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Minutes of SMC Meeting - Tuesday 1 April 2008

Minutes of the SMC Meeting held on Tuesday 01 April 2008
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Dr Ken Paterson (Chairman), Professor James Barbour, Dr Keith Beard, Professor John Cairns, Mr David Carson, Mr Tom Divers, Dr Jonathan Fox, Ms Susan Goldsmith, Dr Barclay Goudie, Dr Jan Jones, Dr Harpreet Kohli, Dr Graham Lowe, Dr Alan MacDonald, Dr John McElhinney, Ms Aileen Muir, Mrs Pat Murray, Dr Andrew Power, Ms Fiona Ramsay, Dr Nick Reed, Dr Sandy Simpson, Mr Keith Thompson, Ms Angela Timoney, Mrs Sheila Tunstall-James, Professor Tony Wells

In Attendance: Ms Ailsa Brown, Dr Sara Davies, Ms Susan Downie, Mr Stephen Ferguson, Mrs Hazel Illingworth, Mrs Anne Lee, Ms Rosie Murray, Ms Corinne O’Dowd, Mrs Maureen Stark

Apologies: Mrs Laura Ace, Mrs Margo Biggs, Mr Colin Brown, Dr Keith Brown, Dr David Crookes, Dr Grace Lindsay, Dr Chris Lush, Mr Colin McAllister, Mrs Laura McIver, Mr Billy Malcolm, Professor Dilip Nathwani, Dr Andrew Riley, Ms Alex Robertson, Dr Sarah Taylor, Mr Alistair Thorburn, Dr Andrew Walker

1.Welcome and Apologies for Absence

1.1 This was the first meeting for the new Chairman and he advised that it was an honour to be placed in the position of Chairman of SMC. 

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

The Chairman welcomed:

  • Ms Susan Goldsmith, Director of Finance, NHS Lanarkshire, who was attending her first meeting as a member.
  • Miss Corinne O’Dowd, economic assessor, who was deputising for Dr Andrew Walker.

Thank You and Goodbye

The Chairman thanked Dr Graham Lowe and Mrs Fiona Ramsay, for their involvement and input to SMC. Dr Lowe and Mrs Ramsay were attending their last meeting of SMC.

The Chairman advised that new members will be joining SMC over the next few months.

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 March 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 paliperidone prolonged-release tablets (INVEGA) Janssen-Cilag (No. 453/08)

4.1.1 The SMC advice for paliperidone (INVEGA) for the treatment of schizophrenia, will be posted on the SMC website on Monday, 07 April 2008.

4.1.2 The Chairman advised that amendments had been made to the Detailed Advice Document in the section entitled “Additional Information: Previous SMC Advice”.  The amended Advice will be reissued to ADTCs and NHS Boards on Friday, 04 April 2008 and published on the SMC website on Monday, 07 April 2008.

4.2 nelarabine (Atriance) GlaxoSmithKline UK (No. 454/08)

4.2.1 The SMC advice for nelarabine (Atriance), for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to, or has relapsed following treatment, with at least two chemotherapy regimens, will be posted on the SMC website on Monday 07 April 2008.

4.3 methoxy polyethylene glycol-epoetin beta (Mircera) Roche (No. 455/08)

4.3.1 The SMC advice for methoxy polyethylene glycol-epoetin beta (Mircera), for the treatment of anaemia associated with chronic kidney disease, will be posted on the SMC website on Monday, 07 April 2008.

4.4 maraviroc (Celsentri) Pfizer Ltd (No. 458/08)

4.4.1 The SMC advice for maraviroc (Celsentri), in combination with other antiretroviral medicinal products, for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable, will be posted on the SMC website on Monday, 07 April 2008.

Abbreviated Submissions

4.5 efavirenz, emtricitabine, tenofovir disoproxil fumarate (Atripla) Bristol Myers Squibb /Gilead Sciences/Merck Sharp & Dohme Ltd  (No. 442/08)

4.5.1 The SMC advice for efavirenz, emtricitabine, tenofovir disoproxil fumarate (Atripla), for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months, will be posted on the SMC website on Monday, 07 April 2008.

