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Minutes of the SMC Meeting - June 2010

Minutes of the SMC Meeting held on Tuesday 01 June 2010
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: Professor Ken Paterson (Chairman), Mrs Margo Biggs, Dr Jennifer Burns, Professor Scott Bryson, Mr Robert Calderwood, Mr Dave Carson, Dr David Crookes, Dr Sara Davies, Dr Jonathan Fox, Dr Barclay Goudie, Dr Jan Jones, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Mrs Sandra McNaughton, Dr Paul McNamee, Dr Anthony Ormerod, Ms Veronica Moffat, Ms Aileen Muir, Dr Mercia Page, Dr Robert Peel, Dr Andrew Power, Mr Andrew Powrie-Smith, Dr Nick Reed, Mrs Sheila Tunstall-James, Mr Alistair Thorburn, Mr Keith Thompson, Ms Angela Timoney, Dr Andrew Walker

In Attendance: Mrs Corinne Booth, Mrs Anne Lee, Dr Michael McMahon, Ms Fiona Marley, Ms Rosie Murray, Ms Emma Riches, Ms Alex Robertson, Mrs Maureen Stark, Mrs Catherine Tait

Apologies: Mrs Laura Ace, Professor James Barbour, Dr Keith Beard, Ms Ailsa Brown, Mr Colin Brown, Dr Keith Brown, Mrs Susan Downie, Mr Stephen Ferguson, Dr John Gemmill, Dr Chris Lush, Dr Simon Maxwell, Mrs Laura McIver, Professor Dilip Nathwani, Mr Michael Pratt, Dr Sarah Taylor, Professor David Wray, Professor Tony Wells

1. Welcome and Apologies for Absence

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

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

  • Ms Fiona Marley, Deputy Director (Corporate Affairs), National Commissioning Group
  • Dr Michael McMahon, NDC member and Lead Assessor who was 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 06 April 2010 were accepted as an accurate record of the meeting.  Please note there was no SMC meeting in May 2010.

4. Matters Arising

Full Submissions

4.1 raltegravir (Isentress)  Merck Sharpe & Dohme Ltd (No. 613/10)

4.1.1 The SMC advice for raltegravir (Isentress), in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. 

Please note it has been brought to our attention that there was a slight error in the advice box for raltegravir (Isentress).  Advice has been amended and distributed to the company, and was published on the SMC website on Monday, 10 May 2010.

4.2 extended release nicotinic acid/laropiprant, 1000mg/20mg modified release tablets (Tredaptive) Merck Sharpe & Dohme Ltd  (No. 614/10) 

4.2.1 The SMC advice for extended release nicotinic acid/laropiprant, 1000mg/20mg modified release tablets (Tredaptive),  for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non familial) as monotherapy in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated, was published on the SMC website on Monday, 10 May 2010.

4.3 gefitinib 250mg film-coated tablets (Iressa)  AstraZeneca UK Ltd  (No. 615/10)

4.3.1 The SMC advice for gefitinib 250mg film-coated tablets (Iressa), for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK), was published on the SMC website on Monday, 10 May 2010.

Resubmission

4.4 lenalidomide, 5mg, 10mg, 15mg and 25mg capsules (Revlimid)  Celgene Ltd   (No. 441/08)

4.4.1 The SMC advice for lenalidomide, 5mg, 10mg, 15mg and 25mg capsules (Revlimid), in combination with dexamethasone, for the treatment of multiple myeloma patients who have received at least one prior therapy,  was published on the SMC website on Monday, 10 May 2010.

Non Submissions

4.5 telmisartan (Micardis)  Boehringer Ingelheim Limited  (No. 617/10)

4.5.1 The SMC advice for telmisartan (Micardis), for use in cardiovascular prevention (to reduce cardiovascular morbidity in patients with manifest atherothrombotic cardiovascular disease history of coronary heart disease, stroke, or peripheral arterial disease) or type 2 diabetes mellitus with documented target organ damage, was published on the SMC website on Monday, 10 May 2010.

