A DISEASE BURDEN AND BUDGET IMPACT ANALYSIS OF FINERENONE IN HFPEF IN THE US POPULATION

Abstract

Background: Heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF) presents a growing challenge in cardiovascular care, particularly among older adults. Finerenone, a non-steroidal mineralocorticoid receptor antagonist, has shown clinical benefit in reducing heart failure (HF) hospitalizations and cardiovascular mortality in this population. However, its budgetary impact in the U.S. remains unknown. Objective: To evaluate the 3-year budget impact of incorporating finerenone as an adjunct to standard therapy for HFpEF/HFmrEF from a general U.S. payer perspective, using real-world cost inputs and clinical effectiveness data from the FINEARTS-HF trial. Methods: A static Excel-based cohort model was developed comparing the current standard of care (SOC) with SOC plus finerenone. The analysis included direct medical costs (drug acquisition and hospitalization costs) from the 2023 MEPS database and hospitalization reduction rates from the FINEARTS-HF trial. Uptake assumptions (2%, 6%, and 10% over three years) were modeled, with annual and cumulative cost outcomes evaluated. A one-way sensitivity analysis assessed the impact of key input uncertainties. Results: Cumulative 3-year drug cost for finerenone was $3.21 billion, with avoided hospitalization savings of $176 million, yielding a net budget impact of $3.03 billion. Only ~5.5% of drug costs were offset by hospitalization savings. The model was most sensitive to hospitalization costs and finerenone acquisition costs. Conclusion: Finerenone substantially increases short-term costs when added to SOC for HFpEF/HFmrEF, with limited cost offset from reduced hospitalizations. These findings provide timely insights for U.S. payers in anticipation of FDA approval and market entry.