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SMC Minutes - Tuesday 7 September 2004

Minutes of Meeting
Held on Tuesday 7 September, 2004
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman), Mr Jeff Ace, Ms Chris Beech, Mrs Marion Bennie, Professor Martin Brodie, Dr Keith Beard, Mrs Barbara Black, Professor John Cairns, Dr Peter Donnan, Dr Barclay Goudie, Dr David Hood, Mrs Moira Howie, Dr Chris Lush, Professor Angus Mackay, Dr Marianne Nicholson, Mr Chris Nicolson, Ms Wendy Nganasurian, Ms Fiona Ramsay,  Dr Andrew Riley, Dr Philip Rutledge, Ms Angela Timoney, Ms Fiona Scott, Dr Sandy Simpson, Mr Mike Wallace, Professor David Webb, Dr John Webster

In Attendance: Mr Steven Fenocchi, Ms Joy Hosie, Dr Harpreet Kohli, Mr Rob MacPhail, Ms Laura McIver, Miss Rosie Murray, Mr Robert Peterson, Mrs Maureen Stark

Apologies: Professor James Barbour, Dr Corri Black, Ms Michelle Caldwell, Mr Tom Divers,
Mr John Glennie, Dr John Haughney, Ms Angela Munday, Dr Ken Paterson, Ms Helen Tyrrell,
Mr Derek Yuille 

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting and apologies for absence were noted.  Mr Robert Peterson, Finance Officer, Scottish Executive was welcomed as an observer.  Maureen Stark, who recently joined the SMC secretariat as Co-ordinator, was also welcomed. 

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 (03.08.04)

3.1 The minutes of the meeting of 3 August, 2004, were agreed as an accurate record of the meeting with an amendment to No 7.1.1. 

Change to:  It was reported that the Patient Interest Group Guidance and Submission Template is currently being revised.  This will be approved through PAPIG and the revised version posted on the SMC website.

4 Matters Arising From the Previous Minutes

4.1 Relationship with SMC and NHS Quality Improvement Scotland

4.1.1 This part of the meeting was confined to members only.

The Chairman outlined the continual difficulties both with the administrative arrangements for SMC and in the lack of a final agreed budget for the current financial year.

He drew members attention to the recent surge in applications for SMC consideration and noted that under present arrangements some of these could not be dealt with until four meetings hence - a situation which was unacceptable to all and could give rise to 'SMC blight'.

It was agreed unanimously that he should take all possible steps to rectify the position speedily, as failure to do so would inevitably have undesirable long term consequences for the effectiveness of SMC in the eyes of both patients, of Health Boards and ADTCs and of the pharmaceutical industry. 

Given the success of SMC to date, it would be tragic were its continued existence to be undermined by lack of a clearly defined baseline administrative structure and the necessary attendant financial under-pinning.

4.2 Freedom of Information

4.2.1 Paul Gibbons, Consultant working with SMC regarding Freedom of Information, updated members on developments.  Following a meeting with staff from the Freedom of Information Commissioner¿s office, it was confirmed that SMC is not specifically noted within the listing of the Publication Scheme.  As SMC is not separately constituted as a public body its responsibilities under the FOI Act will be discharged through the 15 NHS Boards whose Area Drug and Therapeutics Committees are closely linked to SMC. SMC will therefore adhere to the regulations of the scheme via Health Boards who would have responsibility for ensuring access to information as part of their policy framework.

The 15 Health Boards have all adopted a Model Publication Scheme (MPS) prepared by NHS and SEHD representatives and approved by the Commissioner. It is proposed that a request will be put forward to the National Steering Group to insert a phrase relating to SMC advice in whichever of the classes of information deemed appropriate.

It is imperative that the SMC Detailed Advice is operational in the public domain when the act comes into force in January, 2005. 

A further meeting of the FOI Sub Group is scheduled for Tuesday 5 October, 2004, and members will be updated on developments.

4.3 Public Domain Working Group

4.3.1 Further to discussions and the objective to publish the 6 page recommendation document, which has been renamed 'SMC Detailed Advice', representatives of the clinical and economic assessment team, led by Laura McIver, met with two company representatives who volunteered to pilot recommendations that have been through the SMC process.  Documentation was reviewed and agreement secured regarding core pieces of information, language style, explanation notes and criteria for use in the production of the advice documentation, to be shared in the public domain.  The document was reviewed and comments received from the SMC User Group Forum at their meeting in August. SMC members reviewed the document and agreed that it should now be issued to ABPI to allow industry the opportunity to raise any issues.  SMC will then consider for final approval.  The NDC assessment team will use the document with immediate effect.  The Chairman thanked all those involved for their invaluable input to the group and stated that it is a significant step forward.

