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Minutes of the SMC Meeting held on Tuesday 07 October 2008

Minutes of the SMC Meeting held on Tuesday 07 October 2008
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: 
Dr Ken Paterson (Chairman), Dr Keith Beard, Mrs Margo Biggs, Dr Keith Brown,Professor John Cairns, Mr David Carson, Dr David Crookes, Mr Tom Divers, Dr John Gemmill, Ms Susan Goldsmith, Dr Barclay Goudie, Dr Jan Jones,Dr Frances Macdonald, Dr John McElhinney,Mr Billy Malcolm,Ms Veronica Moffat, Ms Aileen Muir,Dr Anthony Ormerod, Dr Andrew Power,Mr Andrew Powrie-Smith, Dr Sandy Simpson,Mr Alistair Thorburn, Ms Angela Timoney,  Mrs Sheila Tunstall-James,Dr Andrew Walker.

In Attendance: 
Mrs Corinne Booth, Ms Ailsa Brown, Ms Susan Downie, Mrs Anne Lee, Ms Rosie Murray, Mrs Maureen Stark.

Apologies:
Mrs Laura Ace,  Professor James Barbour, Mr Colin Brown, Dr Sara Davies,Mr Stephen Ferguson, Dr Jonathan Fox, Dr Grace Lindsay, Dr Chris Lush, Mr Colin McAllister, Dr Alan MacDonald,Dr Simon Maxwell,Professor Dilip Nathwani, Dr Nick Reed,Ms Alex Robertson,Mrs Catherine Tait,Dr Sarah Taylor, Mr Keith Thompson, Professor Tony Wells.

 1. Welcome and Apologies for Absence

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

The Chairman thanked members for making efforts to attend the meeting in the face of serious travel disruption across Scotland.

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 September 2008 were agreed as an accurate record.

4. Matters Arising From the Previous Minutes

4.1 SMC Conference: Tuesday 23 September  2008

Verbal feedback from delegates suggests that they found the event interesting and worthwhile.  The formal presentations were well received however some delegates suggested that more time for questions and discussion would have been preferred.  The results of the formal evaluation will be reported in due course.

The Chairman expressed his thanks to the Secretariat for the organisation and smooth running of the Conference with particular thanks to Ailene Botfield, SMC Administrator, for facilitating the process.

Full Submissions

4.2 capecitabine 150mg and 500mg tablets (Xeloda)  No.  (507/08)  Roche Products Limited

4.2.1 The SMC advice for capecitabine (Xeloda), for the treatment of metastatic colorectal cancer, will be posted on the SMC website on Monday, 13 October 2008.

4.3 11.7mg etonogestrel / 2.7mg ethinylestradiol vaginal ring (NuvaRing)  No. (502/08)  Schering-Plough                                    

4.3.1 The SMC advice for etonogestrel/ethinylestradiol vaginal ring (NuvaRing), for contraception, will be withheld pending confirmation of licence and availability.

4.4 pegylated liposomal doxorubicin, 2mg/ml concentrate for solution for infusion  (Caelyx)  No.  (503/08) Schering Plough                                          

4.4.1 The SMC advice for pegylated liposomal doxorubicin, (Caelyx), in combination with bortezomib 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 transplant, will be posted on the SMC website on Monday, 13 October 2008.

4.5 sitagliptin, 100mg tablet (Januvia) No.  (505/08) Merck Sharp and Dohme Limited

4.5.1 The SMC advice for sitagliptin (Januvia), for patients with type 2 diabetes mellitus to improve glycaemic control in combination with a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; or in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control, will be posted on the SMC website on Monday, 13 October 2008.

4.6 fosaprepitant, 115mg powder for solution for infusion (Ivemend) No. (506/08) Merck Sharp & Dohme Limited  

The SMC advice for fosaprepitant, (Ivemend), for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy, will be posted on the SMC website on Monday, 13 October 2008.

Resubmissions

4.7 maraviroc, 150 mg and 300 mg tablets  (Celsentri)  No.  (458/08) Pfizer Ltd

4.7.1 The SMC advice for maraviroc (Celsentri), in combination with other antiretroviral medicinal products, for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable, will be posted on the SMC website on Monday, 13 October 2008.

