Bristol-Myers Squibb Co.'s Opdivo was rejected by the U.K.'s National Institute for Health and Care Excellence for routine use in the U.K. National Health Service to treat bladder cancer.
In its final guidance, NICE said it could not recommend Opdivo, also known as nivolumab, to treat patients with urothelial carcinoma that has grown outside the bladder and cannot be surgically removed, or whose cancer has spread to other parts of the body. These patients have had platinum-containing therapy.
The regulator said Opdivo has not been directly compared with other treatments so it is unclear whether the drug is more effective than current standard treatment and is therefore not suitable for use within the U.K. Cancer Drugs Fund.
NICE also highlighted cost concerns for Opdivo, saying there was "substantial uncertainty" in the incremental cost-effectiveness ratios of the drug because the model used a simulated treatment comparison.
In an initial guidance in 2017, NICE rejected Opdivo for the same indication for failing to meet its cost-effectiveness criteria.
In March 2018, Merck & Co. Inc.'s Keytruda, Opdivo's biggest rival, received backing from NICE for treating bladder cancer.