4.6 abatacept (Orencia ®)  Bristol-Myers Squibb Pharmaceuticals Ltd  (No. 618/10)

4.6.1 The SMC advice for abatacept (Orencia ®),  for the treatment of juvenile idiopathic arthritis,  was published on the SMC website on Monday, 10 May 2010

Deferred Advice

4.7 certolizumab pegol, 200 mg/ml solution for injection (prefilled syringe) (Cimzia)  UCB Pharma Ltd  (No. 590/09)

4.7.1 In April 2010, SMC reviewed a full submission for certolizumab pegol, 200 mg/ml solution for injection (prefilled syringe) (Cimzia) , in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease modifying anti-rheumatic drugs, including methotrexate, has been inadequate, monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Distribution of advice was withheld after April SMC in order for discussion to take place around some process issues that were raised.  Advice was distributed to Boards on Friday 07 May 2010, and will be published on the SMC website on Monday 07 June 2010.

4.8 Amended Advice

4.8.1 Please see above raltegravir (Isentress)  Merck Sharpe & Dohme Ltd (No. 613/10)

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 the July meeting of SMC. 

Verbal Update  - Mrs Tunstall-James

Work is progressing to establish a Patient and Public Involvement Officer (PPIO) which will support the work of SMC and ensure that a patient view is considered for new medicines under review.  It is hoped that this work will be completed over the coming months and will update on developments at the next SMC meeting in July. 

The Chairman acknowledged that progress is now being made towards the establishment of this new role.
 

7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 Secondment Post to NHSQIS

Mrs Laura McIver, Chief Pharmaceutical Adviser has been offered a secondment to NHSQIS for a period of 18 months to provide strategic and professional pharmaceutical leadership.  Mrs McIver is expected to take up the post within the next 1-2 months.

8.2 CEL 17 (2010) Introduction and Availability of Newly Licensed Medicines in NHS in Scotland

CEL 17 (2010) regarding the Introduction and Availability of Newly Licensed Medicines in NHS in Scotland was published on Monday 17 May, 2010.  A copy of this has been sent to SMC/NDC members.

8.3 New medicines in Scotland- who decides what the NHS can provide?

A patient leaflet describing the process by which new medicines are licensed and accepted for use by the NHS in Scotland and was produced by Health Rights Information Scotland (HRIS), a joint initiative of Consumer Focus Scotland and the Scottish Government Health Directorates, and published on 17 May, 2010. 

8.4 ADTC Seminar – 11 May 2010

At the recent ADTC/NES Seminar on the 11th May SMC agreed to take forward a nationally coordinated piece of work to deliver an implementation framework for the CEL.  A small working group, with regional representation, will be set up to prepare a first draft of the implementation framework.  The group will draft a framework for the CEL e.g. definition of Individual Patient Treatment Request, panel membership, patient involvement etc based on the discussion from the seminar.

8.5 NICE Single Technology Appraisal (STA) Guidance No 189- Sorafenib for the treatment of advanced hepatocellular carcinoma, published 26 May 2010

Summary of NICE STA

Sorafenib is not recommended for the treatment of advanced hepatocellular carcinoma in patients for whom surgical or locoregional therapies have failed or are not suitable. People currently receiving sorafenib for the treatment of advanced hepatocellular carcinoma should have the option to continue treatment until they and their clinician consider it appropriate to stop.

SMC Advice

SMC published advice for sorafenib (Nexavar) in July 2008 (SMC No. 482/08)

sorafenib (Nexavar) is not recommended for use within NHS Scotland for the treatment of hepatocellular carcinoma.  In one trial in patients with advanced hepatocellular carcinoma, sorafenib was superior to placebo in terms of overall survival, but not for the time to symptomatic progression.   The manufacturer’s justification of the treatment’s cost in relation to its benefit was not sufficient to gain acceptance by SMC.

There is no material difference between the recommendations of the NICE STA and the SMC.   STAs have no status in NHS Scotland.

