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Minutes of SMC meeting - Tuesday 03 November 2009

Minutes of the SMC Meeting
held on Tuesday 03 November 2009
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP


Present: Professor Ken Paterson (Chairman),Mrs Laura Ace, Professor James Barbour,Dr Keith Beard, Mrs Margo Biggs,Dr Keith Brown,Mr Scott Bryson,Dr Jennifer Burns, Mr Dave Carson,
Dr David Crookes,Dr John Gemmill, Dr Jan Jones,Dr Chris Lush, Dr Frances Macdonald,Dr John McElhinney,Mrs Sandra McNaughton,Dr Simon Maxwell,Ms Veronica Moffat,Ms Aileen Muir,
Dr Mercia Page,Dr Robert Peel,Dr Andrew Power,Mr Mike Pratt,Dr Nick Reed,Ms Angela Timoney,
Mrs Sheila Tunstall-James,Professor Tony Wells.

In Attendance:
Mrs Corinne Booth,Ms Ailsa Brown,Mr Stephen Ferguson,Ms Sophie Hadlow,
Mrs Laura McIver,Ms Rosie Murray, Ms Emma Riches,Ms Alex Robertson,Dr Euan Sandilands,
Mrs Maureen Stark.

Apologies: Mr Colin Brown,Mr Robert Calderwood,Dr Sara Davies,Mrs Susan Downie,Dr Jonathan Fox, Ms Susan Goldsmith, Dr Barclay Goudie, Mrs Anne Lee, Dr Alan MacDonald,Professor Dilip Nathwani,Dr Anthony Ormerod, Mr Andrew Powrie-Smith, Mrs Catherine Tait,Dr Sarah Taylor,
Mr Keith Thompson, Mr Alistair Thorburn, Dr Andrew Walker, Dr Iain Wallace,Professor David Wray.

1. Welcome and Apologies for Absence


1.1 The Chairman welcomed members to the meeting and apologies for absence were noted.  Mrs Sandra McNaughton, Associate Director, Contracted Community Pharmacy Services and CHP Development, Lothian Primary Care, was welcomed to her first meeting as a member of SMC.  

1.2 A further welcome was extended to the following observers:

Ms Sophie Hadlow, Market Access Manager, AstraZeneca UK Ltd and member of the SMC User Group Forum; Dr Euan Sandilands, trainee in clinical pharmacology and therapeutics, NHS Lothian.

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 October 2009 were accepted as an accurate record of the meeting, subject to a minor amendment to item 6.1.

4. Matters Arising

Full Submissions

4.1 esomeprazole, 40mg vial of powder for solution for intravenous injection or infusion (Nexium I.V.“) AstraZeneca  No. (578/09)

4.1.1 The SMC advice for esomeprazole, (Nexium I.V.“), for prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers, will be published on the SMC website on Monday 09 November 2009.

4.2 filgrastim, 30 million units (300 microgram)/0.5mL and 48 million units (480 microgram)/0.8mL, prefilled syringe containing solution for injection or infusion (Ratiograstim“)  Ratiopharm UK Ltd No.  (577/09)

4.2.1 The SMC advice for filgrastim (Ratiograstim“), for reduction in the duration of neutropenia and the incidence of febrile neutropenia (FN) 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); As long term administration, to increase neutrophil counts and to reduce the incidence and duration of infection-related events in 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; 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, will be published on the SMC website on Monday 09 November 2009.

4.2.2 Filgrastim (RatiograstimÆ) is a biosimilar product and has demonstrated equivalency in terms of efficacy and safety to a reference granulocyte colony stimulating factor (filgrastim (NeupogenÆ).  The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name.


4.3 fentanyl 50 micrograms / dose, 100 micrograms/dose,  200 micrograms / dose nasal spray (Instanyl“)   Nycomed UK Ltd No.  (579/09)                                   

4.3.1 The SMC advice for fentanyl nasal spray (Instanyl), for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain, will be published on the SMC website on Monday 09 November 2009.

