You are here:

SMC Minutes 5th July 2011

Minutes of the SMC Meeting
held on Tuesday 05 July 2011
Healthcare Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: 
Ms Angela Timoney (Chairman), Ms Sandra Auld, Professor Scott Bryson, Dr Jennifer Burns, Mrs Helen Cadden, Mr Robert Calderwood, Mrs Alison Campbell, Mr Dave Carson, Dr Jonathan Fox, Dr Barclay Goudie, Dr Jacqui Howes, Dr Jan Jones, Professor Stephen Lawrie, Dr Chris Lush, Dr Frances Macdonald, Dr John McElhinney, Dr James McLay, Dr Paul McNamee, Dr Simon Maxwell, Ms Aileen Muir, Mrs Anne Murray, Dr Mercia Page, Dr Robert Peel, Mr Michael Pratt, Mrs Sheila Tunstall-James, Dr Andrew Walker, Professor David Wray

In Attendance: 
Ms Melanie Barnes, Mrs Corinne Booth, Ms Ailsa Brown, Mrs Linda McGlynn, Dr Mike McMahon, Ms Rosie Murray, Dr Libby Sillito, Mrs Maureen Stark, Professor Colin Suckling

Apologies:
Mrs Laura Ace, Professor James Barbour, Mr Colin Brown, Dr Keith Brown, Dr Dominic Culligan, Ms Sara Davies, Mrs Susan Downie, Dr David Dunlop, Mr Stephen Ferguson, Dr John Gemmill, Mrs Anne Lee, Dr Alan MacDonald, Mrs Margo McGurk, Mrs Sandra McNaughton, Ms Veronica Moffat, Dr Brian Robson, Professor Dilip Nathwani, Ms Alex Robertson, Mrs Catherine Tait, Dr Sarah Taylor

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:

Public Involvement Officer:
Mrs Linda McGlynn, recently appointed Public Involvement Officer.

Observers:
Dr Libby Sillito, Principal Pharmaceutical Analyst, Scottish Medicines Consortium
Professor Colin Suckling, Public Partner Designate

NDC Members/Lead Assessors presenting submissions to SMC:
Dr Mike McMahon

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 (07 June 2011)

3.1 The minutes of the SMC meeting held on 07 June 2011 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

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

The SMC advice for paliperidone palmitate prolonged release suspension for injection (Xeplion®), for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone, will be published on the SMC website on Monday, 11 July 2011.

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

The SMC advice for ranibizumab (Lucentis®), for the treatment of visual impairment due to diabetic macular oedema in adults, will be published on the SMC website on Monday, 11 July 2011.

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

The SMC advice for retigabine (Trobalt®), for adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy, will be published on the SMC website on Monday, 11 July 2011.

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

The SMC advice for alteplase (Actilyse®), for the fibrinolytic treatment of acute ischaemic stroke, will be withheld pending confirmation of the licence.

Resubmissions

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

The SMC advice for prucalopride (Resolor®), for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief, will be published on the SMC website on Monday, 11 July 2011.

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

The SMC advice for trabectedin (Yondelis®), for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents, will be published on the SMC website on Monday, 11 July 2011.

Deferred Advice

4.7 Nothing to report.

Amended Advice

4.8 Nothing to report.

5. Appeals Update

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

In June 2011, SMC considered but did not recommend a submission for paliperdione palmitate prolonged release suspension for injection (Xeplion®), 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.  The licence holder has intimated their intention to make a resubmission.

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

In June 2011, SMC considered but did not recommend a submission for prucalopride (Resolor®), 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.  The licence holder has intimated their intention to make a second resubmission.

6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the PAPIG Meeting Held on 07 June 2011

The minutes of the PAPIG meeting held on 07 June 2011 were noted.

6.2 New Public Partner

On behalf of PAPIG, Mrs Tunstall-James welcomed Professor Colin Suckling to the meeting. Professor Suckling is currently being introduced to the work of SMC and PAPIG and will formally take up his membership of SMC in September 2011, as a Public Partner.

