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Minutes of the SMC Meeting held on Tuesday 2 December 2008

Minutes of the SMC Meeting held on Tuesday 2 December 2008
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: Dr Ken Paterson (Chairman), Mrs Laura Ace, Dr Keith Beard, Dr Keith Brown, Professor John Cairns, Dr David Crookes, Dr Sara Davies, Mr Tom Divers, Dr Jonathan Fox, Dr Barclay Goudie, Dr Jan Jones, Dr Chris Lush, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Dr Simon Maxwell, Ms Aileen Muir, Dr Andrew Power, Mr Andrew Powrie-Smith, Dr Nick Reed, Dr Sandy Simpson, Mr Keith Thompson, Ms Angela Timoney, Mrs Sheila Tunstall-James, Professor Tony Wells, Dr Andrew Walker.

In Attendance: Mrs Corinne Booth, Ms Ailsa Brown, Mr Edward Clifton, Ms Susan Downie, Dr Jacob George, Mrs Anne Lee, Dr Tiong K Lim, Mr Owen Moseley, Ms Rosie Murray, Mrs Maureen Stark, Mrs Catherine Tait.

Apologies: Professor James Barbour, Mrs Margo Biggs, Mr Colin Brown, Mr David Carson, Mr Stephen Ferguson, Dr John Gemmill, Ms Susan Goldsmith, Dr Grace Lindsay,Ms Veronica Moffat, Professor Dilip Nathwani, Dr Anthony Ormerod, Ms Alex Robertson,Dr Sarah Taylor, Mr Alistair Thorburn.

1. Welcome and Apologies for Absence

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

A particular welcome was extended to the following individuals who were observing the meeting:

  • Mr Edward Clifton, trainee health economist who is supporting the work of the Ayrshire and Arran Medicines Resource Group in implementing the introduction of new medicines following SMC advice.
  • Dr Jacob George, Clinical Lecturer and Honorary Specialist Registrar in Clinical Pharmacology, Ninewells Hospital, Dundee.
  • Dr T K Lim Clinical Lecturer/Specialist Registrar Trainee in Cardiology and Clinical Pharmacology, Ninewells Hospital, Dundee.
  • Mr Owen Moseley, trainee health economist who is supporting the work of the Ayrshire and Arran Medicines Resource Group in implementing the introduction of new medicines following SMC advice.

1.2 The Chairman expressed his good wishes to Mrs Susan Downie who will be absent from the Consortium during a period of maternity leave.

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 04 November 2008 were accepted with a minor amendment to wording.

4. Matters Arising

4.1 NICE Consultation End of Life Medicine

NICE intends to supplement the advice it gives to its Appraisal Committees when they are asked to appraise life-extending medicines licensed for terminal illnesses affecting small numbers of patients.  The purpose of this supplemental advice is to indicate the circumstances in which it may be appropriate to recommend the use of life-extending medicines.  NICE are seeking comments on their proposals. 

The Scottish Government Health Department (SGHD) asked SMC to comment on the NICE consultation and other related matters.   With the aid of a briefing paper, shared with NDC and SMC members, the SMC Executive prepared draft responses to both the SGHD  and NICE.  The draft responses were considered and discussed in detail by SMC. 

SMC welcomed a dialogue on how more drugs can be made available and aimed to be constructive in their response. SMC however, had concerns over some of the proposals and criteria in terms of their practicality and the potential impact they may have on wider prescribing practice.   SMC’s views will be reflected in the final responses to NICE and the SGHD.

Full Submissions

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

4.2.1 The SMC advice for miconazole (Loramyc), for the treatment of oropharyngeal candidiasis in immunocompromised patients with cancer of the head and neck who had received radiotherapy, will be posted on the SMC website on Monday, 08 December 2008.

4.3 methylnaltrexone bromide 12mg/0.6ml solution for injection (Relistor) John Wyeth & Brother Limited  (No. 518/08)

4.3.1 The SMC advice for 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, will be posted on the SMC website on Monday, 08 December 2008.

4.4 atazanavir, 100mg/150mg/200mg capsules (Reyataz)  Bristol-Myers Squibb Pharmaceuticals  Ltd  (No. 520/08)

4.4.1 The SMC advice for atazanavir (Reyataz), in antiretroviral treatment naïve HIV-1 infected adults in combination with other antiretroviral medicinal products, will be posted on the SMC website on Monday, 08 December 2008.

4.4.2 Following comparator comments, an amendment has been made to the section entitled “Summary of Clinical Effectiveness Issues”.  The advice will be reissued to NHS Scotland on Friday 5 December 2008.

