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Minutes of the SMC Meeting - 1 December 2009

Minutes of the SMC Meeting held on Tuesday 1 December 2009
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: Professor Ken Paterson (Chairman), Mrs Margo Biggs, Dr Keith Brown, Mr Scott Bryson, Dr Jennifer Burns, Mr Robert Calderwood,Dr David Crookes, Dr Sara Davies, Dr Jonathan Fox, Dr Barclay Goudie, Dr Jan Jones, Dr Chris Lush, Dr Frances Macdonald, Dr John McElhinney, Dr Simon Maxwell, Ms Aileen Muir, Dr Anthony Ormerod, Dr Mercia Page, Dr Robert Peel, Dr Andrew Power, Mr Andrew Powrie-Smith, Mr Mike Pratt, Dr Nick Reed, Mr Keith Thompson, Ms Angela Timoney, Mrs Sheila Tunstall-James, Dr Andrew Walker, Dr Iain Wallace, Professor Tony Wells

In Attendance: Mrs Corinne Booth, Ms Ailsa Brown, Mr Stephen Ferguson, Mrs Laura McIver, Ms Rosie Murray, Ms Emma Riches, Ms Alex Robertson, Mrs Maureen Stark

Apologies: Mrs Laura Ace, Professor James Barbour, Dr Keith Beard, Mr Colin Brown, Mr Dave Carson, Mrs Susan Downie, Dr John Gemmill, Mrs Anne Lee, Dr Alan MacDonald, Ms Veronica Moffat, Professor Dilip Nathwani, Dr Euan Sandilands, Mrs Catherine Tait, Dr Sarah Taylor, Mr Alistair Thorburn, 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 further welcome was extended to the following NDC Members/Lead assessors who were presenting submissions to SMC: Professor Peter Helms; Mrs Sandra McNaughton; and Ms Janice Watt.

Dr Paul McNamee, a Senior Research Fellow, with the Health Economics Research Unit, University of Aberdeen, was welcomed to his first meeting of SMC as a member.

1.3 The Chairman intimated that Mrs Susan Goldsmith, Director of Finance, NHS Lothian, has resigned from SMC due to other commitments.  The Chairman expressed his thanks to Mrs Goldsmith for her contribution to the work of SMC and her active role in establishing the process for accepting Patient Access Schemes (PAS) in Scotland.  Mrs Goldsmith remains Co-Vice Chair of the Patient Access Scheme Assessment Group (PASAG).  A nomination from the Directors of Finance group is being sought to replace Mrs Goldsmith on SMC.

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 03 November 2009 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 tafluprost 15 micrograms/mL preservative-free eye drops single-dose container (Saflutan) Merck Sharp and Dohme (No. 581/09)

4.1.1 The SMC advice for tafluprost (Saflutan), for the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension: as monotherapy in patients who would benefit from preservative-free eye-drops, who are insufficiently responsive to first-line therapy, or who are intolerant or contraindicated to first-line therapy; or as adjunctive therapy to beta-blockers, will be published on the SMC website on Monday, 07 December 2009.

4.2 liraglutide 6mg/mL prefilled pen for injection (3mL) (Victoza)  Novo Nordisk Ltd (No. 585/09)

4.2.1 The SMC advice for liraglutide (Victoza), for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control: in combination with metformin or a sulphonylurea, in patients with insufficient glycaemic  control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea; in combination with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy, will be published on the SMC website on Monday, 07 December 2009.

4.3 imatinib 100mg and 400mg film-coated tablets (Glivec)  Novartis Pharmaceuticals UK Ltd  (No. 584/09)

4.3.1 The SMC advice for imatinib (Glivec), for the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive gastrointestinal stromal tumours (GIST), will be published on the SMC website on Monday, 07 December 2009.

Resubmission

4.4 bemiparin sodium 3,500 IU in 0.2mL solution for injection in prefilled syringes (Zibor) Archimedes Pharma UK Ltd (No. 204/05)

4.4.1 The SMC advice for bemiparin sodium (Zibor), for the prevention of thromboembolic disease in patients undergoing orthopaedic surgery, will be published on the SMC website on Monday, 07 December 2009.

Abbreviated Submissions

4.5 valganciclovir powder for 50mg/mL oral solution (Valcyte)  Roche  (No. 586/09)

4.5.1 The SMC advice for valganciclovir (Valcyte), for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS), will be published on the SMC website on Monday, 07 December 2009.

