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SMC Minutes - Tuesday, 4 October 2005

Minutes of Meeting held on Tuesday 4 October 2005
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman) , Dr Keith Beard, Mrs Barbara Black, Dr Keith Brown, Professor John Cairns, Mrs Michelle Caldwell, Dr Barclay Goudie, Dr John Haughney,
Dr David Hood, Mrs Moira Howie, Dr Graham Lowe, Dr Jan Jones, Dr Harpreet Kohli, Dr Chris Lush, Mrs Pat Murray, Dr Marianne Nicholson, Mr Chris Nicolson, Dr Ken Paterson, Ms Fiona Ramsay, Dr Philip Rutledge, Dr Sandy Simpson, Ms Helen Tyrrell, Mr Mike Wallace, Dr John Webster, Mr Derek Yuille

In Attendance: Dr Jennifer Armstrong, Professor David Barnett, Dr Ross Camidge, Ms Sara Davies, Ms Catriona Gregory, Mrs Anne Lee, Dr Carole Longson, Mrs Laura McIver, Mr Patrick Maitland-Cullen, Aileen Muir, Miss Rosie Murray, Dr Jill Nelson, Mrs Maureen Stark, Dr Andrew Walker

Apologies: Professor James Barbour, Mr Tom Divers, Dr Peter Donnan, Mr John Glennie, Dr Grace Lindsay, Mr Hector Mackenzie, Mrs Angela Munday, Ms Wendy Nganasurian, Dr Andrew Riley, Mrs Fiona Scott
 

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:

  • Professor David Barnett, Chair Appraisals Committee (NICE)
  • Dr Carole Longson, Director, Centre for Health Technology Evaluation (NICE)
  • Ms Catriona Gregory, Senior Policy Development Manager, Department of Health NICE Liaison Unit
  • Dr Jill Nelson, Head of Clinical Effectiveness Co-ordinator Unit, NHS QIS
  • Dr Andrew Walker, Lead Economic Assessor, New Drugs Committee (NDC)

1.3 Dr Keith Brown, Consultant Psychiatrist, Forth Valley, and past NDC member was welcomed as a new member of SMC. 

1.4 Dr Ross Camidge, Clinical Lecturer in Medical Oncology and Clinical Pharmacology, Edinburgh Cancer Centre, Western General Hospital, Edinburgh, has been observing the work of SMC, but is taking up a post as Assistant Professor in the University of Colorado, Denver.  Dr Camidge was thanked for his input to the committee.

1.5 As a consequence of a change to job remit, Mr Hector Mackenzie has left SMC.  Dr Sara Davies will replace Hector at SMC and Mr Nick Brown will be the policy lead on clinical quality.  There is no date yet for the formal handover.  The Chairman expressed his thanks on behalf of the Committee to Hector for his invaluable contributions to 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 (06.09.05)

3.1 The minutes of the meeting of 6 September, 2005, were agreed as an accurate record of the meeting with minor amendments noted.

4 Matters Arising From the Previous Minutes

4.1 ABPI Meeting - From Clinical Trials to NHS Adoption - 15 September 2005

4.1.1 The NDC Chairman reported that this was an interesting meeting attended by representatives of SMC where issues surrounding the evolution of medicines from clinical trials to NHS usage was discussed. There was a clear understanding that exit strategies from clinical trials, and procedures to deal with compassionate use pre-licensing, must be developed and the outcome of the meeting was to produce a consensus statement which would be circulated when finalised and agreed to promote discussion of the issues. It was agreed comments should be feedback to the NDC Chairman and the ABPI will move forward with industry. The Chairman stated that he was impressed by the broad principles drawn out in the document and thanked those who attended the meeting for their input.


FULL SUBMISSIONS

4.2 diclofenac epolamine (Voltarol Gel Patches 1%)  Novartis  (No 199/05)
  
4.2.1 SMC advice for diclofenac epolamine (Voltarol Gel Patches 1%) for the local symptomatic treatment of pain in epicondylitis and ankle sprain, was withheld pending product launch.   However, following confirmation of product launch on 1 October, 2005, Advice will be distributed to NHSScotland on Friday 7 October and posted on SMC website on Monday 7 November, 2005.

4.3 glyceryl trinitrate 0.4% (Rectogesic Rectal Ointment) ProStrakan Group PLC (No: 200/05)
                               
4.3.1 SMC advice for glyceryl trinitrate 0.4% (Rectogesic Rectal Ointment), for the relief of pain associated with chronic anal fissure, will be posted on the SMC website on Monday 10 October, 2005.

4.4 docetaxel (Taxotere)  (Breast Cancer)  Sanofi-aventis  (No: 201/05)

4.4.1 SMC advice for docetaxel (Taxotere), for the adjuvant treatment of operable, node-positive breast cancer, will be posted on the SMC website on Monday 10 October, 2005.
   
