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Minutes of the SMC Meeting held on Tuesday 5 December 2006

NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Ms Laura Ace , Professor James Barbour, Mrs Marion Bennie, Mrs Barbara Black, Professor John Cairns, Mr Dave Carson, Mr Tom Divers,
Dr Barclay Goudie, Dr Jan Jones, Mr Billy Malcolm, Ms Angela Munday, Mrs Pat Murray, Ms Wendy Nganasurian, Dr Ken Paterson, Dr Andrew Power, Ms Fiona Ramsay, Dr Nick Reed,
Dr Philip Rutledge, Ms Angela Timoney, Mr Mike Wallace, Dr John Webster

In Attendance: Dr Jennifer  Armstrong, Dr Elizabeth Bream, Ms Ailsa Brown, Mrs Hazel Illingworth, Mrs Anne Lee, Miss Rosie Murray, Mr Mark Parsons, Mrs Maureen Stark, Dr Andrew Walker

Apologies: Dr Keith Beard, Ms Rosaleen Beattie, Dr Keith Brown, Mr Nick Brown, Dr David Crookes, Dr Sara Davies, Dr Peter Donnan, Mr Jim Eadie, Mr Steven Fenocchi, Mr Stephen Ferguson, Mr John Glennie, Dr John Haughney, Dr Harpreet Kohli, Dr Grace Lindsay, Dr Graham Lowe, Dr Chris Lush, Mr Colin McAllister, Mrs Laura McIver, Dr Andrew Riley, Dr Sandy Simpson,
Dr Sarah Taylor, Ms Helen Tyrrell

1 Welcome and Apologies for Absence

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

The Chairman also welcomed Dr Elizabeth Bream, Department of Public Health, Lothian, and Mr Mark Parsons, NDC Member, Principal Clinical Pharmacist, Surgery and Oncology, Ninewells Hospital and Medical School, who were observing the meeting.

The Chairman congratulated Angela Timoney on her new appointment as Director of Pharmacy for Tayside.

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. He also reiterated to the members the need for confidentiality.

3 Minutes of the Previous Meeting

3.1 The minutes of the SMC meeting held on 07 November 2006 were agreed as an accurate record.

4 Matters Arising From the Previous Minutes

4.1 There were no matters arising from the previous minutes.

Full Submissions

4.2 adalimumab (Humira)  Abbott Laboratories Ltd  (No: 300/06)

4.2.1 The SMC advice for adalimumab (Humira), for the treatment of adults with severe active ankylosing spondylitis who have an inadequate response to conventional therapy, will be posted on the SMC website on Monday, 11 December 2006.

4.3 mitotane (Lysodren)  Laboratoire HRA Pharma  (No: 328/06)

4.3.1 The SMC advice for mitotane (Lysodren) for the symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma, will be posted on the SMC website on Monday, 11 December 2006.

4.4 natalizumab (Tysabri)  Biogen Idec Ltd  (No: 32906)

4.4.1 The SMC advice for natalizumab (Tysabri) as a single disease modifying therapy in highly active relapsing remitting multiple Sclerosis (RRMS) for the following patient groups; patients with high disease activity despite treatment with beta-interferon and in patients with rapidly evolving severe RRMS, will be posted on the SMC website on Monday, 11 December 2006.

4.5 rituximab (MabThera) Roche  (No: 330/06)

4.5.1 The SMC advice for rituximab (MabThera) as maintenance therapy for patients with relapsed/refractory follicular lymphoma responding to induction therapy with chemotherapy with or without rituximab, will be posted on the SMC website on Monday, 11 December 2006.

Deferred Re-Submission

4.6 temozolomide (Temodal)  Schering-Plough UK Ltd  (No:  244/06)

4.6.1 The SMC advice for temozolomide (Temodal), for the treatment of newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and subsequently as monotherapy treatment, will be posted on the SMC website on Monday, 11 December 2006.

Re-Submissions

4.7 gemcitabine (Gemzar)  Eli Lilly & Company Ltd  (No: 154/05) 

4.7.1 The SMC advice for gemcitabine (Gemzar), for the treatment of patients with metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy, will be posted on the SMC website on Monday, 11 December 2006.

4.8 rasagiline (Asilect) Lundbeck Ltd and Teva Pharamceuticals Ltd (No 243/06)

4.8.1 The SMC advice for rasagaline (Asilect), for the treatment of idiopathic Parkinson’s disease as monotherapy (without levodopa), will be posted on the SMC website on Monday, 11 December 2006.

