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SMC Minutes - Tuesday 2 December 2003

Minutes of Meeting
Held on Tuesday 2 December, 2003
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman), Dr Keith Beard, Mrs Marion Bennie, Professor Martin Brodie, Professor John Cairns, Mrs Michelle Caldwell, Mr Tom Divers, Dr Barclay Goudie, Dr David Hood, Ms Moira Howie, Dr Chris Lush, Professor Angus Mackay, Mrs Chris McBeath, Ms Wendy Nganasurian, Dr Marianne Nicholson,  Dr Ken Paterson, Dr Philip Rutledge, Dr Sandy Simpson, Ms Angela Timoney, Ms Helen Tyrrell, Professor David Webb, Dr John Webster, Dr Derek Yuille

In Attendance: Mrs Barbara Black, Dr Corri Black, Ms Joy Hosie, Mr Hector Mackenzie, Mr Rob MacPhail, Ms Ali McAllister, Mrs Jill Mitchell, Miss Rosie Murray, Dr James Oliver (clinical pharmacology observer), Dr Andrew Walker

Apologies: Mr Jeff Ace, Dr Harpreet KohliMr Chris NicolsonDr Brian PaiceMs Fiona ScottMr Mike WallaceDr Leslie Wilkie
  

1. Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting and apologies for absence were noted.  Dr Andrew Walker, Health Economic Assessor, New Drugs Committee, was welcomed as an observer.

1.2 Confidentiality

The Chairman reminded members of the confidentiality of proceedings and requested any media enquiries are channelled through the Communications Department of NHS Quality Improvement Scotland. 

1.3 SMC Paperwork

Due to difficulties with Royal Mail the Chairman requested those members who paid postage on receipt of SMC paperwork complete an expenses form and submit to the secretariat for reimbursement.

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 (04.11.03)

3.1 The minutes of the meeting of 4 November, 2003 were agreed as an accurate record.

4. Matters Arising From the Previous Minutes

4.1 Scottish Executive Directive regarding SMC Recommendations

4.1.1 The committee reviewed the Scottish Directive explaining the arrangements being put in place to strengthen the role of the SMC and to establish a new process to ensure the national implementation of innovative new drugs.  Drugs to be reviewed by SMC will be placed into one of the following categories:

  • Unique drugs for specific conditions, which, if approved by SMC, will be introduced into NHS Scotland to an agreed national programme.
  • Drugs for conditions where alternative drug treatments already exist which, if approved by SMC, the implementation will be subject to local NHS Board decision.

Discussion ensued regarding identification of 'unique' medicines.  The Chairman stated it is part of SMC remit to identify phraseology that is comprehensible and this will be addressed in the Frequently Asked Questions and Answers document which is on the SMC website.  The Chairman requested members forward suggestions to the secretariat for consideration.  He stated that budget impact would be more succinct than in the past and opinions more clearly focused. 

Mr Divers advised that Professor James Barbour, Chief Executive, Lothian NHS Board and Professor Tony Wells, Chief Executive, Tayside NHS Board, have been approached to join SMC to ensure a NHS Board Chief Executive will be present at SMC meetings to bring forward issues to the Scottish Executive.  Should they accept the invitation Professor Barbour and Professor Wells will be co-opted to the consortium until membership rotation in April and will become full members thereafter. 

4.2 Antibiotic Prescribing Policy

4.2.1 At the last SMC meeting members agreed the necessity to consider the specific remit of the group before finally agreeing to the proposal put forward.  The Chairman discussed the requirement with Dr Nathwani and presented the defined remit and proposed membership of the group to members for discussion and agreement.  This was agreed.  The Chairman will request Dr Nathwani take this Group forward and will feedback progress to SMC accordingly.

4.3 Christmas/New Year Event

4.3.1 An event for SMC and NDC members commencing with education presentations and followed by dinner will take place on Monday 2 February, 2004, in the Royal College of Physicians & Surgeons in Glasgow.  The routine SMC meeting on 3 February, 2004 will commence at the earlier time of 10.00 am.  Details will be confirmed at the January meeting. 

4.4 Adalimumab (Humira):  Abbott Laboratories Ltd  No 81/03

4.4.1 The recommendation for Adalimumab (Humira), for the treatment of rheumatoid arthritis, will be posted on the SMC website on Monday, 8 December 2003. 

4.5 Salmeterol/ Fluticasone (Seretide):  GlaxoSmithKline  No. 82/03

4.5.1 The recommendation for Salmeterol/ Fluticasone (Seretide), for the treatment of chronic obstructive pulmonary disease, will be posted on the SMC website on Monday, 8 December 2003. 

4.5.2 The company identified some factual errors which will be amended and circulated accordingly.

4.6 Testosterone (Testogel):  Schering Health Care Limited   No. 83/03

4.6.1  The recommendation for Testosterone (Testogel), for the treatment of testosterone replacement therapy, will be posted on the SMC website on Monday, 8 December 2003. 

