You are here:

Minutes of the SMC Meeting - Tuesday 06 January 2009

Minutes of the SMC Meeting held on Tuesday 06 January 2009
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: Dr Ken Paterson (Chairman), Professor James Barbour, Mrs Margo Biggs, Dr Keith Brown, Mr David Carson, Dr David Crookes, Mr Tom Divers, Dr John Gemmill, Dr Barclay Goudie, Dr Jan Jones, Dr Chris Lush, Dr Alan MacDonald, Dr Frances Macdonald, Dr Simon Maxwell, Ms Aileen Muir, Dr Anthony Ormerod, Dr Andrew Power, Mr Andrew Powrie-Smith, Dr Nick Reed, Dr Sandy Simpson, Mr Keith Thompson, Mr Alistair Thorburn, Ms Angela Timoney, Mrs Sheila Tunstall-James, Dr Andrew Walker.

In Attendance: Mrs Corinne Booth, Ms Ailsa Brown, Dr Alastair Catto, Mr Stephen Ferguson, Dr Jacob George, Dr Gail Gilbert, Mrs Anne Lee, Mrs Sandra McNaughton, Ms Rosie Murray, Mrs Joy Nicholson, Ms Susan Paton, Dr Jacqui Sneddon, Mrs Maureen Stark, Mrs Catherine Tait.

Apologies: Mrs Laura Ace, Dr Keith Beard, Mr Colin Brown, Professor John Cairns, Dr Sara Davies, Dr Jonathan Fox, Ms Susan Goldsmith, Ms Sharon Hems, Dr John McElhinney, Dr Grace Lindsay, Ms Veronica Moffat, Professor Dilip Nathwani, Ms Alex Robertson, Dr Sarah Taylor, Professor Tony Wells.
 

1. Welcome and Apologies for Absence

1.1  The Chairman welcomed members to the meeting and apologies for absence were noted.
 
 The following new members of staff were welcomed to their first meeting of SMC:

  • Dr Jacqui Sneddon, recently appointed Project Lead for the Scottish Antimicrobial   Prescribing Group (SAPG), who was observing the meeting.
  • Ms Susan Paton, newly appointed Project Officer for SAPG, who was observing the meeting. 
  • Dr Gail Gilbert, who now job-shares with Ms Sharon Hems as Principal Pharmacist, Horizon Scanning, covering Anne Lee’s post.
  • Mrs Joy Nicholson, pharmacist, who prepares lay briefing notes for SMC. 

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

  • Dr Alastair Catto, University of Edinburgh, shadowing Dr Andrew Walker, and observing the meeting.
  • Mrs Sandra McNaughton, NDC member and Lead Assessor, presenting a submission to   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 02 December 2008 were accepted.


4. Matters Arising

4.1 National Institute for Clinical Excellence (NICE) - Consultation on End of Life Medicines

In November 2008, NICE consulted on supplementary advice which they proposed to give to the Institute’s Appraisal Committees, when they appraise treatments which may extend life, at the end of life. SMC made a response to the Consultation outlining some areas of concern and seeking clarification of some of the proposed criteria. 

Following the Consultation, on 02 January 2009, NICE published the following documents:

  • supplementary advice to the Appraisal Committees
  • consultation responses
  • summary response to consultation

The revised proposals were implemented from 5 January 2009 and apply to all ongoing NICE appraisals. Members were referred to the publication document for full details. 

To summarise, the Chairman advised members that the final advice differs from the original in terms of two additional factors. Where the criteria for end of life medicines are satisfied NICE appraisal committees will consider the quality of life benefits, weighted to provide a Quality Adjusted Life Year (QALY) below £30k. Then, an Incremental Cost Effectiveness Ratio (ICER) will be calculated assuming that patients gain full quality of life. 
 
Members questioned whether implementation of the NICE proposals will impact on the exceptional prescribing process in Scotland in terms of approving treatments which have high ICERs. The Chairman advised that the SMC Executive had discussed the likely implications of the NICE proposals with the Chief Medical Officer (CMO) and agreed that SMC’s current process already allows a degree of pragmatism when considering the economic case where the ICER is high. Data show that SMC has in the past accepted QALYs in excess of £30k where special circumstances apply for individual drugs. It is assumed therefore that exceptional prescribing panels will continue to operate as before, applying clinical judgement to SMC advice.

Full Submissions

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

4.2.1 The SMC advice for aliskiren (Rasilez), for the treatment of essential hypertension, will be posted on the SMC website on Monday, 12 January 2009.

