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SMC_Minutes_-_Tuesday_06_April_2010

Minutes of the SMC Meeting held on Tuesday 06 April 2010 NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: Professor Ken Paterson (Chairman), Mrs Laura Ace, Dr Jennifer Burns, Professor Scott Bryson, Mr Robert Calderwood, Mr Dave Carson, Dr John Gemmill, Dr Barclay Goudie, Dr Jan Jones, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Mrs Sandra McNaughton, Dr Paul McNamee, Dr Simon Maxwell, Ms Veronica Moffat, Ms Aileen Muir, Dr Mercia Page, Dr Robert Peel, Dr Andrew Power, Mr Andrew Powrie-Smith, Mr Mike Pratt, Dr Nick Reed, Mr Keith Thompson, Ms Angela Timoney, Professor Tony Wells, Professor David Wray.

 In Attendance: Mrs Corinne Booth, Ms Ailsa Brown, Ms Yvonne Clark, Mr Stephen Ferguson, Mrs Anne Lee, Ms Emma Riches, Mrs Maureen Stark, Mrs Catherine Tait.

Apologies: Professor James Barbour, Dr Keith Beard, Mrs Margo Biggs, Mr Colin Brown, Dr Keith Brown, Dr David Crookes, Dr Sara Davies, Dr Jonathan Fox, Dr Chris Lush, Mrs Laura McIver, Ms Rosie Murray, Dr Anthony Ormerod, Ms Alex Robertson, Dr Sarah Taylor,Mr Alistair Thorburn, Mrs Sheila Tunstall-James, Dr Andrew Walker, Mrs Susan Downie,Professor Dilip Nathwani.

1. Welcome and Apologies for Absence

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

1.2 A further welcome was extended to Ms Yvonne Clark, Senior Medicines Information Pharmacist, Medicines Information Pharmacy Department, Glasgow Royal Infirmary, currently on secondment working with NDC Pharmacy Assessment Team, who was observing the meeting.

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 March 2010 were accepted as an accurate record of the meeting, subject to a minor amendment.

4. Matters Arising

Full Submissions

4.1 paclitaxel (albumin encapsulated injection) Abraxane  Abraxis Bioscience Limited (No. 556/09)                                                                                                              

4.1.1 The SMC advice for paclitaxel (albumin encapsulated injection) Abraxane, for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline containing therapy is not indicated, will be published on the SMC website on Monday, 12 April 2010.

4.2 azacitidine (Vidaza) Celgene UK Limited  (No. 589/09)                                           

4.2.1 The SMC advice for azacitidine (Vidaza), for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (SCT) with intermediate-2 and high-risk myelodysplastic syndrome (MDS), chronic myelomonocytic leukaemia (CMML) or acute myeloid leukaemia (AML), will be published on the SMC website on Monday, 12 April 2010.

4.3 everolimus (Afinitor) Novartis Pharmaceuticals UK Ltd (No. 595/10)   

4.3.1 The SMC advice for everolimus (Afinitor), for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy, will be published on the SMC website on Monday, 12 April 2010.

4.4 tacrolimus (Protopic) 0.03% ointment   Astellas Pharma Ltd  (No. 608/10) 

4.4 1 The SMC advice for tacrolimus (Protopic) 0.03% ointment, for maintenance treatment of moderate to severe atopic dermatitis in children (aged 2 to15 years) for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected), will be published on the SMC website on Monday, 12 April 2010.

4.5 tacrolimus (Protopic) 0.1% ointment   Astellas Pharma Ltd  (No.609/10)

4.5.1 The SMC advice for tacrolimus (Protopic) 0.1% ointment, for maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in adult patients (≥16 years) experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected), will be published on the SMC website on Monday, 12 April 2010.

Abbreviated Submissions

4.6 metformin hydrochloride (Glucophage) 500mg/1000mg Powder for Solution Merck Serono Ltd (No. 610/10) 

4.6.1 The SMC advice for metformin hydrochloride (Glucophage) powder for solution, for the treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control, will be published on the SMC website on Monday, 12 April 2010.

4.7 omalizumab (Xolair) Novartis Ltd (No. 611/10)

4.7 1 The SMC advice for omalizumab (Xolair), as add-on therapy to improve asthma control in children (6 to <12 years of age) with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist,  will be published on the SMC website on Monday, 12 April 2010.

Non Submission

4.8 temsirolimus (Torisel)  Wyeth Pharmaceuticals  (No. 617/10)                                

4.8.1 The SMC advice for temsirolimus (Torisel), for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma [MCL], will be published on the SMC website on Monday, 12 April 2010.

Deferred Advice

4.9 sitagliptin /metformin (Janumet) Merck Sharp and Dohme Ltd (No. 492/08)

4.9.1 In July 2008, SMC reviewed an abbreviated submission for sitagliptin /metformin (Janumet), as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of sitagliptin and metformin.

The SMC advice was withheld pending confirmation of pricing, licence and product availability.   MSD has advised that the product was made available on 01 April 2010, therefore advice will be issued to NHS Boards/ADTCs on Friday, 09 April 2010 and published on Monday, 10 May 2010.

Amended Advice

4.10 tacrolimus (Protopic) 0.1% ointment   Astellas Pharma Ltd  (No.609/10)

4.10.1 It has been brought to our attention that there was an error in the advice box for tacrolimus (Protopic 0.1% ointment) (No.609/10).

In common with tacrolimus (Protopic 0.03% ointment) (No.608/10), the advice should have been restricted to “initiation by dermatologists in secondary care who have experience in treating atopic dermatitis using immunomodulatory therapy”.

The advice for tacrolimus (Protopic 0.1% ointment) has been amended and will be re-issued to NHS Boards/Area Drug and Therapeutic Committees on Friday, 09 April 2010 and published on the website on Monday, 12 April 2010.

