Suggested remit: To appraise the clinical and cost effectiveness of pembrolizumab with gemcitabine and cisplatin within its marketing authorisation for treating untreated advanced biliary tract cancer.
The company has informed NICE that it will not provide an evidence submission for this appraisal. Therefore, we are suspending the appraisal while we consider the next steps.
 
Status Suspended
Technology type Medicine
Decision Selected
Reason for decision Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Process TA
ID number 4034

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Timeline

Key events during the development of the guidance:

Date Update
09 April 2024 Suspended. The company has informed NICE that it will not provide an evidence submission for this appraisal. Therefore, we are suspending the appraisal while we consider the next steps.
09 August 2023 Please note that the company has asked NICE to delay this appraisal. The appraisal will therefore be rescheduled and an update on the revised timelines will be provided when further information is available.
23 March 2023 Following the changes to remove technical engagement as standard from appraisal timelines, the timelines for the appraisal of pembrolizumab with gemcitabine and cisplatin for untreated advanced biliary tract cancer have been revised. It is anticipated that the appraisal will begin in early-July 2023.
29 September 2022 As you will be aware, the Department for Health & Social Care has asked NICE to conduct an appraisal of Pembrolizumab with gemcitabine and cisplatin for untreated advanced biliary tract cancer. Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in mid-April 2023.
26 July 2022 - 23 August 2022 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
26 July 2022 In progress. Scoping commenced
28 January 2022 Awaiting development. Status change linked to Topic Selection Decision being set to Selected

For further information on our processes and methods, please see our CHTE processes and methods manual