Suggested remit - To appraise the clinical and cost effectiveness of alpelisib within its marketing authorisation for treating advanced hormone-receptor positive, HER2-negative, PIK3CA-positive breast cancer
 
Status In progress
Process STA 2018
ID number 1412

Provisional Schedule

Expected publication 09 December 2020

Project Team

Project lead Michelle Adhemar

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
29 March 2019 In progress, This appraisal has been 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 the NICE’s reporting targets for timeliness. In addition, through this request for delay the company accepts that this drug will not be eligible to receive interim CDF funding from the date of marketing authorisation. The appraisal is now anticipated to begin during late January 2020 when we will write to you about how you can get involved.
08 February 2019 Suspended, This appraisal has been 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 the NICE’s reporting targets for timeliness. In addition, through this request for delay the company accepts that this drug will not be eligible to receive interim CDF funding from the date of marketing authorisation. The appraisal is now anticipated to begin during late January 2020 when we will write to you about how you can get involved.
08 October 2018 - 05 November 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
31 July 2017 In progress, Topic referred

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