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SMC Minutes - Tuesday, 4 November 2003

Minutes of Meeting
Held on Tuesday 4 November, 2003
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman), Mr Jeff Ace, Dr Keith Beard, Professor Martin Brodie, Professor John Cairns, Mr Tom Divers, Dr Barclay Goudie, Dr David Hood, Ms Moira Howie, Dr Chris Lush, Mrs Chris McBeath, Mr Chris Nicholson, Dr Marianne Nicholson, Dr Ken Paterson, Dr Philip Rutledge, Dr Sandy Simpson, Ms Angela Timoney, Mr Mike Wallace, Professor David Webb, Dr John Webster, Dr Derek Yuille

In Attendance: Mr Steven Fenocchi (Scottish Executive observer), Ms Joy Hosie, Dr Harpreet Kohli, Mr Hector Mackenzie, Mr Rob MacPhail, Ms Ali McAllister, Mrs Jill Mitchell, Miss Rosie Murray, Dr James Oliver (clinical pharmacology observer)

Apologies: Mrs Marion Bennie, Mrs Barbara Black, Dr Corri Black, Mrs Michelle Caldwell, Professor Angus Mackay, Ms Wendy Nganasurian, Dr Brian Paice, Ms Fiona Scott, Ms Helen Tyrrell, Dr Leslie Wilkie
 
1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting and apologies for absence were noted.   Mr Steven Fenocchi, Scottish Executive, was welcomed as an observer. Dr Harpreet Kholi, Acting Interim Director, NHS Quality Improvement Scotland, was also welcomed.  Dr Kholi will now replace Professor Karen Facey, as an observer at SMC meetings.

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 (07.10.03)

3.1 The minutes of the meeting of 7 October, 2003 were agreed as an accurate record of the meeting.

3.2 The Chairman reported recent press articles highlighting a directive from the Scottish Executive to establish a mandatory process for implementation of SMC advice.  Mr Mackenzie advised that discussions are ongoing within the Scottish Executive and will be reported to SMC in December.   It is envisaged that Health Boards will be encouraged to have a comprehensive process in place to deal with SMC recommendations from now on.   SMC recommendations should be carefully considered and implemented in the light of local clinical need.

3.2.1 The Chairman requested members direct any media queries to the communication department within NHS QIS.

Ann Single, Director of Communications and Public Involvement: 0141 225 6994Rob MacPhail, Communications Officer: 0141 225 6992

4 Matters Arising From the Previous Minutes

4.1 Zoledronic Acid (Zometa)

4.1.1 The independent review panel met on Monday, 27 October 2003. The results of the review will be presented to SMC on 2 December, 2003.  The Chairman thanked all those involved and in particular Dr John Webster who chaired the meeting. 

4.2 Industry Briefing Meeting (03.11.03)

4.2.1. The ABPI representative thanked those who presented and attended the meeting.  He advised that preliminary feedback has been positive with an increasing awareness of SMC.  A list of actions arising from the meeting will be circulated to members in due course.

4.3 Rotation of Members

4.3.1 Further to discussion with Dr David Steel, Chief Executive, NHS QIS, existing membership of SMC/NDC will remain as presently constituted until March 2004.

4.4 Christmas/New Year Event

4.4.1 It is envisaged a two-day event commencing with education presentations (for SMC & NDC members) and incorporating the routine SMC meeting will take place at the beginning of February.  SMC and NDC members will be invited to attend and to celebrate a post Christmas/pre rotation dinner.  Details will be clarified and reported at the December meeting.

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

4.5.1 The recommendation for Sertraline (Lustral) will be posted on the SMC website on Monday, 10 November 2003. 

4.5.2 An error within the numbering of the recommendation was noted.  This will be relayed to ADTCs and NHS Boards and an amended recommendation circulated.

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

4.6.1 The recommendation for Mometasone furoate (Asmanex Twisthaler) will be posted on the SMC website on Monday, 10 November 2003.

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

4.7.1 The recommendation for Botulinum toxin type A (Botox) will be posted on the SMC website on Monday, 10 November 2003.

4.8 Ketotifen hydrogen fumarate (Zaditen Eye Drops):  Novartis  No. 65/03

4.8.1 The recommendation for Ketotifen hydrogen fumarate (Zaditen Eye Drops) will be posted on the SMC website on Monday, 10 November 2003.

4.9 Pimecrolimus (Elidel Cream 1%): Novartis
Resubmission

4.9.1 The recommendation for Pimecrolimus (Elidel Cream 1%) will be posted on the SMC website on Monday, 10 November 2003.

4.10 Methyl amonolevulinate (Metvix cream) Actinic Keratoses:  Galderma No. 50/03
Resubmission

4.10.1 ResubmissionThe recommendation for Methyl amonolevulinate (Metvix cream) for Actinic Keratoses will be posted on the SMC website on Monday, 10 November 2003.

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

4.11.1 The recommendation for Methyl amonolevulinate (Metvix cream) for Basal Cell Carcinoma will be posted on the SMC website on Monday, 10 November 2003.

4.12 Avonex Liquid (Intereron beta 1a):  Biogen Ltd  No. 58/03

4.12.1 The recommendation for Avonex Liquid (Intereron beta 1a) will be posted on the SMC website on Monday, 10 November 2003.


