Suggested remit - To appraise the clinical and cost effectiveness of ivosidenib within its marketing authorisation for treating adults with relapsed or refractory acute myeloid leukaemia which is isocitrate dehydrogenase-1 mutation-positive
 
Status In progress
Process STA 2018
ID number 1548

Provisional Schedule

Expected publication 28 April 2021

Project Team

Project lead Michelle Adhemar

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
03 December 2019 (14:00) Scoping workshop (London)
21 November 2019 This appraisal will be rescheduled to allow the company to include important data to be presented in their submission. This delay means that this appraisal will be removed from NICE’s reporting targets for timeliness. In addition, as the delay will mean a NICE recommendation will not be available at the point of marketing authorisation, the company accepts that this drug will consequently not be eligible to receive interim CDF funding from the date of marketing authorisation as no NICE recommendation will be made at that point . For information, it is anticipated that the appraisal will now begin in early June 2020 when we will write to you about how you can get involved.
18 October 2019 - 15 November 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
29 March 2019 As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of ivosidenib for treating relapsed or refractory IDH1-positive acute myeloid leukaemia. Please note that following on from advice received from the company the timelines for this appraisal have been revised. We now anticipate that the appraisal will begin during late January 2020 when we will write to you about how you can get involved.
22 March 2019 Proposed, As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of ivosidenib for treating relapsed or refractory IDH1-positive acute myeloid leukaemia. Please note that following on from advice received from the company the timelines for this appraisal have been revised. We now anticipate that the appraisal will begin during late January 2020 when we will write to you about how you can get involved.
22 March 2019 In progress, As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of ivosidenib for treating relapsed or refractory IDH1-positive acute myeloid leukaemia. Please note that following on from advice received from the company the timelines for this appraisal have been revised. We now anticipate that the appraisal will begin during late January 2020 when we will write to you about how you can get involved.
17 October 2018 In progress, Topic referred

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