Ulcerative colitis (acute exacerbations) - infliximab: review proposal - April 2011
The planned date for review of TA140; infliximab for subacute manifestations of ulcerative colitis was February 2011 and the planned review date for TA163; infliximab for the treatment of acute exacerbations of ulcerative colitis is December 2011.
These dates relate to the time at which the Institute decides whether sufficient new evidence has emerged for the Appraisal Committee to be asked to undertake an update of the existing guidance. Because NICE has been asked to develop a joint clinical guideline and quality standard for the management of ulcerative colitis, and both of these appraisals are relevant to that work, we have decided to look at this evidence now to coincide with the early stages of scoping of the clinical guideline.
The Institute has carried out a search for information relevant to these appraisals, and believes that it is appropriate to recommend the following:
- A decision to review TA140 should be deferred until the outcome of the recently referred single technology appraisal of adalimumab for the second-line treatment of moderate to severe ulcerative colitis is known. If appropriate, it can be proposed that the appraisals are reviewed together.
- There are several ongoing clinical trials that are due to report in 2011 and 2012. We propose that the decision to review TA163 should be deferred until the completion of the GETAID CYSIF and CONSTRUCT trials.
In order to be completely confident that this is appropriate, we are asking all relevant consultees and commentators, to inform us of any evidence which would suggest that a review would be beneficial. Please see appendix A for a full list of the organisations we have contacted.
This page was last updated: 06 April 2011