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Minutes of the SMC Meeting - Tuesday 12 January 2010

Minutes of the SMC Meeting held on Tuesday 12 January 2010
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: Professor Ken Paterson (Chairman), Professor James Barbour, Dr Keith Beard, Mrs Margo Biggs, Dr Keith Brown, Professor Scott Bryson, Dr Jennifer Burns, Mr Robert Calderwood, Mr Dave Carson, Dr David Crookes, Dr Sara Davies, Dr John Gemmill,  Dr Barclay Goudie,  Dr Jan Jones, Dr Chris Lush, Dr Alan McDonald, Dr Frances Macdonald, Dr John McElhinney, Dr Paul McNamee, Mrs Sandra McNaughton, Ms Veronica Moffat, Ms Aileen Muir, Dr Anthony Ormerod,  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,  Mrs Sheila Tunstall-James, Dr Andrew Walker, Professor Tony Wells,Professor David Wray.

In Attendance: Mrs Corinne Booth, Ms Ailsa Brown, Mrs Susan Downie, Mr Stephen Ferguson, Mrs Laura McIver, Ms Rosie Murray,  Ms Jane Pearson, Ms Emma Riches, Dr Stephen Rogers, Ms Marina Shannon, Mrs Maureen Stark.

Apologies: Mrs Laura Ace, Mr Colin Brown, Dr Jonathan Fox, Mrs Anne Lee  Dr Simon Maxwell, Professor Dilip Nathwani,Ms Alex Robertson, Mrs Catherine Tait, Dr Sarah Taylor, Mr Alistair Thorburn,  Dr Iain Wallace.

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 the following NDC Members/Lead assessors who were presenting submissions to SMC: Ms Jane Pearson; Ms Marina Shannon; Dr Stephen Rogers, Consultant Haematologist / Clinical Director, NHS Fife and NDC member, 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 01 December 2009 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 rituximab, 100mg and 500mg concentrate for solution for infusion  (MabThera) Roche  (No. 591/09)

4.1.1 The SMC advice for rituximab (MabThera), for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL) in combination with chemotherapy, will be published on the SMC website on Monday, 18 January 2010.

4.2 eslicarbazepine 800mg tablets (Zebinix) Eisai Ltd  (No. 592/09)

4.2.1 The SMC advice for eslicarbazepine (Zebinix), for adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation, will be published on the SMC website on Monday, 18 January 2010.

4.3 plerixafor, 20mg/mL solution for injection (Mozobil)  Genzyme Therapeutics Limited (No. 594//09)

4.3.1 The SMC advice for plerixafor (Mozobil), in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly, will be published on the SMC website on Monday, 18 January 2010.

4.4 tocilizumab, 20mg/mL concentrate for solution for injection (RoActemra) Roche Products Ltd  (No. 593/09)

4.4.1 The SMC advice for tocilizumab (RoActemra), in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs or tumour necrosis factor antagonists, will be published on the SMC website on Monday, 18 January 2010.

4.5 ustekinumab 45 mg solution for injection (Stelara®) Janssen-Cilag Ltd (No. 572/09)

4.5.1 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), has been withheld for operational reasons, until further notice.

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

4.6.1 The SMC advice for certolizumab pegol (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, has been withheld for operational reasons, until further notice.

Non Submission

4.7 tolvaptan (Samsca®)  Otsuka UK  (No: 605/10)

4.7.1 The SMC advice for tolvaptan (Samsca®), for adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH), will be published on the SMC website on Monday 18 January 2010.

Deferred Advice

4.8 Nothing to report.

Amended Advice

4.9 Nothing to report.

4.10 Proposed revision to SMC Advice

In order to make advice clearer, SMC is considering a new format for the advice box contained in the detailed advice document (DAD), particularly when the advice is restricted.  SMC will consider examples of the new format against the old format in February 2010.

5. Appeals Update

5.1 eslicarbazepine 800mg tablets (Zebinix) Eisai Ltd  (No. 592/09)

In December 2009 SMC did not recommend eslicarbazepine, for adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.  The manufacturer has advised their intention to resubmit.
5.2 imatinib 100mg and 400mg film-coated tablets (Glivec)  Novartis Pharmaceuticals UK Ltd  (No. 584/09

In November 2009 SMC did not recommend imatinib, for the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117) positive gastrointestinal stromal tumours (GIST).  The manufacturer has advised their intention to resubmit.

6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the previous meeting of PAPIG

The minutes of the PAPIG meeting held on 01 December 2009, were noted.

