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SMC Minutes - Tuesday, 3 October 2006

Minutes of the SMC Meeting held on Tuesday 3 October 2006
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman); Professor James Barbour; Dr Keith Beard; Mrs Marion Bennie; Dr Keith Brown; Mr Dave Carson; Dr David Crookes; Mr Tom Divers; Mr Jim Eadie; Dr Barclay Goudie; Dr John Haughney; Dr Jan Jones; Dr Harpreet Kohli; Dr Chris Lush;
Mr Billy Malcolm; Ms Angela Munday; Ms Wendy Nganasurian; Dr Ken Paterson; Dr Andrew Power; Dr Nick Reed; Dr Philip Rutledge; Dr Sandy Simpson; Dr Sarah Taylor; Ms Angela Timoney; Mr Mike Wallace; Dr John Webster

In Attendance: Dr Jennifer  Armstrong; Dr Sara Davies; Mr Stephen Ferguson; Mrs Hazel Illingworth; Mr Alistair Jack; Mrs Laura McIver; Ms Kath Meikle; Miss Rosie Murray; Dr Andrew Walker

Apologies: Ms Laura Ace; Ms Rosaleen Beattie; Mrs Barbara Black; Mr Nick Brown; Professor John Cairns; Dr Peter Donnan; Mr Steven Fenocchi; Mr John Glennie; Mrs Anne Lee; Dr Grace Lindsay; Dr Graham Lowe; Mr Colin McAllister; Mrs Pat Murray; Ms Corinne O'Dowd; Ms Fiona Ramsay; Dr Andrew Riley; Mrs Maureen Stark; Ms Helen Tyrrell

1 Welcome and Apologies for Absence

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

The Chairman also welcomed Mr Alistair Jack, Head of Pharmacy Modernisation, Pharmacy Department, Ashludie Hospital, Monifieth, Dundee and Ms Kath Meikle, PA to Angela Timoney, NHS Tayside who were observing the meeting.

The Chairman congratulated Mrs Pat Murray, who was absent for the meeting, on her new post as Director of Pharmacy, 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 05 September 2006 were agreed as an accurate record.

4 Matters Arising From the Previous Minutes

4.1 There were no matters arising from the previous minutes.


Full Submissions

4.2 co-careldopa (Duodopa) intestinal gel Solvay Healthcare Ltd (No 316/06)

4.2.1 The SMC advice for co-careldopa (Duodopa), for the treatment of advanced levodopa-responsive Parkinson¡¦s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results, will be posted on the SMC website on Monday, 9 October 2006.

4.3 zoledronic acid (Aclasta) Novartis (No 317/06)

4.3.1 The SMC advice for zoledronic acid (Aclasta), for the treatment of Paget¡¦s disease of bone, will be posted on the SMC website on Monday, 9 October 2006.

4.4 ivabradine (Procoralan) Servier Laboratories Ltd (No 319/06)

4.4.1 The SMC advice for ivabradine (Procoralan), for the symptomatic treatment of chronic stable angina in patients with normal sinus rhythm, who have a contra-indication to or intolerance of beta-blockers, will be posted on the SMC website on Monday, 9 October 2006.

4.5 entecavir (Baraclude) Bristol-Myers Squibb Pharmaceuticals Ltd (No 320/06)

4.5.1 The SMC advice for entecavir (Baraclude), for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase levels and histological evidence of active inflammation and or fibrosis, will be posted on the SMC website on Monday, 9 October 2006.

4.6 sunitinib (Sutent) Pfizer Ltd (No 275/06)

4.6.1 The SMC advice for sunitinib (Sutent), for the treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance, will be posted on the SMC website on Monday, 9 October 2006.

4.7 carglumic acid (Carbaglu) Orphan Europe (UK) Ltd  (No:  299/06)

4.7.1 The SMC advice for carglumic acid (Carbaglu) for the treatment of hyperammonaemia due to N-acetylglutamate synthase deficiency, will be posted on the SMC website on Monday, 9 October 2006.

