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Minutes of the SMC Meeting held on Tuesday 3 April 2007

Present: Professor David Webb (Chairman), Mrs Laura Ace, Professor James Barbour, Dr Keith Beard, Mrs Marion Bennie, Mrs Barbara Black, Dr Keith Brown, Professor John Cairns, Mr David Carson, Mr Tom Divers, Mr Jim Eadie, Dr Barclay Goudie, Dr Jan Jones, Dr Alan G MacDonald, Mr Billy Malcolm, Ms Aileen Muir, Mrs Pat Murray, Mrs Wendy Nganasurian, Dr Ken Paterson, Dr Nick Reed, Dr Andrew Riley, Dr Philip Rutledge, Dr Sandy Simpson, Ms Angela Timoney, Mr Mike Wallace

In Attendance: Ms Ailsa Brown, Mr Colin Brown, Ms Karen Burke, Dr James Dear, Mr Steven Fenocchi, Mr Stephen Ferguson, Mrs Hazel Illingworth, Mrs Laura McIver, Dr James McLay, Ms Rosie Murray
Mrs Maureen Stark, Dr Andrew Walker

Apologies: Dr David Crookes, Dr Sara Davies, Mr John Glennie, Dr John Haughney, Dr Harpreet Kohli , Mrs Anne Lee , Dr Grace Lindsay, Dr Graham Lowe, Dr Chris Lush, Ms Angela Munday
Mr Colin McAllister, Dr Andrew Power, Ms Fiona Ramsay, Dr Sarah Taylor, Dr John Webster

1  Welcome and Apologies for Absence

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

The Chairman welcomed Dr Alan MacDonald, Consultant Rheumatologist, Aberdeen Royal Infirmary, Foresterhill, Aberdeen, who is a new member of SMC and was attending his first meeting. He also welcomed Aileen Muir, who has been elected as Co-Vice Chair of NDC, and Dr James Dear, Clinical Lecturer in Clinical Pharmacology, who was observing the meeting.

The Chairman advised that Jennifer Armstrong has been appointed as Senior Medical Officer at the Scottish Health Department and has resigned from her position as an observer at SMC. He also advised that Angela Timoney has stepped down from NDC, and from May 2007, Ken Paterson, Andrew Power and Aileen Muir would be presenting NDC assessments to SMC, along with any lead assessors who are available.  

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 06 March 2007 were agreed as an accurate record.

4 Matters Arising From the Previous Minutes

4.1 Report: Scottish Market Understanding Initiative – Overcoming the barriers to market access for patients in Scotland

The Chairman advised that SMC have compiled a response to the SMUI Report.  A letter has been sent to SMC/NDC, and Health Board and ministerial contacts, to inform them of SMC’s views on the report.

Jim Eadie gave an undertaking that no further reports would be published by ABPI until SMC have had sight of them and had an opportunity to comment.

Full Submissions

4.1 infliximab 100mg powder for intravenous infusion (Remicade) Schering-Plough UK Ltd (No.318/06)

4.1.1 The SMC advice for infliximab (Remicade), for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporine, methotrexate or psoralen ultraviolet A (PUVA), will be posted on the SMC website on Monday, 07 May 2007.

4.2 azelaic acid 15% Gel (Finacea) Valeant Pharmaceuticals Ltd (No.359/07)

4.2.1 The SMC advice for azelaic acid 15% Gel (Finacea), for the topical treatment of papulopustular rosacea, will be posted on the SMC website on Monday, 07 May 2007.

4.3 sitaxentan 100mg tablets (Thelin) Encysive (UK) Ltd (No.360/07)

4.3.1 The SMC advice for sitaxentan (Thelin), for the treatment of patients with pulmonary arterial hypertension classified as WHO functional class III, to improve exercise capacity, will be posted on the SMC website on Monday, 07 May 2007.

4.4 dexrazoxone 500mg for infusion (Savene) TopoTarget A/S (No.361/07)

4.4.1 The SMC advice for dexrazoxone (Savene), for the treatment of anthracycline extravasation, will be posted on the SMC website on Monday, 07 May 2007.

4.5 budesonide/formoterol100/6, 200/6 turbohaler (Symbicort) AstraZeneca UK Ltd (No.362/07)

4.5.1 The SMC advice for budesonide/formoterol (Symbicort), for the regular and relief treatment of asthma where use of a combination (inhaled corticosteroid and long-acting beta2-agonist), will be held in confidence until confirmation of licence and launch.

