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SMC Minutes - Tuesday 2 February 2010

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

Present: Professor Ken Paterson (Chairman), Mrs Laura Ace,  Mrs Margo Biggs,Dr Keith Brown,
Dr Jennifer Burns,Mr Dave Carson,Dr David Crookes, Dr John Gemmill, Dr Barclay Goudie, Dr Jan Jones, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Dr Simon Maxwell, Ms Aileen Muir, Dr Anthony Ormerod, Dr Mercia Page, Dr Robert Peel,Dr Andrew Power, Mr Keith Thompson, Ms Angela Timoney, Mrs Sheila Tunstall-James, Dr Andrew Walker, Professor David Wray.

In Attendance: Mr Richard Belbin, Mrs Corinne Booth, Ms Ailsa Brown, Mr Christopher Brown, Ms Ruth Keir, Mr Risto Antero Kylanpaa, Mrs Anne Lee, Mr Stuart Lennox, Ms Rosie Murray,  Ms Sally Newell, Mrs Maureen Stark, Mrs Catherine Tait.

Apologies: Professor James Barbour, Dr Keith Beard, Mr Colin Brown, Professor Scott Bryson, Mr Robert Calderwood, Dr Sara Davies, Mr Stephen Ferguson, Dr Jonathan Fox, Dr Chris Lush,  Mrs Sandra McNaughton, Mrs Laura McIver, Dr Paul McNamee, Ms Veronica Moffat,Mr Andrew Powrie-Smith, Mr Mike Pratt, Dr Nick Reed, Ms Alex Robertson, Ms Emma Riches, Dr Sarah Taylor, Mr Alistair Thorburn, Dr Iain Wallace, Professor Tony Wells, 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 welcome was extended to the following individuals who were observing the meeting: Dr Stephen Rogers, NDC Member and Lead assessor who is presenting a submission to SMC.

Tayside medical students (accompanying Angela Timoney): Mr Richard Belbin, Mr Christopher Brown, Ms Ruth Keir, Mr Risto Antero Kylanpaa, Mr Stuart Lennox, Ms Sally Newell.
 
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 11 January 2010 were accepted as an accurate record of the meeting.

4. Matters Arising

Deferred Submission

4.1 ustekinumab (Stelara®) Janssen-Cilag Ltd (No. 572/09)

4.1.1 The SMC advice for ustekinumab (Stelara®), for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen and UVA treatment (PUVA), will be published on the SMC website on Monday, 08 February 2010.

Full Submissions

4.2 epoetin alfa 1,000 IU/0.5mL, 2,000 IU/1mL, 3,000 IU/0.3mL, 4,000 IU/0.4mL, 5,000 IU/0.5mL, 6,000 IU/0.6mL, 7,000 IU/0.7mL, 8,000 IU/0.8mL, 9,000 IU/0.9mL, 10,000 IU/1mL, solution for injection in prefilled syringe (Binocrit) Sandoz Ltd  (No. 597/10)        
                                          
4.2.1 The SMC advice for epoetin alfa (Binocrit) for treatment of symptomatic anaemia associated with chronic renal failure in adult and paediatric patients, treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis; treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis, will be published on the SMC website on Monday, 08 February 2010.

4.3 somatropin for injection, 5mg/mL vial of powder and solvent for solution for subcutaneous injection and 3.3mg/mL and 6.7mg/mL penfill cartridge of solution for subcutaneous injection (Omnitrope) Sandoz Ltd (No. 598/10)

4.3.1 The SMC advice somatropin, for subcutaneous injection (Omnitrope), for the treatment of infants, children and adolescents with: Growth disturbance due to insufficient secretion of growth hormone (GH); Growth disturbance associated with Turner syndrome; Growth disturbance associated with chronic renal insufficiency; Growth disturbance (current height standard deviation score  (SDS) <–2.5  and parental adjusted SDS <–1)  in short children/adolescents born small for gestational age, with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity SDS <0  during the last year) by four years of age or later; Prader-Willi syndrome (PWS) disturbance due to insufficient secretion of growth hormone, for improvement of growth and body composition, will be published on the SMC website on Monday, 08 February 2010.
 
4.4 ulipristal 30mg tablet (EllaOne) HRA Pharma UK Ltd  (No. 599/10)         
                             
4.4.1 The SMC advice for ulipristal 30mg tablet (EllaOne) for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure,
will be published on the SMC website on Monday, 08 February 2010.
 