4.4 agomelatine, 25mg film-coated tablets (Valdoxan“) Servier Laboratories UK Ltd (No.564/09)

4.4.1The SMC advice for agomelatine (Valdoxan“), for the treatment of major depressive episodes in adults, will be published on the SMC website on Monday 09 November 2009.

Resubmissions


4.5 sunitinib, 12.5mg, 25mg, 50mg hard capsules (Sutent“)  Pfizer Ltd No.  (275/06)         

4.5.1 The SMC advice for sunitinib (Sutent“), for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance, will be published on the SMC website on Monday 09 November 2009.

4.6 bortezomib, 3.5mg vial of powder for solution for intravenous injection (VelcadeÆ)
Ortho Biotech No.  (302/06)


4.6.1 The SMC advice for bortezomib, (VelcadeÆ), as mono-therapy for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation, will be published on the SMC website on Monday 09 November 2009.

Abbreviated Submission

4.7 pramipexole (Mirapexin“)  Boehringer-Ingelheim (No. 580/09)

4.7.1 The SMC advice for pramipexole (Mirapexin), for the treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, was withheld pending confirmation of licence and product availability, however details have now been confirmed. The SMC advice will be issued to NHS Boards and ADTCs on Friday 06 November 2009 and published on the SMC website on Monday 07 December 2009.

Non Submission

4.8 nepafenac (Nevanac Æ)  Alcon Laboratories  (No. 588/09)

4.8.1 The SMC advice for nepafenac (Nevanac Æ), for prevention and treatment of postoperative pain and inflammation associated with cataract surgery, will be published on the SMC website on Monday 09 November 2009.

Deferred Advice


4.9  Nothing further to report.  (See item 4.7)

Amended Advice

4.10 agomelatine, 25mg film-coated tablets (Valdoxan“) Servier Laboratories UK Ltd (No.564/09)

4.10.1 Agomelatine (Valdoxan), for the treatment of major depressive episodes in adults, was reviewed by SMC on 06 October 2009, however as a result of comments from the manufacturer and the manufacturer of a comparator product, the advice will be amended, re-issued to NHS Scotland on Friday 06 November 2009 and published on the SMC website on Monday 09 November 2009.

4.11 filgrastim, 30 million units (300 microgram)/0.5mL and 48 million units (480 microgram)/0.8mL, prefilled syringe containing solution for injection or infusion (Ratiograstim“)  Ratiopharm UK Ltd No.  (577/09)

4.11.1 Filgrastim (Ratiograstim“), for the treatment of neutropenia, was reviewed by SMC on 06 October 2009, however as a result of comments from the manufacturer of a comparator product, the advice will be amended, re-issued  to NHS Scotland on Friday 06 November 2009 and published on the SMC website on Monday 09 November 2009.  

4.12 bortezomib, 3.5mg vial of powder for solution for intravenous injection (VelcadeÆ)
Ortho Biotech No.  (302/06)


4.12.1 Bortezomib (VelcadeÆ), as mono-therapy for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation, was reviewed by SMC on 06 October 2009 however, as a result of comments from the manufacturer, the advice will be amended, re-issued to NHS Scotland on Friday 06 November 2009 and published on the SMC website on Monday 09 November 2009.  

5. Appeals Update


5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)


6.1 Minutes  of the PAPIG meeting held on  Tuesday 06 October 2009

The minutes of the PAPIG meeting held on Tuesday 06 October 2009, were tabled and noted.

6.2 PAPIG Update

PAPIG intend to offer a one day training seminar for patient interest groups in the late Spring of 2010.   Developing on the 2009 Seminar, work has begun to prepare new workshops for 2010.

7. New Drugs Committee: Chairman's Report

7.1 Dr Andrew Power, NDC Chairman Pro-tem, reported that a full and challenging agenda was reviewed at the October NDC meeting.  The NDC Recommendations will come to the SMC meeting on 01 December 2009 for final appraisal.