Re-submissions

4.6 buprenorphine transdermal patches 5,10 and 20 microgram/hour new 7-day formulation (BuTrans) Napp Pharmaceuticals Ltd (No.234/06)

4.6.1 The SMC advice for buprenorphine transdermal patches (BuTrans), for the treatment of severe osteoarthritis pain in elderly patients (aged 65 years and over), whose pain is not adequately controlled by non-opioid analgesics, or for whom other analgesics are not suitable, will be posted on the SMC website on Monday, 07 May 2007.

Abbreviated Submissions

4.8 desmopressin 240 micrograms oral lyophilisate (Desmomelt) Ferring Pharmaceuticals Ltd  (No: 357/07)

4.8.1 The SMC advice for desmopressin (Desmomelt), for the treatment of primary nocturnal enuresis, will be posted on the SMC website on Monday, 07 May 2007.

4.9 desmopressin 60, 120 and 240 micrograms oral lyophilisate (DDAVP Melt) Ferring Pharmaceuticals Ltd (No. 358/07)

4.9.1 The SMC advice for desmopressin (DDAVP Melt), for the treatment of vasopressin-sensitive cranial diabetes insipidus and in the treatment of post-hypophysectomy polyuria/polydipsia, will be posted on the SMC website on Monday, 07 May 2007.

5. Appeals Update

5.1 natalizumab 300mg concentrate for solution for infusion (Tysabri) Biogen Idec Ltd.  No. (329/06)

Biogen Idec has indicated their intention to make a resubmission for natalizumab (Tysabri), as single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups; patients with high disease activity despite treatment with beta-interferon and in patients with rapidly evolving severe RRMS.

5.2 rimonabant (Acomplia) sanofi-aventis(No. 341/07)

Sanofi Aventis has indicated their intention to make a resubmission for rimonabant (Acomplia), for the treatment of obese patients (body mass index (BMI) ≥30 kg/m2), or overweight patients (BMI >27 kg/m2) with an associated risk factor or risk factors such as type 2 diabetes or dyslipidaemia.

6. Patient and Public Involvement Group (PAPIG)

6.1 The Chairman of PAPIG advised that the minutes of their meeting held today would be available at the next meeting of SMC.

She advised that PAPIG should have a new lay member in place by June 2007, but would be looking for a new SMC representative to join the Committee.  She asked any members of SMC who were interested to contact the Secretariat.

She referred to the recent issues with regards to the website and was pleased that a meeting had been set up between the NHSQIS Communications group and the website developers to resolve the ongoing issues.

With regards to submissions received she advised that to date PAPIG have received 12 Patient Interest Group Submissions in 2007, making a total of 94 altogether, with 67% being accepted or accepted for restricted use.

7. New Drugs Committee: Chairman’s report

7.1 Feedback from SMC to NDC

The NDC Chairman advised that further to the Brainstorming session and discussion of feedback of SMC decisions to NDC, NDC members have confirmed that they are content with the feedback provided regarding SMC decisions.

7.2 London Cancer Group – Conference 12th March 2007

The Chairman of NDC advised that he had attended this meeting and took part in a panel discussion and workshops regarding health technology assessments.  This was a good meeting, attended mostly by Pharmacists and commissioners from NHS England, with positive feedback regarding SMC.

8. Chairman’s Business

8.1 OFT Report

The Chairman advised that the NDC Chairman will draft a response to the OFT report. He asked members to contact the Secretariat if they would be interested in joining a small group to work on this response.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 infliximab (Remicade) Schering- Plough UK Ltd (Severe active Crohn’s disease).(No: 363/07)

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 and comments received from the company. A manufacturer’s response dated 22 March 2007 was tabled for review. Detailed discussion followed and the group agreed that infliximab (Remicade), for maintenance treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies, should not be recommended for use within NHS Scotland.  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 ADTCs and NHS Boards on Friday, 6 April 2007.

9.2 infliximab (Remicade) Schering- Plough UK Ltd (Fistulating active Crohn’s disease (364/07)

9.2.1 Declarations of interest were 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 and comments received from the company. A manufacturer’s response dated 22 March 2007 was tabled for review. Detailed discussion followed and the group agreed that infliximab (Remicade), for maintenance treatment of fistulising, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy), should not be recommended for use within 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 ADTCs and NHS Boards on Friday, 6 April 2007.

9.3 dibotermin alfa (InductOs) Medtronic (No: 365/07)

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

9.3.2 The NDC Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that dibotermin alfa (InductOs ), for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary nail fixation in patients in whom there is a substantial risk of non-union, should be accepted for restricted use within 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 ADTCs and NHS Boards on Friday, 6 April 2007.

9.4 topotecan hydrochloride (Hycamtin) GlaxoSmithKline (No: 366/07)

9.4.1 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.