4.6.2 A minor amendment was made to the wording within the final recommendation.  This will be circulated accordingly.

4.7 Teriparatide  (Forsteo):    Eli Lilly & Company Ltd  No. 71/03

4.7.1 The recommendation for Teriparatide (Forsteo), for the treatment of established (severe) osteoporosis in postmenopausal women, will be posted on the SMC website on Monday, 8 December 2003.

4.7.2 The company identified some factual errors which will be amended and circulated accordingly.   

4.8 Classification of Recommendations

4.8.1 The Chairman stated in light of the ministerial statement, recommendations would be reviewed to identify if they fit into the 'unique' category.

5. Appeals Update

5.1 Pimecrolimus Cream (Elidel)  No. 35.03:  Novartis

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.  The Chairman highlighted that NICE opinion regarding Pimecrolimus Cream (Elidel) is due in June 2004 and will supersede the advice of the IRP and SMC.  The company are aware of the position.

6. Correspondence

6.1. There was no correspondence to note.

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.  The Chairman encouraged members to attend.  The PAPIG Group is scheduled to meet after the SMC meeting and the minutes of their meeting will be available for review at the SMC meeting in January.

8. New Drugs Committee Update

8.1 Company Responses

8.1.1 The NDC Chairman stated it would be beneficial for the clinical and economic assessment team to be included in the distribution of company responses following the draft NDC recommendation, and to provide comments where necessary.  Assessors stated this would not unduly interfere with the assessment of new submissions. Company comments will therefore be routinely copied to assessors for review and comment.

9. NDC Assessment Reports - Full Submissions

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

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

9.1.2 The SMC Vice Chairperson 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 Propofol 1% (10mg/ml) Emulsion (Propofol-®Lipuro 1%), for the induction and maintenance of general anaesthesia, 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 5 December, 2003.

9.1.4 Prior to considering this individual product the Chairman asked members to note that it exemplified an unusual situation.   The product itself was not competitive at the current list price, but the licence holder had informed the secretariat of the nationally agreed hospital prices, at which level the product was competitive.   It is appropriate for members to take into account this contract price which is agreed nationally for all Scottish hospitals. The product itself is licenced as a hospital only product.  In this circumstance SMC can consider contract prices when assessing the product.

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

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

9.2.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified and the draft recommendation.  Detailed discussion followed and the group agreed that Pegylated liposomal doxorubicin HCl (PLD) (Caelyx), for the treatment of metastatic breast cancer, should be not be recommended for use within NHS Scotland.  Amendments to wording were noted.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 December, 2003.

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

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

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 Topiramate (Topamax), for the treatment of epilepsy, 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 5 December, 2003.

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

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

9.4.2 The SMC Vice Chairperson 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 Cancidas®  (Caspofungin MSD), for the treatment of invasive candidiasis in non-neutropenic adults, should be accepted for restricted use within NHS Scotland.  Amendments to wording were noted.

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 5 December, 2003.

NDC Assessment Reports - Abbreviated Submission

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

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

9.5.2 The NDC Chairman provided an overview of the assessment.  Entacapone (Stalevo), for the treatment of Parkinson's disease and end of dose motor fluctuations not stabilised on levodopa/dopa decarboxylase inhibitor treatment, should be accepted for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to presenting to SMC.

9.5.2 The SMC advice will be issued to ADTCs and NHS Boards on 5 December, 2003.

NDC Assessment Reports - Resubmission

9.6 Memantine (Ebixa):  Lundbeck  No. 57/03  

9.6.1 No declarations of interest were recorded in relation to this product and comparator drugs. 

9.6.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation, summary of comments received from the company and submission of evidence from a patient interest group.  Detailed discussion followed and the group agreed that Memantine (Ebixa), for the treatment of Alzheimer's disease, should not be recommended 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 5 December, 2003.

Independent Review Panel

9.7 Zoledronic Acid (Zometa):  Novartis  No. 29/03 

9.7.1 A declaration of interest was recorded in relation to this product. 

9.7.2 The Chairman thanked Dr Webster and SMC members of IRP for their invaluable input. 

9.7.3 Dr Webster, Chair of the IRP provided background information regarding the SMC process and how Zometa had reached a stage of review by the Independent Review Panel.  He stated whilst licence approval demonstrates the efficacy, safety and quality of Zoledronic acid, the role of the SMC was to provide advice regarding its clinical and cost effectiveness for use within NHS Scotland. Details regarding the previous submissions to SMC were highlighted. Detailed discussion followed.  The group agreed with the review of the IRP and concluded that Zoledronic Acid (Zometa), for the prevention of skeletal related events in patients with advanced prostate cancer involving bone should not be recommended for use within NHS Scotland.

9.7.4 The SMC advice will be issued to ADTCs and NHS Boards and members of the IRP on 5 December, 2003.

10. Forthcoming Submissions

10.1 List of Forthcoming Submissions

10.1.1. A revised list of forthcoming submissions was reviewed. 

11. ADTC Feedback

No ADTC feedback was reported.

12. Any Other Business

12.1. No other business was reported.

13. Date of Next Meeting

13.1 The date of the next meeting was confirmed as Tuesday, 6 January, 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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