4.6 valganciclovir powder for 50mg/mL oral solution (Valcyte)  Roche  (No. 587/09)

4.6.1 The SMC advice for valganciclovir (Valcyte), for the prevention of CMV disease in CMV-negative patients who have received a solid organ transplant from a CMV-positive donor, will be published on the SMC website on Monday, 07 December 2009.

Non Submission

4.7 Nothing to report.

Deferred Advice

4.8 Nothing to report.

Amended Advice

4.9 liraglutide 6mg/mL prefilled pen for injection (3mL) (Victoza)  Novo Nordisk Ltd (No. 585/09)

liraglutide (Victoza), for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control: in combination with metformin or a sulphonylurea, in patients with insufficient glycaemic  control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea; in combination with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy, was reviewed by SMC on 03 November 2009 however, as a result of comments from the manufacturer of a comparator product, the Advice has been amended.   Revised advice will be published on the SMC website on Monday 07 December 2009. 

5. Appeals Update

5.1 agomelatine, 25mg film-coated tablets (Valdoxan)  Servier Laboratories UK Ltd (No. 564/09)

In October 2009, SMC did not recommend agomelatine (Valdoxan), for the teatment of major depressive episodes in adults.  Servier Laboratories UK Ltd has indicated their intention to resubmit.

6. Patient and Public Involvement Group (PAPIG)

6.1 PAPIG Update

Mrs Tunstall-James advised that PAPIG had met immediately prior to the SMC meeting and minutes would be available at the January meeting of SMC. 

6.2 Training Day for Patient Interest Groups

PAPIG will be offering a training day (with a provisional date of Tuesday 18 May 2010) for patient interest groups interested in finding out what SMC does and how they can get involved.

6.3 Patient and Public Involvement Officer

PAPIG are hopeful of securing resources in the near future to recruit a patient and public involvement officer (PPIO). The PPIO will support the voluntary health sector to engage more fully with SMC.

6.4 PAPIG – Role and Remit

PAPIG has prepared a Role and Remit, with the approval of the SMC Executive.

6.5 Presentation of Patient Interest Group Submissions to SMC

In order to bring the patient view more clearly into focus, PAPIG in collaboration with the SMC Executive, has been piloting a different method for presenting patient interest group submissions to SMC. SMC discussed and agreed that the changes add greater weight to the patient view and should be incorporated into standard process.

7. New Drugs Committee: Chairman’s Report

7.1 Review of process/standard operating procedures

SMC is currently reviewing the process for critiquing the clinical aspects of submissions. Given the size and scope of some submissions received, the aim is to rationalise the process and perhaps move towards a ‘checklist’ approach, similar to the way the economic assessors currently work, i.e. they will produce a detailed critique of the key points within the submission.

7.2 Proposed revision to SMC Advice

In order to make advice clearer, SMC are considering a new format for the advice box contained in the detailed advice document (DAD), particularly when the advice is restricted.  SMC will consider examples of the new format against the old when they consider the NDC Recommendations in January 2010.  If supported the new format will be incorporated into standard practice.

8. Chairman’s Business

8.1 Membership

SMC and NDC are conducting their annual review of membership. Members will be contacted by the Secretariat to advise when their term of membership is due to expire. Area Drug and Therapeutic Committees (ADTCs) have been approached for nominations. 

8.2 NICE Multiple Technology Appraisal Guidance No TA184 - Topotecan for the treatment of relapsed small-cell lung

Summary of NICE MTA

Oral topotecan is recommended as a possible treatment for people with relapsed small-cell lung cancer if:

  • re-treatment with the previous treatment is not considered appropriate and
  • there is a medical reason why they cannot take the combination of cyclophosphamide, doxorubicin and vincristine (CAV).

Intravenous topotecan is not recommended for people with relapsed small-cell lung cancer.  Healthcare professionals should not stop prescribing topotecan for people with relapsed small-cell lung cancer who were already taking it when the guidance was issued. These people should be able to carry on taking topotecan until they and their specialist decide that it is the right time to stop treatment.

SMC Advice

SMC published advice in March 2009:  topotecan capsules (Hycamtin) No. (545/09) are accepted for restricted use within NHS Scotland as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. The efficacy of topotecan capsules relative to standard IV chemotherapy is unknown. Topotecan capsules are restricted to use in patients for whom standard intravenous chemotherapy is inappropriate and who would otherwise receive best supportive care. In one study, oral topotecan plus best supportive care (BSC) was superior to BSC alone for the primary endpoint of median survival.