8.6 NICE (Multiple) Technology Appraisal Guidance No 188 – Human growth hormone (somatropin) for the treatment of growth failure in children (review of NICE  technology appraisal guidance 42)

NICE recommends human growth hormone (somatropin) as a possible treatment for some children with growth failure (see below).

Who can have human growth hormone (somatropin)?

Children should be able to have human growth hormone (somatropin) if they have any of the following:

  • growth hormone deficiency
  • Turner syndrome
  • Prader–Willi syndrome
  • chronic renal insufficiency
  • growth failure at 4 years or older and were born small for gestational age
  • short stature homeobox-containing gene (SHOX) deficiency.
     

Treatment should continue until the child stops growing unless growth is slow in the first year of treatment or the child doesn’t wish to carry on with the treatment.  The specialist should carefully consider weight and height before stopping treatment in children with Prader–Willi syndrome.

SMC Advice

SMC published advice for somatropin (Genotropin) injection in February 2006 following an abbreviated submission (SMC No. 240/06).

somatropin (Genotropin injection is accepted for restricted use within NHS Scotland for the treatment of growth disturbance (current height Standard Deviation Score (SDS) <-2.5 and parental adjusted height SDS <-1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 Standard Deviations, who failed to show catch-up growth (height velocity SDS < 0 during the last year) by 4 years of age or later.  Treatment should be initiated and monitored by a paediatrician with expertise in managing childhood growth disorders and growth hormone therapy.

SMC also published advice for somatropin (Norditropin SimpleXx) in June 2006 following an abbreviated submission (SMC No. 260/06).

Somatropin (Norditropin SimpleXx) injection is accepted for restricted use within NHS Scotland for the treatment of growth disturbance (current height standard deviation score (SDS) <-2.5 and parental adjusted height SDS <-1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviations, who failed to show catch-up growth (height velocity SDS < 0 during the last year) by 4 years of age or later.  Treatment should be initiated and monitored by a paediatrician with expertise in managing childhood growth disorders and growth hormone therapy.

NICE MTA guidance supersedes SMC advice. The recommendations in the two sets of guidance are consistent.    The SMC website will be updated accordingly.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 indacaterol 150 and 300 micrograms inhalation powder hard capsules (Onbrez Breezhaler®)  Novartis Pharmaceuticals Ltd (No.619/10)

9.1.1 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.

9.1.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice and expert comments.  Detailed discussion followed and the group concluded their advice for indacaterol (Onbrez Breezhaler®), for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). 

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

9.2 sitagliptin, 100mg film-coated tablet (Januvia)   Merck Sharp & Dohme Ltd No. (607/10)

9.2.1 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.

9.2.2 The NDC Co-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 sitagliptin (Januvia), should be accepted for restricted use within NHS Scotland, as monotherapy, to improve glycaemic control in patients with type 2 diabetes mellitus who are inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.  Use is restricted to patients for whom both metformin and sulphonylureas are inappropriate due to contraindications or intolerance.   Sitagliptin met the pre-defined efficacy criterion for non-inferiority versus metformin in a study of treatment naïve patients.  It appears to have minimal effect on body weight.   The health economic case was demonstrated only for a sub-population of patients within the licensed indication.   The licensed indication for sitagliptin has also recently been extended to include use in triple combination therapy with metformin plus thiazolidinediones and use as add-on therapy to insulin. The manufacturer’s submission related only to the use of sitagliptin as monotherapy, therefore SMC cannot recommend the use of sitagliptin in combination with metformin plus thiazolidinediones or as add-on therapy to insulin.  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 June 2010.