4.4 Scottish Antimicrobial Prescribing Policy and Practice Group

4.4.1 Further to discussions at the last meeting regarding the recommendations for good antimicrobial practice in acute hospitals, members reviewed the revised document and accepted all amendments.  This will now be forwarded to the Chief Medical Officer for comment prior to distribution to Area Boards, ADTCs, CMO, NHSQiS and several bodies responsible for education of current and future prescribers.

4.5 Implementation of Unique Drugs Policy

4.5.1 Further to discussions regarding Etanercept, a short life working group has been set up to make recommendations to Boards about which patients should receive Etanercept, at what stage in their illness and for how long the therapy should continue.  The first meeting of the group is scheduled for 29 September, 2004.  Progress will be reported at the next meeting.  ADTCs should aim to introduce this product for use as soon as practical.

FULL SUBMISSIONS

4.6 buprenorphine (Transtec matrix patches): Napp Pharmaceuticals Limited (No.116/04)

4.6.1 SMC advice for buprenorphine (Transtec matrix patches), for the treatment of severe pain, will be posted on the SMC website on Monday 13 September, 2004.

4.7 rabeprazole sodium (Pariet): Janssen-Cilag/Eisai (No. 118/04)

4.7.1 SMC advice for rabeprazole sodium (Pariet), the treatment of gastro-oesophageal reflux disease, will be posted on the SMC website on Monday 13 September, 2004.

4.8 duloxetine (Yentreve):  Eli Lilly and Co Ltd/ Boehringer Ingelheim  (No. 119/04) 

4.8.1 SMC reviewed duloxetine (Yentreve), for the treatment of stress urinary incontinence in August, 2004.  As the licence was not confirmed distribution of the recommendation was withheld.  A licence has now been received and advice will be distributed on the SMC website on Monday 11 October, 2004. 
 
4.9 atazanvir (Reyataz): Bristol-Myers Squibb Pharmaceuticals Limited  (No. 120/04)

4.9.1 SMC advice for atazanvir (Reyataz), for the treatment of HIV, will be posted on the SMC website on Monday 13 September, 2004.

4.10 valsartan/hydrochlorothiazide (Co-Diovan): Novartis Pharmaceuticals  (No.  121/04)

4.10.1 SMC advice for valsartan/hydrochlorothiazide (Co-Diovan), for the treatment of essential hypertension, will be posted on the SMC website on Monday 13 September 2004.  It was noted that a launch date for the lower strength, 80/12.5, is yet to be confirmed. 

5 Appeals Update

5.1 The following companies have advised of their intention to resubmit following negative recommendations for their products:

  • AstraZeneca: fulvestrant (Faslodex), No 114/04, for the treatment of postmenopausal women with advanced breast cancer.
  • Napp Pharmaceuticals Limited:  buprenorphine (Transtec matrix patches), No.116/04, for the treatment of moderate to severe cancer pain and severe pain that does not respond to non-opioid analgesics.
  • Gilead Sciences International Ltd: adefovir dipivoxil (Hepsera), No: 54/03, oral therapy for the treatment of chronic hepatitis B.

6 Correspondence

6.1 There was no correspondence to note.

7 Patient and Public Involvement Group (PAPIG)

7.1 Meetings scheduled with SIGN to discuss issues regarding patient and public involvement have been cancelled.  Developments will be discussed at a future meeting. 

It was noted that not all Patient Interest Groups are using the new documentation which includes a section to state declarations of interest.  The secretariat will contact groups who make submissions on the old documentation and request declarations are submitted and highlight that new documentation is available for future submissions.

Following discussions at the last meeting regarding indemnity for members of patient interest groups to attend SMC in observer capacity, the CLO have advised that it is sufficient for such representatives to complete a confidentiality agreement.  The CLO will provide the relevant agreement for use.  Representatives from Patient Interest Groups who have made a submission to SMC will be invited to attend SMC, with no more than one representative per meeting.
 
8 New Drugs Committee Update

8.1 Resignation of Dr R Brown
 
8.1.1 Dr R Brown has resigned from NDC, due to conflicting work commitments.  Steps are being taken to secure a replacement member. The Chairman has written to thank Dr Brown for his services to NDC.

8.2 SMC User Group Forum

8.2.1 Dr Keith Brown, has replaced Dr R Brown as NDC representative on the SMC User Group Forum.
 
9 NDC Assessment Reports - Full Submissions

9.1 ibandronic acid (Bondronat) - HCM : Roche (No. 122/04)

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

9.1.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and comments received from the company.  Detailed discussion followed and the group agreed that ibandronic acid (Bondronat) ¿ HCM, for the treatment of tumour-induced hypercalcaemia with or without metastases, should be accepted for use within NHS Scotland. Amendments to wording were noted.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 September, 2004.
 
9.2 ibandronic acid (Bondronat) ¿ MBD:  Roche (No. 123/04)

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

9.2.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and comments received from the company.  Detailed discussion followed and the group agreed that ibandronic acid (Bondronat) ¿ MBD, for the treatment of metastatic bone disease, should be accepted for use within NHS Scotland. Amendments to wording were noted.