4.9 rasagiline (Asilect) Lundbeck Ltd and Teva Pharamceuticals Ltd (No 255/06)

4.9.1 The SMC advice for rasagaline (Asilect), for the treatment of idiopathic Parkinson’s disease as adjunct therapy (with levodopa) in patients with end of dose fluctuations, will be posted on the SMC website on Monday, 11 December 2006.

Abbreviated Submissions

4.10 triptorelin (Decapeptyl SR 11.25mg)  Ipsen Ltd  (No: 331/06)

4.10.1 The SMC advice for triptorelin (Decapeptyl), for the treatment of precocious puberty (onset before 8 years in girls and 9 years in boys), will be posted on the SMC website on Monday, 11 December 2006.

4.11 methotrexate for injection (Metoject)  Medac UK  (No: 332/06) 

4.11.1 The SMC advice for methotrexate for injection (Metoject), for the treatment of severe active rheumatoid arthritis in adult patients where treatment with a parenteral disease modifying drug (DMARD) is indicated, will be posted on the SMC website on Monday, 11 December 2006.

Non-Submissions

4.12 lanreotide (Samatuline LA) Ipsen Ltd (No. 231/06)

4.12.1 The SMC advice for lanreotide (Samatuline LA), for the treatment of thyrotrophic adenomas when the circulating level of thyroid stimulating hormone remains inappropriately high after surgery and/or radiotherapy, will be posted on the SMC website on Monday, 11 December 2006.

4.13 pregabalin (Lyrica) Pfizer Ltd (No. 339/06)

4.13.1 The SMC advice for pregabalin (Lyrica), for generalised anxiety disorder in adults, will be posted on the SMC website on Monday, 11 December 2006.

5 Appeals Update

5.1 ibritumomab tiuxetan (Zevalin) Schering Health Care Ltd (No. 171/05)

The Chairman advised that Schering Healthcare had indicated their intention to make a resubmission for their product Zevalin, for the treatment of adult patients with rituximab-relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma.

5.2 fondaparinux sodium (Arixtra) GlaxoSmithKline (No 287/06)

The Chairman advised that GlaxoSmithKline had indicated their intention to make a re-submission for their product Arixtra, for the prevention of venous thromboembolic events (VTE) in patients undergoing high risk abdominal surgery.

6 PAPIG

6.1 Minutes from the previous meeting were circulated with the papers.

7 New Drugs Committee: Chairman’s report

7.1 Nothing to report.

8 Chairman’s Business

8.1 dorzolomide hydrochloride timolol maleate (Cosopt) Abbreviated (No.  293/06)

The Chairman advised that dorzolomide hydrochloride timolol maleate (Cosopt) will launch on 22, November 2006.  This product was reviewed by SMC in July 2006 and was accepted for restricted use in NHS Scotland for the treatment of elevated intra-ocular pressure in patients with open-angle glaucoma and pseudo-exfoliative glaucoma when topical beta-blocker monotherapy is not sufficient.  This preparation is substantially more expensive than the equivalent multi-dose eye drop preparation and should be restricted to use in patients for whom a combination of these two agents is appropriate and who have proven sensitivity to the preservative benzalkonium chloride. 

The advice will be sent to NHS Boards and ADTCs on Friday, 8 December and published on the website on Monday, 11 December 2006.

8.2 syner-KINASE® (urokinase) Syner-Med (PP)

The Chairman advised that Syner-Med (PP) Ltd will launch syner-KINASE® (urokinase) on Friday, 8th December 2006.  This product was originally licensed for use before the inception of SMC and was widely used in hospitals.  In 2000 the license holder, Serono Ltd, withdrew the product, not for clinical/safety issues but for commercial reasons. It is understood that hospitals have continued to import unlicensed urokinase since 2000.  Syner-Medica Ltd a sister company of Syner-Med Pharmaceutical Products Ltd has recently received a Marketing Authorisation Licence for urokinase (syner-KINASE®) which is indicated for the lysis of blood clots in the following conditions:

a) thrombosed intravascular catheters and cannula that are blocked by fibrin clots.

b) thromboembolic occlusive vascular disease such as deep vein thrombosis, pulmonary embolism, and peripheral vascular occlusion.

SMC has advised Syner-Med (PP) Ltd, who are appointed as the sole United Kingdom Distributors for Syner-KINASE® that as the original licence predates the inception of SMC it is outwith our remit and a submission is not required. Syner-Med (PP) Ltd is actively marketing urokinase (Syner-KINASE®).  Their product provides a licensed alternative to unlicensed imported products and its use should be considered a local formulary decision.

A statement will be issued to NHS Boards on Friday, 8 December advising them of this.

