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SMC Minutes - Tuesday 2 August 2005

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

Present: Dr Ken Paterson (Chairman), Dr Keith Beard, Mrs Barbara Black, Professor John Cairns, Mrs Michelle Caldwell, Dr David Crookes, Mr Tom Divers, Dr Peter Donnan, Dr Barclay Goudie, Dr John Haughney, Mrs Moira Howie, Dr Jan Jones, Dr Harpreet Kohli, Mrs Angela Munday, Ms Wendy Nganasurian, Mr Chris Nicolson, Ms Fiona Ramsay, Dr Andrew Riley, Dr Philip Rutledge, Ms Helen Tyrrell, Mr Mike Wallace, Dr John Webster, Mr Derek Yuille

In Attendance: Dr Jennifer Armstrong, Ms Ruth Ford, Mrs Anne Lee, Mr Hector Mackenzie, Ms Cathy McKerrel, Ms Aileen Muir, Miss Rosie Murray, Mr Patrick Maitland-Cullen, Mrs Maureen Stark

Apologies: Professor James Barbour, Dr Corri Black, Mr John Glennie, Dr David Hood, Dr Chris Lush, Mrs Laura McIver, Dr Marianne Nicholson, Dr Sandy Simpson, Professor David Webb

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 who were observing the work of the SMC:

  • Ms Ruth Ford, SMC Horizon Scanning Administrator
  • Ms Aileen Muir, NDC Member ¿ presenting cilostazol (Pletal)
  • Ms Cathy McKerrel, Project Manager, Representing Patient Interest Group - InContact, Scotland

1.3 Dr David Crookes, Medicines Management Advisor, Lothian and past NDC member was welcomed as a new member of SMC. 

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 (05.07.05)

3.1 The minutes of the meeting of 5 July, 2005, were agreed as an accurate record of the meeting with minor amendments noted.

4 Matters Arising From the Previous Minutes

4.1 Experts

Work is in progress to review the existing database and to 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.

FULL SUBMISSIONS

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

4.2.1 SMC advice for oxybutynin transdermal patches (Kentera), for the treatment of urge incontinence and/or increased urinary frequency and urgency in patients with unstable bladder, will be posted on the SMC website on Monday 8 August, 2005.

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

4.3.1 SMC advice for capecitabine (Xeloda), for the adjuvant treatment of patients following surgery for Stage III (Dukes' C stage) colon cancer, will be posted on the SMC website on Monday 8 August, 2005.

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

4.4.1 SMC advice for pemetrexed disodium (Alimta), for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma, will be posted on the SMC website on Monday 8 August, 2005.
   
4.4.2 Following comments from the company post-SMC minor amendments will be made to the DAD and reissued to NHS Boards and ADTCs on Friday 5 August, 2005.

4.4.3 The company have suggested that the product is given unique status.  SMC did not identify pemetrexed disodium (Alimta) as falling within this category, however comments have been noted and will be the subject of further discussion.

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

4.5.1 SMC advice for voriconazole (Vfend), for the treatment of candidaemia in non-neutropenic patients, will be posted on the SMC website on Monday 8 August, 2005

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

4.6.1 SMC advice for strontium ranelate (Protelos), for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures, will be posted on the SMC website on Monday 8 August, 2005

4.6.2 Following discussions post-SMC minor amendments will be made to the DAD and reissued to NHS Boards and ADTCs on Friday 5 August, 2005.

RESUBMISSION

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

4.7.1 SMC advice for pregabalin (Lyrica), for the treatment of peripheral neuropathic pain in adults, will be posted on the SMC website on Monday 8 August, 2005.
 
4.7.2 Pfizer have requested a meeting with representative of SMC to discuss the way forward following the SMC Advice.

ABBREVIATED SUBMISSIONS

4.8 carbomer gel 0.25% (Liquivisc)  Allergan Ltd  ((No: 191/05)

4.8.1 SMC advice for carbomer gel 0.25% (Liquivisc), for the symptomatic treatment of dry eye syndrome where a carbomer product is the treatment of choice, will be posted on the SMC website on Monday 8 August, 2005.

5 Appeals Update

5.1 Nothing to report.

6 PAPIG

6.1 The Minutes of the PAPIG meeting held on 5 July 2005 were reviewed. 

The PAPIG draft response to 'Refreshing the NHS QiS Patient and Public Partnership - A Reform Agenda' was discussed.  The Chairman stated that this was a thoughtful and considered response from PAPIG.  Members were asked to review the response and feedback comments to the secretariat for consideration and endorsement at the next SMC meeting. It was noted that the views of PAPIG may, on occasion, be independent and need not necessarily reflect the view of SMC as a whole. 

7 Freedom of Information

7.1 Nothing to report.

8 New Drugs Committee: Update

8.1 NDC Meeting - December 2005

The NDC meeting is scheduled for 27 December, 2005, a public holiday, and will therefore be moved forward to 20 December, 2005. 

