Bristol-Myers' Opdivo racks up latest NICE rejection, this time in head and neck cancer

Bristol-Myers Squibb’s Opdivo hasn’t even won marketing approval for head and neck cancer in England and Wales yet, but their cost watchdog is already shutting it out.

The National Institute for Health and Care Excellence on Tuesday introduced the latest in a series of setbacks for the BMS immuno-oncology hotshot: draft guidance that doesn’t recommend it as a head and neck cancer therapy.

The med’s costs—£439 per 40-mg vial and £1,097 per 100-mg vial, less a confidential discount agreed to with Bristol-Myers—“were considered to be very high in relation to its benefit to be recommended for routine NHS use at present,” Carole Longson, director of NICE’s health technology evaluation center, said in a statement.

RELATED: The top 15 best-selling cancer drugs in 2022Opdivo

NICE often rejects pricey cancer drugs on their first try, only to change its mind after further negotiations with drugmakers. Bristol-Myers itself has experienced this; the agency initially stymied Opdivo in kidney cancer, too, before a discount convinced it to flip-flop.

The head and neck cancer rejection, however, is just the latest in a series for Opdivo—which is still awaiting EMA approval in head and neck cancer following last month's backing from a review committee. Last October, the gatekeeper turned down Opdivo in lung cancer, though it did leave open the possibility of backing from England’s Cancer Drugs Fund while Bristol-Myers gathers more information.

RELATED: NICE turns down Opdivo for lung cancer

Unfortunately for Bristol-Myers, however, the list of Opdivo’s recent struggles doesn’t end with NICE. After a brutal first-line lung-cancer trial failure that handed Opdivo’s lead in that field to Merck’s Keytruda, Bristol-Myers has also seen delays to a combo development program, alongside Yervoy, that allowed Merck to race even further ahead.

Meanwhile, Bristol-Myers—along with healthcare professionals and the public—now has the opportunity to make its voice heard on the draft guidance until early May. NICE will then take their comments into account before publishing a second round of guidance, it said.