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Minutes of the SMC Meeting held on Tuesday 05 February 2008

Minutes of the SMC Meeting held on Tuesday 05 February 2008
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Dr Keith Beard, Mrs Margo Biggs, Dr Keith Brown, Dr David Crookes, Mr Tom Divers, Dr Jonathan Fox, Dr Barclay Goudie, Dr Jan Jones, Dr Harpreet Kohli, Dr Chris Lush, Dr John McElhinney, Mr Billy Malcolm, Ms Aileen Muir, Mrs Wendy Nganasurian, Dr Ken Paterson, Dr Andrew Power, Dr Nick Reed, Mr Keith Thompson, Mr Alistair Thorburn,  Ms Angela Timoney, Mrs Sheila Tunstall-James, Mr Mike Wallace

In Attendance: Ms Carmelia Alae-Carew, Ms Nurul Iftida Binti Basri, Ms Ailsa Brown, Ms Elaine Jennifer Bryce, Mr Scott Bryson, Ms Amy Davidson, Ms Susan Downie, Mr Steven Fenocchi, Mr Stephen Ferguson, Mrs Hazel Illingworth, Mrs Anne Lee, Dr Frances McDonald, Mr Alistair Maddock, Ms Rosie Murray, Ms Alex Robertson, Mr Jonathan Seeley, Mrs Maureen Stark, Mr Mark Stephen Thompson, Dr Andrew Walker

Apologies: Mrs Laura Ace, Professor James Barbour, Mr Colin Brown, Professor John Cairns, Mr David Carson, Dr Sara Davies, Dr Grace Lindsay, Dr Graham Lowe, Mr Colin McAllister, Dr Alan MacDonald, Mrs Laura McIver, Mrs Pat Murray, Professor Dilip Nathwani,  Ms Fiona Ramsay, Dr Andrew Riley, Dr Sandy Simpson, 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 Chairman welcomed the following who were observing the meeting:

  • Mrs Margo Biggs recently appointed Public Partner Member.
  • Mr Keith Thompson recently appointed Public Partner Member.
  • Dr Frances McDonald who will be replacing Mr Mike Wallace as ABPI representative.

The Chairman also welcomed:

  • Mr Scott Bryson, member of the New Drugs Committee
  • Dr John McElhinney, General Practitioner, Fife, previous member of NDC and attending his first meeting of SMC.

Thank you and Goodbye

The Chairman thanked Mr Steven Fenocchi for his valuable contributions to the work of SMC. Mr Fenocchi is moving posts within the Scottish Government.

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 08 January 2008 were agreed as an accurate record.

4. Matters Arising From the Previous Minutes

There were no matters arising from the previous minutes.

Full Submissions

4.1 telbivudine (Sebivo) Novartis Pharmaceuticals UK Limited (No: 438/08)

4.1.1 The SMC advice for telbivudine (Sebivo), for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase levels and histological evidence of active inflammation and/or fibrosis, will be posted on the SMC website on Monday, 11 February 2008.

4.2 fondaparinux sodium (Arixtra) STEMI GlaxoSmithKline (No: 439/08)

4.2.1 The SMC advice for fondiparinux sodium (Arixtra), for the treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy, will be posted on the SMC website on Monday, 11 February 2008.

Resubmissions

4.3 glyceryl trinitrate 0.4% ointment (Rectogesic) Prostrakan (No: 200/05)

4.3.1 The SMC advice for glyceryl trinitrate 0.4% ointment (Rectogesic), for relief of pain associated with chronic anal fissure, will be posted on the SMC website on Monday, 11 February 2008.

4.4 pemetrexed (Alimta) Eli Lilly and Company Limited (No: 342/07)

4.4.1 The SMC advice for pemetrexed (Alimta), as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, will be posted on the SMC website on Monday, 11 February 2008.

4.5 levetiracetam (Keppra) adjunctive UCB Pharma Limited (No: 394/07)

4.5.1 The SMC advice for levetiracetam (Keppra), as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in children from 4 years of age with epilepsy, will be posted on the SMC website on Monday, 11 February 2008.

4.6 levetiracetam (Keppra) adjunctive UCB Pharma Limited (No: 395/07)

4.6.1 The SMC advice for levetiracetam (Keppra), as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy, will be posted on the SMC website on Monday, 11 February 2008.