4.6 insulin glargine (Lantus SoloStar) Sanofi-aventis (No. 456/08)

4.6.1 The SMC advice for insulin glargine (Lantus SoloStar), for the treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required, will be posted on the SMC website on Monday, 07 April 2008.

4.7 insulin glulisine (Apidra SoloStar) Sanofi-aventis (No. 457/08)

4.7.1 The SMC advice for insulin glulisine (Apidra SoloStar), for the treatment of adult patients with diabetes mellitus, in whom treatment with this insulin analogue is appropriate and in whom the use of a pre-filled pen offers advantages over a pen and cartridge device, will be posted on the SMC website on Monday, 07 April 2008.

NON SUBMISSIONS

4.8 retapamulin (Altargo) GlaxoSmithKline (No. 472/08)

4.8.1 The SMC advice for retapamulin (Altargo), for the short treatment of the following superficial skin infections; impetigo and infected small lacerations, abrasions, or sutured wounds, will be posted on the SMC website on Monday, 07 April 2008.

AMENDED ADVICE

4.9 salmeterol fluticasone inhaler (Seretide 500 Accuhaler) GlaxoSmithKline (No. 450/08)

4.9.1 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.

4.9.2 The Chairman advised that this product was reviewed by SMC in February 2008; however, minor amendments have been made to the section entitled ‘Cost of relevant comparators’.  The advice will be reissued to NHS Boards and ADTCs on Friday, 4 April. The amended advice has been posted on the SMC website.

4.10 vildagliptin 50mg tablets (Galvus) Novartis No. (435/07)

4.10.1 For the treatment of type 2 diabetes mellitus as dual oral therapy in combination with metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin.

4.10.2 The Chairman advised that this product was reviewed by SMC in December 2007; however, due to comparator comments amendments will be made to the Detailed Advice Document.  The advice will be reissued to NHS Boards and ADTCs on Friday, 4 April 2008 and published on the SMC website on Monday 07 April 2008.

5. Appeals Update

5.1 maraviroc (Celsentri)  Pfizer Ltd  (No. 458/08)                                                                 

The Chairman advised that Pfizer Ltd has advised of their intention to make a resubmission for maraviroc (Celsentri), in combination with other antiretroviral medicinal products, for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable.

6. Patient and Public Involvement Group (PAPIG)

6.1 The Chairman of PAPIG advised that the group had met earlier in the day and the minutes of that meeting would be available at the next meeting of SMC.

The Chairman of SMC thanked Sheila Tunstall-James for taking on the role of Chair of PAPIG.

7. New Drugs Committee Chairman’s Report

7.1 Nothing to report.


8. Chairman’s Business

8.1 ScotMARAP

The Chairman advised that ScotMARAP was launched on Monday 17 March.  SMC has been asked to host a clinical forum to take forward the work of ensuring the implementation of the new antibiotic resistance action plan. Its aim will be to improve the quality of prescribing of antibiotics, and other classes of drugs that fight harmful infections, across all healthcare settings in Scotland. This will be achieved through analysing antibiotic use and resistance data, improved systems and education. This work will require strong partnership working between SMC, NHS Boards and other stakeholders. In tasking SMC with this work the Scottish Government is recognising the strong and effective alliances that SMC has established over the years with health boards.

8.2 Radio Five Live – The Five Live Report

The Chairman advised that he had taken part in a radio programme with Mike Tomlinson on the availability of new drugs. 