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

4.5.1 The SMC advice for bivalirudin (Angiox), for the treatment of adult patients with acute coronary syndromes (unstable angina/non-ST segment elevation myocardial infarction) planned for urgent or early intervention, will be posted on the SMC website on Monday, 08 December 2008.

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

4.6.1 The SMC advice for rivaroxaban (Xarelto), for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery, will be posted on the SMC website on Monday, 08 December 2008.

Abbreviated Submissions

4.7 aripiprazole for intramuscular use (Abilify)  Bristol-Myers Squibb Pharmaceuticals  Ltd  (No. 522/08)

4.7.1 The SMC advice for aripiprazole (Abilify), for the rapid control of agitation and disturbed behaviours in patients with schizophrenia when oral therapy is not appropriate, will be posted on the SMC website on Monday, 08 December 2008.

4.8 flecainide acetate 200mg capsules (Tambocor XL)  Meda Pharmaceuticals  Ltd  (No. 521/08)

4.8.1 The SMC advice for 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, will be posted on the SMC website on Monday, 08 December 2008.

Non Submission

4.8 cetuximab 5mg/ml solution for  infusion (Erbitux) MerckKGaA (No. 526/08)

4.8.1 SMC initially considered issuing a non-recommendation based on a non-submission 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.  However, on further consideration it has been noted that the new indication is narrower than advice issued for cetuximab (Erbitux) SMC (No.155/05) in October 2006, following an IRP and therefore it is not necessary to issue advice on this occasion.

4.9 Deferred Advice

4.9.1 Nothing to report.

4.10 Amended Advice

4.10.1 Nothing further to report.

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 the SMC meeting and minutes would be available at January SMC. 

Mr Andrew Powrie-Smith advised that a meeting took place with the Long Term Conditions Association (LTCA) in relation to funding or hosting a public involvement officer to support the work of PAPIG.  The LTCA has registered an interest and the matter will be discussed more fully at their Board meeting in January 2009.

6.2 Addition to the SMC Website

Following the recently published lay summary of SMC’s approval process, Mrs Tunstall-James advised that there has been difficulty in finding and accessing the document on the website.  The Chairman acknowledged the problems and advised that work is ongoing to improve the website and make it more user-friendly.

6.3 SMC Membership on PAPIG

The Chairman reminded members that there is still a vacancy for an NHS member on PAPIG, representing SMC. Members should be committed to attending the Group meeting every second month and supporting the development of patient and public involvement.  The Chairman asked members who may be interested in getting involved, to please contact him. 

7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 Quoting Previous SMC Advice in DAD

The Chairman advised that the PAT team has been considering the best way to include details of previous SMC Advice in the DAD and have supplied the SMC Executive with various options for consideration.  The Executive has now agreed that details of previous advice will remain within the DAD to inform NDC and SMC but will be removed post-SMC.  An appendix of the previous advice will however be retained by the Secretariat in the event that there may be a request from the service for this information.

8.2 Annual Review of Membership

The annual review of membership is underway.  Those members whose term of office is due to end shortly will be contacted by the Secretariat.

8.3 NICE – Single Technology Appraisal (STA) Guidance

NICE issued STA guidance No 162, on 26 November, 2008:  Erlotinib (Tarceva) is recommended as an alternative to docetaxel for patients with non-small-cell lung cancer (NSCLC) who have already tried one chemotherapy regimen but it has not worked. Erlotinib should be used only when the manufacturer provides the drug at the same overall treatment cost as docetaxel. This cost includes the cost of giving the drug, treatments for any side-effects and the cost of monitoring patients to check that treatment is working.

If the overall treatment cost is equal, specialists should discuss with patients the potential benefits and risks of erlotinib and docetaxel before deciding which treatment to use.  Erlotinib is not recommended for people with locally advanced or metastatic NSCLC who cannot take docetaxel and have already tried one chemotherapy regimen but it has not worked.  Erlotinib is not recommended for people who have already tried two chemotherapy regimens, including docetaxel, but they haven't worked.  Healthcare professionals should not stop prescribing erlotinib for people who were already taking it when the guidance was issued. These patients should be able to carry on taking erlotinib until they and their specialist decide that it is the right time to stop treatment.

