Suggested remit: To appraise the clinical and cost effectiveness of nivolumab with ipilimumab within its marketing authorisation for treating squamous cell carcinoma of the head and neck.
As you will be aware the Department for Health and Social Care has asked NICE to conduct an appraisal of nivolumab with ipilimumab for treating platinum-refractory squamous cell carcinoma of the head and neck. For information, the company announced that Checkmate 714 did not meet its primary endpoints in the platinum-refractory cohort and will not be pursuing a marketing authorisation application in 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.
 
Status Suspended
Process STA 2018
ID number 1355

Project Team

Project lead Michelle Adhemar

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
16 May 2019 Suspended, As you will be aware the Department for Health and Social Care has asked NICE to conduct an appraisal of nivolumab with ipilimumab for treating platinum-refractory squamous cell carcinoma of the head and neck. For information, the company announced that Checkmate 714 did not meet its primary endpoints in the platinum-refractory cohort and will not be pursuing a marketing authorisation application in 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.
16 May 2019 As you will be aware the Department for Health and Social Care has asked NICE to conduct an appraisal of nivolumab with ipilimumab for treating platinum-refractory squamous cell carcinoma of the head and neck. For information, the company announced that Checkmate 714 did not meet its primary endpoints in the platinum-refractory cohort and will not be pursuing a marketing authorisation application in 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.
11 October 2018 As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of nivolumab with ipilimumab for treating squamous cell carcinoma of the head and neck. Following on from advice received from the company the timelines for this appraisal are to be aligned with the latest regulatory expectations and further information regarding the scheduling of this appraisal will be available in due course.
18 July 2018 - 15 August 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
21 March 2017 In progress, Topic referred

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