http://www.nice.org.uk/article.asp?a=13526

Press Release

NICE 2000/ 052

Issued: 22 December 2000

NICE is extending the timeline for its appraisal of two drugs ; the beta interferons and glatiramer acetate - used in the treatment of multiple sclerosis, to enable further research to be undertaken on their cost effectiveness.

NICE Chief Executive Andrew Dillon said today;During our appraisal we have considered evidence that included economic models supplied by manufacturers and independent researchers, including data not previously submitted. The models are used to inform our judgement on the cost effectiveness of these drugs.

We have looked carefully at these models and whilst it’s clear that considerable effort has been put into their development, detailed examination has raised a number of issues that the Institute’s Appraisal Committee, using the information available, has been unable to resolve. The evidence relating to the cost effectiveness of these medicines is critically important in this appraisal. The Institute has therefore decided to commission further economic modelling on the beta interferons and glatiramer acetate. The process of specifying, commissioning and evaluating this new research will be transparent. The results will be published in full and consultees in the appraisal will have the opportunity to comment on it. ;

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Notes for Editors

• The commissioning, construction and evaluation of the new modelling will take some months and therefore the timeline for the appraisal process for both medicines will be extended.
• The Institute anticipates that the Appraisal Committee will reconsider the evidence, which will consist of the new modelling and any other new evidence available at the time, in July 2001.
• The Institute has notified all consultees of this course of action.
• Although the Institute accepts that its guidance will now be delayed, it considers that this action is in the best interests of people with MS and those who care for them. It is of the utmost importance that the Institute’s guidance is both evidence-based and seen to be fair by those effected by it. Until the Institute’s appraisal is complete, NHS organisations will wish to operate in accordance with NHS Guidance that states they should continue with their own local arrangements. [HSC (99) 176].
• The Institute will proceed quickly and its Research and Development Committee will convene as early as possible in January. Its first step will be to consider and agree the process and timetable for commissioning the new model. The outcome of this meeting will be reported to consultees and will be posted on the Institute’s web site. Progress reports will be similarly reported.
• This decision has been taken by the Institute following the Appraisal Committee meeting on December 13th 2000. The Appraisal Committee considered the original evidence in light of the appeal panel’s decision, in addition they considered some new evidence, (including a new economic model submitted as commercial in confidence by Schering) and heard again from the groups that represent people with MS and their carers. The groups were the MS Society and the MS Research Trust and their representatives included people with MS.