PBAC's latest decision on Vedolizumab: Deferred (2025). Considered for Dose escalation from 8-weekly to 4-weekly intravenous maintenance treatment in adults with moderate to severe ulcerative colitis or severe Crohn disease who experience loss of clinical response on 8-weekly dosing.
PBAC outcome
Deferred
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
7
first 2014
PBS spend
$153M
63,372 scripts · 2024
Eligible population
Adults with moderate to severe ulcerative colitis or severe Crohn disease on vedolizumab 8-weekly intravenous maintenance who have insufficient response and would not be sufficiently maintained on 8-weekly dosing.
No ICER analysis presented; this is a dose-escalation/balance of supply submission with proposed cost-neutrality via Special Pricing Arrangement amendment.
Risk sharing
Risk-sharing arrangement in place — Special Pricing Arrangement (SPA) proposed to offset the net budget impact of doses additional to Q8W dosing.
PBS expenditure
The Australian government paid $153M in PBS benefits for Vedolizumab in 2024 across 63,372 scripts, at $2,419 per script.
Submission history
Jul 2014: Recommended with restriction · Authority Required
Mar 2015: Recommended with restriction · Authority Required
Mar 2015: Not recommended · Authority Required
Nov 2020: Recommended with restriction · Authority Required
Mar 2024: Recommended with restriction · Restricted
Jul 2024: Recommended with restriction · Authority Required