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SMC Minutes - Tuesday 5 July 2005

Minutes of Meeting held on Tuesday 5 July 2005
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman) , Professor James Barbour, Dr Keith Beard,
Ms Chris Beech, Mrs Barbara Black, Professor Martin Brodie, Professor John Cairns,
Mrs Michelle Caldwell, Dr Barclay Goudie, Dr Jan Jones, Dr Chris Lush, Mrs Angela Munday,
Ms Wendy Nganasurian, Dr Ken Paterson, Dr Philip Rutledge, Mrs Fiona Scott, Dr Sandy Simpson,
Ms Helen Tyrrell

In Attendance: Dr Jennifer Armstrong, Dr Ross Camidge, Ms Lindsay Kinnaird, Dr John Larkin,
Mr Hector Mackenzie, Dr Triona McCarthy, Dr John McElhinney, Mr Patrick Maitland-Cullen,
Mrs Laura McIver, Miss Rosie Murray, Mrs Maureen Stark

Apologies: Dr Corri Black, Ms Sandra Blevings, Mr Tom Divers, Dr Peter Donnan, Mr John Glennie, Dr John Haughney, Mrs Moira Howie, Dr David Hood, Dr Harpreet Kohli, Mrs Anne Lee,
Dr Marianne Nicholson, Mr Chris Nicolson, Ms Fiona Ramsay, Dr Andrew Riley, Mr Mike Wallace,
Dr John Webster, Mr Derek Yuille

1 Welcome and Apologies for Absence

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

A welcome was extended to the following who were observing the work of the SMC:

  • Ms Lindsay Kinnaird, Patient Interest Group observer representing Alzheimer Scotland
  • Dr John Larkin, Consultant Rheumatologist, Glasgow and New Drugs Committee member
  • Dr Triona McCarthy, SpR in Public Health, seconded to NHS QIS
  • Dr John McElhinney, General Practitioner, Fife and New Drugs Committee member

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 (07.06.05)

3.1 The minutes of the meeting of 7 June, 2005, were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1 Experts

4.1.1 Work is in progress to review the existing database, identify areas of clinical specialty which are not represented and move forward with the new process.  A set of generic questions have been presented to APBI for review and input.

The Scottish Medical and Scientific Advisory Committee (SMASAC) have agreed that SMC can request the expertise of their specialty advisers.  SMC will only call upon this group if they are experiencing difficulty identifying experts through the routine process.

Progress will be reported at the next meeting of SMC. 

4.2 Membership

4.2.1 The Chairman provided an update regarding new membership of SMC and NDC and thanked those who are leaving the committee for their commitment and support.  New members will commence membership over the next 3 months.

4.3 Orphan Drugs

4.3.1 Useful discussion has taken place internally regarding how to structure the planning of orphan drugs.  This will continue over the coming months and there will be further discussion at the SMC conference in October, 2005. 

4.4 SMC Brainstorming Event

4.4.1 The SMC Brainstorming Event took place on Tuesday 14 June, 2005.  This event provided an opportunity for open discussion on a variety of issues.  Brief action points arising from the issues discussed have been circulated to all members.

4.5 Non Submissions

4.5.1 The secretariat has communicated with companies who have not made a submission to SMC and the response and intention to submit has been positive.  SMC do not wish to disadvantage companies who have submitted on time and will schedule the follow-up submissions into the work programme accordingly.

FULL SUBMISSIONS

4.5 ciclesonide (Alvesco) Altana Pharmaceuticals Ltd (No: 184/05)  
  
4.5.1 SMC advice for ciclesonide (Alvesco), for the prophylactic treatment of persistent asthma in adults (18 years and older), will be posted on the SMC website on Monday 11 July, 2005. 

4.5.2 Following comparator comments minor amendments will be made to the DAD and reissued to NHS Boards and ADTCs on Friday 8 July, 2005.

4.6 montelukast (Singulair) Merck Sharp & Dohme Ltd (No: 185/05)
                                
4.6.1 SMC advice for montelukast (Singulair), for the symptomatic relief of seasonal allergic rhinitis (SAR) in adult patients in whom montelukast is indicated in asthma, as add-on oral therapy at steps 3 and 4 of the BTS/SIGN asthma guidelines, will be posted on the SMC website on Monday 11 July, 2005.

