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 R132 mutation-positive who are not eligible for intensive treatment including HSCT.
Following on from information provided to NICE by the company in December 2020 the appraisal of Ivosidenib for treating relapsed or refractory IDH1-positive acute myeloid leukaemia [ID1548] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
 
Status Discontinued
Decision Selected
Process TA
ID number 1548

Project Team

Project lead Emily Richards

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
20 December 2022 Discontinued. Following on from information provided to NICE by the company in December 2020 the appraisal of Ivosidenib for treating relapsed or refractory IDH1-positive acute myeloid leukaemia [ID1548] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
10 December 2020 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of ivosidenib for treating relapsed or refractory IDH1-positive acute myeloid leukaemia. For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application from the European Medicines Agency for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
10 December 2020 Suspended. Topic is suspended
19 May 2020 The National Institute for Health and Care Excellence (NICE) has been asked to consider an appraisal of ivosidenib for treating relapsed or refractory IDH1-positive acute myeloid leukaemia. We have recently invited stakeholders to respond to a written consultation on the draft scope for this appraisal. The consultation on the draft scope closed on Friday 01 May 2020. Following the receipt of an update from the company that market Ivosidenib, NICE has agreed that continuing the scoping exercise at this time would not be appropriate. As a consequence of this, the scoping exercise will not continue at this time and will be rearranged for a later date. We apologise for any inconvenience this may cause. If you have any comments or concerns please contact the project manager for this proposed appraisal Emily Richards on (44 (0)161 413 4070 or via email on emily.richards@nice.org.uk)
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.
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 Awaiting development. 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

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