Ref: NICE 2001/ 004
Issued: 29 January 2001
MEDIA UPDATE
Health Technology Appraisal: beta interferons & glatiramer acetate for Multiple Sclerosis.
NICE has written to the consultees in the appraisal of Interferon beta /glatiramer for MS on 3 issues:
1. Consulting on its proposals for the process for commissioning the development of the new economic modelling and identifying where stakeholders are involved (Annex 1 below).
2. Asking if stakeholders are prepared to release data they may have, including patient specific data from clinical trials, that is likely to be of use to the modellers. Data would be made available through the Institute and treated in accordance with the Institute's standard arrangements for handling data supplied by consultees.
3. Requesting nominations of individuals or organisations that consultees' consider have the capability and experience to undertake the economic modelling.
The Institute should receive consultation feedback, and responses on the 9 February 2001. A final version of the process document will be issued following consultation.
Ends.
Annex 1:
CONSULTATION DRAFT: issue date 25 January 2001
National Institute for Clinical Excellence
Health Technology Appraisal: beta interferons and glatiramer acetate for Multiple Sclerosis
Additional Economic Modelling: Proposed Process for Engaging with Consultees - subject to consultation with Stakeholders.
1 The Institute intends to commission additional modelling to better inform the Appraisal Committee in its advice on the use of these medicines in the NHS in England and Wales.
2 In accordance with the principles of openness and transparency which the Institute has adopted, the formal consultees in this appraisal will have the opportunity to influence this work as it progresses. The Institute will retain full responsibility for the structure of the modelling which it accepts from the modeller, for the assumptions on which it is based and for interpreting the results for the purposes of preparing guidance on the use of the beta interferons and glatiramer acetate in the NHS in England and Wales.
3 The process which the Institute will follow in commissioning the new modelling and the way in which consultees can engage in the process (shown in italics) are set out below.
4 Step 1
- Process statement (this document) prepared.
- Consultees are invited to comment on the process document by 9 February.
5 Step 2
- Consultees are invited to suggest modelling groups which the Institute should consider for this work. These groups should have sufficient experience and credibility to undertake the work. The Institute itself will simultaneously identify suitable modelling groups. Furthermore, consultees which own or which have access to data (including patient-specific data) are asked to indicate whether they will allow access to it by whichever modeller the Institute appoints. They should do so by 9 February. The appointed modeller will be subject to the Institute's arrangements for maintaining the confidentiality of data.
6 Step 3
- The Research and Development Committee will consider and circulate a draft a commissioning document for the new modelling.
- Consultees have two weeks to comment on the commissioning document from 12 February to 23 February.
- The commissioning document will be approved by the Research and Development Committee.
7 Step 4
• A commission is placed with the chosen modeller on or about 28 February. Selection and appointment of the modeller will be at the Institute's discretion having regard to any comments made in step 2.
8 Step 5
- A draft model is received by the Institute on or about 31 May.
- Assuming the model is delivered on schedule, consultees will have 4 weeks to comment on the modelling during June. They will receive a copy of the model with any commercial in confidence data removed.
9 Step 6
- The new modelling is considered, with the comments from the consultees, by the Appraisal Committee at its July 2001 meeting.
- After Step 6, the appraisal process will continue according the Institute's published process. The Appraisal Committee will, at its July meeting, prepare and circulate either a provisional or a final appraisal determination.
Consultation closes, and responses should be received by the Institute on the 9 February 2001.
Ends.