4.7 levetiracetam (Keppra) adjunctive UCB Pharma Limited (No: 396/07)

4.7.1 The SMC advice for levetiracetam (Keppra), as adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with generalised idiopathic epilepsy, will be posted on the SMC website on Monday, 11 February 2008.

4.8 levetiracetam (Keppra) monotherapy UCB Pharma Limited (No: 397/07) 

4.8.1 The SMC advice for levetiracetam (Keppra), as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy, will be posted on the SMC website on Monday, 11 February 2008.

Abbreviated Submissions

4.9 clobetasol propionate 0.05% shampoo (Etrivex) Galderma UK Limited (No: 434/07)

4.9.1 The SMC advice for clobetasol propionate (Etrivex), for the topical treatment of moderate scalp psoriasis in adults, will be posted on the SMC website on Monday, 11 February 2008.

Non Submissions

4.10 colesevelam 625mg film coated tablets (Cholestagel)  Genzyme Therapeutics (No: 451/08)

4.10.1 The SMC advice for colesevelam (Cholestagel), for the treatment of primary hypercholesterolaemia, co-administered with HMG-CoA reductase inhibitor (statin), as adjunctive therapy to diet to provide an additive reduction in LDL-cholesterol levels in patients not adequately controlled with a statin alone; as adjunctive therapy to diet for reduction of elevated total and LDL-cholesterol in patients with isolated primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated, will be posted on the SMC website on Monday, 11 February 2008.

4.11 trabectedin (Yondelis) 0.25mg powder for concentrate for solution for infusion  Pharma Mar, SA  (No: 452/08)

4.11.1 The SMC advice for trabectedin (Yondelis), for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents, will be posted on the SMC website on Monday, 11 February 2008.

Deferred Advice

4.12 valsartan 320mg tablet (Diovan) Novartis Pharmaceuticals UK Ltd (No. 351/07)

valsartan (Diovan), for the treatment of hypertension.  In patients for whom the use of valsartan is appropriate, it allows administration of a 320mg dose as a single tablet at less cost than 2x160 mg capsules.  Angiotensin receptor blockers are an alternative to ACE inhibitors where these are not tolerated.

This product was reviewed by SMC in February 2007 and the advice was withheld pending confirmation of licence and availability.  The product is now available and the advice will be sent to NHS Boards and ADTCs on Friday, 08 February 2008 and posted on the SMC website on Monday, 11 February 2008.

4.13 losartan 100mg/hydrochlorothiazide 12.5mg tablet (Cozaar-Comp 100/12.5) Merck Sharp & Dohme Ltd (No. 295/06)

losartan (Cozaar-Comp), for the treatment of hypertension in patients whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy.

This product was reviewed by SMC in July 2006 and the advice was withheld pending confirmation of the product availability.  The product is now available and the advice will be sent to NHS Boards and ADTCs on Friday, 08 February 2008 and posted on the SMC website on Monday, 11 February 2008.

Amended Advice

4.14 beclometasone 100mcg formoterol 6mcg metered dose inhaler (Fostair) Trinity-Chiesi Pharmaceuticals Ltd No. (373/07)

Beclometasone (Fostair) for the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short acting beta2-agonist; or patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists. It should be used in patients for whom beclometasone and formoterol are appropriate choices of corticosteroid and long-acting beta-agonist, respectively, and for whom a metered dose inhaler is an appropriate delivery device. It has costs similar to other combination products containing a corticosteroid and long-acting beta2-agonist to which it was clinically non-inferior. The 100mcg dose of beclometasone in Fostair® is not bioequivalent to a 100mcg dose of beclometasone in several other inhaler formulations. The Fostair® summary of product characteristics contains information on transferring from these inhalers to Fostair®.

This product was reviewed by SMC in April 2007; amendments have been made to the advice box.

The amended advice has been posted on the SMC website and will be issued to NHS Boards and ADTCs on Friday, 08 February 2008.

5. Appeals Update

5.1 rufinamide 100mg, 200mg and 400mg tablets (Inovelon) Eisai Limited No. (416/07)

5.1.1 Following a non recommendation from SMC in October 2007, Eisai Limited have indicated their intention to make a submission for rufinamide (Inovelon), as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients four years and older.