8.3 Freedom of Information (FoI) (Scotland) Act 2002

The Chairman advised that SMC has received a request from Ipsen Ltd for full details of the abbreviated submissions made by Pfizer Ltd for somatropin (Genotropin) and by NovoNordisk Ltd for somatropin (Norditropin SimpleXx).  The request is being processed and a response will be made by 21 December 2006.  Health Boards have been advised accordingly, via their FoI contacts.

8.4 APBI Event -17 November

The Chairman advised that the event had been very successful.  The morning consisted of presentations on the SMC Evaluation Programme, Horizon Scanning and on how to make a good submission. Workshops relating to these topics took place in the afternoon and had been very well received. 

8.5 Meeting with SIGN

The Chairman advised that the meeting had been most helpful. Issues of when advice may differ between SIGN and SMC were discussed. It was agreed that a joint letter from SIGN and SMC would be issued to the Service detailing the role and remit of each.

8.6 SMC Budget

A member of SMC asked for re-assurance that SMC would not encounter any difficulties when setting the budget for 2007/2008.  The Chairman advised that SMC would be part of the NHS/QIS budgeting process for the next year, and a meeting was being held on Tuesday, 12 December. An update will be given at a future meeting.

9 NDC ASSESSMENT REPORTS

DEFERRED SUBMISISON

9.1 clofarabine (Evoltra)  Bioenvision  (No: 327/06)

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

9.1.2 The SMC Vice Chairman provided an overview of the draft advice. Detailed discussion followed and the group agreed that clofarabine (Evoltra), for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients (= 21 years) who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response, should be accepted for restricted use within 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 ADTCs and NHS Boards on Friday, 8 December 2006.

FULL SUBMISSIONS

9.2 lidocaine 5% plaster (Versatis) Grunenthal GmbH (No 334/06) 

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

9.2.2 The NDC Vice Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group concluded their advice for lidocaine 5% plaster (Versatis), for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia). The SMC advice will be withheld pending confirmation of launch.

9.3 ertapenem (Invanz) diabetic foot Merck Sharp & Dohme (No 335/06) 

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

9.3.2 The NDC Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that ertapenem (Invanz), for the treatment of diabetic foot infections of the skin and soft tissue when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required, should be accepted for restricted use within 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 ADTCs and NHS Boards on Friday, 8 December 2006.

9.4 varenicline 1mg tablets (Champix) Pfizer (No 336/06)  

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

9.4.2 The SMC Vice Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that varenicline (Champix), for smoking cessation in adults, should be accepted for use within 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 ADTCs and NHS Boards on Friday, 8 December 2006.

9.5 busulfan IV (Busilvex) Pierre Fabre Ltd (No 337/06)

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

9.5.2 The NDC Vice Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that busulfan IV (Busilvex), as part of a combination regimen for conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in paediatric patients and, in adult patients, when the combination is considered the best available option, should be accepted for use within 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 ADTCs and NHS Boards on Friday, 8 December 2006.

RE-SUBMISSIONS

9.6 omalizumab (Xolair) Novartis Pharmaceuticals UK Ltd (No 259/06)

9.6.1 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.

9.6.2 The NDC Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company. A revised copy of the draft advice was tabled for review. A member of PAPIG presented Patient Interest Group Submissions from Asthma UK Scotland and from British Lung Foundation Scotland. Detailed discussion followed and the group agreed that omalizumab (Xolair), as add-on therapy to improve asthma control in adult and adolescent patients (12 years of age and above) with severe persistent allergic asthma, should not be recommended for use within 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 ADTCs and NHS Boards on Friday, 8 December 2006

ABBREVIATED SUBMISSIONS

9.6 daptomycin (Cubicin) 500mg Novartis Pharmaceuticals UK Ltd (No 338/06)

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

9.6.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that daptomycin 500mg (Cubicin), for the treatment of complicated skin and soft-tissue infections in adults, should be accepted for restricted use within 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 ADTCs and NHS Boards on Friday, 8 December 2006


10 Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

11 ADTC Feedback

11.1 A member of SMC advised that some Health Boards had set up a team of experts to look at the budget impact of some of the drugs reviewed by SMC. The information gathered will be forwarded to SMC at a later date.

12 Any Other Business

12.1 Detailed Advice Documents (DADs)

The Chairman was asked if it would be possible for the DADs to be produced in a format that patients and the wider general public would be able to understand.

The Chairman advised that this would be discussed further with the NHS/QIS Communications team and an update would be given at a future meeting.

13 Date of the Next Meeting

13.1 The date of the next meeting was confirmed as Tuesday, 9 January 2007 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.