PBAC's latest decision on Budesonide: Recommended (2024). Considered for Short-term treatment of mild to moderate ulcerative colitis, limited to the rectum (ulcerative proctitis), in adult patients.
PBAC outcome
Recommended
Unrestricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
11
first 2013
Submissions
11
2013 → 2024
Eligible population
Adult patients with acute ulcerative proctitis (mild to moderate ulcerative colitis limited to the rectum).
Therapy area
Gastroenterology
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Other
Pivotal trial size
571 patients
Key trials
BUS-4/UCA
Comparator
budesonide foam (BUF)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.
ICER (historical)
$30k/QALY–$50k/QALY in an earlier submission (2021) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Jul 2013: Recommended · Unrestricted
Jul 2017: Not recommended · Restricted
Nov 2017: Deferred · Authority Required
Jul 2018: Recommended with restriction · Authority Required
Mar 2019: Recommended · Restricted
Mar 2019: Recommended with restriction · Authority Required
Mar 2021: Recommended with restriction · Authority Required
Nov 2021: Recommended with restriction · Authority Required — ICER $50k/QALY