4.7 peginterferon alfa-2a (40KD) (Pegasys) Roche (No. 186/05)

4.7.1 SMC advice for peginterferon alfa-2a (40KD) (Pegasys), for the treatment of HBeAg-positive or HBeAg-negative chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, increased ALT and histologically verified liver inflammation and/or fibrosis, will be posted on the SMC website on Monday 11 July, 2005.
   
4.8 fosamprenavir (Telzir) GlaxoSmithKline (No. 188/05)

4.8.1 SMC advice for fosamprenavir (Telzir), in combination with low dose ritonavir for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults in combination with other antiretroviral medicinal products, will be posted on the SMC website on Monday 11 July, 2005.

4.8.2 Following comparator comments minor amendments will be made to the DAD and reissued to NHS Boards and ADTCs on Friday 8 July, 2005.

RESUBMISSION

4.9 strattera (Atomoxetine) Eli Lilly & Company Ltd (153/04)
                                           
4.9.1 SMC advice for strattera (Atomoxetine), for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children of 6 years and older or in adolescents, will be posted on the SMC website on Monday 11 July, 2005.
 
ABBREVIATED SUBMISSIONS

4.10 aripiprazole (Abilify) 5mg Bristol Myers Squibb Ltd (No. 187/05)
    
4.10.1 SMC advice for aripiprazole (Abilify), for the treatment of schizophrenia, will be posted on the SMC website on Monday 11 July, 2005.

4.11 transdermal fentanyl (Durogesic D Trans) Patches Janssen-Cilag Ltd (No. 189/05)  

4.11.1 SMC advice for, transdermal fentanyl (Durogesic D Trans), for patients with chronic intractable pain due to non-malignant conditions, will be posted on the SMC website on Monday 11 July, 2005.

DEFERRED DISTRIBUTION OF SUBMISSIONS

4.12 Reminyl XL Shire Pharmaceuticals (No: 139/04)

4.12.1 SMC advice for Reminyl XL, for the treatment of mild-to-moderately severe dementia in Alzheimer's disease in patients for whom therapy with galantamine is appropriate, was posted on the SMC website on Monday 13 June, 2005.

5 Appeals Update

5.1 cetuximab (Erbitux) (No: 155/05) Merck Pharmaceuticals

5.1.1 The Independent Review Panel (IRP) for cetuximab (Erbitux) has been scheduled for Thursday 4 August, 2005.  The findings of the IRP will be presented to SMC for review and final decision at their meeting on Tuesday 6 September, 2005.

6 Patient and Public Involvement Group (PAPIG)

6.1 The PAPIG met prior to SMC and the notes of the meeting will be presented at the next meeting of SMC for review.  

It was noted that PAPIG response to the NHS QiS consultation paper entitled 'Refreshing the NHS QiS patient and public partnership  - a reform agenda', will be issued with the paperwork for the next SMC meeting for review.  

Due to resource issues within the secretariat there are a number of items that have been on the agenda for some time, but it is anticipated these will be addressed and will move forward within the next couple of months.

It was noted that due to e-mail difficulties two Patient Interest Group submissions were not received by the secretariat for review by SMC.  Steps have been taken to ensure a similar situation does not recur.

7 Freedom of Information

7.1 There has been a request for information regarding Omacor for secondary prevention after MI, treatment of hypertriglyceridaemia.  The deadline for response is 7 July, 2005.

8 New Drugs Committee: Update

8.1 There were no items to report

9 Chairman's Business

9.1 SMC Conference

9.1.1 There has been an encouraging response to the SMC Conference with approximately 130 registrations to date.  The Chairman requested members register for the event as soon as possible in order to reserve a place. 

9.2 zoledronic acid (Zometa) (No: 29/02)

9.2.1 The Chairman provided an update regarding correspondence received from two Consultant Urologists in relation to the SMC advice for zoledronic acid (Zometa) and guidelines published by the British Association of Urological Surgeons.  A response has been made and it is hoped that future correspondence will be channelled appropriately.

9.3 2nd Annual Meeting of Health Technology Assessment International ¿ Rome, 20 June 2005

9.3.1 The NDC Chairman briefed members regarding his attendance at the HTAi annual meeting in Rome where he presented the Scottish Approach to Managing New Orphan Drugs and Rapid HTA for New Drug Therapies.  He reported that the feedback from the meeting was extremely positive with a high level of interest in the work of SMC and has made useful contacts with representatives of organisations currently carrying out or wishing to develop drug evaluation processes. 