6.2 Verbal Update  - Mrs Tunstall James

Funding has now been made available for the establishment of a Patient and Public Involvement Officer (PPIO), and Mrs Tunstall-James thanked the SMC Executive for their ongoing support in pursuing the initiative.  Final plans for implementation are under negotiation and it is hoped that recruitment can begin in the very near future.

However, due to earlier delays encountered in putting the PPIO in place, PAPIG have decided to postpone the planned Training Day for patient interest groups until 2011.  PAPIG are making alternative arrangements to engage with patient groups during 2010. 

7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 NICE Annual Conference - 01 December 2009

The Chairman attended the NICE Annual Conference and provided brief feedback on the programme.

8.2 EU Conference on Assessment of New Medicines – Stockholm, 03 December 2009

The Chairman gave a presentation to the Conference on the work of SMC which provoked good interaction and discussion amongst the delegates.

9. NDC ASSESSMENT REPORTS

DEFERRED ADVICE

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

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 At the SMC meeting on 01 December 2009, the NDC Lead Assessor 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 PSALV, Psoriasis Scotland and Skin Care Campaign Scotland (SCCS).  SMC initially withheld advice for operational reasons however,SMC has now agreed that ustekinumab (Stelara), should be accepted for restricted use in NHS Scotland, 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).

Significantly more patients treated with ustekinumab achieved at least 75% improvement in their Psoriasis Area and Severity Index (PASI) score at week 12, compared with those treated with a tumour necrosis factor alpha antagonist.  Continued treatment should be restricted to patients who achieve a PASI 75% response within 16 weeks.

9.1.3 This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ustekinumab. The SMC advice is dependent upon the continuing availability of the patient access scheme in NHS Scotland.

9.1.4 Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 15 January 2010.

FULL SUBMISSIONS

9.2 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)                                                      

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

9.2.2 The NDC Chair provided an overview of the assessment, draft advice and expert comments. Detailed discussion followed and the group agreed that epoetin alfa (Binocrit), should be accepted for use in NHS Scotland, for the 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. 

Binocrit can be used to increase the yield of autologous blood from patients in a predonation programme.  Its use in this indication must be balanced against the reported risk of thromboembolic events.  Treatment should only be given to patients with moderate anaemia (haemoglobin 10 to 13g/dL [6.2 to 8.1 mmol/L], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more for males).

9.2.3 Epoetin alfa (Binocrit) is a biosimilar product and has demonstrated equivalence in terms of efficacy and safety to a reference product (epoetin alfa (Eprex)).

Unlike other erythropoiesis stimulating agents, Binocrit is only licensed for administration by the intravenous route in the indications under review.

The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name.

9.2.4 Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 15 January 2010.

9.3 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)                                                  

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 and  expert comments. Detailed discussion followed and the group agreed that somatropin, for subcutaneous injection (Omnitrope), should be accepted for use in NHS Scotland, 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. 

9.3.3 Somatropin (Omnitrope) is a biosimilar product and has demonstrated equivalence in terms of efficacy and safety to a reference recombinant human growth hormone (somatropin (Genotropin)).

The British National Formulary advises that it is good practice to use the brand name when prescribing biological medicinal products.

9.3.4 Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 15 January 2010.

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

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, expert comments, revised data/analyses and comments received from the company.  A Summary of Information for Patients was provided by the manufacturer.  A member of PAPIG presented patient interest group submissions from Brook, the Family Planning Association (FPA) and the British Pregnancy Advisory Service (BPAS).  Detailed discussion followed and the group agreed that ulipristal (EllaOne), should be accepted for use in NHS Scotland, for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. 

9.4.3 Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 15 January 2010.

9.5 sildenafil 20mg (as citrate) tablets (Revatio) Pfizer Ltd  (No. 596/10)                                                              

9.5.1 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.

9.5.2 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 sildenafil (Revatio), should be accepted for restricted use in NHS Scotland, for the treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class II, to improve exercise capacity.  Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.   It is restricted to initiation by specialists working in the Scottish Pulmonary Vascular Unit or similar specialists.
 
9.5.3 Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 15 January 2010.

RESUBMISSIONS

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

9.6.1 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.

9.6.2 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 aliskiren (Rasilez), should not be recommended for use in NHS Scotland, for the treatment of essential hypertension. 

9.6.3 Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 15 January 2010.

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

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

9.7.2 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 Beating Bowel Cancer and Bowel Cancer UK.  Detailed discussion followed and the group agreed that cetuximab (Erbitux), should be accepted for restricted use in NHS Scotland, 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. 

