script.reportAU
Oncology

Enzalutamide

Brand: Xtandi

PBAC's latest decision on Enzalutamide: Recommended with restriction (2024). Considered for Treatment of patients with non-metastatic hormone-sensitive prostate cancer (m0HSPC) with high-risk biochemical recurrence (BCR), defined by prostate-specific antigen doubling time (PSADT) ≤9 months, who have had prior primary curative treatment (radical prostatectomy or radiation therapy) and are not candidates for salvage radiotherapy.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
7
first 2014
PBS spend
$158M
45,672 scripts · 2024

Eligible population

Adults with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence (PSADT ≤9 months) after prior primary curative treatment (radical prostatectomy or radiation therapy), with ECOG performance status ≤1, not candidates for salvage radiotherapy.

Therapy area
Oncology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
EMBARK
Comparator
ADT alone (Leuprorelin + Placebo in EMBARK trial)
Economic model
CUA
ICER note
ICER value is commercially sensitive and redacted in the public document.
ICER (historical)
$45k/QALY–$75k/QALY across 2 submissions (2017) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Risk sharing
Risk-sharing arrangement in place — Managed Access Program (MAP) proposed to manage uncertainty related to metastasis-free survival (MFS) and overall survival (OS). Sponsor would agree to revise the price of enzalutamide following the collection of final trial data from EMBARK.

PBS expenditure

The Australian government paid $158M in PBS benefits for Enzalutamide in 2024 across 45,672 scripts, at $3,459 per script.

Submission history

Similar precedents

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