NICE turns down BMS' blockbuster Opdivo for urothelial carcinoma

Just in time for the NHS’ 70th birthday, UK watchdog NICE has announced that it has taken the decision to reject Bristol-Myers Squibb’s blockbuster immunotherapy drug Opdivo (nivolumab) for use on the health service in the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC).

The news is particularly impactful for UK patients with the condition given the limited treatment options available. It is the seventh most common cancer in the country, and around 10,000 new cases emerge every year.

Opdivo was approved as a treatment for the same indication in adult patients who prove unresponsive to platinum-containing therapy back in June last year, driven by Phase 2 data which showed that it demonstrated a response rate of 20%. However, this most recent decision was made based on the fact that NICE could not determine the drug’s efficacy in relation to comparable treatments.

"Nivolumab has been studied in a clinical trial, but it has not been directly compared with other treatments. So it is not clear how effective nivolumab is compared with current clinical practice," the guidance read.

Furthermore, NICE came to the conclusion that, based on this fundamental issue, Opdivo would not be suitable for use on the Cancer Drugs Fund because further data gathered from either ongoing trials or clinical practice would do nothing to alleviate the concerns over efficacy.

Because it could not accurately determine the drug’s efficacy, cost-effectiveness estimates were also highly uncertain, with projections placing the price tag at around £59,000 and £79,000 per Quality Added Life Year gained compared to current treatments, coming in much higher than the usual threshold for value for money.

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