Abbreviated Submissions

4.8 levetiracetam (Keppra) IV formulation UCB Pharma Ltd  (No 311/06)

4.8.1 The SMC advice for levetiracetam (Keppra), as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults and children from 4 years of age with epilepsy, will be posted on the SMC website on Monday, 9 October 2006.

4.9 bimatoprost 0.03%/timolol 0.5% (Ganfort) Allergan Ltd (No 312/06)

4.9.1 The SMC advice for bimatoprost 0.03%/timolol 0.5% (Ganfort), for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues and for whom this combination offers an appropriate choice, will be posted on the SMC website on Monday, 9 October 2006.

4.10 etoricoxib (Arcoxia) Merck Sharpe & Dohme Ltd (No 313/06)

4.10.1 The SMC advice for etoricoxib (Arcoxia), for the symptomatic relief of osteoarthritis, rheumatoid arthritis and the pain and signs of inflammation associated with gouty arthritis, in patients for whom the use of etoricoxib is appropriate, taking account of current advice on the place in therapy for specific inhibitors of cyclo-oxygenase-2 (COX-2), will be posted on the SMC website on Monday, 9 October 2006.

4.11 tobramycin nebulising solution (Bramitob 300mg/4ml Nebuliser Solution) Trinity Chiesi Pharmaceuticals Ltd  (No 314/06)

4.11.1 The SMC advice for tobramycin nebulising solution (Bramitob), for the long-term management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis aged 6 years and older, will be withheld pending confirmation of launch.

4.12 lercanidipine (Zanidip) 20mg Recordati Pharmaceuticals (No 315/06)

4.12.1 The SMC advice for lercanidipine (Zanidip), for the treatment of mild to moderate essential hypertension in patients for whom this is an appropriate antihypertensive agent, will be posted on the SMC website on Monday, 9 October 2006.

4.13 choriogonadotropin alfa (Ovitrelle) Serono (No 263/06)

4.13.1 The SMC advice for choriogonadotropin alfa (Ovitrelle), for use in women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation, will be posted on the SMC website on Monday, 9 October 2006.

In April 2006, SMC issued a ¡§Not Recommended¡¨ statement for choriogonadotropin alfa (Ovitrelle) (No 263/06) as this product was identified as a non-submission, i.e. a submission was not made to SMC within a specified timeframe and therefore a ¡§Not Recommended¡¨ statement was issued.  SMC have now reviewed an abbreviated submission from the manufacturer. This advice supersedes the previous ¡§Not Recommended¡¨ advice.

4.14 choriogonadotropin alfa (Ovitrelle) Serono (No 264/06)

4.14.1 The SMC advice for choriogonadotropin alfa (Ovitrelle), for the treatment of oligo-ovulatory women, will be posted on the SMC website on Monday, 9 October 2006.

In April 2006, SMC issued a ¡§Not Recommended¡¨ statement for choriogonadotropin alfa (Ovitrelle) (No 264/06) as this product was identified as a non-submission, i.e. a submission was not made to SMC within a specified timeframe and therefore a ¡§Not Recommended¡¨ statement was issued.  SMC have now reviewed an abbreviated submission from the manufacturer. This advice supersedes the previous ¡§Not Recommended¡¨ advice.

5 Appeals Update

5.1 rotigotine transdermal patch (Neupro) Schwarz Pharma (No.289/06)

Schwarz Pharma has advised of their intention to make a resubmission for rotigotine Transdermal Patch (Neupro) for the treatment of the signs and symptoms of early-stage idiopathic Parkinson¡¦s disease as monotherapy.

5.2 ivabradine (Procoralan) Servier Laboratories Ltd (No. 319/06)

Servier Laboratories Limited has advised of their intention to make a resubmission for ivabradine (Procoralan) for the symptomatic treatment of chronic stable angina in patients with normal sinus rhythm who have a contra-indication or intolerance for beta-blockers.

6 PAPIG

6.1 Minutes from the previous meeting were circulated with the papers.

6.2 Website

The Chair of PAPIG had attended a meeting to discuss the Patient and Public Involvement section of the SMC website. This is in development and it is anticipated that the site will be more user friendly and the introduction of a feedback form will allow members of the public to voice their views regarding their experience of individual medicines.

