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SMC Minutes - Tuesday 6 July 2010

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

Present: Professor Ken Paterson (Chairman);Dr Keith Beard; Mrs Margo Biggs; Dr Keith Brown; Professor Scott Bryson; Mr Robert Calderwood; Dr David Crookes; Dr Dominic Culligan; Dr Jonathan Fox; Dr Barclay Goudie; Dr Jan Jones; Dr Frances Macdonald; Dr John McElhinney; Mrs Sandra McNaughton; Dr Paul McNamee; Dr Anthony Ormerod; Dr Simon Maxwell; Ms Veronica Moffat; Ms Aileen Muir; Dr Mercia Page; Dr Robert Peel; Dr Andrew Power; Mr Michael Pratt; Dr Nick Reed; Mrs Sheila Tunstall-James; Mr Alistair Thorburn; Mr Keith Thompson; Ms Angela Timoney; Professor Tony Wells; Dr Andrew Walker.

In Attendance: Mrs Corinne Booth; Ms Ailsa Brown; Mrs Susan Downie; Mr Stephen Ferguson;Dr Gordon Forrest; Mrs Anne Lee;Ms Rosie Murray; Mrs Maureen Stark.

Apologies: Mrs Laura Ace; Professor James Barbour; Mr Colin Brown; Dr Jennifer Burns; Mr Dave Carson; Dr Sara Davies; Dr John Gemmill; Dr Chris Lush; Dr Alan MacDonald; Mrs Laura McIver; Professor Dilip Nathwani; Mr Andrew Powrie-Smith; Dr Brian Robson; Ms Emma Riches; Ms Alex Robertson; Mrs Catherine Tait; Dr Sarah Taylor; Professor David Wray.

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: Dr Dominic Culligan, Consultant Haematologist, Aberdeen Royal Infirmary, who was attending his first meeting as a  member of SMC. Dr Gordon Forrest, NDC member and Lead Assessor, who was presenting a submission to SMC.

1.3 The Chairman expressed his thanks to Dr David Crookes, who was attending his final meeting as a member of SMC.  Dr Crookes served full terms with both the New Drugs Committee and the Scottish Medicines Consortium and was a highly valued member of both committees.

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 (01 June 2010)

3.1 The minutes of the SMC meeting held on 01 June 2010 were accepted as an accurate record of the meeting.  

4 Matters Arising

Full Submissions

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

4.1.1 The SMC advice for indacaterol (Onbrez Breezhaler®), for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD), was withheld pending confirmation of licence and availability however, availability has now been confirmed.  Advice will be distributed to NHS Boards and Area Drug and Therapeutic Committees on Friday 09 July 2010 and published on the website on Monday 09 August 2010.  

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

4.2.1 The SMC advice for sitagliptin (Januvia), 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, will be published on the SMC website on Monday, 12 July 2010.

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

4.3.1 The SMC advice for mifamurtide (Mepact), 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, will be published on the SMC website on Monday, 12 July 2010.

4.4 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)

4.4.1 The SMC advice for epoetin theta (Eporatio), for the treatment of symptomatic anaemia associated with chronic renal failure in adult patients, will be published on the SMC website on Monday, 12 July 2010.

Resubmissions

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

4.5.1 The SMC advice for 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, will be published on the SMC website on Monday, 12 July 2010.

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

4.6.1 The SMC advice for ketoprofen/omeprazole (Axorid), 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, will be published on the SMC website on Monday, 12 July 2010.

Non Submissions

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

4.7.1 The SMC advice for miglustat (Zavesca ®), for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease, will be published on the SMC website on Monday, 12 July 2010.

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

4.8.1 The SMC advice for corifollitropin alfa (Elonva ®), 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, will be published on the SMC website on Monday, 12 July 2010.

4.9 Amended Advice

4.9.1 lenalidomide, 5mg, 10mg, 15mg and 25mg capsules (Revlimid) SMC No. 441/08   

Lenalidomide (Revlimid) was reviewed by SMC in April, 2010, and accepted for restricted use in patients who have received at least two prior lines of therapy.

