Suggested remit: To appraise the clinical and cost effectiveness of avacopan within its marketing authorisation for treating anti-neutrophil cytoplasmic antibody-associated vasculitis.
 
Status Proposed
Process STA pre-2018
ID number 1178

Project Team

Project lead Emily Richards

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
14 February 2019 As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of avacopan for inducing remission in anti-neutrophil cytoplasmic antibody-associated vasculitis. Following on from advice received from the company the timelines for this appraisal are currently to be confirmed. This is because the company have decided to withdraw the avacopan application for a Conditional Marketing Authorisation (CMA) with the European Medicines Agency based on Phase II data, in light of the upcoming availability of data from the pivotal phase III trial Advocate. Therefore, NICE will continue to liaise with the company regarding the anticipated regulatory timings of avacopan in this indication and further information regarding the scheduling of this appraisal will be available in due course.
20 March 2018 - 19 April 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
17 August 2017 The consultation on the draft scope closed on Tuesday 15 August 2017. The company that markets the technology has advised that the regulatory filing strategy for this product is delayed and still under consideration. NICE has agreed that a scoping workshop would not be appropriate at this time. As a consequence of this the scoping workshop arranged for 15 September 2017 has been cancelled. We apologise for any inconvenience this may cause.
18 July 2017 - 15 August 2017 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators

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