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

5.2.1 Following a non recommendation from SMC in December 2006, Grunenthal UK have indicated their intention to make a submission for lidocaine 5% plaster (Versatis), for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia)

6. Patient and Public Involvement Group (PAPIG)

6.1 The Chairman of PAPIG advised that the minutes of their meeting held today, would be available at the next meeting of SMC.

She also advised that to date PAPIG had received 120 patient interest group submissions.

7. New Drugs Committee Chairman’s Report

7.1 NDC Meetings

The Chairman of NDC advised that he had chaired his last meeting of NDC on Tuesday, 29 January 2008 in preparation for taking up the Chair of SMC in April 2008.  Dr Jan Jones will Chair the next meeting of NDC, in February 2008. 

7.2 European Workshop, Stockholm, 14/15 January

The Chairman of NDC advised that he had recently represented SMC and Scotland at a symposium in Sweden on the introduction of new medicines.  Many other major European countries also took part.  It became evident at the symposium that the work of SMC is widely recognised and several countries requested an opportunity to observe the work of the consortium more closely.

8. Chairman’s Business

8.1 Director - ABPI Scotland

The Chairman advised that ABPI has announced the appointment of Mr Andrew Powrie-Smith as Director, ABPI Scotland. Andrew is currently Head of the British Lung Foundation in Scotland and Northern Ireland.  He will replace Jim Eadie as ABPI representative on SMC and it is likely his appointment will commence in April 2008.

8.2 NICE

pemetrexed 500mg infusion (Alimta), Eli Lilly, No.  (192/05)

SMC issued advice for pemetrexed 500mg infusion (Alimta), in combination with cisplatin in August 2005 accepting for restricted use for the treatment of chemotherapy-naïve patients with stage III/IV unresectable malignant pleural mesothelioma. Pemetrexed in combination with cisplatin prolonged survival compared with cisplatin alone in patients with unresectable malignant pleural mesothelioma. Pemetrexed is the first licensed agent for the treatment of malignant pleural mesothelioma.  

The Chairman advised that following an MTA the National Institute for Health and Clinical Excellence (NICE) issued guidance in January 2008 to the NHS in England and Wales recommending as a possible treatment for malignant pleural mesothelioma in people with advanced disease; whose cancer is not suitable for surgical resection (removal) and; who have a World Health Organization (WHO) performance status of 0 (able to carry out all normal activity without restriction) or 1 (restricted in strenuous activity but able to move around and carry out light work).   Healthcare professionals should not stop prescribing pemetrexed for people who were already taking it when the guidance was issued. These patients should be able to carry on taking pemetrexed until they and their specialist decide that it is the right time to stop treatment.

8.3 Media

The Chairman advised the members that a feature had appeared in the Scotsman newspaper regarding SMC on Friday, 25 January 2008.  Copies of the article were tabled at the meeting.

9. NDC ASSESSMENT REPORTS

 DEFERRED SUBMISSION

9.1 nilotinib 200mg capsules (Tasigna) Novartis Pharmaceuticals UK Limited (No: 440/08)

9.1.1 Declarations of interest were 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, revised data/analyses and comments received from the company, detailed discussion followed and the group concluded their advice for nilotinib (Tasigna), for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib.

9.1.3 The SMC advice will be withheld pending confirmation of licence and product availability.

FULL SUBMISSIONS

9.2 diclofenac, 75mg/2ml of solution for intravenous injection (Dyloject) Javelin Pharmaceuticals UK Ltd (No.446/08)

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

9.2.2 The NDC lead assessor provided an overview of the assessment, draft advice and expert comments.  Detailed discussion followed and the group agreed that diclofenac (Dyloject), for the prevention of post-operative pain by intravenous injection, in supervised healthcare settings 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.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 February 2008.

9.3 zoledronic acid 5mg solution for infusion (Aclasta) Novartis Pharmaceuticals UK Limited No. 447/08)

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

9.3.2 The NDC Vice Chair 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 the National Osteoporosis Society. Detailed discussion followed and the group agreed that zoledronic acid (Aclasta), for the treatment of osteoporosis in post-menopausal women at increased risk of fractures, 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 for the advice.

