PBAC's latest decision on Odevixibat: Recommended with restriction (2025). Considered for Treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older with elevated serum bile acids and pruritus.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2024
Submissions
2
2024 → 2025
Eligible population
Patients with progressive familial intrahepatic cholestasis (PFIC) aged 6 months or older with elevated serum bile acids and a pruritus score of ≥2 on the Prucision™ ObsRO Pruritus Scale.
Therapy area
Hepatology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Pruritus response and serum bile acid response
Key trials
PEDFIC 1, PEDFIC 2, OvEC
Comparator
standard of care (SoC) including partial external biliary diversion (PEBD) and liver transplantation (LT)
Economic model
CUA
Eligible patients/year
4
ICER note
ICER values are redacted (commercial-in-confidence). Document states prices and ICER calculations are redacted with '$' symbols and '***' placeholders. Economic model exists but specific ICER figures are not published in this public summary.
Risk sharing
Risk-sharing arrangement in place — Risk sharing arrangement (RSA) in the form of annual expenditure caps, adjusted to incorporate a 'cost' approach and exclusion of genetic non-responders.
Submission history
Jul 2024: Deferred · Authority Required
Mar 2025: Recommended with restriction · Authority Required