PBAC's latest decision on Seladelpar: Recommended with restriction (2025). Considered for Treatment of primary biliary cholangitis in patients with inadequate response to ursodeoxycholic acid (UDCA) or intolerance to UDCA.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2025
Submissions
2
2025 → 2025
Eligible population
Patients aged 18 years or older with primary biliary cholangitis who have had an inadequate response to UDCA (despite at least 52 weeks of treatment) or are intolerant to UDCA, and have elevated ALP (≥1.67x ULN) or elevated total bilirubin (1-2x ULN).
Therapy area
Hepatology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
Surrogate
Key trials
RESPONSE
Comparator
best supportive care, obeticholic acid, elafibranor
Economic model
CEA
ICER note
The submission proposed a placeholder DPMQ with no published or effective price for seladelpar. The ICER was deliberately overestimated due to confidential special pricing arrangements for the comparator (OCA).
Risk sharing
Risk-sharing arrangement in place — The PBAC considered that seladelpar should join the risk sharing arrangement for OCA.
Submission history
Jul 2025: Recommended with restriction · Authority Required
Jul 2025: Recommended with restriction · Authority Required