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SMC Minutes - Tuesday, 5 November 2002

Present:

Ms Angela Timoney (Chairperson); Mr Jeff Ace; Dr Keith Beard; Mrs Marion Bennie; Professor Martin Brodie; Mrs Michelle Caldwell; Dr Barclay Goudie; Dr David Hood; Ms Moira Howie; Professor Angus Mackay; Mr Hector Mackenzie;Ms Wendy Nganasurian;Mr Chris Nicholson; Dr Ken Paterson; Dr Philip Rutledge; Dr Sandy Simpson; Ms Helen Tyrrell; Mr Mike Wallace; Professor David Webb; Dr John Webster; Dr Derek Yuille
 
In Attendance:

Ms Joy Hosie; Mrs Jill Mitchell; Mr Rob MacPhail; Ms Rosie Murray; Mr Bill Scott; Ms Pamela Warrington; Mr Hugh Whyte
 
Apologies:

Dr Corrie Black; Mr Tom Divers; Professor Karen Facey; Ms Morag Ferguson; Dr John Forbes; Professor David Lawson; Dr Chris Lush; Dr Marianne Nicholson; Mrs Chris McBeath; Dr Brian Paice; Dr Keith Ridge; Ms Fiona Scott; Dr Leslie Wilkie

1 Welcome and Apologies for Absence

1.1 The Chairperson welcomed members to the meeting. Apologies for absence were noted. Ms Joy Hosie, representative from CLO was welcomed to the meeting.

1.2 It was reported that Lord Naren Patel has been appointed as Chairman and Mr David Steel, Chief Executive, of NHS Quality Improvement Scotland.

1.3 The Chairperson advised that SMC intend to hold an Open Day on Thursday 13 February, 2003, at the Royal College of Physicians in Edinburgh. The programme is being finalised and will be circulated to members within the next couple of weeks.

2 Declarations of Interest

2.1 The Chairperson requested that members declare interests in the products to be discussed and the comparator drugs as noted on the assessment reports. The Chairperson highlighted to members that they are bound by a confidentiality undertaking.

3 Minute of the Previous Meeting (30.09.02)

3.1 The minutes of the meeting of 30 September, 2002, were agreed as an accurate record of the meeting with the following amendments noted (bold and italics):

  • Page 2, No 3:  · Minute of Previous Meeting - Change date: (03.09.02)
  • Page 6, last paragraph No. 8.6.3:  · Add:  A vote was taken with 2 members against the proposed recommendation and the remaining members in favour.
  • Page 7:  11.1.2: SMC Meeting ¿ Change date: 7 January, 2003
  • Page 7:  11.1.2: Meeting scheduled for 5 January 2002, Change date: 7 January 2003.
  • Page 7:  11.1.2: It was therefore agreed to cancel the January meeting and hold an extended meeting on 4 February - Change date: 4 March, 2003.
  • Page 7:  11 Date of next meeting: Change numbering from 11 to 12.
  • Page 7:  11.1 - Change numbering from 11.1 to 12.1.

3.2 The Minutes of the meeting of 30 September, 2002, will be posted on the website on Friday 8 November, 2002.

4 Matters Arising From the Previous Minutes

4.1 Bexarotene (Targertin) (No. 14/02): Elan Pharma

4.1.2 The Chairperson advised that the recommendation for Bexarotene (Targretin) for the treatment of patients with advanced (stages IIb or III) cutaneous T-cell lymphoma will be posted on the SMC website on Friday 8 November, 2002. 

4.2 Omega-3-Acid Ethyl Esters (Omacor) - Treatment of secondary prevention after MI (No. 15/02): Solvay Healthcare Ltd

4.2.1 The Chairperson advised that the recommendation for Omega-3-Acid Ethyl Esters (Omacor) for the treatment of secondary prevention after MI will be posted on the SMC website on Friday 8 November, 2002.

