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SMC Minutes Tuesday 7 June 2011

Minutes of the SMC Meeting
held on Tuesday 07 June 2011
Healthcare Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: 
Ms Angela Timoney (Chairman), Mrs Laura Ace, Ms Sandra Auld, Professor James Barbour, Dr Keith Brown, Dr Jennifer Burns, Mrs Helen Cadden, Mrs Alison Campbell, Dr Dominic Culligan, Ms Sara Davies, Dr David Dunlop, Dr John Gemmill, Dr Jan Jones, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Mrs Sandra McNaughton, Ms Aileen Muir, Mrs Anne Murray, Dr Mercia Page, Dr Robert Peel, Dr Sarah Taylor, Mrs Sheila Tunstall-James, Dr Andrew Walker

In Attendance: 
Ms Melanie Barnes, Mrs Corinne Booth, Ms Ailsa Brown, Mrs Susan Downie, Mr Stephen Ferguson, Dr Gordon Forrest, Mrs Anne Lee, Dr Gerry McKay, Ms Rosie Murray, Mr Ishtiaq Mohammed, Ms Alex Robertson, Dr Libby Sillito, Mrs Catherine Tait

Apologies:
Mr Colin Brown, Professor Scott Bryson, Mr Robert Calderwood, Mr Dave Carson, Dr Jonathan Fox, Dr Barclay Goudie, Dr Jacqui Howes, Professor Stephen Lawrie, Dr Chris Lush, Dr Simon Maxwell, Mrs Margo McGurk, Dr James McLay, Dr Paul McNamee, Ms Veronica Moffat, Professor Dilip Nathwani, Mr Michael Pratt, Dr Brian Robson, Mrs Maureen Stark, 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 welcome was extended to:

Observers:
Mr Ishtiaq Mohammed, Clinical Effectiveness Pharmacist,NHS Fife. 
Dr Libby Sillito, Principal Pharmaceutical Analyst, Scottish Medicines Consortium.

NDC Members/Lead Assessors presenting submissions to SMC:
Dr Gordon Forrest
Dr Gerry McKay

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 (03 May 2011)

3.1 The minutes of the SMC meeting held on 03 May 2011 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submission

4.1 filgrastim, 30 million units (300 micrograms)/0.5mL, 48 million units (480 micrograms)/0.5mL, solution for injection or infusion in pre-filled syringe (Zarzio®) SMC No. (704/11) Sandoz Ltd

The SMC advice for filgrastim (Zarzio®), for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Mobilisation of peripheral blood progenitor cells (PBPC).  In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of = 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.  Treatment of persistent neutropenia (ANC = 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate, will be published on the SMC website on Monday, 13 June 2011.

Resubmissions

4.2 tapentadol, 50, 100, 150, 200 and 250mg prolonged-release tablets (Palexia® SR) SMC No. (654/10) Grünenthal Ltd

The SMC advice for tapentadol, (Palexia® SR), for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics, will be published on the SMC website on Monday, 13 June 2011.

4.3 ferric carboxymaltose 50mg iron/mL solution for injection/infusion (Ferinject®) SMC No. (463/08) Vifor Pharma UK Ltd 

The SMC advice for ferric carboxymaltose (Ferinject®), for the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used.

As a result of a request from the company a minor amendment has been made to the advice box in relation to the wording of the SMC restriction.  In addition, as a result of comparator comments, a minor amendment has been made to the Summary of clinical effectiveness issues to indicate that SMC has now completed its review of iron isomaltoside 1000 solution for injection/infusion (Monofer), comparator, and advice has been published. Amended advice will be will be reissued to NHS Boards and ADTCs on Friday, 10 June 2011, and published on the SMC website on Monday, 13 June 2011.

Abbreviated Submissions

4.4 triptorelin (Decapeptyl SR®) 22.5mg powder and solvent for suspension for injection SMC No. (705/11) Ipsen Ltd

The SMC advice for triptorelin (Decapeptyl SR®) for treatment of patients with locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration.  Treatment of metastatic prostate cancer, will be published on the SMC website on Monday, 13 June 2011.

4.5 olmesartan medoxomil/amlodipine besilate/hydrochlorothiazide 20mg/5mg/12.5mg, 40mg/5mg/12.5mg, 40mg/10mg/12.5mg, 40mg/5mg/25mg, 40mg/10mg/25 mg film-coated tablets (Sevikar HCT®) SMC No. (706/11) Daiichi Sankyo UK Ltd

The SMC advice for olmesartan medoxomil/amlodipine besilate/hydrochlorothiazide 20mg/5mg/12.5mg, 40mg/5mg/12.5mg, 40mg/10mg/12.5mg, 40mg/5mg/25mg, 40mg/10mg/25 mg film-coated tablets (Sevikar HCT®), as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide taken as a dual component (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single formulation (hydrochlorothiazide or amlodipine), will be withheld pending confirmation of licence and availability.

