PBAC's latest decision on Obeticholic acid: Recommended with restriction (2021). Considered for Primary biliary cholangitis (previously known as primary biliary cirrhosis) in combination with ursodeoxycholic acid in UDCA inadequate responders and as monotherapy in patients intolerant to UDCA.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
$75k/QALY
Range: $55k/QALY–$75k/QALY
Submissions
4
first 2018
Submissions
4
2018 → 2021
Eligible population
Adults with primary biliary cholangitis inadequately responding to ursodeoxycholic acid treatment for at least 12 months, or adults unable to tolerate UDCA due to severe side effects.
Therapy area
Hepatology
Line of therapy
Not applicable
Evidence base
Cost-utility
Primary endpoint
QoL
Comparator
ursodeoxycholic acid (UDCA)
Economic model
CUA
Eligible patients/year
5,000
Risk sharing
Risk-sharing arrangement in place — Risk sharing arrangement with financial caps approximately 29% below revised financial estimates, beyond which percentage rebates would be applied.
Submission history
Nov 2018: Recommended with restriction · Authority Required
Jul 2019: Recommended with restriction · Authority Required
Nov 2020: Recommended with restriction · Restricted
Mar 2021: Recommended with restriction · Restricted — ICER $75k/QALY