6.3 Email Alert

The email alert system for subscribers to SMC was discussed.  It was confirmed that SMC provide regular updates regarding advice issued each month but subscribers are not alerted every time there is a change to the work programme.

6.4 Patient Interest Group Summaries

Clarity was sought regarding Patient Interest Group summaries. PAPIG members produce personal aides memoire to assist with the presentation of Patient Interest Group submissions and these do not form part of the paperwork.

7 New Drugs Committee: Chairman¡¦s report

7.1 NDC Membership

The NDC Chairman advised that after 3 years as an ABPI representative on the New Drugs Committee, Nick Bruce's, membership has now ended.  He will be replaced by Phil Booth, Head of HTAs, Amgen Ltd.

7.2 Training for NDC/SMC members

The NDC Chairman advised that by way of introductory training for new members of NDC and also to update and provide continuing development for existing members SMC are planning to hold a training session in early 2007 which will address economic and statistical analysis.  Discussion is underway with economic assessors on the content and format of the session and details will be made available in due course. Invitations will be extended to both NDC and SMC members.  The Chairman advised members that if they have any specific topics they would wish to have included on the programme, to contact the secretariat.

7.3 Size of recent Submission Documents

The NDC Chairman advised that concern has been expressed over the increasing size of submission documents in recent months. Whilst the existing guidance to manufacturers provides an indication of the word counts expected for each section of the New Product Assessment Form (NPAF) there is increasingly a trend for several large appendices to be supplied in addition to the NPAF.  The NPAF is no longer always in the form of a stand alone document, requiring the reader to scrutinize all supporting appendices to gain an understanding of the submission.  This issue has been raised at the User Group Forum and will be discussed further at the ABPI/SMC event on 17th November, when companies can discuss this in relation to 'How to make a Good Submission'.  It has been agreed that a working group will be set up to address the matter fully. 

8 Chairman¡¦s Business

8.1 Meeting Dates for 2007

The Chairman advised that a list of the meeting dates for 2007 were included with the paperwork for information. These remain the first Tuesday of each month, with the exception of the January meeting which will be held on Tuesday, 9 January 2007.

8.2 Visit from Representatives of the Welsh Medicines Partnership

The Chairman advised that representatives of the Welsh Medicines Partnership visited the SMC secretariat on Tuesday 18 September, 2006.  The main purpose of the visit was to see the administrative process and learn any lessons that would be useful to the Welsh system.  They met with key members of the secretariat and SMC Executive team. All aspects of the process as well as an overview of horizon scanning were discussed.   

8.3 NICE STAs ¡V NICE have recently issued an STA for rituximab and docetaxel

8.3.1 Rituximab: NICE STA has recommended rituximab for the first line treatment of follicular lymphoma, within its licensed indications (in combination with cyclophosphamide, vincristine and prednisolone or CVP) as an option for the treatment of patients with symptomatic stage III and IV follicular lymphoma who have previously been untreated.

SMC issued advice for rituximab (MabThera) in December 2004 accepting for use within NHS Scotland for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with cyclophosphamide, vincristine and prednisolone (CVP) chemotherapy. Rituximab is for use only by oncologists or haematologists who have expertise in treating lymphoma.  It should be administered in a hospital environment where full resuscitation facilities are available. Limited results show that rituximab plus CVP significantly increased the time to treatment failure compared with CVP alone.

8.3.2 Docetaxel: NICE STA has recommended docetaxel for the treatment of early breast cancer following surgery.  NICE recommended that Docetaxel, when given concurrently with doxorubicin and clylophosphamide (the TAC regime) in accordance with its licensed indication, is recommended as an option for the treatment of women with early node-positive breast cancer following surgery.

SMC issued advice for docetaxel (Taxotere„¥) in October 2005 accepting for use within NHS Scotland in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of operable, node-positive breast cancer. Docetaxel in combination with doxorubicin and cyclophosphamide was associated with a significant improvement in disease free survival at 5 years when compared with one of the standard treatment regimens. However, this benefit is associated with an increased risk of toxicity.  Docetaxel has demonstrated cost effectiveness in comparison to standard treatment regimen used in NHS Scotland.

