Minutes of SMC Meeting - Tuesday, 7 April 2009
Minutes of the SMC Meeting held on Tuesday 07 April 2009
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP
Present: Prof Ken Paterson (Chairman), Professor James Barbour, Dr Keith Beard, Mrs Margo Biggs, Professor John Cairns, Mr Robert Calderwood, Mr David Carson, Dr David Crookes, Dr Sara Davies, Dr Barclay Goudie, Dr Jan Jones, Dr Chris Lush, Dr Frances Macdonald, Dr John McElhinney, Ms Aileen Muir, Dr Anthony Ormerod, Dr Mercia Page, Dr Andrew Power, Mr Andrew Powrie-Smith, Dr Nick Reed, Mr Keith Thompson, Mr Alistair Thorburn, Ms Angela Timoney, Mrs Sheila Tunstall-James, Dr Andrew Walker, Professor Tony Wells, Professor David Wray.
In Attendance: Dr Jennifer Burns, Mrs Corinne Booth Ms Ailsa Brown, Mr Andy Hockey, Mrs Anne Lee, Ms Rosie Murray, Ms Inger Smith, Ms Alex Robertson, Mrs Maureen Stark, Mrs Catherine Tait
Apologies: Mrs Laura Ace, Mr Colin Brown, Dr Keith Brown, Mr Stephen Ferguson, Dr Jonathan Fox, Dr John Gemmill, Ms Susan Goldsmith, Dr Alan MacDonald, Dr Simon Maxwell, Ms Veronica Moffat, Professor Dilip Nathwani, Ms Emma Riches, Dr Sarah Taylor.
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 observers:
- Ms Inger Smith, NovoNordisk (Industry representative on SMC UGF)
- Mr Andy Hockey, Lundbeck ((Industry representative on SMC UGF)
- Dr Jennifer Burns, NDC member who will be presenting a submission (Dr Burns will rotate to SMC in July)
The Chairman also welcomed:
Mr Robert Calderwood, Chief Executive, NHS Greater Glasgow and Clyde who has replaced Mr Tom Divers as CEO representative on SMC, who was attending his first meeting as a member of SMC.
Professor David Wray, Professor of Oral Medicine, Glasgow Dental Hospital and School, who was attending his first meeting as a member of SMC.
Dr Mercia Page, Director of Medical Affairs in Merck Sharp and Dohme Ltd, who was attending her first meeting as a member of SMC.
Emma Riches, medical writer who has been on maternity leave.
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 03 March 2009 were accepted as an accurate record of the meeting, subject to a minor amendment in paragraph 1.2.
4. Matters Arising
4.1.1 Statement by Nicola Sturgeon on Improving Access to New Medicines
Members may be aware that on Wednesday 26 March 2009 Nicola Sturgeon made a statement in the Parliament outlining changes designed to improve access to new medicines and provide guidance for patients who seek private care.
The statement was very supportive of SMC and its processes and covered four main areas, several of which will impinge on the work of SMC:
- SMC will shortly publish a set of modifiers (as previously discussed and agreed by NDC and SMC members) that can be applied when considering new medicines. Ms Sturgeon underlined that the Modifiers would be applied flexibly and not only for cancer or end-of-life drugs but to any new drug coming before SMC.
- Patients should not have to rely on exceptional prescribing arrangements for medicines that are SMC recommended. However, when a drug is not recommended by SMC, it is important that exceptional prescribing arrangements are in place to consider the circumstances of individual patients, which could justify the prescription of a particular medicine. Steps are being taken to establish consistent arrangements across Scotland and to provide clearer information to the public on the arrangements.
- Ms Sturgeon accepted the recommendation of SMC’s Short Life Working Group that a national framework for assessing proposed patient access schemes should be established. The new arrangements, the operational details of which will now be finalised, will maintain the integrity of the current SMC arrangements.
- Final guidance has been issued on co-payments, in those situations where NHS patients may wish to include elements of private health care, including medicines, in the management of their clinical conditions.
4.1.2 Update on Patient Access Schemes in NHS Scotland
Anne Lee provided an update on Patient Access Schemes in NHS Scotland and highlighted the following:
- A patient access scheme is when the company offers to make a medicine available with a rebate or a discount that effectively reduces its cost to the NHS.
- The Cabinet Secretary announced that she has accepted the recommendations made in a report from the short life working group on PAS set up by SMC. The group was chaired by Susan Goldsmith and had both an ABPI and public partner members.
- A set of key principles has been drawn up to underpin the introduction of patient access schemes and the group has recommended that they should be introduced on an equitable basis across Scotland. The framework mirrors the provisions made for PAS under the new Pharmaceutical Price Regulation Scheme (PPRS) and the group was of the view that commonality between the English and Scottish approach to these schemes would be helpful.
- The group has recommended that a new group is set up to assess schemes proposed by companies – termed the Patient Access Schemes Assessment Group (PASAG) and to maintain the independence of the SMC assessment process it is essential that the PASAG operates separately from SMC. The recommendation is that the PASAG should be established under the auspices of NHS National Services Scotland.