6.3 Appointment of Mrs Linda McGlynn, LTCAS/SMC Public Involvement Officer

In order to increase and promote public involvement, Mrs Linda McGlynn, Public Involvement Officer, has been appointed to support SMC, PAPIG and patient interest groups.  Linda was informally introduced to PAPIG, prior to the SMC meeting. 

7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 Patient and Public Involvement Group (PAPIG): Chairman Designate

Mrs Sheila Tunstall-James completes her term of office as a member of SMC and will demit the Chair of PAPIG in August 2011.  Mrs Anne Murray, Public Partner, will take the Chair of PAPIG on an interim basis, for a period of 6 months.  The SMC Chair thanked Mrs Murray for accepting the position.

8.2 NICE Single Technology Appraisal Guidance No 225 – Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying antirheumatic drugs

NICE recommends golimumab as a possible treatment for some adults with rheumatoid arthritis in the same circumstances as other drugs for the condition.

The Scottish Medicines Consortium (SMC) has received a submission from the manufacturer of golimumab and is due to publish a Statement of Advice on this medication for this indication in November 2011. When this is available, NHS Scotland should adhere to this advice.

Note: Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

Further information is noted in the Appendix to the minutes.

8.3 NICE Single Technology Appraisal Guidance No 226 – Rituximab for the first-line maintenance treatment of follicular non-Hodgkin’s lymphoma

NICE recommends rituximab as a possible treatment to maintain remission in people with follicular non-Hodgkin's lymphoma.

The Scottish Medicines Consortium (SMC) published a Statement of Advice (675/11), on this medication for this indication, in February 2011. It stated that: rituximab (MabThera®) is accepted for restricted use within NHS Scotland for the maintenance treatment of follicular lymphoma patients responding to induction therapy.  The treatment is restricted to patients who have responded to induction with rituximab plus chemotherapy.

There is no material difference between the recommendations of the NICE STA and the SMC.

Note: Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

Further information is noted in the Appendix to the minutes.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 nilotinib 150mg hard capsules (Tasigna®) SMC No. (709/11)  Novartis Pharmaceuticals UK Ltd

9.1.1 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.

9.1.2 An 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 nilotinib (Tasigna®), should be accepted for use in NHS Scotland, for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase. 

First-line treatment with nilotinib in newly diagnosed patients has resulted in significantly higher molecular and cytogenetic response rates compared to the standard tyrosine kinase inhibitor. Further longer term follow-up data are needed to confirm the duration of this response and assess the impact on disease progression and overall survival.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of nilotinib. This SMC advice is contingent upon the continuing availability of the PAS 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, 08 July 2011. 

9.2 collagenase clostridium histolyticum 0.9mg powder and solvent for solution for injection (Xiapex®)  SMC No. (715/11)  Pfizer Ltd

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

9.2.2 An NDC Co-Vice Chair provided an overview of the assessment, draft advice, updated expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from the International Depuytren Society.  Detailed discussion followed and the group agreed that collagenase clostridium histolyticum (Xiapex®), should not be recommended for use in NHS Scotland, for treatment of Dupuytren’s contracture in adult patients with a palpable cord. 

Collagenase clostridium histolyticum compared to placebo significantly reduces primary joint contracture in adults with Dupuytren’s contracture and a palpable cord.

The submitting company 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, 08 July 2011.

9.3 capecitabine, 150mg, 500mg, tablets (Xeloda®) SMC No. (716/11)  Roche Products Limited

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

9.3.2 An NDC Co-Vice Chair provided an overview of the assessment, draft advice, expert comments, and revised data/analyses.  Detailed discussion followed and the group agreed that capecitabine (Xeloda®), should be accepted for use in NHS Scotland, for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer in combination with oxaliplatin. 

At 55 months, disease free survival was significantly increased for capecitabine plus oxaliplatin-treated patients compared with a recognised regimen containing a fluoropyramidine in the adjuvant treatment of patients with completely resected stage III (Dukes’ C) colon cancer.

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 July 2011. 

