The National Institute for Health and Care Excellence has now issued final guidance rejecting NHS funding for use of Bristol-Myers Squibb’s Opdivo as a treatment for locally advanced unresectable or metastatic urothelial carcinoma (mUC).

Opdivo (nivolumab) was cleared for use in Europe to treat adults with locally advanced unresectable or mUC after failure of prior platinum-containing therapy in June last year, on the back of data from the Phase II CheckMate-275 trial, in which 20 percent of patients responded to treatment with the drug.

However, the cost regulator noted that Opdivo has not been directly compared with other treatments, and so it is not clear how effective it is compared with current clinical practice.

The committee considered that cost-effectiveness estimates for the drug in this setting are “highly uncertain” and likely to fall between £58,791 per QALY gained (compared with paclitaxel) and £78,869 per QALY gained (compared with docetaxel), thus far higher than what is normally considered value for money for the NHS.

In a further blow, NICE reiterated that it is unlikely that any data collected during a period in the Cancer Drugs Fund (including from research already underway) would be able to adequately inform a subsequent review.

Patients will be disappointed by the news, given that treatment options for people with locally advanced unresectable or metastatic urothelial carcinoma who have had platinum-containing therapy are limited. They are usually offered docetaxel, paclitaxel and best supportive care.

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.