9.3 mifamurtide, 4mg powder for suspension for infusion (Mepact) Takeda UK and Ireland Ltd  No. (621/10)

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, revised data/analyses and comments received from the company.  A member of PAPIG presented patient interest group submissions from Bone Cancer Research Trust and Sarcoma UK.  Detailed discussion followed and the group agreed that mifamurtide (Mepact), should not be recommended for use within NHS Scotland,  in combination with post-operative multi-agent chemotherapy for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection, in children, adolescents and young adults.  Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis.  Mifamurtide has been shown to increase overall survival compared to multi-agent chemotherapy alone in patients under 30 years with newly-diagnosed resectable osteosarcoma.  The manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC and in addition the manufacturer did not present a sufficiently robust economic analysis.  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, 04 June 2010.
                                                        
9.4 epoetin theta, 1,000 IU/0.5mL, 2,000 IU/0.5mL, 3,000 IU/0.5mL, 4,000 IU/0.5mL, 5,000 IU/0.5mL, 10,000 IU/1mL, 20,000 IU/1mL, 30,000 IU/1mL solution for injection in pre filled syringe (Eporatio) Ratiopharm UK Limited No.(620/10)
                 
9.4.1 There were no declarations of interest recorded in relation to this product/comparator drugs.

9.4.2 The NDC Lead Assessor provided an overview of the assessment, draft advice and expert comments.  Detailed discussion followed and the group agreed that epoetin theta (Eporatio), should be accepted for use within NHS Scotland, for the treatment of symptomatic anaemia associated with chronic renal failure in adult patients.  Epoetin theta demonstrated non-inferiority to another erythropoietin analogue in maintaining stable haemoglobin levels in renal failure associated anaemia both in patients not yet receiving dialysis (subcutaneous route) and in those receiving haemodialysis (intravenous route).  The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name.  Other erythropoietin stimulating agents are available at lower cost.   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 June 2010.

RESUBMISSIONS

9.5 lapatinib, 250mg film-coated tablets (Tyverb) GlaxoSmithKline (No.  526/09)

9.5.1 Declarations of interest were 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.  A member of PAPIG presented a joint patient interest group submission from Breakthrough Breast Cancer; Breast Cancer Campaign; Breast Cancer Care.  Detailed discussion followed and the group agreed that lapatinib (Tyverb), should not be recommended for use within 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.   In a randomised open-label study the median time to progression for lapatinib plus capecitabine was significantly longer than for capecitabine monotherapy.  There was no statistically significant difference in overall survival.  Compared with capecitabine monotherapy, the manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC. There was also uncertainty about the comparative effectiveness and cost-effectiveness compared to use of trastuzumab and capecitabine in patients with metastatic disease confined to the central nervous system, itself a treatment of unproven cost-effectiveness.  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, 04 June 2010. 

9.6 ketoprofen/omeprazole, 100mg/20mg; 200mg/20mg modified release capsules (Axorid)  Meda Pharmaceuticals No.  (606/10)

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

9.6.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice and  expert comments.  Detailed discussion followed and the group agreed that ketoprofen/omeprazole (Axorid),  should be accepted for use within NHS Scotland, for the symptomatic treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis in patients with a previous history or who are at risk of developing NSAID associated gastric ulcers, duodenal ulcers and gastroduodenal erosions in whom continued treatment with ketoprofen is essential.  Studies in healthy volunteers demonstrated the bioequivalence of this combination product to the reference products, modified-release ketoprofen and omeprazole.  Other nonsteroidal anti-inflammatory drugs can be co-prescribed with proton pump inhibitors at lower cost.  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, 04 June 2010.

NON SUBMISSIONS

9.7 miglustat (Zavesca ®)100 mg hard capsules Actelion Pharmaceuticals UK Ltd (No. 632/10)

9.7.1 In the absence of a submission from the holder of the marketing authorisation, miglustat (Zavesca ®), should not be recommended for use within NHSScotland for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.

9.7.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 June 2010.

9.8 corifollitropin alfa (Elonva ®) 100 and 150mcg solution for injection MSD (No. 633/10)

9.8.1 In the absence of a submission from the holder of the marketing authorisation, corifollitropin alfa (Elonva ®) should not be recommended for use within NHSScotland for the treatment of Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program.

9.8.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 June 2010. 

10.Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

11. SMC User Group Forum (UGF)

11.1 Nothing to update.

12. Area Drug and Therapeutics Committees (ADTC) Issues

12.1 Nothing to update.

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 06 July 2010 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.