OBJECTIVES: The aim of the study was to assess the cost-effectiveness of rivaroxaban 2.5mg twice daily plus acetylsalicylic acid (ASA) 100mg once daily (RIV+ASA) versus ASA alone, for the prevention of atherothrombotic events among patients with coronary artery disease (CAD) or peripheral artery disease (PAD), from the Spanish National Health System perspective.

METHODS: A Markov model, with an appropriate structure for decision making according NICE, with a lifetime horizon was developed using input data from the COMPASS trial. The model used three-month cycles and included six health states: event-free, acute and post-acute of myocardial infarction, ischaemic stroke, or intracranial haemorrhage, and death. Direct costs regarding drug cost and resource use related to health states and health events were estimated based on Spanish publicly available sources and expert opinion (n=4). Costs and benefits were discounted 3.0% annually. Deterministic and probabilistic sensitivity analyses, as well as scenario analyses, were performed to assess the robustness of the results.

RESULTS: A life treatment with RIV+ASA compared to ASA alone is associated with an increase in quality adjusted life years (QALYs) (0.19) and life years (LYs) (0.21) and with an increase in costs €3,742 in the population of patients with CAD or PAD. The incremental cost-effectiveness ratio (ICER) was €19,522 per QALY gained and €17,572 per LY saved. The RIV+ASA strategy is particularly beneficial in patients with high-risk cardiovascular feature (CAD and PAD, PAD, CAD and renal impairment, CAD and chronic heart failure, CAD and diabetes) with an even lower ICERs per QALY gained. The sensitivity analyses suggested that the model was robust to changes in the majority of input parameters.

CONCLUSIONS: RIV+ASA compared to ASA would provide better health outcomes being cost-effective in the prevention of cardiovascular events in patients with CAD or PAD in Spain.