Suggested remit: To appraise the clinical and cost effectiveness of moxetumomab pasudotox within its marketing authorisation for relapsed or refractory hairy-cell leukaemia.
 
Status In progress
Process STA 2018
ID number 1142

Provisional Schedule

Expected publication 22 September 2021

Project Team

Project lead Louise Jafferally

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
29 April 2020 In progress, Topic is now in progress
29 April 2020 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of Moxetumomab pasudotox for treating hairy-cell leukaemia. Following advice received from the company, 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. The appraisal is now anticipated to begin during late October 2020 when NICE will write to you about how you can get involved.
11 March 2020 - 08 April 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
11 March 2020 Proposed, Following an update from the company this appraisal has been scheduled for a scope review.
14 September 2018 Suspended, Following on from advice received from the company, the timelines for this appraisal are currently to be confirmed and therefore the appraisal is suspended. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties as and when the situation changes.
21 August 2018 On receiving updated regulatory timing information from the company that markets moxetumomab pasudotox, NICE has agreed that holding a scoping workshop at this time would not be appropriate. Consequently the scoping workshop arranged for the 3 September 2018 will be cancelled. The scoping exercise will be rescheduled to take place in line with anticipated regulatory approval timings. We apologise for any inconvenience this may cause.
18 July 2018 - 15 August 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
16 February 2018 The National Institute for Health and Care Excellence (NICE) has been asked to conduct an appraisal of moxetumomab pasudotox for treating hairy-cell leukaemia. We have recently invited stakeholders to respond to a written consultation on the draft scope and to attend a scoping workshop for this appraisal. On receiving updated regulatory timing information from the company that markets moxetumomab pasudotox, NICE has agreed that holding a scoping workshop at this time would not be appropriate. Consequently the scoping workshop arranged for the 27 February 2018 will be cancelled. The scoping exercise will be rescheduled to take place in line with anticipated regulatory approval timings. We apologise for any inconvenience this may cause.
05 December 2017 In progress, DH Referral

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