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 February 2008.

9.4 infliximab 100mg powder for concentrate for solution for infusion (Remicade) Schering Plough (No. 448/08)

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

9.4.2 The NDC Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that infliximab (Remicade), for the treatment of severe, active Crohn’s disease, in paediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies, 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 for the advice.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 February 2008.

9.5 daptomycin 350mg and 500mg vials of powder for solution for infusion (Cubicin) Novartis Pharmaceuticals UK Limited (No. 449/08)

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

9.5.2 The NDC Vice-Chair provided an overview of the assessment, draft advice and expert comments.  Detailed discussion followed and the group agreed that daptomycin (Cubicin), for the treatment of Staphylococcus aureus bacteraemia (SAB) when associated with right-sided infective endocarditis (RIE) or with complicated skin and soft-tissue infections (cSSTI) 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 for the advice.

9.5.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 February 2008.

9.6 salmeterol/fluticasone 50/500 micrograms inhaler (Seretide 500 Accuhaler) GlaxoSmithKline (No. 450/08)

9.6.1 Declarations of interest were 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 the British Lung Foundation. Detailed discussion followed and the group agreed that salmeterol/fluticasone (Seretide 500 Accuhaler), 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 within NHS Scotland.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution for the advice.

9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 February 2008.

ABBREVIATED SUBMISSIONS

9.7 follitropin alpha 150 IU/lutropin alpha75 IU for solution for injection (Pergoveris) Merck Serono UK (No. 444/08)

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

9.7.2 The NDC Chairman provided an overview of the assessment, draft summary of advice and comments received from the company. Discussion followed and the group agreed that follitropin alpha 150 IU/lutropin alpha75 IU for solution for injection (Pergoveris), for stimulation of follicular development in women with severe luteinising hormone (LH) and follicle-stimulating hormone (FSH) deficiency, 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 for the advice.

9.7.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 February 2008.

9.8 mesalazine 1200mg gastro-resistant, prolonged release tablet (Mezavant XL) Shire Pharmaceuticals Limited (No. 445/08)

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

9.8.2 The NDC Chairman provided an overview of the assessment, draft summary of advice and comments received from the company. Discussion followed and the group agreed that mesalazine (Mezavant XL), for the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis, and for maintenance of remission, 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 for the advice.

9.8.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 February 2008.

NON SUBMISSIONS

9.9 bevacizumab (Avastin) Roche No. (459/08)

9.9.1 In the absence of a submission from the holder of the marketing authorisation, bevacizumab (Avastin), in combination with interferon alfa-2a for the first line treatment of patients with advanced and/or metastatic renal cell cancer, should not be recommended for use within NHS Scotland.

9.9.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 February 2008.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted.

11. SMC User Group Forum

The Chairman of the User Group Forum advised that the group had met on Tuesday 29th January 2008 and the minutes from that meeting would be available at the next meeting of SMC.

He also advised that the group had discussed the abbreviated submission process and risk sharing, and explained that each of these items is making progress slowly.  The group had concerns regarding the acceptance rates of submissions, which appeared to be reducing. 

12. ADTC Feedback

12.1 Non Recommendations

A member of SMC advised that following a meeting of NHS Lanarkshire ADTC, it was agreed that it would be useful to seek further information from SMC about non-recommendations for medicines due to non-submission.  Some members of the committee believed that this may put more pressure on boards to approve such medicines on an exceptional case basis or indeed lead to ‘postcode’ prescribing of non-recommended medicines. 

Discussion followed and the Chairman explained that ‘not recommended’ advice has the same status whether or not a submission had been made to SMC. It would, therefore, be up to each individual ADTC to decide if a drug should be prescribed on an exceptional case basis.

12.2 Scotland on Sunday Article - Scots Denied Best NHS Drugs

A member of SMC referred to the Scotland on Sunday Article, ‘Scots Denied Best NHS Drugs’, and asked if the points raised in the article regarding SMC had been addressed. The Chairman advised that the article confused ‘postcode’ prescribing with formulary choice in situations where other equivalent medicines were available. In addition, the paper had already published a retraction of some of the ‘evidence’.

13. Any Other Business

13.1 No other business was noted.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 04 March 2008 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.