9.4.2 The SMC Vice-Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that topotecan (Hycamtin), for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate, should not be recommended for use within 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 ADTCs and NHS Boards on Friday, 6 April 2007.

9.5 standardised allergen extract of grass pollen from Timothy (Phleum pratense) 75,000 SQ-T per oral lyophilisate (Grazax)  ALK-Abello Ltd (No: 367/07)

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

9.5.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that standardised allergen extract of grass pollen 75,000 per oral lyophilisate (Grazax), for the treatment of grass pollen induced rhinitis and conjunctivitis in adult patients with clinically relevant symptoms and diagnosed with a positive skin prick test and/or specific IgE test to grass pollen, should not be recommended for use within 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 ADTCs and NHS Boards on Friday, 6 April 2007.

9.6 esomeprazole (Nexium) AstraZeneca UK  Ltd  (No: 368/07)

9.6.1 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.

9.6.2 The NDC Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group concluded their advice for esomeprazole (Nexium), for patients in the age group 12-17 years inclusive, for the treatment of erosive reflux oesophagitis, the long-term management of patients with healed oesophagitis to prevent relapse, and the symptomatic treatment of gastro-oesophageal reflux disease.

9.6.3 The SMC advice will be held in confidence until confirmation of licence and launch

9.7 docetaxel (Taxotere) (Head and Neck Cancer)  sanofi-aventis  (No: 369/07)

9.7.1 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.

9.7.2 The NDC Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that docetaxel (Taxotere), for the induction treatment of patients with unresectable locally advanced squamous cell carcinoma of the head and neck in combination with cisplatin and 5-fluorouracil, should be accepted for restricted use within 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 ADTCs and NHS Boards on Friday, 6 April 2007.

9.8 dasatinib (Sprycel) Bristol-Myers Squibb Pharmaceuticals Ltd (Chronic Myeloid Leukaemia (CML) (No: 370/07)

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

9.8.2 The SMC Vice-Chairman 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 Leukaemia Care. Detailed discussion followed and the group agreed that dasatinib, 20mg, tablets (Sprycel), for the treatment of adults with chronic myeloid leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesylate, should be accepted for restricted use within 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 ADTCs and NHS Boards on Friday, 6 April 2007.

9.9 dasatinib (Sprycel) Bristol-Myers Squibb Pharmaceuticals Ltd (Acute Lymphoblastic Leukaemia (ALL)  (No: 371/07)

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

9.9.2 The SMC Vice-Chairman 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 Leukaemia Care. Detailed discussion followed and the group agreed that dasatinib 20mg (Sprycel), for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia with resistance or intolerance to prior therapy, should not be recommended for use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.9.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 6 April 2007.

ABBREVIATED SUBMISSIONS

9.10 testosterone gel 2% (Tostran) ProStrakan  (No: 372/07)

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

9.10.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group concluded their advice for testosterone 2% gel (Tostran), for replacement therapy with testosterone for male hypogonadism when testosterone deficiency has been confirmed by clinical symptoms and laboratory analyses.

9.10.3 The SMC advice will be held in confidence until confirmation of licence and launch.

9.11 beclometasone dipropionate and formoterol (Fostex Modulite)  Trinity-Chiesi Pharmaceuticals Ltd  (No: 373/07)

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

9.11.2 The NDC Chairman provided and overview of the assessment and the draft summary of advice. Discussion followed and the group concluded their advice for beclometasone 100mcg, formoterol 6mcg metered dose inhaler (Fostex Modulite), for the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short acting beta2-agonist; or patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.

9.11.3 The SMC advice will be held in confidence until confirmation of licence and launch.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

11. ADTC Feedback

11.1 Exceptional Circumstances Status Paper

The Chairman advised that this paper had been provided for information only and not as SMC policy.  He thought that the paper might be of benefit to ADTCs and Health Boards.

12. Code of Practice on Declarations of Interest

The Code of Practice document was discussed and some changes were suggested. The Chairman advised members who had further comments to send these to the Secretariat for consideration.

13. Any Other Business
 
13.1 NICE STA and SMC Decisions

The Chairman asked the Scottish Executive representatives when the HDL on SMC advice and NICE STAs would be distributed.  Steven Fennocchi advised that the HDL had been finalised and should be distributed soon.

13.2 Pharma Times Article 20 March 2007

A member of SMC advised that there had been an article in the Pharma Times saying that the EMEA is expecting the volume of requests for scientific advice to increase this year, largely as a result of the EU’s regulation on paediatric medicines. This could result in an increase in workload for SMC. The Chairman asked the secretariat to investigate with EMEA how likely it was that this increase in workload would emerge next year.

14. Date of the next meeting

14.1 The date of the next meeting was confirmed as Tuesday, 01 May 2007 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.