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

4.3.1 The SMC advice for thalidomide (Thalidomide Pharmion), in combination with melphalan and prednisone, for first line treatment, of patients with untreated multiple myeloma, aged 65 or over or ineligible for high dose chemotherapy, will be posted on the SMC website on Monday, 12 January 2009.

4.4 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)

4.4.1 The SMC advice for 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), will be posted on the SMC website on Monday, 12 January 2009.

Resubmissions

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

4.5.1 The SMC advice for salmeterol/fluticasone (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, will be posted on the SMC website on Monday, 12 January 2009.

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

4.6.1 The SMC advice for buprenorphine transdermal patch (BuTrans), for the treatment of severe opioid responsive pain conditions, which are not adequately responding to non-opioid analgesics, will be posted on the SMC website on Monday, 12 January 2009.

Non Submission

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

4.7.1 The SMC advice for zoledronic acid (Aclasta), for the treatment of osteoporosis in men at increased risk of fracture, including those with a recent low-trauma hip fracture, will be posted on the SMC website on Monday, 12 January 2009.

4.8 Deferred Advice

4.8.1 fentanyl, 100, 200, 400, 600 and 800 microgram buccal tablet (Effentora) No. (510/08) Cephalon UK Ltd

SMC reviewed fentanyl buccal tablet (Effentora), in October 2008.  Advice was withheld pending product availability, however, the product will be made available to prescribers on 19 January 2009.  At the licence holder’s request, advice will be  issued to NHSScotland on Friday 9 January 2009 and published on the SMC website on Monday 8 February, 2008.

4.8.2 11.7mg etonogestrel/2.7mg ethinylestradiol vaginal ring (NuvaRing)  No. (502/08) Schering-Plough

SMC reviewed etonogestrel/ethinylestradiol vaginal ring (NuvaRing) in September 2008.  Advice was withheld pending product availability, however the product will be made available to prescribers on 12 January 2009.  Advice will be issued to NHSScotland on Friday 9 January 2009 and published on the SMC website on Monday 8  February, 2008.  The licence holder has advised its intention to resubmit.

4.9 Amended Advice

4.9.1 Nothing to report.


5. Appeals Update

5.1 miconazole 50mg muco-adhesive buccal tablets (Loramyc) No. (517/08) SpePharm UK Ltd
            
In November 2008, SMC did not recommend miconazole buccal tablets (Loramyc) for the treatment of oropharyngeal candidiasis in immunocompromised patients.  The licence holder, SpePharm UK Ltd, has advised its intention to resubmit. 


6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the Previous PAPIG Meeting

The minutes of the PAPIG meeting held on 02 December 2008, were noted.

With regards to item 3.1 of the minutes, Mrs Tunstall-James advised that a date had been agreed to attend a Board meeting of the Long Term Conditions Alliance to discuss the establishment of an SMC Patient and Public Involvement Officer.

PAPIG’s current priority is to finalise arrangements for the training day for patient interest groups.  The Chairman indicated that the Executive would be happy to provide support for the event as required.


7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.


8. Chairman’s Business

8.1 NICE – Single Technology Appraisal (STA) Guidance
 
NICE issued STA Guidance No 163 on 17 December 2008: infliximab (Remicade) for acute exacerbations of ulcerative colitis is recommended as a possible treatment for people with acute, severely active ulcerative colitis only if ciclosporin is considered inappropriate for them, or they are taking part in a research study (clinical trial).

SMC published advice in March 2007 following a non-submission: infliximab (Remicade) is not recommended for use within NHSScotland for the treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies.  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 NHSScotland.

NICE issued STA Guidance No 164 on 17 December: Febuxostat for the management of hyperuricaemia in people with gout within its marketing authorisation is recommended as an option for the management of chronic hyperuricaemia in gout only for people who are intolerant of allopurinol or for whom allopurinol is contraindicated

SMC has not yet produced advice on this medicine. NICE STAs have no status in Scotland.

8.2 Distribution of SMC Meeting Papers

As copying, collating and distributing of meeting papers requires considerable resource, it would be very helpful if members could tender their apologies at the earliest possible time and also advise the Secretariat whether they do, or do not, require meeting papers in their absence.