Following a query from the Service an error has been highlighted in the Detailed Advice Document (DAD) in relation to patient numbers in the budget impact section.  The DAD has been amended and a revised copy will be distributed to NHS Boards and ADTCs and re-published on Friday, 9 July 2010. 

5 Appeals Update

5.1 Nothing to report.

6 Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the previous PAPIG meeting (01 June 2010)

The minutes of the previous PAPIG meeting held on 01 June 2010 were noted.

6.2 Update

Mrs Tunstall-James was very pleased to announce that the Public Involvement post had gone out to advert, with interviews scheduled for the end of July.

Two of the Public Partners recently participated in one-to-one interviews as part of NHSQIS / SMC’s application for ‘Investing in Volunteers’ status.  The purpose of the meetings with the awarding body was to find out whether SMC’s Public Partners consider they are treated and supported appropriately at all times. 

7 New Drugs Committee: Chairman’s Report

7.1 Succession Planning

Dr Jan Jones, NDC Chair, will complete her three year term of office in December 2010.  SMC will shortly be seeking her successor to allow a three month handover period.

8 Chairman’s Business

8.1 Capacity Issues

Due to a significant increase in the number of submissions received from manufacturers over the last two months, SMC is currently in a backlog situation for reviewing submissions received.   SMC expects the situation to remain for at least the next three months and during that time submitting companies can anticipate delays in scheduling of one to two months.

8.2 SMC Membership

The Chief Medical Officer (CMO) has approved nominations for six new members of SMC, to replace retiring members.  They will begin to take their places between July and October.

8.3 HTAi Conference, Dublin, 7-9 June 2010

Professor Paterson gave a presentation on patient and public involvement, to the international HTA conference held in Dublin in June.  His presentation was well received and provoked interesting discussion.  SMC also had an exhibition stand at the conference which drew interest from several countries, either to commend SMC’s processes or to find out more on how the processes work.

8.4 Invitation to speak to the  Federal Joint Committee, Germany

The process for introducing new drugs in Germany is undergoing review and development.  Professor Paterson has been invited to speak with the Secretary of State for Health, representatives of the association of German pharmaceutical companies and the German health insurance body, to learn about SMC and share experience. 

9 NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 betamethasone 2.5mg medicated plaster (Betesil®)  Genus Pharmaceuticals (No. 622/10)

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

9.1.2 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 a patient interest group submission from PSALV, Psoriasis Scotland.  Detailed discussion followed and the group agreed that betamethasone 2.5mg medicated plaster (Betesil®), should not be recommended for use in NHS Scotland, for the treatment of inflammatory skin disorders which do not respond to treatment with less potent corticosteroids, such as eczema, lichenification, lichen planus, granuloma annulare, palmoplantar pustulosis and mycosis fungoides.  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 July 2010.

9.2 trastuzumab 150 mg as powder for concentrate for solution for infusion (Herceptin®)  Roche  (No. 623/10)

9.2.1 A declaration of interest was 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, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from Bowel Cancer UK which was tabled at the meeting.  Detailed discussion followed and the group agreed that trastuzumab (Herceptin®) should not be recommended for use in NHS Scotland, in combination with capecitabine or 5-fluorouracil and cisplatin, for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.  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 July 2010.

9.3 olanzapine Long Acting injection (ZypAdhera®))  Eli Lilly and Company Limited  (No.624/10)

9.3.1 A declaration of interest was 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 a patient interest group submission from The National Schizophrenia Fellowship (Scotland).  Detailed discussion followed and the group agreed that olanzapine Long Acting injection (ZypAdhera®), should not be recommended for use in NHS Scotland, for maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.  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 July 2010.

9.4 eltrombopag 25mg and 50mg film-coated tablets (Revolade®)  GlaxoSmithKline UK  (No.625/10)

9.4.1 Declarations of interest were 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, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from The ITP Support Association.  Detailed discussion followed and the group agreed that eltrombopag (Revolade®), should be accepted for restricted use in NHS Scotland, for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).  Eltrombopag may be considered as second-line treatment for adult non splenectomised patients where surgery is contraindicated.  Eltrombopag (Revolade) is restricted for use in both the splenectomised and non-splenectomised patient populations, restricted to use in patients with severe symptomatic ITP or a high risk of bleeding.  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 July 2010.

