Cost effectiveness of rivaroxaban for stroke prevention in German patients with atrial fibrillation.

OBJECTIVE: The aim of this study was to assess the cost effectiveness of the novel fixed-dose anticoagulant rivaroxaban compared with the current standard of care, warfarin, for the prevention of stroke in patients with atrial fibrillation (AF). METHODS: A Markov model was constructed to model the costs and health outcomes of both treatments, potential adverse events, and resulting health states over 35 years. Analyses were based on a hypothetical cohort of 65-year-old patients with non-valvular AF at moderate to high risk of stroke. The main outcome measure was cost per quality-adjusted life-year (QALY) gained over the lifetime, and was assessed from the German Statutory Health Insurance (SHI) perspective. Costs and utility data were drawn from public data and the literature, while event probabilities were derived from both the literature and rivaroxaban's pivotal ROCKET AF trial. RESULTS: Stroke prophylaxis with rivaroxaban offers health improvements over warfarin treatment at additional cost. From the SHI perspective, at baseline the incremental cost-effectiveness ratio of rivaroxaban was 15,207 per QALY gained in 2014. The results were robust to changes in the majority of variables; however, they were sensitive to the price of rivaroxaban, the hazard ratios for stroke and intracranial hemorrhage, the time horizon, and the discount rate. CONCLUSIONS: Our results showed that the substantially higher medication costs of rivaroxaban were offset by mitigating the shortcomings of warfarin, most notably frequent dose regulation and bleeding risk. Future health economic studies on novel oral anticoagulants should evaluate the cost effectiveness for secondary stroke prevention and, as clinical data from direct head-to-head comparisons become available, new anticoagulation therapies should be compared against each other