PBAC's latest decision on Hydrocortisone: Recommended with restriction (2021). Considered for Replacement therapy of adrenal insufficiency in patients aged six years or younger, or patients aged six years or older with swallowing difficulties or tablet phobia where treatment compliance is an ongoing issue.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2021
Submissions
1
2021 → 2021
Eligible population
Patients aged six years or younger with adrenal insufficiency, or patients aged six years or older with swallowing difficulties or tablet phobia resulting in poor treatment compliance.
Therapy area
Endocrinology
Line of therapy
Not applicable
Evidence base
Single-arm
Primary endpoint
Safety
Key trials
Infacort 001, Infacort 003, Infacort 004
Comparator
hydrocortisone 4 mg and 20 mg tablets
Economic model
Not modelled
ICER note
No economic analysis was presented in the submission. The submission stated that cost-effectiveness modelling versus hydrocortisone tablets would be inappropriate given the lack of comparative studies and the highly uncertain results from single-arm studies.