Ulcerative colitis (acute exacerbations) - infliximab: consultees and commentators

Dear Consultees and Commentators,

The Institute is currently appraising infliximab for treatment of ulcerative colitis as a single technology appraisal.

On 20 November, the Appraisal Committee reviewed the response to consultation on the Appraisal Consultation Document. This response included clarification from the manufacturer on the use of infliximab for treatment of acute exacerbations of ulcerative colitis that usually require inpatient management. The Appraisal Committee also reviewed further clarification from the regulatory authorities, the European Medicines Agency, on the marketing authorisation of infliximab in this disease area.

The Committee noted the concern of the manufacturer that '[this] request had come at a late stage in this appraisal process and has significantly limited [our] ability to provide a comprehensive assessment of the evidence'. The Committee appreciated that the appraisal of infliximab for the treatment of acute exacerbations warrants a comprehensive, and separate, assessment of the evidence.

The Institute accepts the Committee's view and has decided to 'split' this appraisal into two single technology appraisals; one that continues with the original base case population submitted by the manufacturer ('chronic ulcerative colitis, normally managed in an outpatient setting'), and a new appraisal of infliximab, within its licensed indication, for the treatment of acute exacerbations of ulcerative colitis ('acute ulcerative colitis, normally managed in an inpatient setting').

In order to be able to issue guidance to the NHS as quickly as possible on the use of infliximab in the 'chronic' patient population, the Appraisal Committee will agree a Final Appraisal Determination at its next meeting on 22 January 2008.

The new single technology appraisal of infliximab, within its licensed indications, for the treatment of patients with 'acute exacerbations of ulcerative colitis will be scheduled into the Institute's the work program for 2008.

I know that you will be disappointed in this further extension of the timeline for this appraisal, but I hope you agree that the way forward outlined above will enable the development of a complete set of guidance which in the end will be more appropriate for the NHS.

Please be advised that you will be informed of the outcomes associated with the January meeting and invited to become involved with the new STA process once dates have been finalised.

If you have any questions or queries please contact the Project Manager for this appraisal, Ms Eloise Saile email: eloise.saile@nice.org.uk or phone: 020 7067 5929.

Yours Sincerely

Dr Carole Longson


Centre for Health Technology Evaluation

This page was last updated: 30 March 2010