PBAC's latest decision on Empagliflozin: Deferred (2025). Considered for Extension of listing for chronic kidney disease to include additional patient subgroups with eGFR 20 to 90 mL/min/1.73 m², including those with eGFR <45 mL/min/1.73 m² or UACR <200 mg/g.
PBAC outcome
Deferred
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
8
first 2014
Submissions
8
2014 → 2025
Eligible population
Adults with chronic kidney disease, defined as abnormalities of kidney structure or function present for ≥3 months, with eGFR 20 to 90 mL/min/1.73 m² (with UACR ≥200 mg/g required if eGFR 45–90), not already on ACE inhibitor or ARB monotherapy, and stabilised on ACE inhibitor or ARB for ≥4 weeks.
Therapy area
Endocrinology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Composite of kidney disease progression and cardiovascular death
Key trials
EMPA-KIDNEY
Comparator
placebo plus standard care (standard care includes ACE inhibitor or ARB)
Economic model
CUA
ICER note
The document indicates the economic model was revised; however, no numeric ICER is explicitly stated in the public text. The resubmission completely revised the economic evaluation but no ICER values are disclosed.
Submission history
Jul 2014: Recommended with restriction · Authority Required
Nov 2015: Recommended with restriction · Authority Required
Nov 2015: Recommended with restriction · Authority Required
Nov 2021: Recommended with restriction · Restricted
Nov 2022: Recommended with restriction · Authority Required
Nov 2023: Recommended with restriction · Authority Required
Mar 2024: Recommended with restriction · Authority Required