FINERENONE
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Kerendia®
- Form and strength:
-
- Tablet 10 mg
- Tablet 20 mg
- Tablet 40 mg
- Submission sponsor:
- BAYER AUSTRALIA LTD
- Condition/indication:
(therapeutic use) -
- Heart failure
- Listing requested:
- To request listing of finerenone for the treatment of adult patients with symptomatic heart failure (New York Heart Association (NYHA) Class II-IV) and a left ventricular ejection fraction (LVEF) of greater than or equal to 40%.
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required (STREAMLINED)
- PBAC Submission type:
- New PBS listing (Category 2)
- Comment:
- --
- Other PBAC consideration:
Progress Details
-
Submission received for: - July 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 25/03/2026 and close 20/05/2026 (see PBS Website)
-
PBAC meeting: - Held on 08/07/2026
-
PBAC outcome published: - Not Recommended (see PBAC Outcomes)
-
Lodgement of required documentation: - Not applicable
-
Agreement to listing arrangements: - Not applicable
-
Government processes: - Not applicable
-
Medicine listed on the PBS: - Not applicable
PBAC Outcome
The PBAC did not recommend PBS subsidy of finerenone for the treatment of adults with symptomatic heart failure (New York Heart Association Class II‒IV) and left ventricular ejection fraction (LVEF, the percentage of blood pumped out of the heart's main chamber after each beat) of greater than or equal to 40%. This includes patients with heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF), that is, heart failure where the heart’s pumping function is relatively normal or only mildly impaired. The PBAC considered that the evidence showed finerenone was more effective than current treatment. However, the main benefit from the clinical evidence was a reduction in hospitalisations and it remains unclear whether finerenone reduces cardiovascular death.
The PBAC welcomed comments from an organisation, which highlighted the substantial burden of heart failure and the ongoing need for additional effective therapies. It noted that finerenone may reduce worsening of heart failure symptoms that require urgent medical treatment, and improve symptoms and wellbeing, but that without PBS subsidy it would be unaffordable for many patients.
The PBAC noted that the submission overestimated finerenone’s health benefits and considered that further review and revision of the estimated benefits were required. The PBAC advised the medicine would be cost-effective with a price reduction reflecting more realistic estimates of benefits and costs. The PBAC considered that the estimate of the cost to the PBS if finerenone was listed also required revision. The PBAC advised that these issues could be addressed in an early re-entry submission.
Sponsor’s Comment:
The sponsor had no comment.