Suggested remit: To appraise the clinical and cost effectiveness of obeticholic acid within its marketing authorisation for treating liver fibrosis in people with non-alcoholic steatohepatitis.
 
Status In progress
Process STA 2018
ID number 1645

Provisional Schedule

Expected publication 15 December 2021
Expected publication 08 June 2022

Project Team

Project lead Emily Richards

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
15 January 2021 The Department for Health and Social Care has asked NICE to conduct an appraisal of obeticholic acid within its marketing authorisation for treating liver fibrosis in people with non-alcoholic steatohepatitis. Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in mid-July 2021. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission.
15 January 2021 In progress. Topic is in progress
09 September 2020 The Department for Health and Social Care has asked NICE to conduct an appraisal of obeticholic acid within its marketing authorisation for treating liver fibrosis in people with non-alcoholic steatohepatitis. Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in early February 2021. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission.
07 May 2020 Schedule affected by COVID-19. Topic update: this appraisal has not been defined as therapeutically critical. The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide an update when this information is available.
13 March 2020 (14:00) Scoping workshop (Manchester)
20 January 2020 - 17 February 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance