not recommended its use within NHS Scotland.

In February 2009, the European Medicines Agency completed a review of efalizumab (Raptiva®) after concerns about its safety .The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of efalizumab do not outweigh its risks, and that the Marketing Authorisation should be suspended across the EU.  The SMC website has been updated accordingly.

8.4 Scottish Government Health Department (SGHD): Health Economic Seminar – 17 April 2009 

The SGHD registered their thanks to Dr Andrew Walker for his input to the seminar on Quality Adjusted Life Years (QALYs) which took place on 17 April 2009.

8.5 Research and Development: A Collaboration with EMEA on Drug Information in Computerised Prescribing Systems

EMEA and the Karolinska Institutet, Stockholm, are preparing a joint research and development project on e-SPC's and are seeking appropriate clinicians to participate in the project.  The Collaboration is seeking practising physicians with an interest in improving access to drug information at point of care and with a background in pharmacotherapy and/or clinical pharmacology. Any interested SMC members were asked to discuss further with the Chairman.

8.6 Agenda for June SMC

The Short Life Working Group on Biosimilars has made progress and will report formally to SMC in late summer 2009.  However, it has been agreed that the second half of the June SMC agenda should be given over to a presentation on biosimilar medicines to provide members with background information and the issues that relate to their use. 

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 rituximab (MabThera®) Roche (No. 540/09)

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

9.1.2 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 Leukaemia Care and the Chronic Lymphocytic Leukaemia Support Association.  Detailed discussion followed and the group agreed that rituximab (MabThera®), should be accepted for restricted use in NHS Scotland, for first-line treatment of patients with chronic lymphocytic leukaemia (CLL) in combination with fludarabine and cyclophosphamide.  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 08 May 2009.

9.2 romiplostim (Nplate®) Amgen (No. 553/09) 

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

9.2.2 The SMC 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 a patient interest group submission from the ITP Support Association. Detailed discussion followed and the group concluded their advice for romiplostim (Nplate®), for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). 

9.2.3 The SMC advice will be withheld pending confirmation of licence and product availability.

RESUBMISSIONS

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

9.3.1 A declaration of interest was 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 aripiprazole oral formulations (Abilify®), should not be recommended for use in NHS Scotland 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.  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 08 May 2009.

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

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

9.4.2 The Acting Chief Pharmaceutical Adviser provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from the Roy Castle Lung Cancer Foundation.  Detailed discussion followed and the group agreed that pemetrexed (Alimta®), in combination with cisplatin, should not be recommended for use in NHS Scotland for first-line treatment of patients with locally advanced or metastatic non- small cell lung cancer other than predominantly squamous cell histology.  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 08 May 2009.

ABBREVIATED SUBMISSION

9.5 tadalafil (Cialis®) Lilly UK (No. 555/09) 

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

9.5.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice, and revised data/analyses.  Detailed discussion followed and the group agreed that tadalafil 2.5mg and 5mg tablets (Cialis®), should be accepted use in NHS Scotland for regular once-daily administration in patients with erectile dysfunction.  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 08 May 2009.

9.6 terlipressin acetate (Glypressin  Solution®) Ferring Pharmaceuticals Ltd (No. 554/09)

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

9.6.2 The NDC Co-Vice Chair provided an overview of the assessment, and draft advice.  Detailed discussion followed and the group concluded their advice for terlipressin acetate 0.12mg/ml solution for injection (Glypressin Solution®), for the treatment of bleeding oesophageal varices. 

9.6.3 The SMC advice will be withheld pending confirmation of licence and product availability.

NON-SUBMISSION

9.7 sapropterin (Kuvan®) 100mg soluble tablets (No.558/09) Merck Serono

sapropterin (Kuvan®) is not recommended for use within NHSScotland 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.

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.

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, will be presented to SMC at the June meeting.

11.2 Dr Frances MacDonald updated SMC on progress with the following  issues:

  • The Short Life Working Group for Biosimilars
  • The Short Life Working Group for developing standards in budget impact forecasting
  • Association of British Pharmaceutical Industry (ABPI)/Office of Health Economics (OHE) Review re Recommendation Rates from SMC – a methodological approach
  • Guidance to manufacturers on the use of uncontrolled, Phase IV data in economic analysis

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

12.1 No other business was raised.

13. Any Other Business

13.1 EACPT 2009: European Association  for Clinical Pharmacology and Therapeutics, Edinburgh, Scotland, 12-15 July 2009

Dr Simon Maxwell reminded members of the forthcoming Congress of the European Association for Clinical Pharmacology and Therapeutics (EACPT), which will take place in Edinburgh in July 2009.  He strongly advised members who wished to attend to register in advance of the Congress.  Reduced delegate rates for early booking will only be available until 08 May.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 02 June 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.