9 Chairman's Business

9.1 tamsulosin (Flomaxtra XL), Yamanouchi Pharma Ltd - Abbreviated submission

9.1.1 Tamsulosin hydrochloride film-coated extended release tablets 400 microgram (equivalent to 367 microgram tamsulosin), for functional symptoms of benign prostatic hypertrophy as an alternative to modified release capsules) was reviewed by SMC in December 2004 and accepted for use in NHS Scotland, but advice was withheld pending confirmation of launch.  The product will launch on 15 August, 2005 and advice will be distributed to NHS Boards and ADTCs on Friday 5 August, 2005 and, with the agreement of the company, will be posted on the website on Monday 8 August.

10 NDC Assessment Reports - Full Submissions

10.1 anastrazole (Arimidex) AstraZeneca UK Ltd (No: 198/05)

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 company comments.  A member of the PAPIG presented a Patient Interest Group submission from Breast Cancer Care Scotland.  Detailed discussion followed and group agreed that anastrazole (Arimidex), for first-line therapy in the adjuvant treatment of postmenopausal women with oestrogen receptor- positive early invasive breast cancer, 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 5 August, 2005.

10.2 duloxetine (Cymbalta) Eli Lilly & Co Ltd/Boehringer Ingelheim (No: 195/05)

10.2.1 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 meeting.

10.2.2 The SMC Vice Chairman provided a detailed overview of the assessment, the draft advice and company comments.  A member of the PAPIG presented a Patient Interest Group submission from Depression Alliance Scotland.  Detailed discussion followed and group agreed that duloxetine (Cymbalta), for the treatment of major depressive episodes, 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.   

10.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 5 August, 2005.

10.3 oxycodone hydrochloride (OxyContin) Napp Pharmaceuticals Ltd (No: 197/05)

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

10.3.2 The SMC Vice Chairman provided a detailed overview of the assessment, the draft advice and company comments. Detailed discussion followed and group agreed that oxycodone hydrochloride (OxyContin) for the treatment of severe non-malignant pain requiring a strong opioid, 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 5 August, 2005.

RESUBMISSIONS

10.4 eflornithine 11.5% cream (Vaniqa) Shire Pharmaceuticals (No: 159/04)

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

10.4.2 The NDC Lead Assessor provided a detailed overview of the assessment, the draft advice and company comments. Detailed discussion followed and group agreed that eflornithine 11.5% cream (Vaniqa), for the treatment of facial hirsutism in woman, 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.

10.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 5 August, 2005

10.5 cilostazol (Pletal) Otsuka Pharmaceuticals (No: 86/04)

10.5.1 Declarations of interest were recorded in relation to this product/comparator drugs. The Chairman declared a personal specific interest and left the room for this part of the meeting.  The SMC Vice Chairman chaired the meeting for this part of the agenda.

10.5.2 The NDC Lead Assessor provided a detailed overview of the assessment, draft advice and company comments. Detailed discussion followed and group concluded their advice for cilostazol (Pletal), for improvement of the maximal and pain-free walking distances in patients with intermittent claudication, who do not have rest pain and who do not have evidence of peripheral tissue necrosis. 

It was however agreed that as the Diagnosis and Management of Peripheral Arterial Disease currently under review by the Scottish Intercollegiate Guidelines Network (SIGN), distribution of advice will be deferred until discussions have taken place with SIGN.  The outcome of discussions will be reported to SMC.

10.6 pioglitazone (Actos) Takeda (No: 115/04)

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

10.6.2 The NDC Vice Chairman provided a detailed overview of the assessment, draft advice and company comments. Detailed discussion followed and group agreed that pioglitazone (Actos), as monotherapy for type 2 diabetes mellitus patients in whom consideration is otherwise being given to commencing insulin therapy, 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.

10.6.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 5 August, 2005

ABBREVIATED SUBMISSIONS

10.7 brimonidine tartrate/timolol (Combigan) Allergan Ltd (No: 196/05)

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

10.7.2 The NDC Vice Chairman provided an overview of the assessment, draft summary of advice and company comments.  Discussion followed and the group agreed that brimonidine tartrate/timolol (Combigan), for the reduction of intra-ocular pressure in patients with chronic open-angle glaucoma or ocular hypertension, 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 5 August, 2005

11 Forthcoming Submissions
 
11.1 A revised list of forthcoming submissions was reviewed.

12 ADTC Feedback

12.1 Nothing to report.

13 Meeting Schedule 2006

13.1 The SMC Meeting schedule for 2006 was reviewed.

14 Any Other Business

14.1 There were no other items for discussion.

15 Date of Next Meeting

15.1 The date of the next meeting was confirmed as Tuesday 6 September, 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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