8. Chairmanís Business

8.1 Short Life Working Group (SLWG) for new oral anticoagulants in stroke prevention

Dabigatran (Etexilate) and rivaroxaban (Xarelto), are in late stage clinical development for the prevention of stroke in atrial fibrillation and it is anticipated that the first of these may receive marketing authorisation during financial year 2010/11.     

The introduction of these agents, if accepted for use by SMC, is likely to result in a significant impact on drug budgets and will also lead to a significant change to the delivery of anticoagulant services in NHS Scotland.  SMC is seeking to establish a Short Life Working Group (SLWG), led by Dr Chris Lush, to explore the potential implications for anti-coagulant services in NHS Scotland. The group will produce a Report which will be circulated to all Area Drug and Therapeutic Committees (ADTCs) to help in local discussions and decision-making about the use of these drugs.  SMC have written to Chairmen of ADTCs to request nominations for the group from a mix of haematologists, general practitioners, pharmacists, nurse practitioners and laboratory staff who are able to provide information on the current local system(s) of delivery of anticoagulation control and who could participate in discussion to explore the possible impacts of the newer agents. It is anticipated that the group will initially concentrate on the new oral anticoagulants but may in the longer term consider in relation to low molecular weight heparins (LMWH).

8.2 NICE Single Technology Appraisal Guidance No 182 ñ Prasugrel for the treatment of acute coronary syndromes with percutaneous coronary intervention

Summary of NICE STA
Prasugrel in combination with aspirin is recommended as an option for preventing blockages in the arteries of people with acute coronary syndromes who are having a treatment called percutaneous coronary intervention only when: immediate percutaneous coronary intervention is necessary to treat an ST-segment-elevation myocardial infarction (a type of heart attack) or a blood clot has blocked a stent (a small mesh-like tube inserted into an artery to keep it open) during treatment with a drug called clopidogrel or the patient has diabetes mellitus.

SMC Advice
Following a full submission, SMC published advice for prasugrel (Efient) (No. 562/09), in September 2009.

prasugrel (Efient), co-administered with aspirin is accepted for restricted use within NHS Scotland for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention. Use is restricted to patients who are eligible to receive the 10mg dose of prasugrel. When compared to an alternative antiplatelet agent, prasugrel demonstrated a significant reduction in the incidence of ischaemic events, mainly non-fatal myocardial infarction, in patients with acute coronary syndrome undergoing percutaneous coronary intervention. Prasugrel was, however, also associated with an increased risk of clinically significant bleeding events. Alternative treatments are available at a lower drug acquisition cost.

There is a material difference between the recommendations of the NICE STA and the SMC. In the SMC guidance the patient eligibility criteria are broader.  NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

8.3 NICE Single Technology Appraisal Guidance No 183 ñ Topotecan for the treatment of recurrent and stage IVB cervical cancer

Summary of NICE STA
Topotecan in combination with cisplatin is recommended as a possible treatment for women with recurrent or stage IVB cervical cancer only if they have not received cisplatin before. Healthcare professionals should not stop prescribing topotecan for women who have received cisplatin before and who were already taking topotecan with cisplatin when the guidance was issued. These women should be able to carry on taking topotecan until they and their healthcare professionals decide that it is the right time to stop treatment.

SMC Advice

Following a full submission, SMC published advice for topotecan (Hycamtin)
(No. 421/07), in December 2007.

topotecan (Hycamtin) is accepted for restricted use within NHS Scotland in combination with cisplatin for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage IVB disease. It is restricted to patients who are cisplatin-naÔve. In an open-label study, overall and progression-free survival was significantly longer for cisplatin plus topotecan compared with cisplatin alone. Haematological adverse events were more common in the cisplatin plus topotecan group.
The economic submission demonstrated that topotecan plus cisplatin was cost effective compared to cisplatin alone in cisplatin-naÔve patients. However, the manufacturerís justification of the treatmentís cost in relation to its health benefit was not sufficient to gain acceptance by SMC for use in patients with previous exposure to cisplatin.
There is no material difference between the recommendations of the NICE STA and the SMC.  NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