9.4 darunavir 400mg tablets (Prezista®) SMC No. (707/11)  Janssen

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

9.4.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, and revised data/analyses.  A member of PAPIG presented a patient interest group submission from HIV Scotland.  Detailed discussion followed and the group agreed that darunavir (Prezista®), should be accepted for use in NHS Scotland, for the treatment of HIV-1 infection in antiretroviral therapy experienced adults with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count =100 cells/mm3.

Darunavir 800mg/ritonavir 100mg once daily was demonstrated to be non inferior to darunavir 600mg/ritonavir 100mg twice daily, when administered with an optimised background regimen that consisted of at least two nucleoside reverse transcriptase inhibitors in treatment experienced HIV infected patients.

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 July 2011. 

RESUBMISSIONS

9.5 glucosamine sulphate 1,500mg powder for oral solution (Glusartel®) SMC No. (647/10)  Rottapharm Madaus

9.5.1 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.

9.5.2 An 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 glucosamine sulphate (Glusartel®), should not be recommended for use in NHS Scotland, for symptoms in mild to moderate osteoarthritis of the knee. 

In a placebo- and active-comparator study, glucosamine sulphate 1,500mg once daily was significantly better than placebo in the treatment of symptoms associated with osteoarthritis of the knee.

Overall the submitting company 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, 08 July 2011. 

9.6 mifamurtide 4mg powder for suspension for infusion (Mepact®) SMC No. (621/10)  Takeda UK and Ireland Ltd

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

9.6.2 The NDC Lead Assessor 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 Sarcoma UK and the Bone Cancer Research Trust.  Detailed discussion followed and the group agreed that mifamurtide (Mepact®), should be accepted for use in NHS Scotland, in combination with post-operative multi-agent chemotherapy for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection, in children, adolescents and young adults.  Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis.

Mifamurtide has been shown to increase overall survival compared with multi-agent chemotherapy alone in patients aged up to 30 years with newly-diagnosed resectable osteosarcoma.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of mifamurtide. This SMC advice is contingent upon the continuing availability of the PAS 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 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 July 2011. 

ABBREVIATED SUBMISSIONS

9.7 alteplase 2mg powder and solvent for solution for injection for infusion (Actilyse Cathflo®) (No: 717/11) Boehringer Ingelheim  

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, draft advice, expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that alteplase (Actilyse Cathflo®), should be accepted for restricted use in NHS Scotland, for thrombolytic treatment of occluded central venous access devices including those used for haemodialysis. 

It is restricted to use where alteplase is the product of choice for the treatment of occluded venous access devices.

This is a new formulation introduced for this extension to the alteplase marketing authorisation and the 2 mL vial is the only presentation licensed for this indication.

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, 08 July 2011.                                    

9.8 calcium carbonate equivalent to 500mg calcium, cholecalciferol (vitamin D3) 800 IU (20 microgram) tablets (Kalcipos-D 500mg/800 IU chewable tablets®)  (No: 718/11 )  Meda Pharmaceuticals Ltd

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

9.8.2 The NDC Chair provided an overview of the assessment and draft advice.  Detailed discussion followed and the group agreed that calcium carbonate / cholecalciferol (Kalcipos-D®), should be accepted for  use in NHS Scotland, for:

  • Prevention and treatment of calcium and vitamin D deficiency in the elderly;
  • Vitamin D and calcium supplement in addition to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency. 

This is a new combination product with a different ratio of calcium to cholecalciferol than alternative combination preparations.  It is a similar price to an alternative product containing 800IU of cholecalciferol per tablet but is more expensive than some other calcium and cholecalciferol combinations.  Any overall budget impact is likely to be small.

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 NHS Boards and ADTCs on Friday, 08 July 2011.