4.8 dexrazoxane 500mg vial of powder for intravenous infusion (Savene) No.  (361/07) TopoTarget A/S                    

4.8.1 The SMC advice for dexrazoxane (Savene), for the treatment of anthracycline extravasation, will be posted on the SMC website on Monday, 13 October 2008.

Abbreviated Submissions

4.9 salbutamol (as sulphate) 100 micrograms per dose as powder for inhalation (Salbulin MDPI Novolizer)  (No: 504/08)  Meda Pharmaceuticals Ltd

4.9.1 The SMC advice for salbutamol (Salbulin MDPI Novolizer), in patients with reversible airways obstruction such as asthma for relief and prevention of asthma symptoms, will be posted on the SMC website on Monday, 13 October 2008.

4.10 insulin lispro 100 units/ml solution for injection in a pre-filled pen (Humalog KwikPen) (No: 508/08) Lilly UK

4.10.1 The SMC advice for insulin lispro (Humalog KwikPen), for the treatment of adults and children with diabetes mellitus who require insulin for maintenance of normal glucose homeostasis, and for the initial stabilisation of diabetes mellitus, was initially withheld pending confirmation of licence and availability, however the product is now available.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 10 October 2008 and posted on the SMC website on Monday 10 November 2008.

4.11 insulin lispro 100 units/ml suspension for injection consisting of insulin lispro 25% and insulin lispro protamine 75% (Humalog Mix25 KwikPen) and insulin lispro 100 units/ml suspension for injection consisting of insulin lispro 50% and insulin lispro protamine 50% (Humalog Mix50 KwikPen) (No: 509/08) Lilly UK

4.11.1 The SMC advice for insulin lispro (Humalog Mix25/Mix50 KwikPen), for the treatment of patients with diabetes mellitus who require insulin for maintenance of normal glucose homeostasis, was initially withheld pending confirmation of licence and availability, however the product is now available.  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 10 October 2008 and posted on the SMC website on Monday 10 November 2008.

Non Submissions

4.12 cinacalcet 30mg, 60mg & 90mg (Mimpara®)  (No. 513/08) Amgen Ltd

4.12.1 The SMC advice for cinacalcet (Mimpara®) for the reduction of hypercalcaemia in patients with primary hyperparathyroidism (HPT) for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated, will be posted on the SMC website on Monday, 13 October 2008.

4.13 duloxetine 30mg & 60 mg hard gastro-resistant capsules (Cymbalta) (No. 514/08)    Eli Lilly and Company Limited 

4.13.1 The SMC advice for duloxetine (Cymbalta) for the treatment of generalised anxiety disorder, will be posted on the SMC website on Monday, 13 October 2008.


Deferred Advice

4.14quetiapine 50mg, 200mg, 300mg and 400mg prolonged-release tablet (Seroquel XL) (No. 433/07) AstraZeneca UK Ltd

4.14.1 Quetiapine prolonged-release tablet (Seroquel XL) was reviewed by SMC in December 2007 and accepted for use within NHS Scotland for the treatment of schizophrenia and manic episodes associated with bipolar disorder, however, advice was withheld pending confirmation of product availability.  The product is now available and advice will be issued to NHS Boards and ADTCs on Friday 10 October and published on the SMC website on Monday 10 November, 2008.


4.15 icatibant 30mg/3ml solution for subcutaneous injection in pre-filled syringes (Firazyr) No.  (476/08)  Jerini AG

4.15.1 Icatibant (Firazyr) was reviewed by SMC in August 2008, and not recommended for use within NHS Scotland for the symptomatic treatment of acute attacks of hereditary angioedema in adults (with C1-esterase-inhibitor deficiency) however advice was withheld pending product availability.  The product is now available and advice will be issued to NHS Boards and ADTCs on Friday 10 October and published on the SMC website on Monday 10 November, 2008.

Amended Advice

4.16 Nothing to report.

5. Appeals Update

5.1 Nothing to report

6. Patient and Public Involvement Group (PAPIG)

6.1 Establishment of a Patient and Public Involvement Officer

As a result of SMC’s Evaluation Programme and previous discussions with the SMC Executive, Mrs Tunstall James reported that PAPIG was aiming to secure funding for an SMC patient and public involvement officer.  PAPIG envisage that the post will add value to SMC decisions, by providing service and support to patient and public organisations.  SMC will be kept informed of progress.

