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SMC Minutes - Tuesday 2 March 2010

Minutes of the SMC Meeting held on Tuesday 02 March 2010
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: Professor Ken Paterson (Chairman), Mrs Margo Biggs, Dr Keith Brown,Professor Scott Bryson, Mr Dave Carson, Dr David Crookes, Dr Sara Davies, Dr Jonathan Fox, Dr John Gemmill,
Dr Barclay Goudie, Dr Jan Jones, Dr Chris Lush, Dr Frances Macdonald, Dr John McElhinney,
Dr Paul McNamee, Ms Veronica Moffat, Ms Aileen Muir, Dr Anthony Ormerod, Dr Mercia Page,
Dr Robert Peel, Dr Andrew Power, Mr Andrew Powrie-Smith, Dr Nick Reed, Dr Sarah Taylor,
Mr Keith Thompson, Ms Angela Timoney, Mrs Sheila Tunstall-James, Dr Andrew Walker,Professor David Wray.

In Attendance: Mrs Corinne Booth, Ms Ailsa Brown,Mrs Gail Caldwell,Mrs Susan Downie, Mrs Christine Gilmour,Mrs Anne Lee, Mrs Laura McIver, Ms Rosie Murray, Mrs Maureen Stark.

Apologies: Mrs Laura Ace, Professor James Barbour, Dr Keith Beard, Mr Colin Brown,
Dr Jennifer Burns, Mr Robert Calderwood, Mr Stephen Ferguson, Dr Alan MacDonald,Mrs Sandra McNaughton, Professor Simon Maxwell, Professor Dilip Nathwani,Mr Mike Pratt,Ms Emma Riches,
Ms Alex Robertson, Mrs Catherine Tait, Mr Alistair Thorburn, Dr Iain Wallace, Professor Tony Wells.

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 Mrs Gail Caldwell, Pharmacy Director, NHS Forth Valley, who was observing the meeting.

1.3 The Chairman welcomed Mrs Christine Gilmour, Co-Chair of the Patient Access Assessment Group (PASAG), who gave a presentation on Patient Access Schemes (PAS), their origins and application and also the remit of PASAG and its key functions. The Chairman acknowledged the huge undertaking involved in establishing PASAG. He thanked Mrs Gilmour for an informative presentation and following discussion.

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 02 February 2010 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 saxagliptin (Onglyza) Bristol-Myers Squibb Pharmaceuticals Limited (No: 603/10)

4.1.1 The SMC advice for saxagliptin (Onglyza), in adult patients with type 2 diabetes mellitus as add-on combination therapy with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control, will be published on the SMC website on Monday, 08 March 2010.

4.2 ketoprofen-omeprazole (Axorid) Meda Pharmaceuticals (No: 606/10)

4.2.1 The SMC advice for ketoprofen-omeprazole (Axorid), for the symptomatic treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis in patients with a previous history or who are at risk of developing NSAID associated gastric ulcers, duodenal ulcers and gastroduodenal erosions in whom continued treatment with ketoprofen is essential, will be published on the SMC website on Monday, 08 March 2010.

Resubmission

4.3 extended release, morphine sulphate for epidural injection (Depodur) Flynn Pharma Ltd (No: 528/09)

4.3.1 The SMC advice for extended release, morphine sulphate for epidural injection (Depodur), for the relief of post-operative pain following major orthopaedic, abdominal or pelvic surgery, will be published on the SMC website on Monday, 08 March 2010.

Non Submission

4.4 rupatadine (Rupafin) GlaxoSmithKline (No. 612/10)

4.4.1 The SMC advice for rupatadine (Rupafin), for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and adolescents (over 12 years of age), will be posted on the SMC website on Monday, 08 March 2010.

Deferred Advice

4.5 Nothing to report.

Amended Advice

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

4.6.1 In December 2009, SMC accepted tocilizumab (RoActemra), in combination with methotrexate, for restricted use in NHS Scotland, 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. Tocilizumab is restricted for use in combination therapy.

