Cost-effectiveness and budget impact analysis of rivaroxaban with or without aspirin compared to aspirin alone in patients with coronary and peripheral artery diseases in Iran.

Background: Low-dose aspirin and rivaroxaban are the cornerstone treatment for cardiovascular prevention in patients with peripheral artery disease (PAD) and/or stable coronary artery disease (SCAD). The combination of rivaroxaban with aspirin imposes a synergistic effect on the inhibition of factor-induced platelet aggregation. The present work aimed at comparing the cost-utility and cost-effectiveness of rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban alone (5 mg twice daily) with aspirin alone in patients with peripheral artery disease (PAD) or coronary artery disease (CAD) and related subgroups.

Methods: This pharmacoeconomic study was performed based on the insurance organization and utilized a state-transition decision Markov model. From the COMPASS trial, Clinical efficacy and Clinical events were collected. Health outcomes and cost were assessed over a 20-year time horizon (lifetime). The direct costs of medical services were included in the analysis. The results were stated based on Incremental Cost-Utility (ICUR) and Incremental Cost Effectiveness Ratio (ICER). Uncertainty was assessed utilizing deterministic and probabilistic sensitivity analyses. Discount rates of .058 and .03 were included for cost and effectiveness data, respectively. The budget impact based on the Markov model was estimated as the financial burden resulting from the insurance coverage of rivaroxaban.

Results: In the total of CAD and PAD patients, treatment with rivaroxaban plus aspirin and rivaroxaban alone were more expensive than the aspirin alone, but also more effective, resulting in ICUR being $4594/QALY and $13601/QALY respectively, and for ICER being $3348/LYG and $9901/LYG. In PAD patients rivaroxaban plus aspirin had higher effectiveness than aspirin alone that ICUR and ICER being $11929/QALY and $9896/LYG respectively. In CAD patients, treatment with rivaroxaban plus aspirin was expensive and less effective than aspirin alone. The estimated annual budget impact was $28,253,135 for the rivaroxaban plus aspirin and $292,593,909 for the rivaroxaban alone in the total of CAD and PAD patients.

Conclusions: This study showed that rivaroxaban plus aspirin is a cost-effective alternative in PAD and total of CAD and PAD patients. In CAD patients, rivaroxaban plus aspirin and rivaroxaban alone were not cost-effective.