6.2 Proposed Training Event for Patient Interest Groups on How to Make a Submission to SMC With support from ABPI (Scotland), a training event for Patient Interest Groups is  planned.  It is likely to take place early in 2009, in Edinburgh and will provide information and guidance on how patient groups can input to SMC’s assessment process.  Further details will be released in due course.

6.3 Membership of PAPIG

PAPIG is seeking an NHS member to replace Mrs Pat Murray, whose term of appointment ended recently.  NHS members of SMC who may be interested in getting involved are asked to notify their interest to the Secretariat.  

7. New Drugs Committee: Chairman’s Report

7.1 Statistical Training for Assessors, NDC and SMC Members

A seminar on statistical analyses relative to health technology assessments recently took place, led by Dr Peter Donnan.  The event was very well attended and those participating found the content and format extremely informative and helpful.  Further seminars are planned and SMC members are welcome to attend.

8. Chairman’s Business

8.1 Staff Changes at SMC

Ms Jacqui Sneddon, currently a Clinical Effectiveness Pharmacist, in NHS Fife, has been appointed to the role of Project Lead for the Scottish Management of Antimicrobial Resistance Action Plan (ScotMARAP).  Ms Sneddon will take up post in November 2008.

From October, Ms Sharon Hems will act for Mrs Anne Lee, (Principal Pharmacist for Horizon Scanning and currently Acting Chief Pharmaceutical Adviser), on a part time basis.  Discussions are underway to fill the remainder of the Horizon Scanning post. 

8.2 Revised Criteria for  Abbreviated Submissions

Following a joint SMC/ industry, short life working group (SLWG) and the conduct of a feasibility study, a revised process for new medicines in children has been introduced and is being piloted for one year.  The aim is to facilitate access to medicines in children by accepting abbreviated submissions where certain criteria are met. 

The perceived benefits are: more rapid access to medicines for children; a reduction in the number of full submissions that would previously have been required, thus maximising efficiency for both industry and SMC.

The revised criteria allow SMC to accept an abbreviated submission for a product previously considered and accepted by SMC (or a product which predates SMC) where it subsequently receives an extended marketing authorisation for use in children.  For products that were not previously recommended a full submission will still be required.

In order to strengthen the process, the SLWG considered it appropriate to have paediatric expert input on the evidence base for the product and current prescribing custom and practice in Scotland.  Two expert advisory bodies, the Scottish Medicines for Children Network (ScotMCN) and the Scottish Neonatal and Paediatric Pharmacists Group (SNAPP), were consulted and agreed to support the process.  A designated cohort of the SMC Executive will review the expert responses and make a decision on the appropriate submission type.  

SMC members considered and discussed the revised criteria and assessment process in depth and looked forward to reviewing an evaluation of the pilot exercise in 12 months time.

8.3 Short Life Working Group (SLWG) on Market Access  Schemes in NHSScotland

SMC has been asked by the Scottish Government Health Department (SGHD), specifically the Chief Medical Officer and the Chief Pharmaceutical Officer, to convene a group to consider whether  and how novel pricing strategies  might be introduced  in order to facilitate  market and patient access to some high cost new medicines.  This is a completely new area of work for NHS Scotland encompassing a broad and complex issue, with many aspects requiring careful and detailed consideration however the SLWG draws a abroad range of expertise round the table. 

A useful first meeting of the Short Life Working Group took place in early October and the Group is tasked with advising the SGHD on the feasibility of operating such schemes within a six month timescale. 

8.4 NICE – Single Technology Appraisal (STA) Guidance

NICE issued STA guidance No 157 on 24 September, 2008, with regards to dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults.  NICE recommended, dabigatran etexilate as a possible treatment to reduce the risk of venous thromboembolism in adults who have surgery to replace their hip or knee joint.
SMC published advice in June 2008 advising that dabigatran etexilate (Pradaxa) is accepted for use within NHS Scotland for the primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.  In two large phase lll studies, in patients undergoing either total knee or total hip replacement surgery, dabigatran was non-inferior to low molecular weight heparin in the incidence of VTE and all cause mortality with patients having a similar incidence of major bleeding events. The two drugs have similar costs per dose but dabigatran has lower administration costs and is an oral therapy. This may facilitate longer duration of thromboprophylaxis, however the risks and benefits of this longer treatment duration need to be considered on a case-by-case basis. 

