Cost regulators for NHS therapies in England and Wales have turned down MSD’s immunotherapy Keytruda as a treatment for locally advanced or metastatic urothelial cancer.

The National Institute for Health and Care Excellence has published an appraisal consultation document rejecting the drug for use in adults who have had prior platinum-containing chemotherapy.

The Committee noted that clinical trial evidence shows that Keytruda (pembrolizumab) significantly improves overall survival versus docetaxel and paclitaxel, the current treatment options patients, and that the drug is likely to extend survival by around three months.

However, it concluded that all plausible cost effectiveness estimates overshoot what NICE normally considers acceptable for end-of-life treatments - £50,000 per quality-adjusted life year (QALY) gained - and thus could not recommend routine NHS use of the drug.

Keytruda’s cost-effective was also considered for people with urothelial carcinoma expressing the PD-L1 protein, as it appears to be more effective in this patient population, but was also turned down because “the results were not reliable,” according to NICE.

The Institute also said the drug could not be recommended for the Cancer Drugs Fund as “it does not have the potential to be cost effective”.

“This initial consultation document is very disappointing and we are working with NICE and NHS England to ensure we can find a solution to give people with advanced or metastatic urothelial cancer access to pembrolizumab as quickly as possible,” said Louise Houson, UK managing director of MSD.

MSD said it is confident that it can work with NICE to find a route for patients and healthcare professionals to access Keytruda for locally advanced or metastatic urothelial carcinoma who have had prior platinum-containing chemotherapy.