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SMC Minutes - Tuesday 7 November 2006

Minutes of the SMC Meeting held on Tuesday 7 November 2006
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman); Ms Laura Ace; Mrs Marion Bennie; Dr Keith Brown; Professor John Cairns; Mr Dave Carson; Mr Tom Divers; Dr Peter Donnan; Dr Barclay Goudie; Dr John Haughney; Dr Jan Jones; Dr Grace Lindsay; Dr Graham Lowe; Dr Chris Lush; Mr Billy Malcolm; Ms Angela Munday; Mrs Pat Murray; Mrs Wendy Nganasurian; Dr Ken Paterson; Dr Andrew Power; Dr Nick Reed; Dr Philip Rutledge; Dr Sandy Simpson; Ms Angela Timoney; Ms Helen Tyrrell; Mr Mike Wallace; Dr John Webster

In attendance: Mr Scott Bryson; Dr Sara Davies; Mr Stephen Ferguson; Mrs Hazel Illingworth; Mrs Ruth Lang; Mrs Anne Lee; Mr Colin McAllister; Mrs Laura McIver; Dr James McLay; Mrs Sandra McNaughton; Ms Rosie Murray; Mrs Maureen Stark; Dr Andrew Walker

Apologies: Dr Jennifer  Armstrong; Professor James Barbour; Dr Keith Beard; Ms Rosaleen Beattie; Mrs Barbara Black; Mr Nick Brown; Dr David Crookes; Mr Jim Eadie; Mr Steven Fenocchi; Mr John Glennie; Dr Harpreet Kohli; Ms Fiona Ramsay; Dr Andrew Riley; Dr Sarah Taylor

1 Welcome and Apologies for Absence

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

The Chairman welcomed Mr Scott Bryson, NDC member, presenting rasagiline (Asilect). Dr James McLay, NDC member, presenting mitotane (Lysodren) and Mrs Sandra McNaughton, NDC member, presenting adalimumab (Humira).

He also gave a warm welcome to Mrs Ruth Lang, from the Patient Interest Group Depression Alliance Scotland, 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 03 October 2006 were accepted with the following amendment:

Item 13.2  Exit strategies from Clinical Trials

Following discussions at SMC, it was agreed that a strategy for managing the use of medicines on the completion of clinical trials would be helpful to the NHS boards.  This will be discussed further with Board Chief Executives.

4 Matters Arising From the Previous Minutes

4.1 There were no matters arising from the previous minutes.


Full Submissions

4.2 fludarabine phosphate (Fludara) oral  Schering Health Care Ltd  (No: 176/05)

4.2.1 The SMC advice for fludarabine phosphate (Fludara), for the treatment of B-cell chronic lymphocytic leukaemia (CLL) in patients with sufficient bone marrow reserve, will be posted on the SMC website on Monday 13 November 2006.

4.2.2 The Chairman approved minor amendments to the Detailed Advice Document. This will be reissued to NHSScotland on Friday, 10 November 2006.

4.3 sorafenib (Nexavar)  Bayer Plc  (No: 321/06)

4.3.1 The SMC advice for sorafenib (Nexavar), for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alfa or interleukin-2 based therapy or are considered unsuitable for such therapy, will be posted on the SMC website on Monday, 13 November 2006.

4.4 anastrazole (Arimidex)  AstraZeneca UK Ltd  (No: 322/06)

4.4.1 The SMC advice for anastrazole (Arimidex), for the adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen, will be posted on the SMC website on Monday, 13 November 2006.

4.4.2 The Chairman approved minor amendments to the Detailed Advice Document. This will be reissued to NHSScotland on Friday, 10 November 2006.

4.5 rituximab (MabThera)  Rheumatoid arthritis  Roche  (No: 323/06)

4.5.1 The SMC advice for rituximab (MabThera), in combination with methotrexate for treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARDs) including one or more tumour necrosis factor (TNF) inhibitor, will be posted on the SMC website on Monday, 13 November 2006.

4.5.2 The Chairman approved minor amendments to the Detailed Advice Document.  This will be reissued to NHSScotland on Friday, 10 November 2006.

Abbreviated Submissions

4.6 vinorelbine soft capsules (Navelbine Oral) Pierre Fabre (No: 324/06)

4.6.1 The SMC advice for vinorelbine capsules (Navelbine), for treatment of advanced breast cancer stage 3 and 4 relapsing after, or refractory to, an anthracycline-containing regimen, will be withheld pending confirmation of launch.

4.7 pegfilgrastim 6mg pre-filled pen (Neulasta) Amgen Limited  (No: 325/06)

4.7.1 The SMC advice for pegfilgrastim 6mg pre-filled pen (Neulasta?), for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes), will be withheld pending further information from the company.

