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SMC Minutes - Tuesday, 11 June 2002

Present:

Professor David Lawson (Chairman); Mr Jeff Ace; Dr Keith Beard; Professor Martin Brodie; Dr John Forbes; Dr David Hood; Dr Robert MacFadyen; Professor Angus MacKay; Mrs Chris McBeath; Dr Marianne Nicholson; Dr Brian Paice; Dr Ken Paterson; Dr Keith Ridge; Dr Philip Rutledge; Ms Fiona Scott; Ms Angela Timoney; Mr Mike Wallace; Professor David Webb; Dr John Webster; Dr Leslie Wilkie; Mr Derek Yuille
 
In Attendance: 

Ms Moira Howie; Mr Hector Mackenzie; Ms Moira McMurray; Mrs Jill Mitchell; Ms Rosie Murray; Ms Ann Single
 
Apologies: 

Ms Marion Bennie; Ms Michelle Caldwell; Mr Tom Divers; Professor Karen Facey; Ms Morag Ferguson; Dr Barclay Goudie; Ms Wendy Nganasurian; Mr Chris Nicholson; Mr Bill Scott; Ms Helen Tyrell; Dr Hugh Whyte

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting.  Moira McMurray, Pharmacist on secondment from GRI to Pharmatrak and Ann Single, Communication Manager with HTBS were welcomed as observers.  Apologies for absence were noted.

1.2 The Chairman advised that Kim Fellows has resigned from the SMC having left her post with ABPI to take up a post within the Scottish Executive. The Board of ABPI had written to SMC advising that Dr A Simpson, Medical Director of Eli Lilly had been nominated to replace Kim Fellows. The Chairman will write to Dr Simpson to formally invite him to join the committee. Chairman had conveyed the thanks of the group for the major effort made by Ms Fellows in the development and establishment of SMC.

2 Declaration of Interests

2.1 The Chairman requested that members declare any interests in the products up for discussion and the comparator drugs as noted on the assessment reports.

2.2 It was requested that the SMC includes its declaration of interest policy in its statement on the website. This was agreed and would be arranged by the secretariat.

3 Minute of the Previous Meeting (07.05.02)

3.1 The minutes of the meeting of 7 May 2002, were agreed as an accurate record. The Minutes will be posted on the website on Friday 14 June, 2002.

4 Matters Arising From the Previous Minutes

4.1 Extension of Clinical Trials Pre & Post Marketing

4.1.1 It was noted that discussions are ongoing between members of SMC and ABPI and that progress would be presented at future SMC meetings.

4.2 Tenofovir disoproxil (Viread®), Gilead Sciences - Recommendation

4.2.1 The Chairman advised that the recommendation would be posted on the SMC website on Friday 14 June, 2002. 

5 New Drugs Committee Update (Update from NDC Chairman)

5.1 Glossary of Terms


5.1.1 A Glossary of Terms was being developed and would be presented at the SMC meeting on 2 July, 2002.

5.2 Powerpoint Presentation

5.2.1 A standard power point presentation detailing the SMC process had been developed and piloted and will be circulated to all SMC/NDC members in the future for their assistance in presentations.

5.3 Expert Advisors

5.3.1 A panel of expert advisors was being developed and progress would be reported at future meetings.

5.4 NDC Economic Paper

5.4.1 A paper about economic evaluations was being devised by NDC outlining the level of information required in submissions. This was in response to the varying amount of economic data being enclosed with submissions, and the different models being used.

6 NDC Recommendation Reports

6.1 Methylphenidate (Concerta®), Janssen-Cilag

6.1.1 Declaration of interests were recorded in relation to this product and the comparator drugs.

6.1.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation. Detailed discussion followed and amendments were noted in relation to the recommendation document.