4.3 Omega-3-Acid Ethyl Esters (Omacor) - Treatment  of Hypertriglyceridaemia (No. 16/02): Solvay Healthcare Ltd

4.3.1 The Chairperson advised that the recommendation for Omega-3-Acid Ethyl Esters for the treatment of hypertriglyceridaemia will be posted on the SMC website on Friday 8 November, 2002. 

4.4 Escitalopram (Cipralex) (No. 17/02): Lundbeck

4.4.1 The Chairperson advised that the recommendation for Escitalopram (Cipralex) for the treatment of major depressive episodes will be posted on the SMC website on Friday 8 November, 2002.

4.4.2 Lundbeck have requested a deferral of the recommendation going into the public domain. The Committee did not agree to a deferral but agreed to add an additional paragraph to the recommendation advising that the company intended to resubmit with additional data in the light of new information.

4.5 Fondaparinux (Arixtra) (No. 18/02): Sanofi-Synthelabo

4.5.1 The Chairperson advised that the recommendation for Fondaparinux (Arixtra) for the prevention of venous thromboembolic events in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee or hip replacement surgery will be posted on the SMC website on Friday 8 November, 2002.

4.6 Anakinra (Kineret) - Review (No. 05/02):  Amgen

4.6.1 The Chairperson advised that the recommendation for Anakinra (Kineret) for the treatment of patients with rheumatoid arthritis will be posted on the SMC website on Friday 8 November, 2002.

4.7 Wording of Recommendations

4.7.1 It was highlighted that the wording of some of the recommendation categories was inconsistent.  It was agreed that this requires to be addressed. In terms of the wording the current form of words would continue to be used until further discussion has taken place.

5 Appeals Update

5.1 The Chairperson advised that minor modifications have been made to the Appeals/Review document. The revised document has been posted on the SMC website.

5.2 The Chairperson advised that additional data had been received from Lundbeck regarding the SMC recommendation for Escitalopram advising of their intent to resubmit in the light of additional data now being available and asked the Committee to consider their request. The Chairperson stated that in keeping with the appeals process the new data would be treated as a resubmission and reviewed by NDC in December and SMC in February (taking account of the fact that there is no SMC in January).  The committee agreed that the timescale for reviewing future resubmissions would be determined by workload.

6 Public Involvement

6.1 It was reported that there are some minor amendments to the Guidance for Patient Representative Organisations on Submission of Guidance document. The User Group had agreed to patient involvement with enquiries being channelled through the secretariat. A Patient Involvement meeting is taking place on Tuesday 3 December, 2002, inviting a selection of voluntary health organisations to test the protocol. It was agreed that written feedback regarding the Patient Involvement Group would be included with the paperwork to be reviewed at the SMC meeting in February.

7 New Drugs Committee Update (Update from NDC Chairman)

7.1 The NDC Chairman reported, for information purposes, cost comparisons between cost per QALY information between NICE and SMC.

7.2 Expert Involvement

7.2.1 Progress will be reviewed at the next NDC meeting and reported to SMC in December. It was noted that experts currently consulted with during the process would be identified. SMC recognise the need to pursue as transparent a process as possible.

8 NDC Recommendation Reports

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

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

8.1.2 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. Tiotropium bromide (Spiriva inhaler) was recommended for general use in the NHS in Scotland for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

8.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 8 November, 2002.

8.1.4 The Chairperson advised that on this and other recommendations, in some cases, editing may occur between the draft NDC recommendation and the SMC final recommendation.

8.2 FemSeven Sequi - Sequential HRT treatment (No. 20/02): Merck Pharmaceuticals

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

8.2.2 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. FemSeven Sequi was recommended for general use within NHS Scotland offering an alternative sequential combined hormone replacement therapy (HRT) for the treatment of oestrogen deficiency symptoms in postmenopausal women.

8.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 8 November, 2002.

