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Minutes of the SMC Meeting held on Tuesday 04 November 2008

NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Dr Ken Paterson (Chairman),Mrs Laura Ace,Professor James Barbour,Dr Keith Beard, Mrs Margo Biggs,Dr Keith Brown,Mr David Carson,Dr David Crookes,Mr Tom Divers,Dr Jonathan Fox,Dr John Gemmill,Dr Jan Jones,Dr Grace Lindsay,Dr Chris Lush, Dr Alan MacDonald,Dr Frances Macdonald, Dr John McElhinney,Ms Aileen Muir,Dr Anthony Ormerod, Dr Andrew Power,
Dr Nick Reed,Mr Keith Thompson,Mr Alistair Thorburn,Mrs Sheila Tunstall-James,Dr Andrew Walker,Professor Tony Wells.

In Attendance: Mrs Corinne Booth,Ms Ailsa Brown,Ms Susan Downie, Ms Julia Earnshaw,Mr Stephen Ferguson,Ms Sharon Hems,Mrs Anne Lee, Ms Rosie Murray, Mrs Maureen Stark, Mrs Catherine Tait.

Apologies: Mr Colin Brown,Professor John Cairns, Dr Sara Davies,Ms Susan Goldsmith,
Dr Barclay Goudie, Mr Billy Malcolm,Dr Simon Maxwell,Ms Veronica Moffat, Professor Dilip Nathwani, Mr Andrew Powrie-Smith, Ms Alex Robertson,Dr Sandy Simpson,Dr Sarah Taylor,
Ms Angela Timoney. 

1. Welcome and Apologies for Absence

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

The Chairman welcomed Julia Earnshaw, GlaxoSmithKline, a member of the SMC User Group Forum, who was observing the meeting.

The Chairman also welcomed: Corinne Booth, recently appointed to SMC as a full time economic assessor; Sharon Hems, acting Principal Pharmacist, Horizon Scanning, covering Anne Lee’s post pro-tem, on a part-time basis.

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 October 2008 were agreed as an accurate record.

4. Matters Arising From the Previous Minutes

Full Submissions

4.1 fentanyl, 100, 200, 400, 600 and 800 microgram buccal tablet (Effentora)
No.  (510/08)  Cephalon UK Ltd

4.1.1 The SMC advice for fentanyl buccal tablets (Effentora), for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain, will be withheld pending confirmation of licence and availability.

4.2 ambrisentan, 5mg and 10mg tablets (Volibris) No.  (511/08) GlaxoSmithKline

The SMC advice for ambrisentan (Volibris), for the treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity, will be posted on the SMC website on Monday, 10 November 2008.

Resubmissions

4.3 rufinamide, 100mg, 200mg and 400mg tablets (Inovelon) No.(416/07)
Eisai Limited

4.3.1 The SMC advice for rufinamide (Inovelon), as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients four years and older, will be posted on the SMC website on Monday, 10 November 2008.

4.4 anidulafungin 100mg powder and solvent for concentrate for solution for infusion (Ecalta ) No.  (465/08) Pfizer Ltd

4.4.1 The SMC advice for anidulafungin (Ecalta), for the treatment of invasive candidiasis in adult non-neutropenic patients, will be posted on the SMC website on Monday, 10 November 2008.

Abbreviated Submission

4.5 insulin glulisine solution for subcutaneous injection 100 units/ml (Apidra) (No: 512/08) Sanofi-aventis

4.5.1 The SMC advice for insulin glulisine (Apidra), for the treatment of adolescents and children, 6 years or older with diabetes mellitus, where treatment with insulin is required and for whom the use of a short-acting insulin analogue is appropriate, will be posted on the SMC website on Monday, 10 November 2008.

Non Submission

4.6 bosentan 62.5mg, 125mg film-coated tablets (Tracleer)  (No. 523/08) Actelion Pharmaceuticals UK Ltd

4.6.1 The SMC advice for bosentan (Tracleer) for the treatment of pulmonary arterial hypertension (PAH) WHO functional class II, will be posted on the SMC website on Monday, 10 November 2008.

4.7 Deferred Advice

4.7.1 Nothing to report.

4.8 Amended Advice

4.8.1 Nothing to report.

5. Appeals Update

5.1 Nothing to report

6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the PAPIG meeting ( 04.10.08)

The minutes of the PAPIG meeting held on 04 October 2008, were noted.

6.2 Addition to the SMC Website

PAPIG recently published a lay summary of the drug approval process.   The paper can be accessed on the Public Involvement section/ ‘SMC Explained’/ of the SMC website.  Mrs Tunstall-James thanked the Executive team for their assistance in publishing.

7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 rimonabant 20mg tablet (Acomplia) No. (341/07)  Sanofi-Aventis

SMC issued advice for rimonabant (Acomplia) in February 2007 and did not recommend for use with NHS Scotland as an adjunct to diet and exercise 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.  Rimonabant was associated with a reduction in mean weight of about 4-5kg over that with placebo.  However, this weight was generally regained within one year of stopping treatment. The economic case was not demonstrated.

The marketing authorisation for rimonabant has now been suspended across the European Union after concerns about its psychiatric safety.

8.2 NICE – Multiple Technology Appraisal (MTA) Guidance

NICE issued MTA guidance No.160 on 27 October 2008, with regards to alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women.

NICE also issued MTA guidance No.161 on 27 October 2008, with regards to alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women.

SMC has previously given advice on risedronate, strontium ranelate, alendronate/colecalciferol and teriparatide in the management of osteoporosis in women.