- A supplementary report on the operational issues has been submitted to SGHD, so steps will now be taken to set up a transitional group that is expected to evolve into the NSS Assessment Group. Companies are being advised via ABPI as of now that submissions incorporating schemes can now be made.
The Chairman recorded his thanks to Susan Goldsmith for chairing the SLWG. He particularly wished to acknowledge his thanks to Anne Lee for the level of work, time and commitment involved in pulling this important piece of work together.
4.1.3 June Meeting of SMC
At the previous SMC meeting the Chairman asked members to highlight issues they may wish to discuss at the June meeting as due to the volume of submissions received it was unlikely the meeting would be lengthy, however, more submissions have now been received and the meeting will proceed as normal.
4.2 fluticasone furoate (Avamys) GlaxoSmithKline (No. 544/09)
4.2.1 The SMC advice for fluticasone furoate (Avamys), for the treatment of the symptoms of allergic rhinitis in adults, adolescents (12 years and over) and children (6 to 11 years), will be published on the website on Tuesday 14 April, 2009.
4.3 topotecan hydrochloride (Hycamtin) 0.25mg and 1mg hard capsules GlaxoSmithKline (No. 545/09)
4.3.1 The SMC advice for topotecan hydrochloride (Hycamtin) 0.25mg and 1mg hard capsules, as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate, will be published on the website on Tuesday 14 April, 2009.
4.4 cetuximab (Erbitux) Merck Serono Ltd (No. 543/09)
4.4.1 The SMC advice for cetuximab (Erbitux), for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer in combination with chemotherapy, will be published on the website on Tuesday 14 April, 2009.
4.5 micronised progesterone (Utrogestan) Ferring Pharmaceuticals Ltd (No. 542/09)
4.5.1 The SMC advice for micronised progesterone (Utrogestan), for adjunctive use with oestrogen in post-menopausal women with an intact uterus (HRT), will be published on the website on Tuesday 14 April, 2009.
4.6 brinzolomide 10mg/ml eye drops, suspension (Azopt) Alcon Laboratories (UK) Limited (No. 546/09)
4.6.1 The SMC advice for brinzolomide 10mg/ml eye drops, suspension (Azopt), to decrease elevated intraocular pressure in ocular hypertension and open-angle glaucoma as monotherapy in patients unresponsive to beta-blockers or in patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues, will be published on the website on Tuesday 14 April, 2009.
4.7 Deferred Advice
Nothing to report.
4.8 Amended Advice
4.8.1 testosterone undecanoate, 1000mg/4ml oily solution for injection (Nebido) Bayer Schering Pharma No. 308/06)
The SMC Advice for testosterone undecanoate, (Nebido), as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests, was published on the SMC website on Monday, 09 March 2009, however as a result of comparator comments, the cost comparator table has been amended. The DAD will be published on the SMC website on Tuesday 14 April, 2009.
4.8.2 tobramycin 300mg/4ml nebuliser solution (Bramitob) (No. 314/06) Trinity Chiesi Pharmaceuticals Ltd – Abbreviated submission
The SMC reviewed tobramycin 300mg/4ml nebuliser solution (Bramitob) in September 2006, as an abbreviated submission. Advice was withheld pending product availability. The product was subsequently launched in January 2009 with advice published on the SMC website on Monday 09 March, 2009.
The advice states that “this preparation offers an alternative to an existing nebuliser solution at lower cost per dose. However, around the time when SMC was issuing advice, prices were changing in line with PPRS (PPRS pricing applied from 01 March 2009) which means that there is now no price differential between Bramitob and the comparator product Tobi. We believe that the price differential detailed in the abbreviated submission for Bramitob reflected the cost to the NHS (and other published sources) at all stages of the SMC assessment up until SMC agreed its final advice for publication and due process was followed. We do not intend to amend the current advice however we have had queries from both the service and the manufacturer of Tobi. To clarify the advice we have included a price cut off date reflecting the pricing situation on the 21st Jan 2009 (when final pricing was checked).
5. Appeals Update
5.1 Nothing to report.
6. Patient and Public Involvement Group (PAPIG)
6.1 Mrs Tunstall-James provided a brief update on the recent meeting at PAPIG. The main focus of the meeting was to finalise the arrangements for the training day for Patient Interest Groups which is taking place on 21 May, 2009. The invitations will be sent out after the Easter holiday and the attendance will be on a first come, first served basis, as there is a restriction to the number of places allocated which is a maximum of 20 places.
7. New Drugs Committee: Chairman’s Report
7.1 Nothing to report.
8. Chairman’s Business
8.1 NICE – (Multiple) Technology Appraisal Guidance
NICE issued MTA guidance No 169 on 25 March, 2009 for sunitinib (Sutent) for the first line treatment of advanced and/or metastatic renal cell carcinoma. Sunitinib is recommended as a possible first drug treatment for people with advanced and/or metastatic renal cell carcinoma if:
- immunotherapy (for example, interferon alfa) would be suitable for them and
- they are mobile and can do light housework or office work.