SMC published advice in May 2006: Erlotinib (Tarceva®) is accepted for restricted use within NHS Scotland for the treatment of patients with locally advanced or metastatic non-small cell lung cancer, after failure of at least one prior chemotherapy regimen. When prescribing erlotinib, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effect of the treatment have been demonstrated in patients with epidermal growth factor receptor (EGFR)-negative tumours. Erlotinib is restricted to use in patients who would otherwise be eligible for treatment with docetaxel monotherapy. No economic case has been made for those whose performance status would make them ineligible to receive docetaxel.

There is no material difference between the NICE STA and the SMC recommendation.   It was noted that NICE STAs have no status in Scotland.

8.4 Meeting Papers for SMC 6 January 2009

The Secretariat will issue papers for the January meeting of SMC on Thursday 11 December, 2008.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 aliskiren 150mg and 300mg film-coated tablets (Rasilez) Novartis Pharmaceuticals UK Ltd (No: 462/08)

9.1.1 Declarations of interest were recorded in relation to this product/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 aliskiren (Rasilez), for the treatment of essential hypertension 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, 05 December 2008.

9.2 thalidomide 50mg hard capsule (Thalidomide Pharmion) Celgene Ltd (No. 525/08)

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, revised data/analyses, the manufacturer’s summary of information for patients and comments received from the company.  A member of PAPIG presented a patient interest group submission from Myeloma UK.  Detailed discussion followed and the group agreed that thalidomide (Thalidomide Pharmion), for first line treatment, in combination with melphalan and prednisone, of patients with untreated multiple myeloma, aged 65 or over or ineligible for high dose chemotherapy, 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.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 December 2008.

9.3 Stiripentol 250mg hard  capsules and 250mg powder for oral suspension in sachet  and 500mg hard  capsules and 500mg powder for oral suspension in sachet    (DIACOMIT) BIOCODEX (No. 524/08)

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

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.  Detailed discussion followed and the group agreed that stiripentol (DIACOMIT) for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet’s syndrome) 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.

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 December 2008.

RESUBMISSIONS

9.4 salmeterol xinafoate / fluticasone propionate 50/500mcg combination inhaler (Seretide) GlaxoSmithKline  (No. 450/08)

9.4.1 Declarations of interest were recorded in relation to this product/comparator drugs.

9.4.2 The NDC Vice-Chair provided an overview of the assessment, draft advice, updated expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that salmeterol (Seretide), for the symptomatic treatment of patients with chronic obstructive airways disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% to <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy 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.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 December 2008.

9.5 buprenorphine transdermal patches 5,10 and 20 mcg/hour, 7 day formulation (BuTrans) Napp Pharmaceuticals Ltd  (No. 234/06)

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

9.5.2 The NDC Vice-Chair provided an overview of the assessment, draft advice, expert comments, the manufacturer’s summary of information for patients and comments received from the company.  Detailed discussion followed and the group agreed that buprenorphine transdermal patch (BuTrans), for the treatment of severe opioid responsive pain conditions, which are not adequately responding to non-opioid analgesics, 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.

9.5.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 December 2008.

NON SUBMISSION

9.6 zoledronic acid (Aclasta)  Novartis Pharmaceuticals UK Ltd  (No. 535/08)

9.6.1 In the absence of a submission from the holder of the marketing authorisation, zoledronic acid (Aclasta), for the treatment of osteoporosis in men at increased risk of fracture, including those with a recent low-trauma hip fracture, should not be recommended for use within NHS Scotland.

9.6.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 December 2008.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted.

11. SMC User Group Forum (UGF)

11.1 Minutes of the previous meeting (28.10.08)

The minutes of the meeting of the User Group Forum, held on 28 October 2008, were noted.

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 is now almost complete.  In general, feedback received has been very positive.  The Chairman’s aim is to make SMC process more accessible to all Boards.  In particular, SMC are looking at the possibility of establishing video-conferencing links to SMC meetings for members of Island Health Boards.  This will be taken forward in the New Year.

13. Any Other Business

13.1 Risk Sharing and Orphan drugs

Mr Divers reported on a recent meeting of Board Chief Executives (CEOs) where the issue of risk sharing between Boards was discussed. He confirmed that CEOs are careful not to undermine SMC process by accepting new, high cost, orphan treatments into a risk sharing scheme when SMC has not assessed or not recommended the medicine.  Mr Divers did however highlight the difficulties that Boards encounter because of the differing processes that apply in England and Scotland for considering such treatments.

The Chairman acknowledged the issue and indicated that the orphan drug agenda would be revisited with the Chief Medical Officer and Chief Pharmaceutical Officer at their next scheduled meeting with SMC.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 06 January 2009 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.