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 lenalidomide (Revlimid) Celgene Europe Ltd (No. 441/08) 
  
9.1.1 The Chairman advised that after the review of lenalidomide (Revlimid) at the March 2008 meeting of SMC, an error had been highlighted; the secretariat had received two patient interest group submissions, one from the Rarer Cancers Forum and one from Myeloma UK; however the patient interest group submission from Myeloma UK had been inadvertently omitted from the paperwork presented to SMC in March.  In view of this, the SMC Executive agreed that lenalidomide (Revlimid) should be taken back to SMC so that the submission could be reconsidered to include the patient interest group submission from Myeloma UK.

9.1.2 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.

The NDC Co Vice Chair provided an overview of the assessment, draft advice, expert comments and comments received from the company.  A member of PAPIG presented patient interest group submissions from the Rarer Cancers Forum and Myeloma UK. Detailed discussion followed and the group agreed that lenalidomide (Revlimid), in combination with dexamethasone for the treatment of multiple myeloma in patients who have received at least one prior 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 of the advice.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 April 2008.


9.2 raltegravir 400mg film-coated tablet (Isentress) Merck Sharp & Dohme (No: 461/08) 

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

9.2.2 The NDC Chairman 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 HIV Scotland. Detailed discussion followed and the group agreed that raltegravir (Isentress), in combination with other antiretroviral medicinal products agents for the treatment of Human Immunodeficiency Virus (HIV-1) infection in treatment experienced adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy, 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, 04 April 2008.

9.3 ferric carboxymaltose 100mg/2ml and 500mg/10ml solution for injection/infusion (Ferinject) Syner-Med (PP) Ltd (No: 463/08)

9.3.1 There were no declarations of interest recorded in relation to this product/comparator drugs.
9.3.2 The NDC co-Vice-Chair provided an overview of the assessment, draft advice, expert comments and comments received from the company. Updated clinical expert responses dated 31 March 2008 were tabled for review. A member of PAPIG presented a patient interest group submission from the National Kidney Federation. Detailed discussion followed and the group concluded their advice for ferric carboxymaltose (Ferinject), for the treatment of Iron deficiency when oral preparations are ineffective or cannot be used.

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

RESUBMISSIONS

9.4 imiquimod 5% cream (Aldara) Meda Pharmaceuticals Ltd (No: 385/07)

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

9.4.2 The NDC co-Vice-Chair provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that imiquimod (Aldara), for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate, 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.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 April 2008.

ABBREVIATED SUBMISSIONS

9.5 buserelin 9.45mg implant for subcutaneous use (Suprefact Depot) Sanofi-aventis  (No: 460/08) 

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

9.5.2 The NDC Chairman provided an overview of the assessment and draft summary of advice. Discussion followed and the group concluded their advice for buserelin (Suprefact Depot), for the treatment of hormone dependent prostatic carcinoma.

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

10. NON SUBMISSIONS

10.1 escitalopram (Cipralex) Lundbeck Limited (No. 475/08)

10.1.1In the absence of a submission from the holder of the marketing authorisation, escitalopram (Cipralex), for the treatment of social anxiety disorder, should not be recommended for use within NHS Scotland.

10.1.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 April 2008.

10.2 aliskerin (Rasilez) Novartis Pharmaceuticals UK Ltd (No. 462/08)

10.2.1 In the absence of a submission from the holder of the marketing authorisation, aliskiren (Rasilez), for the treatment of essential hypertension, should not be recommended for use within NHS Scotland.

10.2.2 The SMC advice will be issued to NHS Boards and ADTcs on Friday 04 April 2008.

11. Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled and noted.

12. ADTC Feedback

12.1 Public Petitions Committee Inquiry Into Availability of Cancer Treatment Drugs on the NHS

The Chairman advised that SMC were invited to contribute to the Public Petitions Committee’s evidence and information gathering exercise, and to give oral evidence before the Committee on 29 April 2008.

12.2 SMC Process

A member of SMC asked if there were processes in place for SMC to receive feedback on SMC decisions from ADTCs.  The Chairman advised that any issues/feedback should be brought to the SMC meetings.

13. Any Other Business

No other business was noted.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 06 May 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.