What is the clinical evidence from this study?

Study design: Other. Population: Heart Failure with Reduced Ejection Fraction (HFrEF) (n=262352). Intervention: Eplerenone (Projected scenario with increased uptake) vs. Current clinical practice (observed MRA use including spironolactone, potassium canrenoate, and canrenone). Primary outcome: Net budget impact (total expenditure over 3 years) (+ €2.01 million (+0.34%)).

What does this research mean for the field?

Increasing the adoption of eplerenone for patients with heart failure with reduced ejection fraction (HFrEF) in Italy is substantially budget-neutral, resulting in a modest net increase in healthcare expenditure of approximately €3.20 per treated patient per year. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

July 22, 2026Advances in Therapy0 citationsOpen Access

Budget Impact of Eplerenone for Heart Failure with Reduced Ejection Fraction: National Perspective and Regional Implications in Italy

GPGiuseppe Pompilio CBClaudio Bellomo FMFranco Maria Pio Mondello Malvestiti

Key Result

Increasing the use of eplerenone for eligible patients with HFrEF in Italy resulted in a modest net budget impact of +€2.01 million (+0.34%) over 3 years, indicating substantial budget neutrality.

Structured PICO

Does increased eplerenone uptake compared to current MRA use impact the healthcare budget for patients with HFrEF in Italy?

Population

262,352 eligible adult patients with heart failure with reduced ejection fraction in Italy, modeled over a 3-year horizon to assess the budget impact of increased eplerenone use.

Intervention

Projected scenario of increased eplerenone uptake

Comparator

Current scenario of observed mineralocorticoid receptor antagonist (MRA) use

Outcome

Net budget impact over a 3-year horizon from the perspective of the Italian National Health Service (INHS)

Expanding eplerenone use for HFrEF in Italy is associated with a minimal budget increase (+0.34%), demonstrating substantial budget neutrality while aligning with guideline recommendations.

Main Result

Effect estimate: + €2.01 million (+0.34%)

Absolute Event Rate: 600.6% vs 598.6%

Limitations

Clinical efficacy estimates were derived from a network meta-analysis, which is sensitive to heterogeneity and the quality of included studies.
The evidence base for comparators canrenone and potassium canrenoate is particularly weak, relying on a single small trial.
A limited overlap between the incident and prevalent patient components in the eligible population estimation cannot be entirely excluded.
Treatment adherence was assumed at 80% without reflecting baseline prescribing patterns and disease prevalence.
The analysis uses national average costs, which may not reflect local or regional variations in tariffs, procurement policies, and clinical practice.
The model assumes uniform treatment effectiveness across all settings, which may not hold in real-world practice.

Abstract

INTRODUCTION: Heart failure with reduced ejection fraction (HFrEF) represents a major clinical and economic burden in Italy, driven by an aging population. Mineralocorticoid receptor antagonists (MRAs) are a cornerstone of guideline-recommended therapy. Eplerenone has demonstrated efficacy in reducing mortality and hospitalizations but remains underutilized. This study assessed the budget impact of increasing eplerenone use in eligible patients with HFrEF from national and regional perspectives. METHODS: A budget impact analysis (BIA) was conducted over a 3-year horizon from the perspective of the Italian National Health Service (INHS). Two scenarios were compared: Current (observed MRA use) and Projected (increased eplerenone uptake). Model inputs included eligible population, treatment distribution, drug acquisition costs, and clinical outcomes (all-cause mortality, hospitalizations, renal impairment, hyperkalemia, and gynecomastia) with associated costs. Clinical inputs were derived from a network meta-analysis (NMA); cost inputs from Italian literature and national tariffs. RESULTS: Total expenditure increased from €598.6 million (M) to €600.6 M over 3 years, corresponding to a net budget impact of + €2.01 M (+ 0.34%), with annual increments of €880,000 (year 1), €885,000 (year 2), and €245,000 (year 3). Increased eplerenone use resulted in higher costs (+ €35.07 M), driven by drug acquisition and hospitalization costs, partially offset by mortality-related savings (-€3.62 M). These were partially counterbalanced by reductions in other MRAs (spironolactone - €6.37 M, potassium canrenoate - €8.32 M, canrenone - €18.37 M), mainly due to fewer hospitalizations, renal events, and a lower drug volume. Results were primarily driven by clinical parameters for eplerenone, particularly NMA-derived hazard ratios for hospitalization and all-cause mortality. The net budget impact was modest in relative terms (< 0.4% of total MRA-related expenditure), indicating substantial budget neutrality. CONCLUSIONS: Greater adoption of eplerenone was associated with a modest net increase in healthcare expenditure for the INHS, corresponding to approximately €3.20 per treated patient per year and consistent with substantial budget neutrality. The budget impact reflects both treatment redistribution and differences in clinical outcomes across MRAs. Expanding eplerenone use in line with guideline-recommended therapy may be achieved at a limited additional cost, while offering a more favorable renal and selectivity profile relative to other MRAs.

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