5 Appeals Update

5.1 Clostridium botulinum type A neurotoxin complex (Botox®):  Allergan (No. 80/03)

Further to the SMC recommendation for Clostridium botulinum type A neurotoxin complex (Botox®), company representatives from Allergan met with the Chairman to discuss the way forward.  They will inform the secretariat if they intend to make a resubmission.

6 Correspondence

6.1 Anti TNF Drugs for Rheumatoid Arthritis

The Chairman reported that he had received some correspondence regarding Anti TNF Drugs for Rheumatoid Arthritis.  He requested members direct any further correspondence to the communication department within NHS QIS.

6.2 Pegylated G-CSF Decision

The Chairman highlighted correspondence regarding the assessment of  pegylated G-CSF (67/03).  He emphasised that the remit of SMC is to compare licensed medicines at licenced doses and not other dose regimens, which may be used in local areas.

7 Antibiotic Prescribing Policy

7.1 Following a presentation to SMC in April by Dr Christie of the Scottish Executive, the Chairman updated members on developments regarding the antibiotic prescribing policy.  He advised that following evidence of wide variation in antibiotic prescribing policy and practice in Scotland and concern about lack of regular liaison between microbiologists, clinicians and pharmacists and concern about adequate supervision of prescribing, a sub group, chaired by Dr Dilip Nathwani, has been formed.  The group identified the following:· 

- The need for work, particularly on hospital prescribing of antimicrobials.
- Evidence of suboptimal linkage between prescribing and infection expertise.
- Need for hospital wide multidisciplinary approach to antimicrobial prescribing including role and limitations of medicines.
- Identified actions for ADTCs

Extensive debate ensued and members agreed about the necessity to consider the specific remit of the proposed group before finally agreeing to any proposals.  The Chairman will meet with Dr Nathwani before the December SMC meeting to clearly define the remit of the group and enable members to agree a decision regarding setting standards on the process of antibiotic prescribing under the auspice of SMC.

8 Patient and Public Involvement Group (PAPIG)

8.1 Notes from the Patient and Public Involvement Group were presented for information.  The programme for the patient event 'Patient Power - Making a Difference', scheduled for 23 January, 2004, has been agreed and will be circulated to members within the next week.
 
9. New Drugs Committee Update

9.1 Industry Representation

9.1.1 Due to the success of industry members on SMC, two members have been nominated to join NDC; Keith Tolley, Ortho Biotech and Nick Bruce, Pfizer. It is anticipated they will commence membership in January 2004, but will be invited to join the meetings in observer capacity prior to this.

9.2 Lead Assessors

9.2.1 It has been agreed that where a lead assessor is unable to attend an NDC meeting another member will be allocated to lead on a product.  The SMC Chairman stated he is aware of the invaluable input from both SMC and NDC members and proposed an increase in NDC membership to ease the workload.  Members agreed this. 

9.3 Proof Reading of Documentation

9.3.1 It was recognised that on occasions when there is a variance between the view of Pharmatrak and that concluded by NDC there is insufficient time to edit draft documentation for circulation to submitting companies and input from a knowledgeable reader would be most helpful. The SMC Chairman stated that discussions regarding this are currently ongoing.

9.4 Negative Recommendation in Absence of Company Submission

9.4.1 It was recognised that in order to ensure equity and consistency, a process should be adopted to identify those companies who have not made a submission to SMC following launch of a product. Should this situation persist it may be necessary to release negative advice in such circumstances. The SMC Chairman stated this was highlighted at the Industry Briefing Meeting and a list of companies to be targeted incorporating a timescale for submission to the secretariat is currently under development. It is anticipated a standard template will be produced and circulated to companies. 

10. NDC Assessment Reports - Full Submissions

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

10.1.1 A member with a personal specific interest left the room for this part of the agenda.

10.1.2 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 Adalimumab (Humira) for the treatment of rheumatoid arthritis, should be accepted for restricted use within NHS Scotland.  Significant amendments to wording were noted.

10.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 November,2003.

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

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

10.2.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, the 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 Salmeterol/ Fluticasone (Seretide), for the treatment of chronic obstructive pulmonary disease, should be accepted for use within NHS Scotland. Significant amendments to wording were noted.

10.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 November, 2003.

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

10.3.1 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.

10.3.2 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 Testosterone (Testogel), for the treatment of testosterone replacement therapy, should be accepted for restricted use within NHS Scotland. Minor amendments to wording were noted.

10.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 November 2003.

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

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

10.4.2 The NDC 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 Teriparatide (Forsteo), for the treatment of established (severe) osteoporosis in postmenopausal women, should be accepted for restricted use within NHS Scotland. Minor amendments to wording were noted.

10.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 November, 2003.

NDC Assessment Reports - Resubmissions

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

10.5.1. Following extensive debate, it was agreed that although additional information was received from Lundbeck, given the complexity of issues raised, and that the key papers were either tabled or unavailable to members, the NDC did not feel comfortable making a recommendation without further time for reflection and discussion.  Memantine has therefore been deferred for assessment by NDC in November.    

11 Forthcoming Submissions

11.1 List of Forthcoming Submissions

11.1.1 A revised list of forthcoming submissions was reviewed. 

12 ADTC Feedback

12.1 SMC Assessments

12.1.1 The NDC Chairman thanked the secretariat for amending the SMC assessment list (routinely circulated to ADTCs) to reflect the outcome of SMC advice.

13 Any Other Business

13.1 No other business was reported.

14 Date of Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 2 December, 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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