In a one-two punch for Bayer, cost watchdogs in England and Germany rejected the company’s new “tumor-agnostic” cancer drug Vitrakvi because of its price and “limitations” in its supporting data.
England’s National Institute for Health and Care Excellence (NICE), in draft guidance published Jan 17, said cost-effectiveness calculations for the pricey med are “very uncertain,” adding that the drug’s benefit over existing treatment options is unknown. Germany’s cost-effectiveness agency, IQWiG, also rejected the med on insufficient data.
Evidence showed NTRK gene fusion cancers shrink after treatment with Bayer’s med, but NICE says it’s “difficult to know how well [Vitrakvi] works because it has not been compared in the trials with other treatments.”
The drug, also known as larotrectinib, costs £15,000 per 30-day supply, NICE says, and Bayer offered a “commercial arrangement” in the event the drug was recommended. NICE estimates around 600 to 700 patients suffer from NTRK gene fusion cancers in England.
In the draft guidance, the agency concluded that Bayer’s new therapy does not have “the potential to be a cost-effective use of NHS resources,” so it rejected the drug through routine use or through the Cancer Drugs Fund.
Further, on Friday Bayer hit a setback in its home country as cost watchdogs at IQWiG rejected the med on insufficient data, citing concerns over a lack of control arms in clinical trials.