OBJECTIVES : The objective is to conduct a model-based economic evaluation of rivaroxaban in patients with coronary artery disease (CAD) or peripheral artery disease (PAD) and to assess the cost-effectiveness of rivaroxaban 2.5mg in combination with aspirin 100 mg (RIV+ASA) compared to aspirin 100mg (ASA), over a lifetime horizon, to the Greek setting.

METHODS : A Markov model was developed using input data from the COMPASS trial (NCT01776424). The model considers the Greek National Healthcare payer perspective. Direct costs related to drug cost, unit costs of resources used per cycle per health state and cost of severe adverse events management were estimated based on publicly available sources (e.g. Official Price Bulletin, Government Gazettes). Deterministic and probabilistic sensitivity analyses were performed to test the robustness of the results.

RESULTS : The model shows that RIV+ASA compared to ASA alone decreases the risk of nonfatal myocardial infarction (MI) and ischaemic stroke or cardiovascular (CV) death and the risk of all health events, except for the risk of major nonfatal bleeding. A lifetime treatment with RIV+ASA compared to ASA alone is associated with an increase in quality adjusted life years (QALYs) (0.33) and life years (LYs) (0.38) and with an increase in costs (€3,815) in the population of patients with CAD or PAD. Clinical benefits and associated costs of RIV+ASA vs ASA result in an incremental cost-effectiveness ratio (ICER) of €11,534 per QALY gained and of €10,146 per LY saved. Sensitivity analyses suggest that the model is robust to changes in the majority of input parameters.

CONCLUSIONS : Overall, the results of the cost-effectiveness model support the use of RIV in combination with ASA as a cost-effective treatment option, at cost-effectiveness threshold of €30,000/QALY, in patients with CAD or PAD, compared to ASA alone, in the Greek setting.