There is no material difference between the NICE MTA and the SMC recommendations, however the NICE guidance has more detail on the risk assessment criteria for fractures.

NICE MTAs normally supersede SMC advice and the SMC website will be updated accordingly.

8.3 Clinical Expert Advice

It was noted in the submissions under consideration, that a number of clinical experts, whom SMC consulted for advice, had declared personal specific interests in the products.  The Chairman re-iterated SMC’s policy not to consider advice from experts who have a stated personal specific interest, unless there are exceptional reasons for doing so.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 miconazole 50mg muco-adhesive buccal Tabs (Loramyc)  SpePharm UK Ltd  (No. 517/08) 

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

9.1.2 The NDC Vice-Chair provided an overview of the assessment, draft advice, revised expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that miconazole muco-adhesive buccal Tabs (Loramyc), for the treatment of oropharyngeal candidiasis in immunocompromised patients, 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.

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

9.2 methylnaltrexone bromide 12mg/0.6ml solution for injection (Relistor)    Wyeth Europa Limited  (No. 518/08) 

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

9.2.2 The NDC Vice-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 Action on Pain, the Highland Hospice and Marie Curie Cancer Care.  Detailed discussion followed and the group agreed that methylnaltrexone bromide  (Relistor), for the treatment of opioid induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient, 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.

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

9.3 atazanavir, 300mg capsules (Reyataz)  Bristol-Myers Squibb Pharmaceuticals  Ltd  (No. 520/08) 

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

9.3.2 The NDC Chair provided an overview of the assessment, draft advice, revised expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that atazanavir (Reyataz), in antiretroviral treatment naïve HIV-1 infected adults in combination with other antiretroviral medicinal products, 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.

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

9.4 bivalirudin 250 mg powder for concentrate for solution for injection or infusion (Angiox)  The Medicines Company  (No. 516/08)

9.4.1 There were no declarations of interest 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 bivalirudin (Angiox), used in conjunction with aspirin and clopidogrel, for the treatment of adult patients with acute coronary syndromes (unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI)) planned for urgent or early intervention, 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.

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

9.5 rivaroxaban  10mg film coated tablets (Xarelto)  Bayer Schering Pharma  (No. 519/08)  

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

9.5.2 The NDC Vice-Chair provided an overview of the assessment, draft advice, revised expert comments, and revised data/analyses. Detailed discussion followed and the group agreed that rivaroxaban (Xarelto), for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery, 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.

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

ABBREVIATED SUBMISSION

9.6 aripiprazole solution for intramuscular injection 7.5 mgl/ml in a 0.75mg vial (Abilify)  Bristol-Myers Squibb Pharmaceuticals  Ltd  (No. 522/08) 

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 aripiprazole for intramuscular use (Abilify), for the rapid control of agitation and disturbed behaviours in patients with schizophrenia when oral therapy is not appropriate,  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 SMC did not previously recommend aripiprazole for the treatment of manic episodes in bipolar 1 disorder, therefore SMC cannot recommend use of the intramuscular formulation for the rapid control of agitation and disturbed behaviours in patients with manic episodes in bipolar 1 disorder.

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

9.7 flecainide acetate 200mg capsules (Tambocor XL)  Meda Pharmaceuticals  Ltd  (No. 521/08)
 
9.7.1 There were no declarations of interest recorded in relation to this product/comparator drugs.

9.7.2 The NDC Chair provided an overview of the assessment, and draft summary of advice.  Discussion followed and the group agreed that flecainide acetate (Tambocor XL), for the treatment of AV nodal reciprocating tachycardia, arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways; paroxysmal atrial fibrillation in patients with disabling symptoms when treatment need has been established and in the absence of left ventricular dysfunction; and the maintenance of normal rhythm following conversion by other means, 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.

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

NON SUBMISSION

9.8 cetuximab 5mg/ml solution for  infusion (Erbitux) MerckKGaA

9.8.1 In the absence of a submission from the holder of the marketing authorisation, cetuximab (Erbitux), for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer as a single agent in patients who have failed oxaliplatin and irinotecan based therapy and are intolerant to irinotecan, should not be recommended for use within NHS Scotland.

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

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted.


11. SMC User Group Forum (UGF)

11.1 Timings for submissions and SMC Assessments

Dr Andrew Walker recently analysed the timing of manufacturers making their submission to SMC.  The outcome suggested that the timing of submissions had varied over the years however the trends for 2007 and 2008 were for less long delays in SMC receiving a submission. Changes to SMC process which includes prompting for new submissions and issuing a non-recommendation where the manufacturer chooses not to submit, has led to more timely submissions.

Dr Frances MacDonald indicated that she would convey that message to industry.

11.2 Short Life Working Group on Market Access  Schemes in Scotland (MASS)

Industry is co-operating with the short life working group, set up to consider potential market access schemes, with a view to facilitating patient and market access.

11.3 Manufacturers’ Budget Impact Forecasts

A short life working group, chaired by David Carson, has been set up to develop more accurate budget impact forecasts.

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

12.1 SMC Chairman’s Programme of Visits  to Area Drug and Therapeutic Committees (ADTCs)

The Chairman’s programme of visits to ADTCs around Scotland continues.  Feedback will be shared with SMC once the programme is complete.

13. Any Other Business

For information, the Chairman highlighted various topics currently being discussed in the media that may be of interest to members, i.e top-up payments for patients, access to cancer drugs, the Pharmaceutical Price Regulation Scheme (PPRS).

14. Date of the Next Meeting

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