9.2.3 he SMC advice will be issued to ADTCs and NHS Boards on 10 September, 2004.

9.3 oxycodone (OxyNorm®):  Napp Pharmaceuticals (No. 125/04)

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

9.3.2 The SMC Vice Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and comments received from the company.  Detailed discussion followed and the group agreed that oxycodone (OxyNorm®), for on-demand treatment of moderate to severe pain in patients with cancer, should be accepted for restricted use within NHS Scotland. Amendments to wording were noted

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 September, 2004.

9.4 bortezomib (Velcade): Ortho Biotech  (No. 126/04)

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

9.4.2 The SMC Vice Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation and comments received from the company. Detailed discussion followed and the group agreed that bortezomib (Velcade), for the treatment of patients with multiple myeloma, should be accepted for use within NHS Scotland.  Amendments to wording were noted.

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 September, 2004.

9.5 esomeprazole IV (Nexium): AstraZeneca (No. 124/04)

9.5.1 Declarations of interest were recorded in relation to this product/comparator drugs.  A member with a personal specific interest left the room for this part of the agenda.  

9.5.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation.  Detailed discussion followed and the group agreed that esomeprazole IV (Nexium), for on-demand treatment of gastroesophageal reflux, should be accepted for use within NHS Scotland. Amendments to wording were noted.

9.5.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 September, 2004.

ABBREVIATED SUBMISSION

9.6 sumatriptan succinate (Imigran Radis):  GlaxoSmithKline  (No. 127/04)

9.6.1 Declarations of interest were recorded in relation to this product/ comparator drugs.
 
9.6.2 The SMC Vice Chairman provided an overview of the assessment, the key issues identified and the draft summary recommendation. Discussion followed and the group agreed that sumatriptan succinate (Imigran Radis), for the treatment of migraine, should be accepted for use within NHS Scotland. Amendments to wording were noted.

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 September, 2004

10 Forthcoming Submissions
 
10.1 A revised list of forthcoming submissions was reviewed. Concern was expressed regarding the recent surge in applications for consideration by SMC and it was noted that review of some of the submissions would be subject to delay.  SMC are currently addressing the backlog of submissions. 

11 ADTC Feedback

11.1 Etanercept

11.1.1 oncern was expressed regarding the delay in setting up a working group to make recommendations for the implementation of Etanercept and advice was sought on how to proceed in the meantime. The Chairman apologised for the delay and advised that Boards should proceed as soon as practical. He advised that it is anticipated that in future drugs that fall within the category of unique treatment are identified in advance and steps will be taken to set up a group to agree a protocol and therefore counteract delays.

11.2 Products that have not been submitted for Approval

11.2.1 The Chairman advised that the secretariat is aware of several marketed products that have not been submitted to SMC for assessment and steps are underway to address this issue.
 
12 SMC User Group Forum

12.1 Minutes of the meeting were presented for information.  

Work towards the publication of the SMC detailed advice is a major step forward.  It was however noted that there was concern regarding challenges in the event of a competitor feeling that incorrect comparator data has been used.  Members of the group were advised that it is the responsibility of the applicant company and if debate arose this would be disputed between companies.

The group are keen to encourage applications for multiple indications for a single product and for extended use of abbreviated submissions and would support this proposal and work with SMC to take these developments forward.  This was accepted for early introduction.

13 SMC Industry Day

13.1 The SMC Industry Day has been scheduled for Monday 6 December, 2004, to be held in the Carlton Hotel, Edinburgh. The agenda is being finalised and the programme with registration details will be posted on the SMC website within the next couple of weeks.

14 Any Other Business

14.1 Replacement for Trevor Jones, Chief Executive, NHS Scotland

Following Mr Jones's resignation, Mr Ian Gordon, Director of Service Policy and Planning has been appointed as Head of the Department and Chief Executive of the NHS on an acting basis.  Mr Peter Bates, Chairman of NHS Tayside will act in support to Mr Gordon. 

14.2 Evaluation Process

The Chairman advised that the evaluation process is ongoing.  Developments will be reported at a future meeting.

14.3 Backlog of Submissions for Assessment

In view of the backlog of submissions for assessment and the absence of the January meeting of SMC in 2005, a request for made for the December meeting of SMC to be extended should this enable more products to be reviewed. The Chairman will investigate the possibilities for this to occur, were we in a position to review more products in the interval.

14.4 Freedom of Information - Disposal of Paperwork

A member expressed concern regarding disposal of policy aspects of paperwork in the light of Freedom of Information.  The Chairman advised that members will be kept informed of developments and necessary actions as these occur.  It was noted that all papers relevant to policy issues should be retained by members if so desired.

15 Date of Next Meeting

15.1 The date of the next meeting was confirmed as Tuesday 5 October, 2004, 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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