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SMC Minutes - Tuesday 7 October, 2003

Minutes of Meeting
Held on Tuesday 7 October, 2003
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman), Mr Jeff Ace, Mrs Marion Bennie, Mrs Barbara Black, Professor Martin Brodie, Professor John Cairns, Mrs Michelle Caldwell, Dr Barclay Goudie, Dr David Hood, Ms Moira Howie, Professor Angus Mackay, Mrs Chris McBeath, Ms Wendy Nganasurian, Dr Marianne Nicholson (part meeting), Dr Ken Paterson, Dr Philip Rutledge, Ms Fiona Scott, Dr Sandy Simpson,  Ms Angela Timoney, Mr Mike Wallace, Professor David Webb, Dr John Webster, Dr Leslie Wilkie, Dr Derek Yuille

In Attendance: Mr Hector Mackenzie, Mr Rob MacPhail, Ms Ali McAllister, Miss Rosie Murray, Dr James Oliver (clinical pharmacology observer)

Apologies: Dr Keith Beard, Dr Corri Black, Mr Tom Divers, Dr Chris Lush, Mrs Jill Mitchell, Mr Chris Nicholson, Dr Brian Paice, Ms Helen Tyrrell
  
1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting and apologies for absence were noted.  

Dr James Oliver, Clinical Pharmacology Trainee, Clinical Research Centre, Department of Medical Sciences, University of Edinburgh, was welcomed to the meeting as an observer and will attend the next two consecutive meetings.  The Chairman advised members that Dr Hugh Whyte, Scottish Executive Health Department, has moved on from his post within the Scottish Executive and has resigned from SMC.

1.2 All Wales Medicines Strategy Group

1.2.1 The Chairman reported that he had met with Professor Roger Walker, Director of Pharmaceutical Public Health, Gwent Health Authority and Chairman of the All Wales Medicines Strategy Group to discuss procedures adopted by the SMC.  Professor Philip Routledge, Professor of Clinical Pharmacology & Medical Director, Welsh Medicines Partnership was unable to attend the meeting but has been formally invited to attend the SMC/ABPI Industry Briefing Meeting on 3 November, 2003, and also attend SMC on 4 November, 2003, as an observer.

 
1.3 Industry Members ' New Drugs Committee

1.3.1 Due to the success of industry members on SMC, two members have been nominated to join NDC.  Members agreed with this development and invitations to join NDC will be sent to these individuals in the near future. It is anticipated they will commence membership in January 2004.

1.4 Industry Briefing Meeting ' 3 November, 2003

1.4.1 The response to the Industry Briefing Day has been positive with approximately 80 registrations to date.

2. Declarations of Interest

2.1 The Chairman requested 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 (02.09.03)

3.1 The minutes of the meeting of 2 September, 2003 were agreed as an accurate record with the following amendment noted:

No. 7.3:  Change Patient Involvement Group to Patient Interest Group.

4. Matters Arising From the Previous Minutes

4.1 Zaditen (Ketotifen hydrogen fumarate):  Novartis  No. 65/03

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

4.1.2 Following correspondence from Novartis outlining the company's intention not to make a submission to SMC in relation to Ketotifen (Zaditen®), for the symptomatic treatment of seasonal allergic conjunctivitis, the consortium agreed to issue a negative recommendation. The SMC recommendation will be circulated to NHS Boards and ADTCs in the usual manner.

4.1.3 The SMC will take this action with any company who do not intend to submit a product for assessment following a request for a submission.

4.2 Avonex Liquid (Interferon Beta 1A):  Biogen Ltd  No. 58/03 Abbreviated Submission

4.2.1 The SMC recommendation for Avonex Liquid (Interferon Beta 1A), for the treatment of selected ambulatory patients with relapsing-remitting multiple sclerosis, will be distributed to NHS Boards and ADTCs on Friday 10 October, 2003.  The Chairman reminded members that this product was reviewed  by SMC in July, but distribution of its advice was withheld until launch of the product.

