EplerenoneAPO-EPLERENONE
Chronic heart failure with left ventricular ejection fraction ≤40%, either within 3-14 days following acute myocardial infarction or in symptomatic patients with NYHA class II, III or IV heart failure.
Decisions on record
- Meeting Dec 2025 Recommended Heart failure no PSD
- Meeting Jul 2025 Deferred Heart failure
Access path
- TGA registered · APO-EPLERENONE
TGA label narrower than the PBS population
- Jul 2005Recommended · restricted
vs placebo (standard medical management)
- Jul 2025Recommended · restricted
Comparator changed: placebo (standard medical management) → placebo / standard care
- Dec 2025Recommended
Comparator changed: placebo / standard care → standard of care / placebo
- PBS listing · Authority Required
From the public summary
6.1 The PBAC deferred making a recommendation for the requested amendments to the current PBS restriction for eplerenone (Inspra®) to align with clinical guidelines for the management of heart failure.PSD · Jul 2025
6.2 The PBAC noted the lack of mineralocorticoid receptor antagonist (MRA) medication options on the PBS, and the barriers to subsidised access of eplerenone due to the current PBS restriction.PSD · Jul 2025
5.12 The requested price is based on the current AEMP of eplerenone.PSD · Jul 2025
5.13 The submission stated that the price of eplerenone in 2006 (DPMQ $114.84), when it was listed on the PBS, is used to examine the cost effectiveness at the time, and then how that has changed in 2025 (DPMQ $54.09).PSD · Jul 2025
5.10 The submission claimed superior comparative effectiveness and inferior comparative safety of eplerenone compared with placebo/standard of care.PSD · Jul 2025
5.11 As a Category 3 submission, no evaluation of the clinical evidence was undertaken.PSD · Jul 2025
5.2 The PBAC noted and welcomed the input from health care professionals (9), individuals who had used this medicine for their own health condition (1), and consumer groups (1) via the Consumer Comments facility on the PBS website. The comments noted that MRA treatment reduces death and hospitalisation outcomes by approximately 30%, and that spironolactone was the preferred MRA due to the current PBS restrictions for eplerenone.PSD · Jul 2025
Cost-effectiveness
No ICER calculated; this is a Category 3 submission requesting restriction amendments to an existing listing, not a new economic evaluation.
The base case modelled incremental cost per extra life-year gained under both models was < $15,000. PSD · 2005
Decision context
PopulationAdult patients with chronic heart failure and documented LVEF ≤40%, either within 3-14 days following acute myocardial infarction or with symptomatic NYHA class II, III or IV heart failure, receiving concomitant optimal standard chronic heart failure treatment including beta-blocker and ACE inhibitor or angiotensin II antagonist.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Dec 2025 | Recommended | standard of care / placebo | — | RCT · Other |
| Jul 2025 | Recommended · restricted | placebo / standard care | — | RCT · CV death or HF hospitalization |
| Jul 2005 | Recommended · restricted | placebo (standard medical management) | — | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| EMPHASIS-HF | Ph 3 | 2,743 | Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitali… | completed |
Consumer voice
Health care professionals, one individual patient, and a consumer group (hearts4heart) provided input supporting MRA treatment, noting its benefits in reducing death and hospitalisation. hearts4heart specifically advocated for expanded eplerenone reimbursement, citing better tolerability and efficacy compared to spironolactone.
MRA treatment reduces death and hospitalisation outcomes by approximately 30% Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to LVEF ≤40% and requires concomitant beta-blocker plus ACE inhibitor/angiotensin II antagonist; TGA allows broader LVEF thresholds without mandatory concomitant therapy specification.