ICER backs cost-effectiveness of Vascepa, Xarelto; Epizyme's lead drug wins speedy US review
→ Drug cost-effectiveness watchdog ICER on Wednesday unveiled preliminary findings from its draft report on additive cardiovascular disease therapies: Amarin’s $AMRN fish oil pill Vascepa and J&J’s $JNJ blood thinner Xarelto. Findings suggest the therapies offer survival benefit over optimal medical management, the institute said. “Assuming clinical signals…hold for patients treated with these interventions and current net prices, the base-case results suggest that costs for treatment with either rivaroxaban (Xarelto) or icosapent ethyl (Vascepa) would fall below commonly cited thresholds for cost-effectiveness.”
Vascepa’s estimated net price ($1,600-2,000) falls below ICER‘s estimated price of $3,400 – $6,200 required to achieve their $50,000 to $100,000 QALY threshold — and nearly 100% of iterations met the $50,000 threshold, noted Jefferies’ Michael Yee. “(H)ence Vascepa is possibly “underpriced” relative to the key benefit thresholds used by ICER.”
→ Less than a year after a partial hold — imposed after a young patient developed secondary T-cell lymphoma — on its lead drug tazemetostat was lifted, Epizyme‘s $EPZM application to market the drug in metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery has been accepted by the FDA. The US regulator has granted the application priority review and expects to make its decision by January 23, 2020.
→ French biotech Valneva is getting up to $23.4 million for its Chikungunya vaccine in development from the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the EU’s Horizon 2020 program. The virus, which is spread by the bites of infected female Aedes mosquitoes akin to Zika, has been highlighted by the WHO as a major public health risk. It was first identified in Tanzania in 1952, with sporadic outbreaks of the disease reported subsequently across Africa and Asia — but since 2004, large-scale outbreaks have been reported leading to a total of over 3.4 million in 43 countries. Climate change is expected to make things worse.