Post hoc analyses from one phase III and one phase II study in patients with KRAS wild-type status who had not previously received chemotherapy for metastatic disease, showed an increase in overall response rate and a small, but statistically significant, increase in median progression free survival time, when cetuximab was added to standard first-line combination chemotherapy.

Cetuximab is restricted to use in patients who have not previously received chemotherapy for their metastatic disease, with liver metastases only that are considered non-resectable but in whom potentially curative liver metastasis resection would be undertaken if the lesions became resectable after treatment with chemotherapy and cetuximab.

9.7.3 This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of cetuximab. The SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland.

9.7.4 Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 15 January 2010.

9.8 pemetrexed 100mg, 500mg, powder for concentrate for solution for infusion (Alimta) Eli Lilly and Company Limited  (No. 531/09)                             

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

9.8.2 The NDC Vice Co-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 the Roy Castle Lung Cancer Foundation.  Detailed discussion followed and the group agreed that pemetrexed (Alimta), should be accepted for restricted use in NHS Scotland, 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. 

It is restricted to patients in whom histology has been confirmed as adenocarcinoma or large cell carcinoma.

In a planned subgroup analysis of a study comparing pemetrexed plus cisplatin with another platinum-based combination regimen, treatment with pemetrexed plus cisplatin resulted in an improvement in median survival in patients with a non-squamous (adenocarcinoma plus large cell carcinoma) histology.

9.8.3 Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 15 January 2010.

ABBREVIATED SUBMISSIONS

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

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

9.9.2 The NDC Chair provided an overview of the assessment and draft advice. Detailed discussion followed and the group agreed that trospium (Flotros), should be accepted for use in NHS Scotland, 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). 

9.9.3 Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 15 January 2010.

9.10 calcium acetate 667mg hard capsules (PhosLo) Fresenius Medical  Care (UK) Ltd (No. 601/10)               

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

9.10.2 The NDC Chair provided an overview of the assessment and draft advice. Detailed discussion followed and the group agreed that calcium acetate (PhosLo), should be accepted for use in NHS Scotland, for prevention/treatment of hyperphosphataemia in patients with advanced renal failure on dialysis. 

9.10.3.Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 15 January 2010.

9.11 tipranavir 100mg/mL oral solution (Aptivus)  Boehringer Ingelheim (No. 602/10) (No. 616/10)                 

9.11.1 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.

9.11.2 The NDC Chair provided an overview of the assessment, draft advice and expert comments.  Detailed discussion followed and the group agreed that tipranavir (Aptivus), should be accepted for restricted use in NHS Scotland, 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. 

The marketing authorisation for tipranavir states that it should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.  In adult patients the Scottish Medicines Consortium has restricted tipranavir to patients with a tipranavir mutation score of less than 4 and this restriction should apply to the age groups that are the subject of this licence extension.  Tipranavir is listed in the British National Formulary for Children for the treatment of HIV infection.

9.11.3 Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 15 January 2010.

9.12 tipranavir  250mg soft capsule (Aptivus)  Boehringer Ingelheim   (No. 616/10)

9.12.1 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.

9.12.2 The NDC Chair provided an overview of the assessment, draft advice and expert comments.  Detailed discussion followed and the group agreed that tipranavir (Aptivus), should be accepted for restricted use in NHS Scotland, 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. 

The marketing authorisation for tipranavir states that it should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.  In adult patients the Scottish Medicines Consortium has restricted tipranavir to patients with a tipranavir mutation score of less than 4 and this restriction should apply to the age groups that are the subject of this licence extension.  Tipranavir is listed in the British National Formulary for Children for the treatment of HIV infection.

9.12.3 Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 15 January 2010.

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

9.13.1 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.

9.13.2 The NDC Chair provided an overview of the assessment, draft advice and expert comments.  A patient interest group submission from HIV Scotland was noted.  Detailed discussion followed and the group agreed that darunavir (Prezista), should be accepted for use in NHS Scotland, co administered with low dose ritonavir in combination with other antiretroviral medicinal products, 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). 

9.13.3 Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 15 January 2010.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

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

12.1 Patient Access Schemes

Dr Gemmill indicated that amongst Boards, there were some anxieties over the costs of administering Patient Access Schemes.  He asked whether, in time, the Patient Access Scheme Assessment Group (PASAG) would provide a standard list of acceptable models which manufacturers could utilise.  The Chairman expressed a hope that simple schemes, which would be easy to operate, would emerge with experience.  Dr Macdonald agreed in principle but suggested that it may take time for PASs to be applied uniformly across the whole of the UK.

The Chairman agreed to raise the concerns with the PASAG.

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 02 February 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.