4.6.2 Following comments from the manufacturer of a comparator product, amendments have been made to the cost comparator table. Amended Advice will be issued to NHS Boards/ADTCs and published on the website on Friday 05 March 2010.

5. Appeals Update

5.1 ketoprofen-omeprazole (Axorid) Meda Pharmaceuticals (No: 606/10)

5.1.1 In February 2010, SMC did not recommend ketoprofen-omeprazole (Axorid), for the symptomatic treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis in patients with a previous history or who are at risk of developing NSAID associated gastric ulcers, duodenal ulcers and gastroduodenal erosions in whom continued treatment with ketoprofen is essential. Meda Pharmaceuticals have indicated their intention to resubmit.

6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the previous meeting of PAPIG (02 February 2010)

The minutes of the PAPIG meeting held on 02 February 2010, were noted.

6.2 Verbal Update - Mrs Tunstall James

Work is progressing to establish a Patient and Public Involvement Officer (PPIO) which will support the work of SMC and ensure that a patient view is considered for new medicines under review.

7. New Drugs Committee: Chairman’s Report

7.1 New Format for Advice Box

A new format has been introduced to the advice box on the front page of the SMC detailed advice document (DAD) or Product Update. The aim is to clearly state the indication under review and any restrictions or additional information SMC may apply to the advice. The revised format will be published from Monday 12 April 2010.

7.2 Development of the Clinical Checklist: Update

Work is ongoing to develop a clinical checklist, similar to that which assessors prepare for the health economic evaluation. An example will be presented to SMC at the April meeting, for consideration and comment.

7.3 Contract Prices

SMC advice is currently based on confirmed NHS list prices. However, SMC is aware that for some hospital-only products national or local contracts may be in place for comparator products that can significantly reduce the acquisition cost to Health Boards. These contract prices are commercial in confidence and cannot be put in the public domain, including via the SMC Detailed Advice Document (DAD). Area Drug and Therapeutics Committees and NHS Boards are therefore asked to consider contract pricing when reviewing advice on medicines accepted by SMC. A statement to that effect has now been now included in the advice context statement of the DAD, effective from the advice issued in March 2010.

7.4 Seminar on Biosimilar Medicines: 1:30pm, Tuesday 30 March 2010

As the March NDC meeting will be shorter than usual, a seminar has been arranged for NDC members and assessors on biosimilar medicines. Speakers will present both an NHS and a pharmaceutical industry perspective. The seminar will take place at 1:30pm, on Tuesday 30 March, 2010, in Delta House. SMC members are cordially invited to attend.

8. Chairman’s Business

8.1 SMC Meeting Scheduled for 04 May 2010

SMC has received only one submission for review at the SMC meeting scheduled for 04 May 2010. SMC agreed that it would be impractical to hold a meeting for one submission. The SMC’s May meeting has therefore been cancelled.

8.2 NICE Single Technology Appraisal Guidance No 185 – Trabectedin for the treatment of advanced soft tissue sarcoma

Summary of NICE STA
Trabectedin is recommended as a possible treatment for people with advanced soft tissue sarcoma if:

  • treatment with anthracyclines and ifosfamide has failed, or
  • they cannot tolerate anthracyclines and ifosfamide, or
  • anthracyclines and ifosfamide are unsuitable.

The manufacturer of trabectedin has agreed to a 'patient access scheme', which means that when a person needs more than five trabectedin treatments, it provides the sixth and any further trabectedin treatments to the NHS free of charge.

SMC Advice

Following a full submission SMC published advice for trabectedin (Yondelis) in August 2008 (No. 452/08)

trabectedin (Yondelis®), is 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 used, the licensed schedule was superior to the alternative one for the primary endpoint, time to progression. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.

There is a material difference between the recommendations of the NICE STA and the SMC. The NICE STA advice is based upon the application of both a Department of Health agreed Patient Access Scheme and consideration of the medicine as a life-extending, end of life treatment. The manufacturer of trabectedin has indicated their intention to provide a resubmission to SMC for consideration. Advice based on a resubmission is anticipated before the end of August 2010.