8.4 'Pharmacoeconomy for Turkeyí : 30 October, 2009, Cappadocia, Turkey

Professor Paterson attended a meeting which was run by the Turkish Chapter of ISPOR (International Society for Pharmacoeconomics and Outcomes Research) to discuss the introduction of health technology appraisals in Turkey.  It was a useful and illuminating meeting.  Professor Patersonís presentation on the work of SMC was well received and delegates commented that SMC is considered by some to be the ëGold Standardí for rapid technology appraisals.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 tafluprost 15 micrograms/ml preservative-free eye drops single-dose container (Saflutan) Merck Sharp and Dohme (No. 581/09)

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 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 tafluprost (Saflutan), should be accepted for restricted use in NHS Scotland for the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension (as monotherapy in patients who would benefit from preservative-free eye-drops, who are insufficiently responsive to first-line therapy, or who are intolerant or contraindicated to first line therapy), or as adjunctive therapy to beta blockers.  Use should be restricted to patients with proven intolerance of the preservative benzalkonium chloride. 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 06 November 2009.

9.2 liraglutide 6mg/mL prefilled pen for injection (3mL) (Victoza)  Novo Nordisk Ltd
(No. 585/09)


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, expert comments, revised data/analyses 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 liraglutide (Victoza),  should be accepted for restricted use in NHS Scotland, for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control: in combination with metformin or a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea, or in combination with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy. Liraglutide should be restricted to third-line use.  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 06 November 2009.

9.3 imatinib 100mg and 400mg film-coated tablets (Glivec)  Novartis Pharmaceuticals UK Ltd  (No. 584/09

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

9.3.1 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 imatinib (Glivec), should not be recommended for use in NHS Scotland, for the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117) positive gastrointestinal stromal tumours (GIST).  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 06 November 2009.

RESUBMISSION

9.4 bemiparin sodium 3,500 IU in 0.2ml solution for injection in prefilled syringes (Zibor)  Archimedes Pharma UK Ltd (No. 204/05)

9.4.1 There were no declarations of interest 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, and revised data/analyses.  Detailed discussion followed and the group agreed that bemiparin sodium (Zibor), should be accepted for use in NHS Scotland, for the prevention of thromboembolic disease in patients undergoing orthopaedic surgery.  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 06 November 2009.

ABBREVIATED SUBMISSIONS

9.5 valganciclovir powder for 50mg/ml oral solution (Valcyte)  Roche  (No. 586/09)

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

9.5.2 The NDC Co-Vice Chair provided an overview of the assessment, and draft advice.  Detailed discussion followed and the group agreed that valganciclovir (Valcyte), should be accepted for restricted use in NHS Scotland, for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).  Use should be restricted to patients undergoing haemodialysis or other patients unable to use the less costly solid oral dosage form. 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 06 November 2009.

9.6 valganciclovir powder for 50mg/ml oral solution (Valcyte)  Roche  (No. 587/09)

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

9.6.2 The NDC Co-Vice Chair provided an overview of the assessment, and draft advice.  Detailed discussion followed and the group agreed that valganciclovir (Valcyte), should be accepted for restricted use in NHS Scotland, for the prevention of CMV disease in CMV-negative patients who have received a solid organ transplant from a CMV-positive donor.  Use should be restricted to patients undergoing haemodialysis or other patients unable to use the less costly solid oral dosage form 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 06 November 2009.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted.  


11. SMC User Group Forum (UGF)

11.1 UGF Update

Dr Frances Macdonald provided an update from the UGF. Resource permitting, representatives of the UGF and NDC will work in partnership to develop and improve certain process methods.  The UGF will brief SMC on developments in due course.

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

12.1 No new issues were raised.

13. Any Other Business

13.1 No other business was raised.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 01 December 2009 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.