PBAC's latest decision on Dapagliflozin: Recommended with restriction (2025). Considered for To reduce the risk of progressive decline in kidney function in adults with chronic kidney disease (CKD).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
15
first 2012
Submissions
15
2012 → 2025
Eligible population
Adults with CKD meeting specific eGFR and UACR criteria: eGFR 20 to 90 mL/min/1.73 m² with varying UACR thresholds depending on eGFR range (UACR ≥200 mg/g for eGFR 45-90, UACR ≥5,000 mg/g for eGFR 25-75, or no UACR minimum for eGFR 20-<25).
Therapy area
Endocrinology
Line of therapy
Not applicable
Evidence base
Registry
Primary endpoint
Surrogate
Key trials
DAPA-CKD, EMPA-KIDNEY, OPTIMISE-CKD
Comparator
empagliflozin
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. Submission requested updating the listing on a cost-minimisation basis to empagliflozin, with no change to current prices.
Submission history
Mar 2012: Not recommended
Mar 2012: Not recommended
Jul 2013: Recommended with restriction · Authority Required
Jul 2014: Not recommended · Authority Required
Nov 2014: Not recommended · Authority Required
Mar 2015: Noted · Authority Required
Jul 2017: Deferred · Authority Required
Nov 2017: Recommended with restriction · Authority Required
Nov 2020: Not recommended · Authority Required
Jul 2021: Recommended with restriction · Authority Required
Jul 2021: Recommended with restriction · Authority Required
Jul 2021: Recommended with restriction · Authority Required
Mar 2022: Recommended · Authority Required
Jul 2023: Recommended with restriction · Authority Required
Sep 2025: Recommended with restriction · Authority Required