SMC published advice in July 2007 advising that sunitinib (Sutent), is not recommended for use within NHS Scotland for the treatment of advanced and/or metastatic renal cell carcinoma (MRCC). In a planned interim analysis, sunitinib improved progression-free survival and objective response rate when compared with interferon alfa. However, as yet there is insufficient information available on overall survival. The manufacturer did not present a sufficiently robust economic analysis and their justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC.
NHS QIS advises that the recommendation is as valid for Scotland as for England and Wales. The NICE MTA therefore supersedes the SMC advice for sunitinib.
9. NDC ASSESSMENT REPORTS
9.1 rotigotine, 1mg, 2mg and 3mg per 24 hours transdermal patch (NeuproÒ) UCB Pharma Ltd (No. 548/09)
9.1.1 Declarations of interest were recorded in relation to this product/comparator drugs.
9.1.2 Dr Jennifer Burns 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 RLS-UK/Ekbom Syndrome Association. Detailed discussion followed and the group concluded their advice for rotigotine, 1mg, 2mg and 3mg per 24 hours transdermal patch (NeuproÒ), for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.
9.1.3 The SMC advice will be withheld pending confirmation of licence and product availability.
9.2 quetiapine, 25mg, 100mg, 200mg, 300mg tablets (Seroquel) AstraZeneca Ltd (No. 549/09)
9.2.1 Declarations of interest were recorded in relation to this product/comparator drugs.
9.2.2 The NDC Vice 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 quetiapine, 25mg, 100mg, 200mg, 300mg tablets (Seroquel), for the treatment of major depressive episodes in the framework of bipolar disorder.
9.2.3 The SMC advice will be withheld pending confirmation of licence and product availability.
9.3 caffeine 5mg/ml solution for injection Viridian Pharma Ltd (No. 550/09)
9.3.1 There were no declarations of interest recorded in relation to this product/comparator drugs.
9.3.2 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 caffeine 5mg/ml solution for injection, should be accepted for restricted use within NHS Scotland for the treatment of apnoea of prematurity. Assessors in liaison with the Secretariat to make the appropriate amendments for review by the Chairman to distribution of the advice.
9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Thursday, 09 April 2009
9.4 pregabalin 25, 50, 75, 100, 150, 200 and 300mg capsules (Lyrica®) Pfizer Ltd - 2nd Re-submission (Following IRP) (No. 157/05)
9.4.1 Declarations of interest were 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, revised data/analyses and comments received from the company. A member of PAPIG presented patient interest group submissions from Pain Concern and the Neuropathy Trust. Detailed discussion followed and the group agreed that pregabalin 25, 50, 75, 100, 150, 200 and 300mg capsules (Lyrica®), should be accepted for restricted use within NHS Scotland, for the treatment of peripheral neuropathic pain in adults. Assessors in liaison with the Secretariat to make the appropriate amendments for review by the Chairman to distribution of the advice.
9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Thursday, 09 April 2009.
9.5 caspofungin 50mg and 70mg powder for concentrate for solution for infusion (Cancidas®) Merck Sharp and Dohme Ltd (No. 551/09)
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 and a draft summary of advice. Detailed discussion followed and the group agreed that caspofungin 50mg and 70mg powder for concentrate for solution for infusion (Cancidas®), should be accepted for use within NHS Scotland, for the treatment of empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropenic paediatric patients.
9.5.3 The SMC advice will be issued to NHS Boards and ADTCs on Thursday, 09 April 2009.
9.6 caspofungin 50mg and 70mg powder for concentrate for solution for infusion (Cancidas®) Merck Sharp and Dohme Ltd (No. 552/09)
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 Chair provided an overview of the assessment and a draft summary of advice. Detailed discussion followed and the group agreed that caspofungin 50mg and 70mg powder for concentrate for solution for infusion (Cancidas®), should be accepted for restricted use within NHS Scotland, for the treatment of invasive candidiasis in non-neutropenic paediatric patients.
9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Thursday, 09 April 2009
9.7 paclitaxel (Abraxane) Abraxis BioScience Limited (No. 556/09)
9.7.1 In the absence of a submission from the holder of the marketing authorisation, paclitaxel (Abraxane®) for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline containing therapy is not indicated, should not be recommended for use within NHS Scotland.
9.7.2 The SMC advice will be issued to NHS Boards and ADTCs on Thursday, 09 April 2009.
10. Forthcoming Submissions
10.1 A list of forthcoming submissions was tabled and noted.
11. SMC User Group Forum (UGF)
11.1 Dr Frances Macdonald stated there was nothing to report, with the exception to actions following the Patient Access Scheme information update received at the meeting today.
12. Feedback from Area Drug and Therapeutic Committees (ADTCs)
12.1 The Chairman suggested that this agenda title be changed to ‘ADTC Issues’, which should provide an opportunity to raise issues at future meetings.
Dr Keith Beard enquired about the programme for the future ADTC event planned in May and whether there was any information on the programme content. The Chairman advised that the programme will be distributed over the coming week. It is intended, following the morning session, to divide the participants into two groups, with the aim of a brainstorming session. The SMC processes will be discussed and this should provide a better understanding of SMC and encourage future possible members.
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, 05 May 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.