PBAC's latest decision on Osilodrostat: Recommended with restriction (2024). Considered for Treatment of endogenous Cushing's syndrome in adults who are not candidates for surgery or for whom surgery was not curative.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
3
first 2023
Submissions
3
2023 → 2024
Eligible population
Adult patients with endogenous Cushing's syndrome who are not candidates for surgery or for whom surgery was not curative, with mean urinary free cortisol level greater than 1.3 times the upper limit of normal.
Therapy area
Endocrinology
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
ORR
Key trials
LINC 4, LINC 3
Comparator
placebo
Economic model
CUA
ICER note
The PBAC considered the submitted economic model unsuitable for decision making because it did not include important long-term benefits expected with durable cortisol control; ICER values not stated in public text.
Submission history
Mar 2023: Recommended with restriction · Authority Required
Mar 2024: Recommended with restriction · Authority Required
Mar 2024: Recommended with restriction · Authority Required