4.8 lopinavir 200mg/ritonavir 50mg (Kaletra)  Abbott Laboratories Ltd  (No: 326/06)

4.8.1 The SMC advice for lopinavir 200mg/ritonavir 50mg (Kaletra), for the treatment of HIV-1 infected adults and children above the age of 2 years, in combination with other antiretroviral agents, will be posted on the SMC website on Monday, 13 November 2006.

5 Appeals Update

5.1 Nothing to report.

6. PAPIG

6.1 The Chairman of PAPIG advised that the group had met prior to SMC and the minutes would be available at the next meeting. She went on to highlight that the Consortium would be considering its eightieth submission for a Patient Interest Group later in the meeting and it was interesting to note that while thirty three of these had come from different groups, two Patient Interest Groups had made a total of seven submissions each.  A full evaluation report on SMC’s Patient and Public Involvement activity is expected by the end of December 2006.

7 New Drugs Committee: Chairman’s report

7.1 Training for SMC/NDC Members

The NDC Chairman advised that further to preliminary discussions at SMC and NDC, an outline programme for a one day event covering statistics and health economics is being prepared.  The Secretariat will contact members shortly with details and potential dates in February or March 2007.

8. Chairman’s Business

8.1 Director of Pharmacy, NHS Lothian

The Chairman congratulated Mrs Pat Murray, on her new post as Director of Pharmacy, NHS Lothian.

8.2 NDC Vice Chairman

Dr Andrew Power and Ms Aileen Muir have agreed to replace Ms Marion Bennie who is temporarily stepping down from her role as NDC Vice Chairman to dedicate time to the evaluation programme.  The two applicants will each work for a six month period, with Dr Power starting at the end of November, 2006.

8.3 Meeting with Chief Medical Officer (CMO), Chief Pharmaceutical Officer (CPO) and representatives of SMC Thursday 26 October 2006

The Chairman provided an update and advised that the meeting with the CMO, CPO and representatives from SMC had been very successful. One key outcome from the meeting arose from a discussion on appointments to SMC.  It was agreed that in future the CMO will receive nominations for membership, but it will be Health Board Chief Executives who will consider the nominations and the CMO will appoint on their approval.

8.4 Cross Borders Meeting

The Chairman provided a brief report following the meeting with representatives from Scottish Executive, SIGN, NICE, All Wales Medicines Group, Welsh Department of Health, Department of Health for Northern Ireland, and SMC.  He advised that this meeting had been very productive, and the group will meet again in 6 months time.

8.5 Budget Impact

The Chairman advised that due to the concerns regarding the budget impact section within the Detailed Advice Document for some of the drugs reviewed, the finance representatives and the prescribing advisors on SMC have agreed to look at this issue and a report will be brought back to a future meeting.

8.6 NICE announcement regarding the outcome of the Alzheimer's appeal. 


The Chairman advised that on Wednesday 11 October, 2006, NICE announced that the appeals lodged by stakeholders against draft guidance on the use of drugs to treat Alzheimer’s Disease had not been upheld. NICE will recommend to the NHS in November that donepezil, galantamine and rivastigmine should only be considered as options in the treatment of people with moderate Alzheimer’s disease. Memantine is only recommended as part of clinical studies for people with moderately-severe to severe Alzheimer’s disease. NICE guidance will be published to the NHS on 22 November and NHS QIS will send an email alert to NHSScotland at time of the NICE MTA publication advising whether the MTA is valid for Scotland or not.

9. NDC ASSESSMENT REPORTS

 FULL SUBMISSIONS

9.1 adalimumab (Humira)  Abbott Laboratories Ltd  (No: 300/06)

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


9.1.2 The NDC Lead Assessor provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that adalimumab (Humira) for the treatment of adults with severe active ankylosing spondylitis who have an inadequate response to conventional therapy, should be accepted for restricted use within NHS Scotland.  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 ADTCs and NHS Boards on Friday, 10 November 2006.

9.2 clofarabine (Evoltra)  Bioenvision  (No: 327/06)

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

9.2.2 The SMC Vice Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed to consider the advice further.  It was therefore decided to defer clofarabine (Evoltra) for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients (= 21 years) who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response, for review at the December meeting of SMC.

9.3 mitotane (Lysodren)  Laboratoire HRA Pharma  (No: 328/06)

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


9.3.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that mitotane (Lysodren) for the symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma, should not be recommended for use within 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 ADTCs and NHS Boards on Friday, 10 November 2006.


9.4 natalizumab (Tysabri)  Biogen Idec Ltd  (No: 329/06)

9.4.1 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.