5. Appeals Update

5.1 Extended release epidural morphine, 10mg/ml (10mg, 15mg and 20mg) (Depodur)    Flynn Pharma Ltd  No.  (528/09)

In March 2010, SMC considered but did not recommend extended release epidural morphine, 10mg/ml (10mg, 15mg and 20mg) (Depodur), for the relief of post-operative pain following major orthopaedic, abdominal or pelvic surgery.  Flynn Pharma have indicated their intention to resubmit.

5.2 everolimus 5 and 10 mg tablets (Afinitor)  Novartis Pharmaceuticals UK Limited  No. (595/10)

In March 2010, SMC considered but did not recommend everolimus 5 and 10 mg tablets (Afinitor), for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.  Novartis Pharmaceuticals UK Limited have indicated their intention to resubmit.

5.3 ferric carboxymaltose, 100mg/2ml and 500mg/10ml solution for Injection / infusion (Ferinject)   Syner-Med (PP) Ltd   No. (463/08)

In April 2008, SMC considered but did not recommend ferric carboxymaltose (Ferinject), for the treatment of iron deficiency when oral preparations are ineffective or cannot be used.  Syner-Med (PP) Ltd have indicated their intention to resubmit.

6. Patient and Public Involvement Group (PAPIG)

6.1 Nothing to update.

7. New Drugs Committee: Chairman’s Report

7.1 Development of Clinical Checklist

A clinical checklist has been developed, similar to that which assessors prepare for the health economic evaluation and is included in the paperwork for raltegravir (Isentress) for consideration and comments.  It is expected the checklist will become routine in all SMC paperwork.

7.2 Presentation on Biosimilars to NDC and SMC Members

As the NDC meeting in March only had one drug for consideration it was agreed to make good use of the extra time and hold a seminar on biosimilars.  This was a very useful event and the speakers at this event covered the following areas:

  • The NHS perspective on biosimilar medicines, Professor Norman Lannigan
  • The pharmaceutical industry perspective on biosimilar medicines, Paula Cox
  • Movers and shakers in the biopharmaceutical market – a shift from tradition, Dr Alexander   Lewis
  • SMC approach to biosimilar medicinal products, Angela Timoney

8. Chairman’s Business

8.1 Nothing to report.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

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

9.1.1 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.

9.1.2 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 raltegravir (IsentressÒ) should be accepted for restricted use within NHS Scotland, in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.  Use is restricted to patients who are intolerant or resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) or when these options are compromised due to drug-drug interactions.  Raltegravir has been shown to be non-inferior to efavirenz in combination with tenofovir and emtricitabine in treatment naïve patients.  In two small open-label studies, raltegravir demonstrated maintenance of viral suppression over 24 weeks when substituted for enfuvirtide in a combination regimen in highly pre-treated patients with a history of triple class failure or intolerance.  The health economic case was demonstrated only for a sub-population of patients within the licensed indication. SMC has previously issued advice for raltegravir in the treatment of HIV infection and this extends the advice to cover a wider patient population. 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 April 2010.

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

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 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 extended release nicotinic acid/laropiprant (Tredaptive®), should be accepted for restricted use within NHS Scotland, 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.  Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with extended release nicotinic acid/laropiprant.  Use is restricted as monotherapy for the treatment of dyslipidaemia in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol) in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated.  In patients, who may or may not have also been taking an HMG-CoA reductase inhibitor, extended release nicotinic acid/laropiprant reduced LDL-cholesterol versus placebo across weeks 12 to 24 and reduced flushing versus extended release nicotinic acid alone during the initiation phase.  Nicotinic acid/laropiprant is also licensed for use in combination with HMG-CoA reductase inhibitors (statins) when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate.  The manufacturer’s submission related only to the use of nicotinic acid/laropiprant as monotherapy.  SMC cannot recommend the use of nicotinic acid/laropiprant in combination with HMG-CoA reductase inhibitors.  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 April 2010.

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

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

9.3.2 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 gefitinib (Iressa), should not be recommended for use within NHS Scotland, 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).   In a comparative study in previously untreated patients, gefitinib was superior to a platinum-based doublet chemotherapy regimen in terms of progression-free survival; subgroup analysis supported this finding in patients with activating mutations of EGFR-TK.   However, 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 case to gain acceptance by SMC.   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 April 2010.

RESUBMISSION

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

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

9.4.2 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 patient interest group submission from Myeloma UK. Detailed discussion followed and the group agreed that lenalidomide (Revlimid), should be accepted for restricted use within NHS Scotland, in combination with dexamethasone, for the treatment of multiple myeloma patients who have received at least one prior therapy.  Use is restricted in patients who have received at least two prior lines of therapy.  Lenalidomide plus dexamethasone significantly increased the time to progression compared with dexamethasone alone in multiple myeloma patients who had been treated with at least one prior therapy.  The health economic case was demonstrated only for a sub-population of patients within the licensed indication.  Taking into account the orphan drug status of lenalidomide and the substantial survival benefit it appears to offer SMC concluded that the economic case was demonstrated.  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 April 2010.

NON SUBMISSIONS

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

9.5.1 In the absence of a submission from the holder of the Marketing Authorisation, 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, should not be recommended for use within NHS Scotland.

9.5.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 April 2010.

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

9.6.1 In the absence of a submission from the holder of the Marketing Authorisation, abatacept (Orencia), for the treatment of juvenile idiopathic arthritis, should not be recommended for use within NHS Scotland.

9.6.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 April 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 Therapeutic Committees (ADTCs): Issues

12.1 No issues were raised.

13. Any Other Business

13.1 No other business was noted.

14. Date of the Next Meeting

14.1 There will be no meeting in May and the date of the next meeting was confirmed as Tuesday 01 June 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.