Xarelto rivaroxaban regulatory update

The U.K.'s NICE issued draft guidance recommending use of Xarelto rivaroxaban from Bayer in combination with aspirin plus clopidogrel or aspirin alone to prevent atherothrombotic events in patients who have acute coronary syndrome (ACS) with elevated cardiac biomarkers. The committee noted the bleeding risk associated with the direct Factor Xa inhibitor and recommended that clinicians assess patients' risk of bleeding before treating them with Xarelto. NICE also advised clinicians to consider carefully treatment beyond 12 months. The base case incremental cost-effectiveness ratio (ICER) for Xarelto compared to clopidogrel plus aspirin or aspirin alone was L6,203 ($9,988) per quality-adjusted life year (QALY) gained. Comments are due Nov. 13, with a second appraisal committee meeting scheduled for Nov. 25. ...