PBAC's latest decision on Avelumab: Recommended with restriction (2022). Considered for Maintenance treatment of locally advanced (Stage III) or metastatic (Stage IV) urothelial carcinoma in patients whose disease has not progressed following first-line platinum-based chemotherapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$75k/QALY
Range: $55k/QALY–$75k/QALY
Submissions
5
first 2018
PBS spend
$57M
9,550 scripts · 2024
Eligible population
Patients with locally advanced (Stage III) or metastatic (Stage IV) urothelial carcinoma with WHO performance status 0 or 1 whose disease has not progressed following first-line platinum-based chemotherapy
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS
Comparator
best supportive care
Economic model
CUA
ICER note
ICER range with financial stopping rule and revised price; without the stopping rule, ICER would be $95,000 to <$115,000/QALY
Risk sharing
Risk-sharing arrangement in place — Sponsor agreed to join existing Risk Sharing Arrangement for second-line pembrolizumab with revised expenditure caps to address uncertainties regarding uptake rates and treatment duration costs
PBS expenditure
The Australian government paid $57M in PBS benefits for Avelumab in 2024 across 9,550 scripts, at $5,926 per script.
Submission history
Jul 2018: Recommended with restriction · Authority Required
Mar 2020: Recommended with restriction · Authority Required
Mar 2021: Recommended with restriction · Authority Required
Mar 2021: Recommended with restriction · Authority Required
Mar 2022: Recommended with restriction · Authority Required — ICER $75k/QALY