PBAC's latest decision on Darolutamide: Recommended with restriction (2022). Considered for Treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) and docetaxel.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
4
first 2020
PBS spend
$59M
16,824 scripts · 2024
Eligible population
Patients with metastatic hormone-sensitive prostate cancer (mHSPC) suitable for treatment with docetaxel, including de novo and relapsed patients, with ECOG performance score of 0 or 1.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS
Key trials
ARASENS
Comparator
Placebo in combination with ADT and docetaxel
Economic model
CUA
ICER note
ICER values are redacted/not stated in the publicly available text; the document indicates commercially sensitive pricing information.
ICER (historical)
$35k/QALY–$45k/QALY across 2 submissions (2021) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
PBS expenditure
The Australian government paid $59M in PBS benefits for Darolutamide in 2024 across 16,824 scripts, at $3,502 per script.
Submission history
Jul 2020: Recommended with restriction · Authority Required
Mar 2021: Recommended with restriction · Authority Required — ICER $55k/QALY