The National Institute for Health and Care Excellence has published draft guidelines rejecting NHS funding for Bristol-Myers Squibb’s Opdivo as a treatment for locally advanced unresectable or metastatic urothelial carcinoma (mUC).

Patients with the condition have limited treatment options and are currently offered docetaxel, paclitaxel and best supportive care.

Opdivo (nivolumab) was approved by the European Commission in to treat adults with locally advanced unresectable or mUC after failure of prior platinum-containing therapy in June, making it the only immuno-oncology agent available in the region for this type of bladder cancer.

The decision came on the back of data from the Phase II CheckMate -275 trial, in which 20 percent of patients responded to treatment with Opdivo, a PD-1 immune checkpoint inhibitor, including 3 percent who experienced a complete response.

However, NICE argues that based on the available evidence, it is difficult to establish the magnitude of the clinical benefit for Opdivo compared with current clinical practice, given that the drug has not been compared with existing therapies in studies.

The committee concluded that the incremental cost effectiveness ratio for the drug would be between £67,205 and £86,030 per QALY gained (when compared with paclitaxel and docetaxel, respectively), and therefore agreed that the most plausible estimate of the ICER was £76,000 per QALY gained, far above what normally considers acceptable for end-of-life treatments.

Also, it said that Opdivo “does not appear to have the potential to be cost effective and is therefore not suitable for use within the Cancer Drugs Fund” in this setting.

Urothelial cancer occurs in the bladder or the ureter. It is the seventh most common cancer in the UK, with around 10,000 new diagnoses every year.