4.5 sildenafil 20mg (as citrate) tablets (Revatio) Pfizer Ltd  (No. 596/10)     

4.5.1 The SMC advice for sildenafil 20mg (as citrate) tablets (Revatio) for treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class II, to improve exercise capacity, will be published on the SMC website on Monday, 08 February 2010.

Resubmissions

4.6 aliskiren 150mg and 300mg film-coated tablets (Rasilez) Novartis Pharmaceuticals UK Ltd (No. 462/08)                    

4.6.1 The SMC advice for aliskiren 150mg and 300mg film-coated tablets (Rasilez) for the treatment of essential hypertension, will be published on the SMC website on Monday, 08 February 2010.

4.7 cetuximab 100mg/20mL and 500mg/100mL solution for intravenous infusion (Erbitux) Merck Serono Ltd  (No. 543/09

4.7.1 The SMC advice for cetuximab (Erbitux) for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, Kirsten rat sarcoma (KRAS) wild-type metastatic colorectal cancer in combination with chemotherapy, will be published on the SMC website on Monday, 08 February 2010.

4.8 pemetrexed 100mg, 500mg, powder for concentrate for solution for infusion (Alimta) Eli Lilly and Company Limited  (No. 531/09)
                            
4.8.1 The SMC advice for pemetrexed (Alimta) in combination with cisplatin for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology, will be published on the SMC website on Monday, 08 February 2010.

Abbreviated Submissions

4.9 trospium chloride 20mg film-coated tablets (Flotros) Galen Ltd (No. 600/10)        

4.9.1 The SMC advice for trospium chloride 20mg film-coated tablets (Flotros) for symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (e.g. idiopathic or neurologic detrusor overactivity), will be published on the SMC website on Monday, 08 February 2010.

4.10 calcium acetate 667mg hard capsules (PhosLo) Fresenius Medical  Care (UK) Ltd (No. 601/10)
              
4.10.1 The SMC advice for calcium acetate 667mg hard capsules (PhosLo) prevention/treatment of hyperphosphataemia in patients with advanced renal failure on dialysis, will be published on the SMC website on Monday, 08 February 2010.

4.11 tipranavir 100mg/ml oral solution and 250mg soft capsule (Aptivus)  Boehringer Ingelheim (No. 602/10)          

4.11.1 The SMC advice for tipranavir 100mg/ml oral solution (Aptivus), in combination with low dose ritonavir, for combination antiretroviral treatment of HIV-1 infection in highly pre-treated children from 2 to 12 years of age with virus resistant to multiple protease inhibitors, will be published on the SMC website on Monday, 08 February 2010.

4.12 tipranavir 100mg/ml oral solution and 250mg soft capsule (Aptivus)  Boehringer Ingelheim (No. 616/10)
          
4.12.1 The SMC advice for tipranavir 250mg soft capsules (Aptivus) in combination with low dose ritonavir, for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adolescents 12 years of age or older with virus resistant to multiple protease inhibitors,  will be published on the SMC website on Monday, 08 February 2010.

4.13 darunavir 75mg, 150mg, 300mg, 600mg film-coated tablets (Prezista) Tibotec (a subsiduary of Janssen-cilag) (No. 604/10)               

4.13.1 The SMC advice for darunavir (Prezista) for the treatment of human immunodeficiency virus (HIV-1) infection in highly pre-treated children and adolescents, from the age of 6 years and at least 20kg body weight, who have failed on more than one regimen containing a protease inhibitor (PI), will be published on the SMC website on Monday, 08 February 2010.

4.14 Non Submission

Nothing to report.
 
Deferred Advice

4.15 Nothing to report.

Amended Advice

4.16 ulipristal 30mg tablet (EllaOne) HRA Pharma UK Ltd  (No. 599/10)                                        

ulipristal 30mg tablet (EllaOne), for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure, was reviewed by SMC on 12 January 2010 however, as a result of comments from the manufacturer the budget impact data have been revised.  Revised advice will be issued to NHS Scotland on Friday 05 February 2010.

4.17 tipranavir 100mg/ml oral solution and 250mg soft capsule (Aptivus)  Boehringer Ingelheim (No. 602/10 & 616/10)                   

tipranavir for treatment of HIV-1 infection in highly pre-treated children from 2 to 12 years of age and adolescents 12 years of age or older.  Two separate Product Updates will now be issued to NHS Scotland, to make clear that, for patients less than 12 years of age, the oral solution is the only available option for treatment with Aptivus, as no data are available on the efficacy and safety of Aptivus capsules in children less than 12 years of age. Revised advice will be issued to NHS Scotland on Friday 05 February 2010.

