New PBS Listing for Rivaroxaban

From 1 December 2020, rivaroxaban 2.5mg tablets are available on the Pharmaceutical Benefits Scheme (PBS) for chronic stable atherosclerotic disease. The PBS criteria requires that rivaroxaban 2.5mg be used in combination with aspirin in high-risk patients with coronary artery disease or peripheral artery disease.

Evidence to support the use of rivaroxaban 2.5mg in this patient group comes from the COMPASS trial. Participants with stable atherosclerotic vascular disease were randomly assigned to receive rivaroxaban 2.5mg twice daily plus aspirin 100mg daily, rivaroxaban 5mg daily, or aspirin 100mg daily. The primary efficacy outcome was the composite of cardiovascular death, stroke, or myocardial infarction. This occurred in 4.1% of the rivaroxaban plus aspirin group, 4.9% of the rivaroxaban alone group, and 5.4% of the aspirin alone group.

There was no significant difference in the rate of intracranial or fatal bleeding events between groups. However, major bleeding events were more common in the rivaroxaban plus aspirin group (3.1% compared to 1.9% in the aspirin alone group). The study was stopped after a mean follow-up of 23 months due to the superiority of rivaroxaban plus aspirin.