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SMC Minutes - Tuesday 6 January 2004

Minutes of Meeting
Held on Tuesday 6 January, 2004
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman); Mr Jeff Ace; Dr Keith Beard; Mrs Marion Bennie; Professor John Cairns; Mr Tom Divers; Dr Barclay Goudie; Dr David Hood; Ms Moira Howie; Professor Angus Mackay; Ms Wendy Nganasurian; Mr Chris Nicolson; Dr Marianne Nicholson; Dr Ken Paterson; Dr Philip Rutledge; Ms Fiona Scott; Ms Angela Timoney; Ms Helen Tyrrell; Dr Derek Yuille; Mr Mike Wallace; Professor David Webb; Dr John Webster

In Attendance: Mrs Barbara Black; Ms Joy Hosie; Dr Harpreet Kohli; Mr Hector Mackenzie; Mr Rob MacPhail; Mrs Jill Mitchell; Miss Rosie Murray

Apologies: Ms Corri Black; Professor Martin Brodie; Mrs Michelle Caldwell; Dr Chris Lush; Ms Ali McAllister; Mrs Chris McBeath; Dr Brian Paice; Dr Sandy Simpson; Dr Leslie Wilkie
  
1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting and apologies for absence were noted.   He thanked members for their work in 2003 and wished them a happy and healthy New Year.

2 Declarations of Interest

2.1 The Chairman requested members declare interests in the products to be discussed and the comparator drugs as noted on the assessment reports.

3 Minutes of the Previous Meeting (02.12.03)

3.1 The minutes of the meeting of 2 December, 2003 were agreed as an accurate record of the meeting.  The Chairman requested members note tabled minutes with amendments to section 4.1.1 and 9.1.4.

4 Matters Arising From the Previous Minutes

4.1 Training Day/SMC Dinner

4.1.1 A draft agenda for the SMC/NDC Educational Event was tabled for review.  This will take place on Monday 2 February, 2004, in the Royal College of Physicians & Surgeons in Glasgow followed by dinner in the evening. The routine SMC meeting on 3 February, 2004 will commence at the earlier time of 10.30 am.

4.2 Propofol 1% (10mg/ml) Emulsion (Propofol-®Lipuro 1%): B Braun Medical Ltd  No. 53/03

4.2.1 The recommendation for Propofol 1% (10mg/ml) Emulsion (Propofol-®Lipuro 1%), for the induction and maintenance of general anaesthesia, will be posted on the SMC website on Monday, 12 January, 2004.

4.3 Pegylated liposomal doxorubicin HCl (PLD) (Caelyx) :Schering-Plough Ltd  No.  84/03

4.3.1 The recommendation for Pegylated liposomal doxorubicin HCl (PLD) (Caelyx), for the treatment of metastatic breast cancer, will be posted on the SMC website on Monday, 12 January, 2004.

4.3 Topiramate (Topamax): Janssen-Cilag Ltd  No.  75/03

4.3.1 The recommendation for Topiramate (Topamax), for the treatment of epilepsy, will be posted on the SMC website on Monday, 12 January, 2004.

4.4 Caspofungin MSD (Cancidas®): Merck Sharp & Dohme Ltd (MSD)  No. 74/03

4.4.1 The recommendation for Caspofungin MSD (Cancidas®), for the treatment of invasive candidiasis in non-neutropenic adults, will be posted on the SMC website on Monday, 12 January, 2004.

4.4.2 It was noted that the wording within the recommendation for Caspofungin should state 'accepted' as opposed to 'recommended'.  The secretariat will amend accordingly.

4.5 Levodopa, carbidopa and entacapone (Stalevo): Orion Pharma (UK) Ltd  No. 85/03 Abbreviated Submission

4.5.1 The recommendation for Levodopa, carbidopa and entacapone (Stalevo), for the treatment of Parkinson's disease and end of dose motor fluctuations not stabilised on levodopa/dopa decarboxylase inhibitor treatment, will be posted on the SMC website on Monday, 12 January, 2004.

4.6 Memantine (Ebixa): Lundbeck  No. 57/03
Resubmission

4.6.1 The recommendation for Memantine (Ebixa), for the treatment of Alzheimer's disease, will be posted on the SMC website on Monday, 12 January, 2004.

4.7 Zoledronic Acid (Zometa): Novartis  No. 29/03
Independent Review Panel

4.7.1 The recommendation for Zoledronic Acid (Zometa), for the prevention of skeletal related events in patients with advanced prostate cancer involving bone, will be posted on the SMC website on Monday, 12 January, 2004.