4.5 bemiparin sodium  (Zibor)  Amdipharm (Nos 203/204/205/206)

4.5.1 SMC advice for bemiparin sodium (Zibor)  for the indications listed below will be posted on the SMC website on Monday 10 October, 2005.

  • Prevention of thromboembolic disease in patients undergoing general surgery
  • Prevention of thromboembolic disease in patients undergoing orthopaedic surgery
  • Prevention of clotting in extracorporeal circuit during haemodialysis
  • Treatment of established deep vein thrombosis, with or without pulmonary embolism, during acute phase  

RESUBMISSIONS

4.6 infliximab (Remicade)  Schering Plough (No: 101/04)
                                           
4.6.1 SMC advice for infliximab (Remicade), for the treatment of ankylosing spondylitis,  will be posted on the SMC website on Monday 10 October, 2005.
 
4.7 anagrelide hydrochloride (Xagrid)  Shire Pharmaceuticals  (No: 163//05)
    
4.7.1 SMC advice for anagrelide hydrochloride (Xagrid), for the reduction of elevated platelet counts in `at risk¿ patients with essential thrombocythaemia who are intolerant of their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy, will be posted on the SMC website on Monday 10 October, 2005.

INDEPENDENT REVIEW PANEL

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

4.8.1 SMC advice following IRP for cetuximab (Erbitux),  in combination with irinotecan for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy will be posted on the SMC website on Monday 10 October, 2005.

ABBREVIATED SUBMISSIONS

4.9 atorvastatin (Liptor)  Pfizer Ltd (No: 202/05) 

4.9.1 SMC advice for atorvastatin (Liptor),  as an adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides in children aged 10 years and older with primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia or combined (mixed) hyperlipidaemia when response to diet and other non-pharmacological measures is inadequate, will be posted on the SMC website on Monday 10 October, 2005.

4.10 triptorelin (Decapeptyl SR11.25mg)   Ipsen Ltd (No: 207/05) 

4.10.1 SMC advice for triptorelin (Decapeptyl SR11.25mg), for the treatment of endometriosis in patients for whom the use of triptorelin is appropriate and who would benefit from reduced frequency of administration compared with triptorelin 3mg injection every 4 weeks (Decapeptyl), will be posted on the SMC website on Monday 10 October, 2005.

5 Appeals update

5.1 Nothing to report.

6 PAPIG

6.1 The notes of the meeting of 6 September, 2005, will be reviewed at the November meeting of SMC.

7 New Drugs Committee: Update from Dr Ken Paterson

7.1 Nothing to report.

8 Chairman's Business

8.1 Freedom of Information

8.1.1 A request has been received via the secretariat for the SMC DAD for bortezomib (Velcade) for multiple myeloma.  This is being actioned accordingly with a deadline for response of 21 October, 2005.

8.2 Antimicrobial Prescribing Policy and Practice in Scotland - Recommendations for Good Antimicrobial Practice in Acute Hospitals

8.2.1 The report, produced for NHS Scotland by the SMC on behalf of the Ministerial HAI Task Force and was launched by the Scottish Executive on Monday 5 September 2005.  Copies were tabled for information.

8.3 Meeting with CEOs - 12 October, 2005

8.3.1 The Chairman is scheduled to attend a meeting of the CEOs on 12 October, 2005 and to give a presentation regarding SMC.  An update will be reported at the next meeting of SMC.

8.4 SIGN Council Meeting - 9 November, 2005

8.4.1 Representatives of SMC have been invited to attend SIGN Council meeting on 9 November, 2005.  An update will be reported at the December meeting of SMC.

8.5 SMC Conference - 10 October, 2005

8.5.1 There have been over 270 registrations for the October conference. An update will be reported at the next meeting of SMC.

8.6 Prix Galien Awards 2006

8.6.1 The Chairman has accepted an invitation to join the UK Board for the Prix Galien Awards.   This is an internationally recognised award within the pharmaceutical industry. It rewards outstanding achievement in research and development, and specifically in innovative research. 

9 NDC RECOMMENDATION REPORTS

DEFERRED SUBMISSION

9.1 cilostazol (Pletal) Otsuka Pharmaceuticals  (No. 86/04)

9.1.1 SMC Advice for cilostazol (Pletal), for the improvement of the maximal and pain-free walking-distances in patients with intermittent claudication, was deferred pending discussions with the Scottish Intercollegiate Guidelines Network (SIGN). Advice will now be issued to ADTCs and NHS Boards on Friday 7 October, 2005. 