SMC published advice in May 2007: topotecan (Hycamtin) No. (366/07) is not recommended for use within NHS Scotland 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. In a trial comparing oral topotecan plus active symptom control (ASC) to ASC alone the difference in median survival was 12 weeks, in favour of the oral topotecan plus ASC group. Topotecan is not available as an oral formulation in the UK, however in one trial the response rate and median survival duration were similar for oral and IV topotecan groups. The treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC.

The NICE MTA guidance supercedes SMC advice.  The SMC website has been updated accordingly.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 rituximab, 100mg and 500mg concentrate for solution for infusion  (MabThera) Roche  (No. 591/09)

9.1.1 A declaration of interest was 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 a patient interest group submission from the Chronic Lymphocytic Leukaemia Support Association (CLLSA). Detailed discussion followed and the group agreed that rituximab (MabThera), should be accepted for restricted use in NHS Scotland, for the treatment of patients with previously untreated and relapsed/refractory 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.  Rituximab is restricted to use by specialists in haematology and haemato-oncology.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 December 2009.

9.2 eslicarbazepine 800mg tablets (Zebinix) Eisai Ltd  (No. 592/09)

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

9.2.2 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 eslicarbazepine (Zebinix), should not be recommended for use in NHS Scotland, for adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. 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, 04 December 2009.

9.3 plerixafor, 20mg/mL solution for injection (Mozobil)  Genzyme Therapeutics Limited (No. 594//09)

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 and comments received from the company.  A member of PAPIG presented patient interest group submissions from Leukaemia CARE; Lymphoma Association; and Myeloma UK. Detailed discussion followed and the group agreed that plerixafor (Mozobil), should be accepted for use in NHS Scotland, in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.     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, 04 December 2009.

9.4 tocilizumab, 20mg/mL concentrate for solution for injection (RoActemra) Roche Products Ltd  (No. 593/09)

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, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from National Rheumatoid Arthritis Society (NRAS).  Detailed discussion followed and the group agreed that tocilizumab (RoActemra), should be accepted for restricted use in NHS Scotland, in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs or tumour necrosis factor antagonists. In these patients, toculizumab can be given as monotherapy in case of intolerance to methotrexate or where continued treatment with methotrexate is inappropriate. 

Tocilizumab is restricted for use in combination therapy.  The manufacturer did not present an economic case for monotherapy. Toculizumab should be used in accordance with the British Society of Rheumatology guidelines for prescribing TNF-α blockers in adults.  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, 04 December 2009. 

9.5 ustekinumab 45 mg solution for injection (Stelara®) Janssen-Cilag Ltd (No. 572/09)

9.5.1 A declaration of interest was 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 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 PSALV, Psoriasis Scotland and Skin Care Campaign Scotland (SCCS).  Detailed discussion followed and the group concluded their advice for ustekinumab (Stelara), 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 therapies including ciclosporin, methotrexate and psoralen and UVA treatment (PUVA). 

9.5.3 For operational reasons, the SMC advice has been withheld until further notice.

9.6 certolizumab pegol, 200 mg/mL solution for injection (prefilled syringe) (Cimzia)  UCB Pharma Ltd (No. 590/09)

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

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 a patient interest group submission from National Rheumatoid Arthritis Society (NRAS).  Detailed discussion followed and the group concluded their advice for certolizumab pegol (Cimzia), for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease modifying anti-rheumatic drugs, including methotrexate, has been inadequate.

9.6.3 For operational reasons, the SMC advice has been withheld until further notice.

NON SUBMISSION

9.7 tolvaptan (Samsca®)  Otsuka UK  (No: 605/10)

9.7.1 In the absence of a submission from the holder of the Marketing Authorisation, tolvaptan (Samsca®), for the treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH), should not be recommended for use within NHS Scotland.

9.7.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday 04 December 2009.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

11. SMC User Group Forum (UGF)

11.1 Update from the UGF

Dr Frances Macdonald reported that the UGF was continuing to explore and develop methodology and process issues.  In addition the group is working to analyse and address manufacturers’ reasons for not making a submission to SMC.

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

12.1 Nothing to Report.

13. Any Other Business

13.1 Patient Access Scheme Assessment Group (PASAG)

Dr Frances Macdonald asked if it would be possible for PASAG to outline their process in a presentation to SMC, once the PASAG is fully established.  The Chairman agreed that such information would be helpful to SMC.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 12 January 2010 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.