9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 doripenem (Doribax)  500mg powder for solution  for infusion Janssen-cilag Ltd (No.529/09)

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

9.1.2 The NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, and revised data/analyses. Detailed discussion followed and the group agreed that doripenem (Doribax), should be accepted for restricted use in NHS Scotland, for the treatment of complicated intra-abdominal infections in adults. Doripenem should be restricted to use as a second or third-line treatment of complicated intra-abdominal infections resistant to current conventional treatments.  It should be used only on the advice of local microbiologists or specialists in infectious diseases. 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, 09 January 2009.

9.2 pemetrexed 100mg, 500mg powder for concentrate for solution for infusion (Alimta)   Eli Lilly and Company Limited (No. 531/09)

9.2.1 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.

9.2.2 The NDC 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 groups submission from the Cancer Foundation.   Detailed discussion followed and the group agreed that pemetrexed (Alimta), should not be recommended for use in NHS Scotland, in combination with cisplatin, for the first-line treatment of patients with locally advanced or metastatic non-small cell  lung cancer other than predominantly squamous cell histology.  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, 09 January 2009.

9.3 lapatinib 250mg film coated tablets (Tyverb) GlaxoSmithKline (No. 526/09)

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

9.3.2 The NDC 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 joint patient interest group submission from Breakthrough Breast Cancer, Breast Cancer Campaign and Breast Cancer Care. Detailed discussion followed and the group agreed that lapatinib (Tyverb), should not be recommended for use in NHS Scotland, in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2) and who have progressive disease following prior therapy including anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting.  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, 09 January 2009.

9.4 sugammadex 100mg/ml solution for injection (Bridion) Schering-Plough (No. 527/09)

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, expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that sugammadex (Bridion), should be accepted for restricted use in NHS Scotland, for the immediate reversal of rocuronium-induced neuromuscular blockade in adults only.  Sugammadex is not recommended for the routine reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults, children and adolescents. 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, 09 January 2009.

9.5 extended release epidural morphine, 10mg/ml (10mg, 15mg,and 20mg)  for injection (Depodur) Flynn Pharma Ltd (No. 528/09)

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

9.5.2 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 extended-release epidural morphine (Depodur), should not be recommended for use in NHS Scotland, for the relief of post-operative pain following major orthopaedic, abdominal or pelvic surgery. 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, 09 January 2009.

9.6 etravirine 100mg tablet (Intelence) Tibotec (Janssen-cilag Limited) (No. 530/09)

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

9.6.2 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 etravirine (Intelence), should not be recommended for use in NHS Scotland, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients. 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, 09 January 2009.

9.7 lacosamide 50mg, 100mg, 150mg and 200mg tablets (Vimpat) UCB Pharma Limited  (No.532/09)

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

9.7.2 The NDC Lead Assessor 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 Epilepsy UK.  Detailed discussion followed and the group agreed that lacosamide (Vimpat), should be accepted for use in NHS Scotland, as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. 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, 09 January 2009.

ABBREVIATED SUBMISSIONS

9.8 adalimumab 40mg solution for injection (Humira) Abbott Laboratories (No. 533/09)

9.8.1 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.

9.8.2 The NDC Chair provided an overview of the assessment, draft advice, and an overview  of expert comments.  Detailed discussion followed and the group agreed that adalimumab (Humira), should be accepted for restricted use in NHS Scotland, in combination with methotrexate, for the treatment of active polyarticular juvenile idiopathic arthritis in adolescents aged 13-17 years who have an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).  It should  be restricted to use within specialist rheumatology services (including those working within the network for paediatric rheumatology).  Adalimumab is one of three TNF-antagonists listed in the British National Formulary for Children as drugs that suppress the rheumatic disease process, and one of two of those drugs licensed for active polyarticular juvenile idiopathic arthritis.  The Scottish Medicines Consortium has previously accepted this product for restricted use for this indication in adults.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.8.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 January 2009.

9.9 sublingual fentanyl  100, 200, 300, 400, 600 and 800mcg sublingual tablets (Abstral) ProStrakan (No. 534/09)

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, and draft advice. Detailed discussion followed and the group agreed that fentanyl sublingual tablets (Abstral), should be accepted for restricted use in NHS Scotland, for the management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.  Use of sublingual fentanyl tablets should be restricted to patients who are unsuitable for other short-acting opioids e.g. oral morphine.  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, 09 January 2009.


10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted.


11. SMC User Group Forum (UGF)

11.1 Nothing to report.


12. Feedback from Area Drug and Therapeutic Committees ( ADTCs)

12.1 Nothing to report.


13. Any Other Business

13.1 No other business was raised.


14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 03 February 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.