NICE expands Bayer's Stivarga prospects with move from CDF

Bayer's Stivarga won an FDA nod in April for second-line liver cancer.

Since the National Institute for Health and Care Excellence took the reins of England’s Cancer Drugs Fund last year, several drugmakers have seen their oncology meds get the boot. Not Bayer.

On Thursday, the cost watchdog recommended the German pharma’s Stivarga, a treatment for gastrointestinal stromal tumors, be moved off the special fund and made routinely available on England’s NHS. The therapy will now be offered as an option to patients with the rare tumors that have spread to other parts of the body or can’t be treated with surgery, or those patients who can’t receive other treatments, NICE said.

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How did Bayer swing the move? First off, it submitted evidence showing Stivarga can extend overall survival by more than 9 months compared with best supportive care. And secondly, it served up a confidential discount on the list price, which sits at £3,744 per three-week treatment cycle, or just under £180 per patient per day.

In return, Bayer expects to treat a large new patient pool within the first year of the NICE arrangement. About 900 cases of gastrointestinal stromal tumors are diagnosed every year in the U.K., and the company estimates that 58% of patients will be eligible for Stivarga therapy.

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NICE’s backing comes at a turning point for Stivarga, which in April won an FDA nod in second-line liver cancer. The indication was key for the drug, which Bayer now markets as part of a regimen with first-line blockbuster Nexavar, and it came at a time when the drug was struggling thanks to competition in its colorectal cancer indication.

As of last month, though, Stivarga has a new liver-cancer rival, and that’s Bristol-Myers Squibb immuno-oncology standout Opdivo. That accelerated approval came on the back of positive overall response and duration of response data, and Bayer is hoping the survival data Stivarga has will help set it apart.