8.3 Valcyte (Valganciclovir) (No. 21/02): Roche

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

8.3.2 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. Valcyte (Valganciclovir) was recommended for restricted use within NHS Scotland as a convenient oral alternative to ganciclovir. Its use should be under the overall supervision of an ophthalmologist and/or a physician experienced in the management of HIV/AIDS patients.

8.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 8 November, 2002.

8.4 Risperidone (consta depot injection) (No. 22/02): Janssen-Cilag Ltd

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.  Risperidone (consta depot injection) was recommended for restricted use within NHS Scotland for the treatment of patients who require an atypical antipsychotic and who have been proven to be non-compliant with oral treatment.

8.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 8 November, 2002.

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

8.5.1 Due to an in-house error in the assessment of Drospirenone ethinylostradiol (Yasmin) the recommendation has been deleted from the minutes. (03.12.02)

9 Forthcoming Submissions

9.1 List of Forthcoming Submissions

9.1.1 A revised list of forthcoming submissions was reviewed. It was noted that the date of the next SMC meeting is 3 December and not 10 December as listed.

9.1.2 The Chairperson requested members to inform the secretariat of any products they are aware of that do not appear on the SMC work programme. Concern was raised regarding the time taken to assess products. The Chairperson advised that if SMC are not looking at drugs at around the time of launch the process would need to be addressed.

10 Communication

10.1 User Group Forum (08.10.02)

10.1.1 An update regarding the User Group Forum was given.

A half-day training session for industry was planned for Tuesday 14 January, 2003, primarily to launch the revised submission form. The Chairman of the User Group stated that the purpose of the training day would be to inform those who attend about the aims and objectives of SMC, the process to be followed to enable companies to submit appropriate submissions and to introduce the revised proforma.

Clarity was sought regarding products that would be exempt from the SMC process. It was agreed that clarification is needed and it was suggested that SMC document ¿Information for Pharmaceutical Companies¿ is revised to incorporate more explicit guidance.

SMC are keen to audit their effectiveness to NHS Scotland and have identified the need to assess in qualitative and quantitative terms.

The next User Group Forum will take place on Tuesday 10 December, 2002.

11 Any Other Business

11.1 Christmas Lunch

11.1.1 The Chairperson reported that a Christmas buffet lunch would be provided at the SMC meeting on 3 December, 2002.

11.2 Detailed Recommendation Form - Website

11.2.1 It was reported that a request had been made to include the detailed recommendation on the website. It was recognised that there may potentially be information in the fuller document that could be confidential and that it would only be possible to make the document available after launch.

11.3 Referencing of Recommendations

11.3.1 The issue regarding the referencing of recommendations was addressed and the NDC Chairman advised that he would speak to the NDC assessment team regarding this. 

11.4 Appeals/Review Document

11.4.1 Clarity was sought regarding the Appeals/Review document and the membership of the Independent Review Panel. The Chairperson advised that the membership, although not fully defined in the document, would be chosen as necessary.

11.5 Communication from Companies

11.5.1 Discussions took place regarding comments received from the company. The Chairperson advised that the Chairman reviews comments and members are informed accordingly.

11.6 Regulation of Pricing of New Drugs

11.6.1 The ABPI representative offered to hold a training session regarding the regulation of pricing of new drugs. Members welcomed this and it is anticipated that this will take place in the New Year.

12 Date of Next Meeting

12.1 The date of the next meeting was confirmed as Tuesday 3 December, 2002,  at 12.30 pm (lunch from 12 noon), in HTBS Headquarters, Delta House, 50 West Nile Street, Glasgow G1 2NP.

 
ADDENDUM TO MINUTES

Appeals Update (as at 5 November, 2002)

Escitalopram (Cipralex) (No. 17/02): Lundbeck

Lundbeck have indicated that they wish to submit additional information in relation to their product Escitalopram (Cipralex) and are seeking a reassessment of SMC position in the light of additional information. A resubmission is expected in due course from Lundbeck.

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