NICE flip-flops to back Bristol-Myers' Opdivo in head and neck cancer despite data 'uncertainties'

In April, England's cost-effectiveness gatekeepers refused to back Bristol-Myers Squibb's Opdivo in head and neck cancer.

Back in April, England’s cost watchdogs said they wouldn’t cover Bristol-Myers Squibb’s Opdivo in head and neck cancer due to “uncertain” clinical evidence. Now, though, they’re singing a different tune.

The National Institute for Health and Care Excellence said it will cover the medication through its Cancer Drugs Fundand it’s a new proposal from Bristol-Myers that changed the body’s mind. It outlined how the company plans to strengthen the data it has on the drug, which it’ll do through a clinical trial and data collection through the CDF.

Opdivo “is an innovative drug that continues to draw attention, but its clinical evidence for some types of cancer can be uncertain. I am pleased the company has worked with us and NHS England to develop a managed access agreement and that we have found a way to provide for patients despite these uncertainties,” Carole Longson, director of NICE’s health technology evaluation center, said in a statement.

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

Bristol, unsurprisingly, will also be providing the NHS a confidential discount on the drug, which bears a list price of £1,097 ($1460) per 100-mg vial. In April, Longson called that sticker “very high in relation” to Opdivo’s benefit.

And that’s not the only condition for Opdivo coverage. Patients taking the drug must stop after two years of uninterrupted treatmentor sooner, if their disease worsens. Clinical data has shown that Opdivo can prolong survival by more than three months compared with current treatments.

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Still, Bristol-Myers will gain access to what NICE estimates is a patient pool of 900 eligible patients, with more on the way; nearly 10,000 new cases of head and neck cancer are diagnosed in the U.K. every year, it said.

And it’ll also gain a head start in a market where archrival Keytruda from Merck isn’t yet approved. That drug, which is currently battling Opdivo in various tumor types including lung cancer, bladder cancer and melanoma, won an FDA approval in head and neck cancer last year, but it has yet to nab an EU green light.