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SMC Minutes - Tuesday, 3 December 2002

Present:

Professor David Lawson (Chairman); Mr Jeff Ace; Dr Keith Beard; Mrs Marion Bennie; Professor Martin Brodie; Mrs Michelle Caldwell; Professor Karen Facey; Dr Barclay Goudie; Dr David Hood; Dr Chris Lush; Mrs Chris McBeath; Ms Wendy Nganasurian; Mr Chris Nicholson; Dr Marianne Nicholson; Dr Ken Paterson; Dr Philip Rutledge; Ms Fiona Scott; Dr Sandy Simpson; Ms Angela Timoney; Ms Helen Tyrrell; Mr Mike Wallace; Professor David Webb; Dr John Webster; Dr Derek Yuille

In Attendance:

Ms Joyce Craig; Ms Joy Hosie; Ms Moira Howie; Ms Kashfa Iqbal; Mrs Jill Mitchell; Ms Rosie Murray; Dr David Steel; Mr Hugh Whyte

Apologies:

Dr Corrie Black; Mr Tom Divers; Ms Morag Ferguson; Dr John Forbes; Professor Angus Mackay; Mr Hector Mackenzie; Mr Rob MacPhail; Dr Brian Paice; Dr Keith Ridge; Mr Bill Scott; Ms Pamela Warrington; Dr Leslie Wilkie

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting. He also welcomed Dr David Steel and congratulated him on his appointment as Chief Executive of NHS Quality Improvement Scotland. Ms Joyce Craig, Senior Health Economist, HTBS and Ms Kashfa Iqbal, Health Economist, HTBS were welcomed to the meeting as observers. Apologies for absence were noted. The Chairman thanked Ms Timoney for chairing the November meeting in his absence.

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 Minute of the Previous Meeting (05.11.02)

3.1 The minutes of the meeting of 5 November, 2002, were agreed as an accurate record of the meeting with the following amendments noted.

The use of the wording of Chairman and Chairperson to be made consistent throughout.

Page 1
Mr Hugh Whyte: Change from Present to Observer
Mr Chris Nicholson: Change from Absent to Present

Page 7 - No 11.6
Change wording: Regulation of Pricing of New Drugs

Page 6 ¿ No 8.5.2
Last sentence: Delete the word strength.

It was noted that discussions took place at the last meeting regarding the assessment of me-too drugs. It was agreed that where medicines of similar properties and licensed indications were seen they would normally be approved if there were no additional cost implications.

The Minutes of the meeting of 5 November, 2002, will be posted on the SMC website on Friday 6 December, 2002.

4 Matters Arising From the Previous Minutes

4.1 Wording of Recommendations

4.1.1 At the SMC meeting in November clarification was sought regarding consistency in the wording of recommendation categories. The committee agreed that in order to ensure a clear structure is in place to enable NHS Boards and ADTCS to implement guidance, standardisation of the first component of the recommendation is necessary with the details provided in the second component being appropriate to circumstances.

4.2 Detailed Recommendation Form - Website

4.2.1 The ABPI representative stated that industry support the concept of more detailed information being put into the public domain, but due to confidentiality issues assurance would be sought that this information be made available post launch only. It was recognised that there are issues to be addressed regarding the process of quality assurance of sections within the fuller recommendation.  The committee agreed in principle and the Chairman will discuss further with the Central Legal Office and report the outcome at the next SMC Meeting.

4.3 Communication from Companies

4.3.1 It was agreed that a robust process and defined deadline to deal with company responses to NDC draft recommendations is necessary. It was recognised that the amount of information received from companies varies greatly and uniformity of responses in the form of a succinct bulleted summary should be encouraged for ease of review. Responses should be available one week before the SMC meeting. This would be discussed at the User Group Forum on 10 December, 2002.

4.4 Tiotropium bromide (Spiriva inhaler) (No. 19/02) ): Boehringer Ingelheim

4.4.1 The Chairman advised that the recommendation for tiotropium bromide (Spiriva inhaler) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) will be posted on the SMC website on Friday 6 December, 2002.

4.5 FemSeven Sequi  (No. 20/02): Merck Pharmaceuticals

4.5.1 The Chairman advised that the recommendation for FemSeven Sequi offering an alternative sequential combined hormone replacement therapy (HRT) for the treatment of oestrogen deficiency symptoms in postmenopausal women will be posted on the SMC website on Friday 6 December, 2002.  
4.6 Valganciclover (Valcyte) (No. 21/02): Roche

4.6.1 The Chairman advised that the recommendation for Valganciclovir (Valcyte) as a convenient oral alternative to ganciclovir will be posted on the SMC website on Friday 6 December, 2002. 

4.7 Risperidone (Risperdal consta) (No. 22/02): Janssen-Cilag Ltd

4.7.1 The Chairman advised that the recommendation for risperidone (Risperdal consta) for the treatment of patients who require an atypical antipsychotic and who have been proven to be non-compliant with oral treatment will be posted on the SMC website on Friday 6 December, 2002. 

4.8 Drospirenone ethinylostradiol (Yasmin) (No. 23/02): Schering Health Care

4.8.1 The Chairman advised that further to correspondence from, and a subsequent meeting with, a representative from Schering Health Care, he accepted an in-house error was made during the assessment of drospirenone ethinylostradiol (Yasmin). In view of this the recommendation will not go into the public domain on Friday 6 December, 2002. A statement will be issued to ADTCs and NHS Boards advising an error was made during assessment and, as a consequence of this, the advice issued on 8 November, 2002 should be disregarded. The NDC assessment team who completed the initial assessment will reassess the data for review by SMC in February. A final recommendation will be issued on 7 February, 2003.

