ICER Announces Final Evidence Report for FibroGen’s Roxadustat, Uncertainties Linger

ICER has released a final evidence report for roxadustat, along with policy recommendations. Cardiovascular risks were one of the concerns surrounding the drug, which is designed to treat anemia in the context of chronic kidney disease. CTAF (California Technology Assessment Forum) members voted unanimously that evidence was insufficient when it comes to these possible cardiovascular events, as well as all-cause mortality.

“During the public meeting, the CTAF panelists voted unanimously (15-0) that the evidence is not adequate to demonstrate that roxadustat provides a net health benefit over ESAs. Further, for the population of patients who are dialysis independent (DI-CKD), and for whom ESAs were not available (i.e., where those patients would otherwise receive blood transfusions), the CTAF also voted unanimously (15-0) that the evidence is not adequate to demonstrate roxadustat provides a net health benefit over usual care.” Read more here.

(Source: ICER, 3/5/21)