NICE shoots down Bayer's Stivarga in liver cancer, citing price, clinical questions

Bayer has through Nov. 27 to make its Stivarga case to NICE.

Bayer is working to position Stivarga as part of a treatment regimen for those in whom its first-line liver cancer fighter, Nexavar, has failed. But that’s not going to work in England. At least, not yet.

The National Institute for Health and Care Excellence (NICE) has shot down the medication for routine NHS use for a couple of reasons—one, as usual, being price. While Bayer has already agreed to a confidential price break on its £3,744-per-treatment-cycle therapy, as an end-of-life treatment, it’s still too expensive, NICE contends.

And the cost watchdog didn’t recommend Stivarga for coverage through its Cancer Drugs Fund, either; “it does not have plausible potential to be cost effective,” it noted. NICE also still has questions about Stivarga’s survival benefit in those who can’t tolerate Nexavar or have more severe liver cancer, and those “clinical uncertainties cannot be resolved by data collection” within the fund.

RELATED: With Stivarga-Nexavar bridge-building complete in liver cancer, Bayer gets ready to run the table

It’s a blow to Bayer, which is working to funnel patients from Nexavar—the only treatment approved in the front-line liver cancer setting—to Stivarga. It’s got new competition in the second-line space from Bristol-Myers Squibb immuno-oncology star Opdivo, which won its approval in September.

The German drugmaker still has time to make its case, though. NICE will now field input through Nov. 27, and it’ll convene again next month for another appraisal meeting.

RELATED: NICE expands Bayer's Stivarga prospects with move from CDF

And Bayer has been successful changing minds at NICE with Stivarga in the past. Last month, the cost-effectiveness gatekeeper recommended moving Stivarga off the CDF and making it routinely available on England’s NHS as a treatment for gastrointestinal stromal tumors.