8.3 NICE Single Technology Appraisal Guidance No 186 – Certolizumab pegol for the treatment of rheumatoid arthritis

Summary of NICE STA
Certolizumab pegol is recommended as a possible treatment for people with rheumatoid arthritis who:

  • have already tried methotrexate and another disease-modifying anti-rheumatic drug (DMARD), usually for at least 6 months,
    and
  • have severe 'active' rheumatoid arthritis, as assessed by a rheumatologist on two separate occasions.

People who are treated with certolizumab pegol should normally also be given methotrexate. If methotrexate does not suit them, they may be given certolizumab pegol on its own. This treatment should only be carried out by a specialist rheumatology team. The treatment should only be continued if the disease has improved sufficiently after 6 months, and the person should continue to have check-ups every 6 months to make sure that their rheumatoid arthritis is still responding to the drug. If a person taking a different TNF inhibitor has to stop during the first 6 months of treatment because it has unwanted effects, their specialist may offer certolizumab pegol after discussion with the person. When assessing if rheumatoid arthritis is 'active', healthcare professionals should take into account any disabilities or difficulties in communicating that might mean that the standard assessments do not provide accurate information.

SMC Advice

SMC has received a submission from the manufacturer of certolizumab pegol (Cimzia) and is due to publish a Statement of Advice on this medication for this indication in May 2010.

NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 paclitaxel (albumin encapsulated injection) Abraxane Abraxis Bioscience Limited (No. 556/09)

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

9.1.2 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 paclitaxel (albumin encapsulated injection) Abraxane, should be accepted for restricted use in NHS Scotland, for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline containing therapy is not indicated. Use is restricted to patients who would otherwise receive docetaxel or 3-weekly solvent-based paclitaxel as second-line treatment for metastatic breast cancer. In one study the overall response rate for paclitaxel albumin was significantly superior to solvent-based paclitaxel in a subgroup analysis of patients who had previously received one or more lines of therapy for metastatic disease. The health economic case was only demonstrated for a subset of the licensed indication which is the basis for the SMC restriction. Note that paclitaxel albumin may have substantially different pharmacological properties compared to other formulations of paclitaxel and is licensed for use in a 3-weekly dosage schedule.

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, 05 March 2010.

9.2 azacitidine (Vidaza) Celgene UK Limited (No. 589/09)

9.2.1 There were no declarations of interest recorded in relation to thisproduct/comparator drugs.

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 a patient interest group submission from the MDS UK Patient Support Group. Detailed discussion followed and the group agreed that azacitidine (Vidaza), should not be recommended for use in NHS Scotland, for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (SCT) with intermediate-2 and high-risk myelodysplastic syndrome (MDS), chronic myelomonocytic leukaemia (CMML) or acute myeloid leukaemia (AML). Azacitidine therapy produced a significant increase in overall survival compared with conventional care regimens in previously untreated higher-risk MDS patients. However, the manufacturer did not present a sufficiently robust economic analysis and their justification for the treatment’s cost in relation to its health benefits was not sufficient 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, 05 March 2010.

9.3 everolimus (Afinitor) Novartis Pharmaceuticals UK Ltd (No. 595/10)

9.3.1 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.

9.3.2 The NDC 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 Kidney Cancer UK. Detailed discussion followed and the group agreed that everolimus (Afinitor), should not be recommended for use in NHS Scotland, for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy. Everolimus, in conjunction with best supportive care (BSC), increased median progression-free survival (PFS) by three months compared with placebo plus BSC in heavily pre-treated patients with metastatic renal cell carcinoma. However, the manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient 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.

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 March 2010.

9.4 tacrolimus (Protopic) 0.03% ointment Astellas Pharma Ltd (No. 608/10)

9.4 1 Declarations of interest were recorded in relation to this product/comparator drugs. Members with personal specific interests left the meeting for this part of the agenda.

