PBAC's latest decision on Iptacopan: Recommended with restriction (2025). Considered for Treatment of adults with complement 3 glomerulopathy (C3G) with either native kidneys or disease recurrence following a kidney transplant.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2024
Submissions
2
2024 → 2025
Eligible population
Adults aged ≥18 years with C3G (complement 3 glomerulopathy) with either native kidneys or disease recurrence following a kidney transplant. For native kidney patients: eGFR ≥30 mL/min/1.73 m², UPCR ≥1.0 g/g (113 mg/mmol), stabilised on ACE inhibitor or ARB unless contraindicated/intolerant. For post-transplant patients: recurrent C3G confirmed by kidney biopsy with eGFR ≥30 mL/min/1.73 m² and stable immunosuppression.
Therapy area
Rare disease
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Surrogate
Comparator
Standard of care
Economic model
CUA
ICER note
ICER value not stated in the public text; economic analysis was performed but specific ICER figure is not published in this PSD.
Submission history
Jul 2024: Recommended with restriction · Authority Required
Nov 2025: Recommended with restriction · Authority Required