9.5 ofatumumab solution for infusion (Arzerra®)  GlaxoSmithKline UK  (No. 626/10)

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, a summary of information for patients (prepared by the manufacturer) and comments received from the company.  A member of PAPIG presented a patient interest group submission from the Chronic Lymphocytic Leukaemia Support Association.  Detailed discussion followed and the group agreed that ofatumumab solution for infusion (Arzerra®), should not be recommended for use in NHS Scotland, for the treatment of chronic lymphocytic leukaemia (CLL) in patients who are refractory to fludarabine and alemtuzumab.  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, 09 July 2010.

RESUBMISSION

9.6 betaine anhydrous (Cystadane®)  Orphan Europe   (No. 407/07)

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

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.  A member of PAPIG presented a patient interest group submission from Children Living with Inherited Metabolic Diseases (CLIMB).  Detailed discussion followed and the group agreed that betaine anhydrous (Cystadane®), should be accepted for restricted use in NHS Scotland, for adjunctive treatment of homocystinuria involving deficiencies or defects in cystathionine beta-synthase (CBS), 5,10-methylene-tetrahydrofolate reductase (MTHFR) or cobalamin cofactor metabolism (cbl).   Betaine anhydrous (Cystadane) is restricted for use in patients who are not responsive to vitamin B6 treatment.  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, 09 July 2010.

ABBREVIATED SUBMISSIONS

9.7 sitagliptin 50mg /metformin 1000mg (Janumet®)  Merck Sharp and Dohme   (No. 627/10)

9.7.1 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.

9.7.2 The NDC Chair provided an overview of the assessment and draft advice.  Detailed discussion followed and the group greed that sitagliptin 50mg /metformin 1000mg (Janumet®), should be accepted for use in NHS Scotland, in combination with a sulphonylurea (i.e., triple combination therapy), as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

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

9.8 dutasteride 0.5 mg /tamsulosin hydrochloride 0.4mg hard capsules (Combodart®)  GlaxoSmithKline UK  (No.  628/10)

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

9.8.2 The NDC Chair provided an overview of the assessment and draft advice.    Detailed discussion followed and the group agreed that dutasteride 0.5 mg /tamsulosin hydrochloride 0.4mg hard capsules (Combodart®), should be accepted for use in NHS Scotland, for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH); Reduction in the risk of acute urinary retention and surgery in patients with moderate to severe symptoms of BPH.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

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

9.9 filgrastim (Tevagrastim®)  Teva UK Ltd  (No. 629/10)

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 filgrastim (Tevagrastim®), should be accepted for use in NHS Scotland, for the treatment of:

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes);Reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia; Mobilisation of peripheral blood progenitor cells (PBPC); In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of < 0.5 x 109/L, and a history of severe or recurrent infections, long term administration is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events; For the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Filgrastim (TevaGrastim®) is a follow on biosimilar product.  It is manufactured at the same production site and is identical to the biosimilar product filgrastim (Ratiograstim®), previously accepted for use by SMC.  The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

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

9.10 aripiprazole (Abilfy®)  Bristol-Myers Squibb Pharmaceuticals Ltd  (No. 630/10)

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

9.10.2 The NDC 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 aripiprazole (Abilfy®), should be accepted for restricted use in NHS Scotland, for the treatment of schizophrenia in adolescents 15 years and older.   Aripiprazole (Abilify) is restricted to initiation and management under the supervision of a child/adolescent psychiatrist.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

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

10 Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted.

11 SMC User Group Forum (UGF)

11.1 Dr Frances Mac Donald reported that workstreams are progressing in line with the UGF Agenda.   

12 Area Drug and Therapeutics Committees (ADTC) Issues

12. 1Nothing to report.

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 03 August 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.