9.4.2 The NDC Chairman 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 Multiple Sclerosis Society Scotland. Detailed discussion followed and the group agreed that natalizumab (Tysabri) as a single disease modifying therapy in highly active relapsing remitting multiple Sclerosis (RRMS) for the following patient groups; patients with high disease activity despite treatment with beta-interferon and in patients with rapidly evolving severe RRMS, should not be recommended for use within 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 ADTCs and NHS Boards on Friday, 10 November 2006.

9.5 rituximab (MabThera) (Follicular Lymphoma)  Roche  (No: 330/06)

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

9.5.2 The SMC Vice Chair provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that rituximab (MabThera) as maintenance therapy for patients with relapsed/refractory follicular lymphoma responding to induction therapy with chemotherapy with or without rituximab, should be accepted for restricted use within 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 ADTCs and NHS Boards on Friday, 10 November 2006.

RE-SUBMISSIONS

9.6 temozolomide (Temodal)  Schering-Plough UK Ltd  (No:  244/06)

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

9.6.2 The NDC Chairman provided a detailed overview of the draft advice.  Detailed discussion followed and the group agreed that temozolomide (Temodal), for the treatment of newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and subsequently as monotherapy treatment, should be accepted for restricted use within NHS Scotland.  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 ADTCs and NHS Boards on Friday, 10 November 2006.

9.7 gemcitabine (Gemzar)  Eli Lilly & Company Ltd  (No: 154/05) 

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 Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that gemcitabine (Gemzar), for the treatment of patients with metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy, should be accepted for use within NHS Scotland.  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 ADTCs and NHS Boards on Friday, 10 November 2006.

9.8 rasagiline (Asilect) Lundbeck Ltd and Teva Pharamceuticals Ltd (No 243/06)

9.8.1 A declaration of interest was recorded in relation to this product/comparator drug. A member with a personal specific interest left the meeting for this part of the agenda.

9.8.2 The NDC Lead Assessor 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 Parkinson’s Disease Society of the UK. Detailed discussion followed the group agreed that rasagaline (Asilect) for the treatment of idiopathic Parkinson’s disease as monotherapy (without levodopa), should not be recommended for use within NHS Scotland.  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 ADTCs and NHS Boards on Friday, 10 November 2006.

9.9 rasagiline (Asilect) Lundbeck Ltd and Teva Pharamceuticals Ltd (No 255/06)

9.9.1 A declaration of interest was recorded in relation to this product/comparator drug. A member with a personal specific interest left the meeting for this part of the agenda.

9.9.2 The NDC Lead Assessor 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 Parkinson’s Disease Society of the UK. Detailed discussion followed the group agreed that rasagaline (Asilect) for the treatment of idiopathic Parkinson’s disease as adjunct therapy (with levodopa) in patients with end of dose fluctuations, should not be recommended for use within NHS Scotland.  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 ADTCs and NHS Boards on Friday, 10 November 2006.

ABBREVIATED SUBMISSIONS

9.10 triptorelin (Decapeptyl SR 11.25mg)  Ipsen Ltd  (No: 331/06)

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

9.10.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that triptorelin (Decapeptyl) for the treatment of precocious puberty (onset before 8 years in girls and 9 years in boys), should be accepted for use within NHS Scotland.  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 ADTCs and NHS Boards on Friday, 10 November 2006.

9.11 methotrexate for injection (Metoject)  Medac UK  (No: 332/06)

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

9.11.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that methotrexate for injection (Metoject) for the treatment of severe active rheumatoid arthritis in adult patients where treatment with a parenteral disease modifying drug (DMARD) is indicated, should be accepted for use within NHS Scotland.  Assessors, in liaison with the secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.11.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 10 November 2006.

NON-SUBMISSIONS

9.12 lanreotide (Somatuline LA) Ipsen Ltd (No. 231/06)

9.12.1 In the absence of a submission from the holder of the marketing authorisation, lanreotide (Somatuline LA) for the treatment of thyrotrophic adenomas when the circulating level of thyroid stimulating hormone remains inappropriately high after surgery and/or radiotherapy, was not recommended for use within NHS Scotland.

9.12.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 10 November 2006.

9.13 pregabalin (Lyrica) Pfizer Ltd (No. 339/06)

9.13.1 In the absence of a submission from the holder of the marketing authorisation, pregabalin (Lyrica) for generalised anxiety disorder in adults, was not recommended for use within NHS Scotland.

9.13.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 10 November 2006.

10 Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

11 ADTC Feedback

Nothing to report.

12 SMC User Group Forum

Minutes of the meeting held on 26 September were noted.

13 Any Other Business


No other business was reported.
 
14 Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 5 December 2006 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.