4.6 omalizumab (Xolair®) 75mg, 150mg solution for injection as prefilled syringe SMC No. (708/11) Novartis Pharmaceuticals UK Ltd.
                                                                                  
The SMC advice for omalizumab (Xolair®), indicated in adults, adolescents (12 years of age and older) and children (6 to <12 years of age) with convincing IgE (immunoglobulin E) mediated asthma, will be published on the SMC website on Monday, 13 June 2011.

Deferred Advice

4.7 Nothing to report.

Amended Advice

4.8 iron isomaltoside 1000, 100mg/mL solution for injection/infusion (Monofer®) Pharmacosmos UK SMC No. (697/11)

SMC reviewed a submission for Iron isomaltoside 1000, 100mg/mL solution for injection/infusion (Monofer®), on 05 April 2011 and accepted it for restricted use, for treatment of iron deficiency anaemia in the following conditions: When oral iron preparations are ineffective or cannot be used; Where there is a clinical need to deliver iron rapidly.  It is restricted to administration by high dose infusion within the licensed indication but excluding use in patients receiving haemodialysis.

As a result of comparator comments, a minor amendment has been made to the Summary of clinical effectiveness issues.  Following comments from the manufacturer there have also been minor changes to the Summary of clinical effectiveness issues, Summary of comparative health economic evidence and Cost of relevant comparators section within the Detailed Advice Document.  Revised advice was reissued to Boards on Friday 06 May 2011 and published on the website on Monday 09 May 2011.

4.9 ticagrelor 90mg film-coated tablets (Brilique®) AstraZeneca SMC No. (699/11)

SMC reviewed a submission for ticagrelor 90mg film-coated tablets (Brilique®), on 05 April 2011 and was accepted for use, co-administered with aspirin, for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non ST elevation myocardial infarction [NSTEMI] or ST elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).  As dual therapy with aspirin, ticagrelor demonstrated a significant reduction in ischaemic events compared with another antiplatelet drug without significantly increasing the incidence of study-defined major bleeding. 

Following comments from the manufacturer changes have been made to the Summary of comparative health economic evidence, within the Detailed Advice Document (revised ICERs in paragraphs 2 and 4, on page 7).  Revised advice was reissued to Boards on Friday 06 May 2011 and published on the website on Monday 09 May 2011.

5. Appeals Update

5.1 Nothing to Report

6. Patient and Public Involvement Group (PAPIG)

6.1 PAPIG Update

Mrs Tunstall-James advised that PAPIG had met immediately prior to SMC meeting and provided a verbal update. 

6.2 Membership of PAPIG

A warm welcome was given to Dr Jennifer Burns, SMC Vice Chairman who has joined the group as a member on PAPIG, and will represent the SMC Executive Team.

6.3 PAPIG’s Annual Training Day for Patient Interest Groups

The Training Day for patient interest groups was well attended and well received by delegates (evaluation recorded a 90% level of approval from delegates). 

Thanks was given to all members who took part in this successful and event, and it is hoped that a similar event will be arranged sometime in 2012.

The Chairman attended this training day and agreed that it was a worthwhile event.

7. New Drugs Committee: Chairman’s Report

7.1 Ms Muir advised in the absence of Dr Fox that there was nothing to report.

8. Chairman’s Business

8.1 Nothing to report.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 paliperidone palmitate 50mg, 75mg, 100mg and 150mg prolonged release suspension for injection (Xeplion) Janssen-Cilag Ltd SMC No. (713/11)

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

9.1.2 The NDC Lead Assessor 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 Support in Mind (operating name of National Schizophrenia Fellowship Scotland) and Sane. Detailed discussion followed and the group agreed that paliperidone palmitate prolonged release suspension for injection (Xeplion), should not recommended be for use within NHS Scotland, for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.  In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, it may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.   Overall the manufacturer did not present a sufficiently robust clinical and economic case to gain acceptance by SMC.

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 June 2011.

9.2 ranibizumab, 10mg/mL solution for injection (Lucentis®) Novartis Pharmaceuticals UK Ltd SMC No. (711/11)

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 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 Diabetes UK Scotland and RNIB Scotland.  Detailed discussion followed and the group agreed that ranibizumab (Lucentis®), should not be recommended for use within NHS Scotland, for the treatment of visual impairment due to diabetic macular oedema in adults.  Ranibizumab significantly improved visual acuity over 12 months compared with standard laser photocoagulation treatment. The manufacturer’s justification of the treatment’s health benefits in relation to its cost was not sufficient and in addition, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.

