Andexanet Alfa (Ondexxya)

Abstract

CADTH recommends that Ondexxya should not be reimbursed by public drug plans for adult patients treated with factor Xa (FXa) inhibitors (rivaroxaban or apixaban) when rapid reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Evidence from a clinical trial (ANNEXA-4) demonstrated that Ondexxya treatment could reduce the activity of FXa inhibitors in the blood and improve imaging and laboratory markers of bleeding; however, without a control group, there is uncertainty in how much the observed benefits were due to Ondexxya treatment rather than chance. Clinical outcomes such as neurologic status and mortality were also uncertain. No evidence was submitted at the time of the review that directly compared Ondexxya to usual care for managing bleeding related to an FXa inhibitor. Observational evidence comparing Ondexxya and prothrombin complex concentrate, which is part of the usual care, was uncertain due to limitations of study design and analysis. Based on the evidence reviewed, the CADTH Canadian Plasma Protein Product Expert Committee (CPEC) was not convinced that treatment with Ondexxya would achieve outcomes that are clinically important to patients or meet needs not already addressed by other available treatments.