There is no material difference between the NICE STA and the SMC recommendation.

Please note NICE STAs have no status in Scotland.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 fentanyl buccal tablets (Effentora)  Cephalon UK Ltd  (No. 510/08)                        

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

9.1.2 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 concluded their advice for fentanyl buccal tablets (Effentora), for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.

9.1.3 The SMC advice will be withheld pending confirmation of licence and product availability.


9.2 ambrisentan (Volibris)  GlaxoSmithKline  (No. 511/08)                                           

9.2.1 Declarations of interest were recorded in relation to this product/comparator drugs. Members with personal specific interests left the meeting for this part of the agenda.

9.2.2 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 ambrisentan (Volibris), for the treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity, should be accepted for restricted use in NHS Scotland.  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, 10 October 2008.

RESUBMISSIONS

9.3 rufinamide (Inovelon)  Eisai Limited  (No. 416/07)                                                  

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

9.3.2 The NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, a summary of information for patients and comments received from the company.  A member of PAPIG presented a patient interest group submission from Epilepsy Scotland.  Detailed discussion followed and the group agreed that rufinamide (Inovelon), as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients four years and older, should be accepted for restricted use in NHS Scotland.  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, 10 October 2008.

9.4 anidulafungin (Ecalta)  Pfizer  (No. 465/08)                                                                

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

9.4.2 The NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, and revised data/analyses.  Detailed discussion followed and the group agreed that anidulafungin (Ecalta), for the treatment of invasive candidiasis in adult non-neutropenic patients, should be accepted for restricted use in NHS Scotland.  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, 10 October 2008.

ABBREVIATED SUBMISSION

9.5 insulin glulisine (Apidra)  Sanofi-Aventis  (No. 512/08)                                             
9.5.1 Declarations of interest were recorded in relation to this product/comparator drugs.  A member with a personal specific interest did not take part in the discussion for this part of the agenda.

9.5.2 The NDC Chair provided an overview of the assessment and a draft summary of advice. Discussion followed and the group agreed that insulin glulisine (Apidra), for the treatment of adolescents and children, 6 years or older with diabetes mellitus, where treatment with insulin is required and for whom the use of a short-acting insulin analogue is appropriate, should be accepted for restricted use in NHS Scotland.  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, 10 October 2008.

NON SUBMISSIONS

9.6 bosentan (Traceleer)® Actelion Pharmaceuticals UK Ltd  (No. 523/08)

9.6.1 In the absence of a submission from the holder of the marketing authorisation, bosentan (Traceleer) for the treatment of pulmonary arterial hypertension (PAH) WHO functional class II, 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, 10 October 2008.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted.


11. SMC User Group Forum (UGF)

11.1 Review of Budget Impact Estimates

Dr Frances MacDonald advised that the User Group Forum (UGF) was beginning a review of budget impact estimates as provided by manufacturers, with a view to developing more accurate budget impact forecasts.

11.2 Revised ABPI Code of Practice 2008

Dr MacDonald drew members’ attention to the revised code of practice for the pharmaceutical industry.  The revised ABPI Code of Practice 2008 brings all European Union (EU) countries into line and tightens up industry’s dealings with healthcare professionals and patient groups.

12. Feedback from Area Drug and Therapeutic Committees ( ADTCs)

12.1 SMC Chairman’s Programme of Visits to ADTCs

The Chairman reported that to date, he had visited six ADTCs and was received very positively.  He received requests for a training seminar for ADTCs on SMC   process and consideration will be given to taking this forward.  ADTC members also requested opportunities to observe NDC and SMC meetings to gain a further insight into how the committees work and perhaps subsequently to assist in succession planning for these committees.

13. Any Other Business

No other business was noted.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 04 November 2008 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.