5 Appeals Update

5.1 Pimecrolimus Cream (Elidel)  No. 35.03:  Novartis

5.1.1 Novartis have advised of their intention to seek an independent review following the SMC recommendation for Pimecrolimus Cream (Elidel).  A panel is currently being identified and it is anticipated a meeting will take place in April/May 2004.

6 Correspondence

6.1 Education in Safe and Effective Prescribing

6.1.1 The Chairman presented correspondence for information from Dr Simon Maxwell, Clinical Pharmacology Unit, University of Edinburgh, detailing education in safe and effective prescribing.  Also tabled for information was a paper written by the Chairman entitled 'Prescribing Errors:  The Way Forward' - A Personal Perspective.

6.2 Oseltamivir (Tamiflu), Roche

6.2.1 The Chairman updated the committee regarding the current position with regards to Oseltamivir (Tamiflu), advising that use of the product in accordance with NICE guidance should not be inhibited by the fact that SMC did not deem it necessary to repeat work already undertaken by NICE. SMC have communicated this statement to NHS Boards and ADTCs.

6.3 Guidelines on the Release of Company Data

6.3.1 A document detailing an agreement between ABPI and NICE on guidelines for the release of company data into the public domain during a health technology appraisal was tabled for review and comment.  The ABPI representative advised the document is the result of discussions which have taken place over the last year to address issues regarding companies submitting information they consider as commercial in confidence to NICE.  ABPI hope SMC would be willing to adopt a similar document, adapted to reflect SMC procedures and process.   The Chairman requested members review and forward comments to the secretariat for consideration at the next SMC meeting.

7 Patient and Public Involvement Group (PAPIG)

7.1 Registration for the patient event 'Patient Power' Making a Difference, scheduled for 23 January, 2004, has been positive with approximately 80 registrations to date.

8 New Drugs Committee Update

8.1 Industry Representatives - NDC

8.1.1 Two industry representatives have now joined the NDC as members and attended their first meeting of NDC in December.

9 NDC Assessment Reports ¿ Full Submissions

9.1 Travoprost 40 mg/ml eye drops solution (Travatan): Alcon Laboratories UK Ltd

9.1.1 No declarations of interest were recorded in relation to this product or comparator drugs.

9.1.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation and summary of comments received from the company.  Detailed discussion followed and the group agreed that Travoprost 40 mg/ml eye drops solution (Travatan), for the decrease of elevated intraocular pressure in patients with ocular hypertension or Open-angle Glaucoma, should be accepted for restricted use within NHS Scotland.  Amendments to wording were noted.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 9 January, 2004.

9.2 Fluvastatin XL (Lescol XL): Novartis Pharmaceuticals  (No. 76/04)

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

9.2.2 The SMC Vice Chairperson provided a detailed overview of the assessment, the key issues identified and the draft recommendation.  Detailed discussion followed and the group agreed that Fluvastatin XL (Lescol XL), for the secondary prevention of coronary events after percutaneous coronary intervention, should be accepted for restricted use within NHS Scotland.  Amendments to wording were noted.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 9 January, 2004. 

NDC Assessment Report ¿ Resubmission

9.3 Frovatriptan (Migard®):A. Menarini UK (No. 49/03)
Resubmission

9.3.1 Declarations of interest were recorded in relation to this product and comparator drugs.

9.3.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation and summary of comments received from the company.  Detailed discussion followed and the group agreed that Frovatriptan (MigardÒ), for the treatment of acute treatment of the headache phase of migraine attacks with or without aura, should be accepted for use within NHS Scotland. Amendments to wording were noted.

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 9 January, 2004.

10 Forthcoming Submissions

10.1 List of Forthcoming Submissions

10.1.1 A revised list of forthcoming submissions was reviewed.

11 ADTC Feedback

11.1 Unique Drugs

11.1.1 Advice was sought regarding identification and categorisation of unique drugs.  The Chairman stated that discussions on this topic are underway, the outcome of which will be reported in due course.

12 SMC User Group Forum

12.1 The minutes of the SMC User Group Forum were presented for information.

12.1.1 Clarification regarding advice and guidance on orphan drugs and the approach to be adopted was sought.   The Chairman stated that submissions to SMC for orphan products are anticipated and detailed debate will take place at that stage.  He anticipated that, on occasion, SMC might consider it appropriate to request NHS Scotland to fund selected orphan drugs before allocating monies pro rata to Health Boards.

12.1.2 The Chairman provided confirmation regarding the current use of experts and stated work is ongoing to refine the process.

13 Any Other Business

13.1 Relationship with SMC and NHS Quality Improvement Scotland

13.1.1 It was reported that arrangements regarding the collaboration between SMC and NHS QIS would be concluded by 31 March, 2004.

14 Date of Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 3 February, 2004, at 10.30 am (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

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