PBAC's latest decision on Elafibranor: Recommended with restriction (2025). Considered for Primary biliary cholangitis (PBC) in patients with inadequate response to ursodeoxycholic acid (UDCA) or intolerance to UDCA, in combination with UDCA or as monotherapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
1
first 2025
Submissions
1
2025 → 2025
Eligible population
Adults aged 18 years or over with primary biliary cholangitis who have experienced inadequate response to UDCA (despite treatment for at least 52 weeks at therapeutic dose) or intolerance to UDCA, with elevated alkaline phosphatase (≥1.67 times ULN with ≥15% reduction from baseline) and bilirubin levels ≤2 times ULN.
Therapy area
Hepatology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
Surrogate
Key trials
ELATIVE, ELFIDENCE
Comparator
obeticholic acid (OCA)
Economic model
CEA
Eligible patients/year
5,695
ICER note
ICER value not stated in the public summary document.