Abstract

Background: The EINSTEIN-extension trial (EINSTEIN-EXT) found that continued treatment with rivaroxaban for an additional 6 or 12 months (versus placebo) after the initial 6-12 months of anticoagulation significantly reduced the risk of recurrent venous thromboembolism (VTE) with a small increased risk of major bleeding (none was fatal or in a critical site). This study aimed to assess the cost impact of rivaroxaban vs. placebo based on EINSTEIN-EXT recurrent VTE and bleed rates. Methods: Total costs were calculated as the sum of drug and clinical event costs, and compared between cohorts from a US managed care perspective. Treatment duration and event rates were obtained from EINSTEIN-EXT. Drug costs were based on wholesale acquisition costs. Cost estimates for clinical events (i.e., recurrent VTE, major bleeding, clinically relevant nonmajor bleeding, and mortality) were determined based on a targeted literature review. Results were examined over a ± 20% range of each cost component in a one-way sensitivity analysis approach. Results: Total cost per person was $1,161 lower for rivaroxaban (vs. placebo) in the base case, with lower cost of clinical events fully offsetting drug costs (Figure 1). The difference in recurrent DVT alone (-$3,102) was greater than drug cost ($3,025). Total cost of rivaroxaban remained lower than placebo in sensitivity analyses. Conclusions: Rivaroxaban is associated with lower total costs compared to placebo in VTE patients who had completed 6 to 12 months of VTE treatment.

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