4.3 Wording of Recommendation Categories

4.3.1 Following reports that the terminology used by SMC has been causing confusion amongst some users, the media and the pharmaceutical industry, the SMC Vice Chairperson presented a report detailing proposals for changing the naming of the recommendation categories.  Following intensive discussion at NDC and input from the Patient and Public Involvement Group, SMC User Group Forum and individual members of SMC, ideas were collated and are now presented for consideration.

It is proposed that changes are made in the way that advice is presented.

· It is recommended that a paragraph be inserted requiring all who quote or refer to SMC advice to quote the entirety of the advice.

· A statement is inserted specifying whether the advice has been issued following a full or abbreviated submission.

· Three categories of recommendation should be used; accepted, accepted for restricted use, not recommended.

· If a product is to be restricted in its use, the nature of the restriction should be stated in the paragraph of 'Reasons for Advice'.

· Stock phrases should be used in the explanatory paragraph to ensure clarity and consistency.

Detailed discussion followed and the group agreed it was a satisfactory move from the current terminology and accepted the suggested categories to be used on all recommendations from this point forward. 

The paper will be forwarded to NHS Boards and ADTCs detailing the background to the changes and defining the new categories.  The ABPI representative asked for permission to distribute to Industry and this was agreed.  It was stated if companies do not present the recommendations appropriately within marketing material this would be recognised as a breach of code of practice. The paper will also be posted on the SMC website.

The SMC Vice Chairperson was thanked for her considerable work and effort in developing the paper.

4.4 Modafinil (Provigil): Cephalon No. 63/03

4.4.1 The recommendation for Modafinil (Provigil) will be posted on the SMC website on Monday, 13 October 2003.

4.5 Moxifloxacin (Avelox) in CAP: Bayer  No. 69/03

4.5.1 The recommendation for Moxifloxacin (Avelox) in CAP will be posted on the SMC website on Monday, 13 October 2003.

4.6 Moxifloxacin (Avelox) in AECB:  Bayer  No. 70/03

4.6.1 The recommendation for Moxifloxacin (Avelox) in AECB will be posted on the SMC website on Monday, 13 October 2003.

4.6.2 It was noted that the indication is not defined within the final recommendation and this will therefore be amended to reflect the indication.

4.7 Pegfilgrastim (Neulasta):  Amgen  No. 67/03

The recommendation for Pegfilgrastim (Neulasta) will be posted on the SMC website on Monday, 13 October 2003.

4.8 Calfovit D3: Trinity Pharmaceuticals Ltd No. 72/03 Abbreviated Submission

4.8.1 The recommendation for Calfovit D3 will be posted on the SMC website on Monday, 13 October 2003.

4.9 Zispin Soltab  (Mirtazapine): Organon  No. 66/03 Abbreviated Submission

4.9.1 The recommendation for Zispin Soltab (Mirtazapine) will be posted on the SMC website on Monday, 13 October 2003.

5. Appeals Update

5.1 Zoledronic Acid (Zometa), Novartis, No. 29/02

It was noted that the independent review panel would meet on Monday, 27 October 2003 and the results of this review would be presented to SMC thereafter.

6. Correspondence

6.1 There was no correspondence to note.

7. Patient and Public Involvement Group (PAPIG)

7.1 The SMC website now has links to the electronic medicines compendium.

7.2 The NHS QIS/ABPI Patient Involvement Group Training event, Patient Power - Making a Difference, has been scheduled to take place on 23 January, 2004 in the Royal College of Physicians, Glasgow. The programme is currently being finalised.

8. New Drugs Committee Update

There was nothing to update from the NDC. 

9. NDC Assessment Reports - Full submissions

9.1 Sertraline (Lustral):  Pfizer Ltd  No. 68/03

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

9.1.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and summary of comments received from the company.  Detailed discussion followed and the group agreed that Sertraline (Lustral) for the treatment of post-traumatic stress disorder (PTSD) in women should not be recommended for use within NHS Scotland. Minor amendments to wording were noted.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 October 2003.

