NICE is unable to make a recommendation about the use in the NHS of pembrolizumab with gemcitabine and cisplatin for untreated advanced biliary tract cancer in adults. This is because Merck Sharp & Dohme has confirmed that it does not intend to make an evidence submission for the appraisal. Merck Sharp & Dohme considers that the technology will not be launched in the UK for treating this indication.


If NHS organisations wish to consider pembrolizumab with gemcitabine and cisplatin for this indication, they should follow the advice on rational local decision making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012. This outlines the approach that should be taken when there is no NICE guidance.

NICE will review the position if the company decides that it wants to make an evidence submission.

ISBN: 978-1-4731-5908-2

  • National Institute for Health and Care Excellence (NICE)