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. Detailed discussion followed and the group agreed that tacrolimus (Protopic) 0.03% ointment, should be accepted for restricted use in NHS Scotland, for maintenance treatment of moderate to severe atopic dermatitis in children (aged 2 to15 years) for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected). Use is restricted to initiation by dermatologists in secondary care who have experience in treating atopic dermatitis using immunomodulatory therapy. Twice weekly maintenance therapy with tacrolimus ointment resulted in reduced disease exacerbations when compared to intermittent use only to treat disease exacerbations.

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, 05 March 2010.

9.5 tacrolimus (Protopic) 0.1% ointment Astellas Pharma Ltd (No.609/10)

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

9.5.2 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 tacrolimus (Protopic) 0.1% ointment, should be accepted for use in NHS Scotland, for maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in adult patients (≥16 years) experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected). Use is restricted to dermatologists in secondary care with experience in treating atopic dermatitis with immunomodulatory therapy. Twice weekly maintenance therapy with tacrolimus ointment resulted in reduced disease exacerbations when compared to intermittent use only to treat disease exacerbations.

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, 05 March 2010.

ABBREVIATED SUBMISSIONS

9.6 metformin hydrochloride (Glucophage) 500mg/1000mg Powder for Solution Merck Serono Ltd (No. 610/10)

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

9.6.2 The NDC Chair provided an overview of the assessment, and draft advice. Detailed discussion followed and the group agreed that metformin hydrochloride (Glucophage) powder for solution, should be accepted for restricted use in NHS Scotland, for the treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control:
• In adults, metformin may be used as monotherapy or in combination with other oral anti-diabetic agents or insulin;
• In children, from 10 years of age and adolescents, metformin may be used as monotherapy or in combination with insulin.
A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure. Use is restricted to patients who are unable to swallow the solid dosage formulation. There is a price premium relative to metformin immediate release tablets but a saving compared to an existing formulation of metformin oral solution.

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, 05 March 2010.

9.7 omalizumab (Xolair) Novartis Ltd (No. 611/10)

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

9.7.2 The NDC Chair provided an overview of the assessment, draft advice, and expert comments. Detailed discussion followed and the group agreed that omalizumab (Xolair), should be accepted for restricted use in NHS Scotland, as add-on therapy to improve asthma control in children (6 to <12 years of age) with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

9.7.3 Omalizumab treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma. Use is restricted to patients who are prescribed chronic systemic steroids and in whom all other treatments have failed. The response to omalizumab treatment should be assessed in all patients at 16 weeks and treatment should be discontinued in patients who have not shown a marked improvement in overall asthma control.

The Scottish Medicines Consortium has previously accepted this product for restricted use in adults and adolescents (12 years of age and above). Omalizumab is listed in the British National Formulary for Children for the prophylaxis of allergic asthma.

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

9.7.4 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 March 2010.

NON SUBMISSION

9.8 temsirolimus (Torisel) Wyeth Pharmaceuticals (No. 617/10)

9.8.1 In the absence of a submission from the holder of the marketing authorisation, temsirolimus (Torisel) for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma [MCL] is not recommended for use in NHS Scotland. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland

9.8.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 March 2010.

10. Abbreviated Submission Process for Medicines in Children and Adolescents

10.1 A revised process to facilitate the assessment of paediatric licence extensions as abbreviated submissions was introduced in August 2008 and has been piloted for a year. Mrs Anne Lee, Principal Pharmacist, SMC, provided a qualitative and quantitative report on progress to date. In general, the process is working well with benefits to all key stakeholders. SMC therefore approved the continuation of the pilot for a further year, subject to minor adjustments which will streamline the process. A further review will be undertaken in January 2011.

11. Forthcoming Submissions

A list of forthcoming submissions was tabled and noted.

12. SMC User Group Forum (UGF)

12.1 Minutes of the previous meeting of UGF (26 January 2010)

12.2 Currency Fluctuations

For information, Dr Frances Macdonald, advised that currency fluctuations may be impacting on UK pharmaceutical prices. The effect may also impact on SMC assessments and Patient Access Schemes (PAS).

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

13.1 No issues were raised.

14. Any Other Business

14.1 No other business was noted.

15. Date of the Next Meeting

15.1 The date of the next meeting was confirmed as Tuesday 06 April 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.