9.2 Olmesartan Medoxomil (Olmetec): Sankyo Pharma UK Ltd  No. 78/03

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

9.22 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 Olmesartan Medoxomil (Olmetec), for the treatment of essential hypertension, should be accepted for restricted use within NHS Scotland. Minor amendments to wording were noted.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 October 2003.

9.3 Mometasone furoate (Asmanex Twisthaler):  Schering-Plough Ltd  No: 79/03

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

9.3.2 The SMC Vice Chairperson provided a detailed overview of the assessment, the key issues identified and the draft recommendation and submission of evidence from the National Asthma Campaign. Detailed discussion followed and the group agreed that Mometasone furoate (Asmanex Twisthaler), for the treatment of asthma, should be accepted for restricted use within NHS Scotland. Minor amendments to wording were noted.

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 October 2003.

9.4 Botulinum toxin type A (Botox): Allergan Ltd  No: 80/03

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

9.4.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and summary of comments received from the company.  Detailed discussion followed and the group agreed that Botulinum toxin type A (Botox), for the treatment of focal spasticity of the wrist and hand associated with stroke in adults, should not be recommended for use within NHS Scotland. Minor amendments to wording were noted.

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 October  2003.

NDC Assessment Reports - Resubmissions

9.5 Pimecrolimus (Elidel Cream 1%): Novartis  No. 35/03 Resubmission

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

9.5.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and summary of comments received from the company, including budget impact figures and correspondence from dermatologists. Detailed discussion followed and the group agreed Pimecrolimus (Elidel Cream 1%) for treatment for prevention of progression to flares of mild to moderate atopic dermatitis (eczema) in patients aged 2 years and over, should not be recommended 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 October 2003.

9.6 Methyl aminolevulinate (Metvix cream) Actinic Keratoses:  Galderma No. 50/03 Resubmission

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

9.6.2 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 Methyl aminolevulinate (Metvix cream) for the treatment of actinic keratoses, should be accepted for use within NHS Scotland. Minor amendments to wording were noted.

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 October 2003.

9.7 Methyl aminolevulinate (Metvix cream) Basal Cell Carcinoma:  Galderma No. 51/03  Resubmission

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

9.7.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified, draft recommendation and summary of comments received from the company. Detailed discussion followed and the group agreed Methyl aminolevulinate (Metvix cream), for the treatment of basal cell carcinoma, should be accepted for restricted use within NHS Scotland. Minor amendments to wording were noted.

9.7.3 The SMC advice will be issued to ADTCs and NHS Boards on 10 October 2003.

10 Forthcoming Submissions

10.1 List of Forthcoming Submissions

A revised list of forthcoming submissions was reviewed.

11 ADTC Feedback

The Chairman has commenced a round of visits to ADTCs and reported favourable feedback for the succinctness of SMC advice.

12 Meeting Schedule 2004

12.1 A list of meeting dates for 2004 was presented.  The Chairman advised the proposal for new membership will be presented to the members of the NHS Quality Improvement Scotland Board at their meeting in November, 2003, for consideration.  Feedback will be reported to SMC in December.

13 Any Other Business

13.1 Declarations of Interest

In preparation for the SMC 2003 Annual report, the secretariat will communicate with members to request updated declarations of interest, designations, etc.

13.2 Identification of Changes within Resubmission AssessmentsFor ease of reference, it was requested a brief narrative defining changes within resubmissions is added to the assessment documentation.  The secretariat to request Pharmatrak provides this.

13.3 Christmas/New Year Event

It is proposed to hold a social event for SMC/NDC members in early January 2004, to thank members for their contributions and improve interaction between the two groups.  The secretariat will inform members of the anticipated date/venue.

14 Date of Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 4 November, 2003, 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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