Please note the NICE STA process has no status in Scotland.

8.4 Scottish Intercollegiate Guidelines Network (SIGN)

SIGN have recently issued guidelines for the diagnosis and management of peripheral arterial disease.  It was noted that reference is made to the SMC decision for cilostazol, for the treatment of intermittent claudication, although this is not quoted in full.

8.5 The Association of the British Pharmaceutical Industry (ABPI) Code

Clarity was sought regarding the SMC position if an ABPI member company was suspended for breaching the Prescription Medicine code of Practice. It was confirmed that this would have no implications for the SMC assessment process.

9 NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

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

9.1.1 Declarations of interest were recorded in relation to this product/comparator drug. A member with a personal non-specific interest left the meeting for this part of the agenda.

9.1.2 The SMC Vice Chairman 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 fludarabine phosphate (Fludara), for the treatment of B-cell chronic lymphocytic leukaemia (CLL) in patients with sufficient bone marrow reserve, 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.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 6 October 2006.

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

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

9.2.2 The NDC Vice Chairman 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 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, 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.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 6 October 2006.

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

9.3.1 Declarations of interest were recorded in relation to this product/comparator drug.

9.3.2 The NDC Vice Chairman provided a detailed 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 Breast Cancer Care. Detailed discussion followed and the group agreed that 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, 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.

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 6 October 2006.

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

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

9.4.2 The SMC Vice Chair provided a detailed 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 the National Rheumatoid Arthritis Society.  Detailed discussion followed and the group agreed that 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, 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.

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday, 6 October 2006.

RE-SUBMISSIONS

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

9.5.1 Declarations of interest were recorded in relation to this product/comparator drug. 

9.5.2 The NDC Chairman provided a detailed 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 temozolomide (Temodal), for the treatment of newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and subsequently as monotherapy treatment, for review at the November meeting of SMC.

ABBREVIATED SUBMISSIONS

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

9.6.1 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.

9.6.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group concluded their advice for vinorelbine capsules (Navelbine), for treatment of advanced breast cancer stage 3 and 4 relapsing after, or refractory to, an anthracycline-containing regimen.

9.6.3 The SMC advice will be withheld pending confirmation of launch.

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

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

9.7.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group concluded their 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).

9.7.3 The SMC advice will be withheld pending further information from the company.

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

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

9.8.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that 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, should be accepted for use within NHS Scotland.  Assessors, in liaison with the secretariat, to make appropriate amendments for review prior to distribution of the advice.

9.8.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 6 October 2006.

NON-SUBMISSIONS

9.9 docetaxel (Taxotere) Sanofi-Aventis UK (No 333/06)

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

9.9.2 In the absence of a submission from the holder of the marketing authorisation, docetaxel (Taxotere), for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease, was not recommended for use within NHSScotland.

9.9.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 6 October 2006.

10 Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

12 ADTC Feedback

Concern was raised regarding the budget impact section within the Detailed Advice Document for some of the drugs reviewed, and how accurate and reliable the manufacturers¡¦ estimates have been. It was agreed that these concerns would be addressed by the SMC evaluation team for further investigation.

13 Any Other Business

13.1 SMC User Group Forum (UGF)

The SMC User Group Forum met on Tuesday, 26 September 2006. Minutes of the meeting will be available at the next meeting of SMC.  The following items were noted:

13.2 Exit Strategies from Clinical Trials

Following discussion between 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.

13.3 Current Approval Statistics

There was concern that the approval rate appeared to have dropped, although it was felt that this may be due to the number of non-submissions issued.  The acceptance rate will be carefully monitored and an analysis undertaken at some stage in the future.

13.4 Comparator Products

Following a request from Industry to make comment in the advice box section of the Detailed Advice Document where SMC do not recommend a drug and where there are only unlicensed or off-label comparators, SMC consider it outwith their remit to advise or comment on the unlicensed use of medicines.

14 Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 7 November 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.