Suggested remit: To appraise the clinical and cost effectiveness of talazoparib within its marketing authorisation for treating BRCA 1 or 2 mutated advanced breast cancer.
 
Status In progress
Process STA 2018
ID number 1342

Project Team

Project lead Michelle Adhemar

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
09 December 2019 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of talazoparib for treating BRCA 1 or 2 mutated advanced breast cancer after prior chemotherapy. Please note that following on from advice received from the company the timelines for this appraisal are to be confirmed. As this appraisal has been referred, NICE will continue to monitor any developments and will provide an update as and when the situation changes.
18 September 2019 As you will be aware the Department for Health and Social Care has asked NICE to conduct an appraisal of talazoparib for treating BRCA 1 or 2 mutated advanced breast cancer after prior chemotherapy. 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 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. It is anticipated that the appraisal will begin in late January 2020 when we will write to you about how you can get involved.
05 July 2018 - 02 August 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
13 February 2018 In progress. DHSC referral received

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