9.9 methotrexate 50mg/mL solution for injection  (Metoject®) prefilled syringes 12.5mg, 17.5mg, 22.5mg, 27.5mg and 30mg      (No: 724/11)  Medac GmbH

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

9.9.2 The NDC Chair provided an overview of the assessment, draft advice and comments received from the company.  Detailed discussion followed and the group agreed that methotrexate (Metoject®), should be accepted for use in NHS Scotland, for polyarthritic forms of severe active juvenile idiopathic arthritis, when the response to non-steroidal anti-inflammatory drugs has been inadequate. 

For patients in whom treatment with disease modifying drugs is indicated and parenteral administration of methotrexate is appropriate, this adds to the range of pre filled syringes available.

The Scottish Medicines Consortium has previously accepted methotrexate for the treatment of severe active rheumatoid arthritis in adult patients where treatment with disease modifying drugs is indicated. Methotrexate injection is listed in the British National Formulary for Children 2010 -11 for the treatment of juvenile idiopathic arthritis.

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 NHS Boards and ADTCs on Friday, 08 July 2011.                                         

NON-SUBMISSIONS

9.10 glucosamine sulphate (Dolenio®) (No.  729/11) Alissa Healthcare Research

9.10.1 In the absence of a submission from the holder of the marketing authorisation, glucosamine sulphate (Dolenio®), for symptomatic treatment of mild to moderate osteoarthritis (OA) of the knee, should not be recommended for use within NHS Scotland.

9.10.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 July 2011.

9.11 bilastine (Ilaxten®) (No. 730/11) A Menarini Pharma  UK SRL

9.11.1 In the absence of a submission from the holder of the marketing authorisation, bilastine (Ilaxten®), for symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria, should not be recommended for use within NHS Scotland.

9.11.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 July 2011.

10. SMC User Group Forum

10.1 Dr Frances Macdonald reported that work-streams were ongoing.

11. Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled and noted. 

12. Area Drug & Therapeutics Committee (ADTC) Issues

12.1 Nothing to report.

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, 02 August 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 on 05 July 2011

NICE Single Technology Appraisal Guidance No 225 – Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying antirheumatic drugs

NICE Guidance

1 Golimumab in combination with methotrexate is recommended as an option for the treatment of rheumatoid arthritis in adults whose rheumatoid arthritis has responded inadequately to conventional disease-modifying anti-rheumatic drugs (DMARDs) only, including methotrexate, if:

  • it is used as described for other tumour necrosis factor (TNF) inhibitor treatments in ‘adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis’ (NICE technology appraisal guidance 130)1, and
  • the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose, agreed as part of the patient access scheme.

2 Golimumab in combination with methotrexate is recommended as an option for the treatment of rheumatoid arthritis in adults whose rheumatoid arthritis has responded inadequately to other DMARDs, including a TNF inhibitor, if:

  • it is used as described for other TNF inhibitor treatments in ‘Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor’ (NICE technology appraisal guidance 195)1, and
  • the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose, agreed as part of the patient access scheme.

http://www.nice.org.uk/TA225

SMC Advice 

The Scottish Medicines Consortium (SMC) has received a submission from the manufacturer of golimumab and is due to publish a Statement of Advice on this medication for this indication in November 2011.  When this is available, NHS Scotland should adhere to this advice.

Note: Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

NICE Single Technology Appraisal Guidance No 226 – Rituximab for the first-line maintenance treatment of follicular non-Hodgkin’s lymphoma

NICE Guidance

Rituximab maintenance therapy is recommended as an option for the treatment of people with follicular non-Hodgkin’s lymphoma that has responded to first-line induction therapy with rituximab in combination with chemotherapy.

http://www.nice.org.uk/TA226

SMC Advice: Following a full submission:

rituximab (MabThera®) is accepted for restricted use within NHS Scotland.

Indication under review: Rituximab maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.

SMC restriction: for maintenance treatment in follicular lymphoma patients who have responded to induction with rituximab plus chemotherapy. Rituximab significantly increased progression free survival following a response to induction therapy in patients with previously untreated follicular lymphoma compared with observation alone. Longer follow up is required to establish benefit in overall survival.

Access the advice of SMC

There is no material difference between the recommendations of the NICE STA and the SMC.

Note: Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.