9.4 European Association for Clinical Pharmacology and Therapeutics (EACPT) Meeting in Poznan - 27 June, 2005

9.4.1 The Chairman briefed members regarding this attendance at the EACPT meeting in Poznan where he presented an abstract, published in the Basic and Clinical Pharmacology and Toxicology, Volume 97, supplement 1, 2005.  This was well received and feedback was encouraging.

9.5 NHS QIS - Relocation Review

9.5.1 It has been announced that NHS QIS will relocate to the eastern half of Glasgow - location to be confirmed.  All NHS QiS staff and NHS Health Scotland will be located in Glasgow.  The move is expected to be complete by May 2007.  Regular progress reports will be provided.

9.6 SMC Meeting - 3 January

9.6.1 The January meeting of SMC is scheduled for 3 January, 2006.  As this is a public holiday and to avoid delays to the work programme members agreed to change the meeting to Wednesday 4 January, 2006.

10 NDC Assessment Reports - Full Submissions

10.1 oxybutynin transdermal patches (Kentera)  UCB Pharma Ltd  (No: 190/05)

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

10.1.2 The NDC Vice Chairman provided a detailed overview of the assessment, the draft advice and expert comments.  Detailed discussion followed and group agreed that oxybutynin transdermal patches (Kentera), for the treatment of urge incontinence and/or increased urinary frequency and urgency in patients with unstable bladder, should be accepted for restricted use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.  
 
10.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 July, 2005.

10.2 capecitabine (Xeloda)  Roche  (No: 193/05)

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

10.2.2 The NDC Vice Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company.  Detailed discussion followed and group agreed that capecitabine (Xeloda), for the adjuvant treatment of patients following surgery for Stage III (Dukes¿ C stage) colon cancer, should be accepted for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

10.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 July, 2005.

10.3 pemetrexed disodium (Alimta)  Eli Lilly & Company  (No: 192/05)

10.3.1 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.

10.3.2 The NDC Chairman provided a detailed overview of the assessment, the draft advice, expert comments, comments received from the company and Patient Interest Group submissions from the British Lung Foundation and Clydebank Asbestos Group.  Detailed discussion followed and group agreed that pemetrexed disodium (Alimta), for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma, should be accepted for restricted use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

10.3.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 July, 2005.

10.4 voriconazole (Vfend)  Pfizer Ltd  (No: 194/05)

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

10.4.2 The NDC Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company.  Detailed discussion followed and group agreed that voriconazole (Vfend), for the treatment of candidaemia in non-neutropenic patients, should be accepted restricted use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

10.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 July, 2005.

10.5 strontium ranelate (Protelos)  Servier Laboratories Ltd  (No: 178/05)

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

10.5.2 The NDC Vice Chairman provided a detailed overview of the assessment, the draft advice, expert comments, comments received from the company and a Patient Interest Group Submission from the National Osteoporosis Society.  Detailed discussion followed and group agreed that strontium ranelate (Protelos), for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures, should be accepted for restricted use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

10.5.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 July, 2005

RESUBMISSION

10.6 pregabalin (Lyrica)  Pfizer  (No: 157/05)

10.6.1 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.

10.6.2 The NDC Lead Assessor provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company. Detailed discussion followed and group agreed that pregabalin (Lyrica), for the treatment of peripheral neuropathic pain in adults, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

10.6.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 July, 2005

ABBREVIATED SUBMISSIONS

10.7 carbomer gel 0.25% (LIQUIVISC)  Allergan Ltd  ((No: 191/05)

10.7.1 No declarations of interest were recorded in relation to this product/comparator drugs.

10.7.2 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Discussion followed and the group agreed that carbomer gel 0.25% (LIQUIVISC), for the symptomatic treatment of dry eye syndrome where a carbomer product is the treatment of choice, should be accepted for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

10.7.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 July, 2005

11 Forthcoming Submissions

11.1 A revised list of forthcoming submissions was reviewed.  

12 ADTC Feedback

12.1 There were no items to report.

13 SMC User Group Forum

13.1 The minutes of the SMC User Group Forum were presented for review.  The Chairman suggested minor amendments which will be actioned accordingly.

14 Any Other Business

14.1 There were no other items for discussion.

15 Date of Next Meeting

The date of the next meeting was confirmed as Tuesday 2 August, 2005, at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

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