PBAC's latest decision on Finerenone: Recommended with restriction (2023). Considered for Treatment of chronic kidney disease in patients with type 2 diabetes mellitus (diabetic kidney disease) with eGFR >25 mL/min/1.73 m² and UACR ≥200 mg/g, in combination with standard of care.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2022
Submissions
2
2022 → 2023
Eligible population
Adults with chronic kidney disease associated with type 2 diabetes, eGFR >25 mL/min/1.73 m², UACR ≥200 mg/g, stabilised on ACEi or ARB for ≥4 weeks, and receiving SGLT2i unless contraindicated or intolerant, excluding those with established HFrEF.
Therapy area
Endocrinology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Composite — onset of kidney failure, sustained decrease of eGFR ≥40% from baseline, or renal death; and composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalisation for heart failure
Key trials
FIDELIO-DKD, FIGARO-DKD, FIDELITY
Comparator
Placebo in combination with standard of care (ACEi or ARB, and SGLT2i unless contraindicated)
Economic model
CUA
ICER note
ICER value is redacted (shown as $ AEMP in the pricing section); the economic evaluation exists but the numerical ICER is commercially sensitive and not published in the public summary document.
Submission history
Jul 2022: Recommended with restriction · Authority Required
Mar 2023: Recommended with restriction · Authority Required