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 June 2011.

9.3 retigabine, 50mg, 100mg, 200mg, 300mg and 400mg film-coated tablets (Trobalt®) GlaxoSmithKline SMC No. (712/11)

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 retigabine (Trobalt®) should be accepted for restricted use within NHS Scotland, for adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy.  SMC restriction: patients with refractory epilepsy. Treatment should be initiated only by physicians who have appropriate experience in the treatment of epilepsy.  In two placebo-controlled studies in patients with refractory epilepsy retigabine was superior to placebo in terms of the proportion of patients experiencing = 50% reduction in partial seizure frequency per 28 days.  An indirect comparison indicates that retigabine has similar efficacy to two other antiepileptic drugs used as adjunctive therapy.

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 June 2011. 

9.4 alteplase, 10mg, 20mg, 50mg, powder and solvent for solution for injection and infusion (Actilyse®) Boehringer Ingelheim  SMC No. (714/11)

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

9.4.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice, expert comments, and revised data/analys.  Detailed discussion followed and the group concluded their advice for alteplase (Actilyse®), for the fibrinolytic treatment of acute ischaemic stroke. Treatment must be started as early as possible within 4.5 hours after onset of the stroke symptoms and after exclusion of intracranial haemorrhage by appropriate imaging techniques (e.g. cranial computerised tomography or other diagnostic imaging method sensitive for the presence of haemorrhage).  Evidence for the extension of the time window in which alteplase can be administered is from a placebo-controlled study.  Alteplase treatment resulted in significantly more patients having no symptoms or no significant disabling symptoms at three months compared to placebo.

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

RESUBMISSIONS

9.5 prucalopride 1mg and 2mg tablet (Resolor) Shire/Movetis SMC No. (653/10)

9.5.1 A member with a personal specific interest left the meeting for this part of the agenda.

9.5.2 The NDC Lead Assessor 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 The Gut Trust and PromoCon Disabled Living.  Detailed discussion followed and the group agreed that prucalopride (Resolor) should not be recommended for use within NHS Scotland, for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.  Overall the manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.

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, 10 June 2011.

9.6 trabectedin, 0.25 and 1mg powder for concentrate for solution for infusion (Yondelis®) Pharma Mar, S.A. Sociedad Unipersonal SMC No. (452/08)

9.6.1 A member with a personal specific interest left the meeting for this part of the agenda.

9.6.2 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 trabectedin (Yondelis®), should not recommended for use  within NHS Scotland, for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.  Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.  In a phase II randomised study in patients with advanced leiomyosarcoma and liposarcoma in which two trabectedin dose schedules were compared, the licensed 3-weekly schedule was superior to the alternative schedule for the primary endpoint, time to progression.  The manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition, the manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC.

Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 10 June 2011. 

10. SMC User Group Forum

10.1 Update from UGF Meeting

Dr Frances Macdonald reported the following:
Progress was being made for Review of SMC Guidance to manufacturers (Process Aspects).
Confidentiality Agreement between NICE and Industry will be on agenda for discussion at the next UGF meeting in July.
All other business as normal.

11. Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled and noted. 

12. Area Drug & Therapeutics Committee (ADTC) Issues

12.1 Mrs Anne Lee advised that a letter had been received from Ms Fiona Doney, NHS Grampian Formularly Group advising they had received communication from a medical representative regarding saxagliptin (Onglyza), advising that this was considered outwith remit from SMC.  The company had contacted SMC to ask about submission requirements and were advised that as this was a change to posology only (section 4.2 in the SmPC), with no change to the licensed indication (Section 4.1), this was not within SMC’s remit. We advised the company that even though a change to posology like this extends the population eligible to receive treatment, a submission to SMC is not required.  
 
Ms Doney had also requested if ADTCs could be routinely be kept informed of products that SMC has decided are outwith remit, and asked that this be discussed at the June meeting.  Following discussion it was noted that in a typical month SMC deals with up to 20 enquiries from companies about submission requirements and that introducing a mechanism to routinely communicate the outcome of these would create capacity issues for both SMC and ADTCs.  ADTC members present at SMC advised that they would prefer to continue to contact the SMC secretariat on an ad hoc basis when specific queries arise locally.  The Secretariat will respond to Ms Doney advising of this and thanking her for bringing this matter to our attention.

13. Any Other Business

13.1 No other business was noted.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 05 July 2011 at 12.30 pm (lunch from 12 noon), in Healthcare Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

NICE Publications

Minutes of the SMC Meeting 07 June 2011

There were no NICE publications reported at the SMC meeting of 07 June 2011.