NICE is unable to make a recommendation about the use in the NHS of pembrolizumab for untreated PD‑L1‑positive, locally advanced or metastatic urothelial cancer when cisplatin is unsuitable. Merck Sharp & Dohme has confirmed that it does not intend to make a complete evidence submission for the appraisal. This is because it does not consider that the new evidence collected when pembrolizumab was in the Cancer Drugs Fund (NICE's technology appraisal guidance 522) shows that it works well enough in this patient population to be cost effective.

NICE and the company have considered all the options for producing guidance on pembrolizumab for this indication. The decision to terminate this appraisal has not been taken lightly. NICE is disappointed that the committee and stakeholders will not have the opportunity to fully review the new evidence collected.

See the NICE Pathway on bladder cancer for other treatments for managing locally advanced or metastatic disease.


If NHS organisations wish to consider pembrolizumab for untreated PD-L1-positive, locally advanced or metastatic urothelial cancer when cisplatin is unsuitable, 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.

People already taking pembrolizumab for this indication through the Cancer Drugs Fund can continue. For those people, it will be funded by the company until they and their NHS clinician consider it appropriate to stop.

ISBN: 978-1-4731-4006-6

  • National Institute for Health and Care Excellence (NICE)