9.1.2 SMC and SIGN now have a process in place to share information on their forthcoming work programmes.

9.2 palonosetron (Aloxi) Cambridge Laboratories/ Helsinn Healthcare SA  (No. 208/05) 

9.2.1 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 agenda.

9.2.2 The SMC Vice Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company. The group agreed that palonosetron (Aloxi), for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, 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.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 October, 2005.

9.3 docetaxel (Taxotere) -  Prostate Cancer  Sanofi-Aventis (No. 209/05) 

9.3.1 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.

9.3.2 The NDC Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company.  The group agreed that docetaxel (Taxotere) for the treatment of patients with hormone refractory metastatic prostate cancer (mHRPC), 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.   

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 October, 2005.

9.4 exemestane (Aromasin)  Pfizer  (No. 210/05)

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 draft advice, expert comments and comments received from the company. The group agreed that exemestane (Aromasin), for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer, following 2-3 years of initial adjuvant tamoxifen 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.   

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 October, 2005.

9.5 etanercept (Enbrel)  AS  Wyeth  (No. 212/05) 

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

9.5.2 The NDC Lead Assessor provided a detailed overview of the assessment, the draft advice, comments received from the company and Patient Interest Group Submission from the National Ankylosing Spondylitis Society (NASS). The group agreed that etanercept (Enbrel), for the treatment of severe active ankylosing spondylitis, 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.

9.5.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 October, 2005.

9.6 oxaliplatin (Eloxatin)  Sanofi-Aventis  (No. 211/05)

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

9.6.2 The NDC Vice Chairman provided a detailed overview of the assessment, the draft advice, expert comments, comments received from the company and Patient Interest Group Submission from Colon Cancer Concern (CCC). The group agreed that oxaliplatin (Eloxatin), for the adjuvant treatment of Stage III (Duke¿s C) colon cancer after complete resection of primary tumour, 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.

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 October, 2005.

RESUBMISSIONS

9.7 calcipotriol/betamethasone (Dovobet)  Leo Pharma  (No. 09/02) 

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

9.7.2 The SMC Vice Chairman provided a detailed overview of the assessment, the draft advice, expert comments, comments received from the company and Patient Interest Group Submissions from Psoriasis Scotland Arthritis Link Volunteers (PSALV), The Psoriasis Association and Psoriatic Arthritis Liaison Scotland. In view of the additional information submitted it was decided in order allow sufficient time to adequately review the additional information, although outwith routine SMC practice, to defer your submission for review at the next SMC meeting scheduled for Tuesday 1 November, 2005.  

9.8 solifenacin (Vesicare) Yamanouchi (No. 129/04) 

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

9.8.2 The NDC Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company. The group agreed that solifenacin (Vesicare), for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder, 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.   

9.8.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 October, 2005.

ABBREVIATED SUBMISSION

9.9 alendronate sodium/colecalciferol  (Fosavance)  Merck Sharp & Dohme Ltd (No. 213/05)

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

9.9.2 The NDC Chairman provided an overview of the assessment and draft summary of advice and comments received from the company. Discussion followed and the group agreed that alendronate sodium/colecalciferol  (Fosavance), for the treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency, 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.   

9.9.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 October, 2005

10 Forthcoming Submissions
 
10.1 A list of forthcoming submissions was tabled for review.  

10.2 The ABPI representative asked that in view of the current and growing workload were SMC confident that they would be able to deliver within the given timescales.  The Chairman advised that there is a resource issue within the secretariat and assessment teams and a request for additional resource and recurrent funding is being addressed as a matter of priority. 

11 ADTC Feedback

11.1 Nothing to report.

12 SMC User Group Forum (SMC UGF)

12.1 The minutes of the SMC UGF held on Tuesday 30 August, 2005, were tabled for review.

13 Any Other Business

13.1 Evaluation Programme

13.1.1 A paper detailing the evaluation programme was tabled for review and comment. It is proposed that the evaluation programme is achieved through a joint collaboration between SMC, ISD and NHS QIS. An identified lead officer from SMC and ISD would be jointly responsible for delivery of the programme and work with a small management group including representation from ISD, SMC and NHS QIS. There will be ex-officio representation from patients and the pharmaceutical industry on the management group. The lead officers from ISD, SMC and NHS QIS would report formally through their respective Executive Teams within each organisation.  Within ISD this work would be managed as part of the Medicines Utilisation Unit. It is recognized that the pharmaceutical industry may be able to provide extensive support and information for this programme, and SMC welcomes their co-operative approach. There will be quarterly meetings of the management group to monitor the evaluation programme. The reference group will meet every 6 months and be given formal progress reports at this stage. Progress of the group will be reported intermittently to SMC.

14 Date of Next Meeting

The date of the next meeting was confirmed as Tuesday 1 November, 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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