Budget Impact Analysis of Eplerenone For the Management of Heart Failure With Reduced Ejection Fraction (HFrEF) in Italy

Author(s)

Giuseppe Pompilio, MSc, Claudio Bellomo, PharmaD, Franco Maria Pio Mondello Malvestiti, MD.
Viatris, Rome, Italy.
OBJECTIVES: Mineralocorticoid receptor antagonists (MRAs) represent one of four evidence-based pillars of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF). Among these, eplerenone has demonstrated a more favorable risk-benefit profile versus spironolactone and potassium canrenoate. Based on this, an Italian national budget impact analysis assessed the economic implications of increasing eplerenone use.
METHODS: A 3-year budget impact model compared current treatment patterns (CURRENT) with a scenario of increased adoption of eplerenone (ALTERNATIVE) in an estimated ~210,000 eligible HFrEF patients annually. Eplerenone uptake was assumed to grow from 1.97% to 4.78% (CURRENT) and from 6.5% to 11.0% (ALTERNATIVE) over the three-year horizon. Drug acquisition costs were taken from the AIFA Transparency Lists and Farmadati, and dosages from the SmPCs. Clinical outcomes included all-cause mortality, hospitalizations, and renal complications. Event rates were derived from published sources and adjusted based on baseline risks estimated via meta-analyses. Avoided deaths, relative to baseline mortality, and hospitalizations were valued at €5,910 and €3,702 per patient, respectively, according to published economic estimates. Renal damage costs were estimated at €590 per event, according to DRG 316 from Italian DRG system tariffs. A one-way deterministic sensitivity analysis varied all parameters by ±20%.
RESULTS: Base-case analysis estimated national cumulative savings of €2,548,545.82 over three years. Hospitalization HRs for eplerenone and canrenone, and the cost per renal failure event, had the greatest impact. Mortality and renal risk had moderate influence, while drug costs had minimal effect. Regional savings ranged from over €430,000 in Lombardia to less than €5,400 in Valle d’Aosta.
CONCLUSIONS: Scaling up eplerenone use in eligible HFrEF patients is supported by recent evidence and demonstrates cost-saving potential for the Italian NHS. The model underscores hospitalization prevention as a key cost driver and highlights the importance of regional planning when implementing value-based therapies in heart failure management.

Conference/Value in Health Info

2025-11, ISPOR Europe 2025, Glasgow, Scotland

Value in Health, Volume 28, Issue S2

Code

EE84

Topic

Economic Evaluation, Health Technology Assessment

Topic Subcategory

Budget Impact Analysis

Disease

Cardiovascular Disorders (including MI, Stroke, Circulatory)

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