5. Appeals Update

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

In January 2009, SMC did not recommend lapatinib (Tyverb), 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.  GlaxoSmithKline has indicated their intention to resubmit.
 
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 March meeting of SMC. 

6.2 Template for Patient Interest Group Submissions

The current template for Patient Interest Group Submissions will be revised with the aim of presentations to SMC being more slick, briefer and meaningful.

6.3 Patient and Public Involvement Officer

PAPIG are hopeful of securing resources in the near future to recruit a patient and public involvement officer (PPIO). The PPIO will support the voluntary health sector to engage more fully with SMC.  Thanks were given to the Chairman for his support in the establishment of this new post. 
 
7. New Drugs Committee: Chairman’s Report

7.1 Proposed revision to SMC Advice

In order to make advice clearer, SMC are considering a new format for the advice box contained in the detailed advice document (DAD), particularly when the advice is restricted.  It was planned for SMC to consider examples of the new format against the old when they considered the NDC Recommendations at today’s meeting.  However, due to some potential issues particularly with niche submissions further work is still required.  It is proposed the new format will now be considered at SMC in March 2010.

7.2 Review of process/standard operating procedures

SMC is currently reviewing the process for critiquing the clinical aspects of submissions.  Given the size and scope of some submissions received, the aim is to rationalise the process and perhaps move towards a ‘checklist’ approach, similar to the way the economic assessors currently work, i.e. they will produce a detailed critique of the key points within the submission.  It is proposed the new checklist will be considered at NDC in February 2010.
 
8. Chairman’s Business

8.1 Nothing to report.
 
9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 saxagliptin (Onglyza) Bristol-Myers Squibb Pharmaceuticals Limited  (No: 603/10)

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 Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses, a summary of information for patients and comments received from the company.  A member of PAPIG presented a patient interest group submission from Diabetes UK Scotland.  Detailed discussion followed and the group agreed that saxagliptin (Onglyza) is accepted for restricted use within NHS Scotland in adult patients with type 2 diabetes mellitus as add-on combination therapy with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control.   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, 05 February 2010.

9.2 ketoprofen-omeprazole (Axorid)  Meda Pharmaceuticals  (No: 606/10)

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

9.2.2 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 ketoprofen-omeprazole (Axorid) is not recommended 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.  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, 05 February 2010.

RESUBMISSION

9.3 extended release, morphine sulphate for epidural injection (Depodur) Flynn Pharma Ltd  (No: 528/09)

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

9.3.2 The NDC Lead Assessor 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, morphine sulphate for epidural injection (Depodur) is not recommended for use within NHS Scotland for the relief of post-operative pain following major orthopaedic, abdominal or pelvic surgery.  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, 05 February 2010.

NON SUBMISSION

9.4 rupatadine (Rupafin)  GlaxoSmithKline (No: 612/10)

9.4.1 In the absence of a submission from the holder of the Marketing Authorisation, rupatadine (Rupafin), for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and adolescents (over 12 years of age), should not recommended for use within NHS Scotland.

9.4.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 February 2010.
 
10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

11. SMC User Group Forum (UGF)

11.1 Update from the UGF

Dr Frances Macdonald reported that the UGF is working to analyse and address manufacturers’ reasons for not making a submission to SMC and that this work is progressing.

11.2 Methods and Process Review SLWG

Dr Macdonald advised that the SLWG to update process and methods review are  continuing to explore and develop methodology and process issues, with the aim of providing more information, in particular to assist new companies and provide a better understanding on submission requirements.

12. Area Drug and Therapeutic Committees (ADTCs): Issues

12.1 Nothing to report

13. Any Other Business

13.1 SMC Acceptance Rates – Report to SMC Executive Team (Q4 2009)

This tabled paper was noted by SMC and congratulations given to the Health Economic Team on the production of this paper.  Members agreed that this information was useful and asked if this would be available in the public domain.  The Chairman confirmed that these data are already available by searching the website but will be incorporated into an annual summary report.  Mrs S Tunstall-James requested that Patient Interest Group Submissions be included in future reports.  The Chairman confirmed that this information could be updated.  The aim is to provide this report on a quarterly basis. 

The Chairman asked, if there are any other suggested analyses that would be useful, to please request to the SMC Secretariat.  Dr F Macdonald suggested to re-run table number 4 for non-submissions by year, and this was agreed.

13.2 SMC Membership Query

Dr F Gemmill enquired if it is possible to have an anaesthetist as an SMC member.  The Chairman advised that this issue has been identified and is currently being addressed.  However we do have back up resources with expert involvement for SMC submissions which is of a very high standard.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 02 March 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.