PBAC's latest decision on Enfortumab vedotin: Recommended with restriction (2024). Considered for First-line treatment of locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer in patients who have not previously received systemic therapy for this condition.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
3
first 2022
Submissions
3
2022 → 2024
Eligible population
Patients with previously untreated locally advanced or metastatic urothelial cancer with WHO performance status of 0, 1, or 2.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS
Key trials
EV-302
Comparator
platinum-based chemotherapy with gemcitabine (Plat+Gem)
Economic model
CUA
ICER note
ICER not stated in the provided PSD text.
ICER (historical)
$75k/QALY–$95k/QALY in an earlier submission (2022) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Mar 2022: Recommended with restriction · Authority Required
Nov 2022: Recommended with restriction · Authority Required — ICER $95k/QALY
Nov 2024: Recommended with restriction · Authority Required