6.1.3 The SMC advice would be issued to ADTCs and NHS Boards on 14 June, 2002.

6.2 Biphasic Insulin Aspart 30 (Novomix 30®), NovoNordisk

6.2.1 Declaration of interests were recorded in relation to this product and the comparator drugs.

6.2.2 The SMC Vice Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation. The Chairman reminded members that, in keeping with SMC policy, the company are advised of NDC draft recommendation. A response had been received from the applicant Company in relation to the draft recommendation from NDC. The comments raised therein were discussed in detail and amendments were noted in relation to the recommendation. It was noted that the SMC recommendation would be issued to ADTCs and NHS Boards on 14 June, 2002.

6.3 Anakinra (Kineret®), Amgen

6.3.1 Declaration of interests were recorded in relation to this product and the comparator drugs.

6.3.2 The NDC Vice Chair provided a detailed overview of the assessment, the key issues and draft recommendation. Detailed discussion followed.

6.3.3 A response had been received from the applicant Company in relation to the draft recommendation from NDC. The Consortium noted the comments raised therein and took them into account in formulating their advice.

6.3.4 The SMC advice would be issued to ADTCs and NHS Boards on 14 June, 2002.

6.4 NDC members were commended on their hard work and effort over the past few months in compiling and presenting their recommendations. Professor Webb was asked to report these views to NDC members at their next meeting.

7 List of Forthcoming Submissions

7.1 A list of forthcoming submissions was reviewed. Members were asked to inform the secretariat of any new products which did not appear on this list, so that they could be pursued.

7.2 The Chairman had received a letter from ABPI expressing concerns about the SMC publishing its workplan on the website.  It was agreed that this matter be discussed with ABPI outwith the forum of the meeting and progress would be reported back.

7.3 It was decided that an abbreviated list of forthcoming submissions could be made available quarterly to ADTCs in order to assist in forward planning by Boards. It was also noted that at the first meeting of the User Group it should be stressed that SMC were now accepting all submissions whether for new chemical entities or for new formulations.

8 Communication

8.1 User Group Forum

8.1 The User Group Forum has been scheduled to meet on 13 August, 2002. Members were requested to forward to the secretariat any issues they wish to raise.

8.2 Frequently Asked Questions Document

8.2.1 The revised document was reviewed and discussion followed. Minor amendments and additional questions were suggested.  The Chairman, Vice Chairman together with those involved in compiling the document will review the final draft prior to it being posted on the SMC website. It was recognised that this is an evolving process and will be amended as necessary.

8.3 Communication Strategy

8.3.1 A paper outlining the communication strategy was presented and discussed. A standard media enquiry list was presented to the group. It was agreed that Pharmatrak would be asked to complete this enquiry list as part of its submission to NDC.

8.4 Information Update ¿ Imatinib (Glivec®), Novartis

8.4.1 The Chairman informed members of the existence of an Appraisal Consultation Document on imatinib published by NICE in May. As SMC had completed their appraisal of imatinib and issued their advice, he explained that this paper was for information only: no discussion was held on this topic.

8.5 Media Update

8.5.1 A media update will now be provided on a quarterly basis to SMC.
 

9 Any Other Business

9.1 Marketing Correspondence

9.1.1 The Chairman had received a copy letter advising clinicians of the availability of samples of a forthcoming product for assessment. Clinicians were being requested to use the product in the three months before launch. It was agreed that SMC correspond to both ABPI and ADTCs regarding this matter, as it appeared to be contradictory to the spirit, if not the letter of the ABPI guidelines, on premarketing availability of new medicines.

9.2 A O C B

9.2.1 It was noted that some ADTCs were restructuring as a consequence of the formation of SMC. The issue of providing detailed information to NHS Boards to help with decision making regarding funding was causing concern to some members.  The Chairman requested members of Boards present to feedback details of information they feel is necessary to ease the decision making process.     

10 Date of Next Meeting

10.1 The date of the next meeting was confirmed as Tuesday 2 July 2002, at 12.30 pm (lunch from 12 noon), in HTBS Headquarters, Delta House, 50 West Nile Street, Glasgow G1 2NP.

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