5 Appeals Update

5.1 No appeals were noted.

6 Public Involvement

6.1 It was reported that the Patient Involvement Group met recently. Three constituent members will test a proposed protocol for public involvement in SMC processes and report back as soon as possible.  It was reported some of the groups had hoped SMC would be proactive in contacting companies but the Chairman advised that in view of the amount of products to be reviewed and the timescales involved this would not be viable.

6.2 Question and Answer Document

An addition to the Question and Answer Document to reflect the work of the Public Involvement Group was tabled for information.

7 New Drugs Committee Update (Update from NDC Chairman)

7.1 Revised Submission Form

The revised submission form is in the final stages and will be reviewed at the User Group Forum and by NDC at their meeting on 10 December, 2002. The group agreed to devolve responsibility for approval to NDC, but an electronic copy of the form will be circulated to SMC members for review and comment.

7.2 Expert Involvement

It was reported that 120 nominations have been received, with 35 acceptances to date. Further nominations are expected and a full list will be presented to SMC in February, 2003.

7.3 Health Economic Sub Group Meeting

The next meeting of the Health Economic Sub Group will take place on 10 December, 2002. The outcome will be reported to SMC in February, 2003.

8 NDC Recommendation Reports

8.1 Transdermal fentanyl (Durogesic) (No. 24/02): Janssen-Cilag

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

8.1.2 The SMC Vice Chairperson 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. Transdermal fentanyl (Durogesic) was recommended for restricted use in the NHS Scotland as a second line alternative for patients with intractable pain due to non malignant conditions which has been controlled by oral means.

8.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 6 December, 2002.

8.2 Voriconazole (Vfend) (No. 25/02): Pfizer

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

8.2.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation and summary of comments received from the company. Detailed discussion followed and amendments were noted in relation to the recommendation document. Voriconazole (Vfend) was recommended for restricted use within NHS Scotland for the treatment of suspected or confirmed cases of invasive aspergillosis.

8.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 6 December, 2002.

8.3 Imatinib CML (No. 26/02): Pharma Novartis

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

8.3.2 The NDC Vice 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. Imatinib CML was recommended for restricted use within NHS Scotland for the first line treatment of patients with chronic myeloid leukaemia.

8.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 6 December, 2002.

8.3.4 It was noted that a plan to develop a register of all patients receiving the product is ongoing.

8.4 Parecoxib (Dynastat injection) (No. 27/02): Pharmacia

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

8.4.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation and summary of comments received from the company. Detailed discussion followed and amendments were noted in relation to the recommendation document. Parecoxib (Dynastat injection) for the treatment of post operative pain was not recommended for use within NHS Scotland.

8.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 6 December, 2002.

8.5 FemSeven Conti (No. 28/02): Merck Pharmaceuticals

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

8.5.2 The SMC Vice Chairperson provided a detailed overview of the assessment, the key issues identified and draft recommendation and summary of comments received from the company. Detailed discussion followed and amendments were noted in relation to the recommendation document.  FemSeven Conti was recommended for general use within NHS Scotland as an alternative continuous combined hormone replacement therapy (HRT) for the treatment of oestrogen deficiency symptoms in postmenopausal women.

8.5.3 The SMC advice will be issued to ADTCs and NHS Boards on 6 December, 2002.

8.6 Zoledronic acid (Zometa) (No. 29/02): Novartis

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

8.6.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation and summary of comments received from the company. However, it was recognised and acknowledged by the company that the information received from the company was incomplete and inconclusive. The committee concluded that zoledronic acid (Zometa) for the prevention of skeletal related events in patients with advanced malignancies involving bone was not to be recommended for use within NHS Scotland on the basis of the available information. The company is in the process of submitting new information on all licensed indications for this product.

8.6.3 The SMC advice will be issued to ADTCs and NHS Boards on 6 December, 2002.

9 Forthcoming Submissions

9.1 List of Forthcoming Submissions

9.1.1 A revised list of forthcoming submissions was reviewed. The Chairman requested members advise the secretariat of any products they are aware of that are not scheduled to be reviewed by SMC.

10 SMC Open Day - 13 February, 2003

10.1 A draft programme outlining the SMC Open Day was tabled.  Invitations will be sent to delegates within the next couple of weeks.

11 Industry Training Day - 14 January, 2003

11.1 The Agenda for the Industry Training Day is being finalised and will be approved at the User Group Forum on 10 December, 2002.  The ABPI representative advised that he will raise the issue of inadequate submissions for discussion.

12 Any Other Business

12.1 New Indications/Formulations

Discussion took place regarding the policy for new indications/formulations going though the SMC process. The ABPI representative is currently redrafting 'Information for Pharmaceutical Companies' and will present to the User Group Forum on 10 December, 2002, and SMC on 4 February, 2003.  It was suggested that a statement should be issued to ADTCs and NHS Boards detailing those products that do not need to be reviewed by SMC.  The Chairman stated he would address this issue after review of the revised 'Information for Pharmaceutical Companies'.

12.2 Appreciation

The Chairman voiced his thanks and appreciation to the pharmatrak and economic assessment teams, the secretariat and all members of NDC and SMC for their continuous hard work and enthusiasm during the year and requested the NDC Chairman to relay this sentiment to members at the next NDC meeting.

13 Date of Next Meeting

13.1 The date of the next meeting was confirmed as Tuesday 4 February, 2003, at 12.30 pm (lunch from 12 noon), in HTBS Headquarters, Delta House, 50 West Nile Street, Glasgow G1 2NP.

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