script.reportAU
Oncology

Trastuzumab deruxtecan

Brand: Enhertu

PBAC's latest decision on Trastuzumab deruxtecan: Recommended with restriction (2025). Considered for Treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma following progression on prior trastuzumab-containing therapy.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
4
first 2022
Submissions
4
2022 → 2025

Eligible population

Patients with locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma who have progressed following treatment with a trastuzumab-containing regimen, with WHO performance status no higher than 1.

Therapy area
Oncology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
OS
Pivotal trial size
187 patients
Key trials
Destiny Gastric 1 (DG-01), Destiny Gastric 2 (DG-02)
Comparator
Standard of care chemotherapy (paclitaxel, irinotecan, docetaxel, or FOLFIRI)
Economic model
CUA
ICER note
ICER value not provided in the publicly available text; document indicates economic evaluation was conducted but specific numeric ICER is redacted or commercially confidential.
ICER (historical)
$55k/QALY–$75k/QALY in an earlier submission (2024) — 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 — Submission proposed a special pricing arrangement (SPA); exact terms not detailed in public text.

Submission history

Similar precedents

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