PBAC's latest decision on Tucatinib: Recommended with restriction (2025). Considered for Metastatic (Stage IV) HER2-positive breast cancer in patients who have received two prior lines of HER2-directed therapy or who have progressed on trastuzumab deruxtecan, for use in combination with trastuzumab plus capecitabine.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$95k/QALY
Range: $75k/QALY–$95k/QALY
Submissions
2
first 2021
Submissions
2
2021 → 2025
Eligible population
Patients with HER2-positive metastatic (Stage IV) breast cancer, including those with brain metastases, who have received two prior anti-HER2-based regimens in the metastatic setting or who have progressed on trastuzumab deruxtecan, with WHO performance status 0 or 1.
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
HER2CLIMB
Comparator
trastuzumab plus capecitabine; trastuzumab emtansine (T-DM1)
Economic model
CUA
ICER note
Base case ICER vs trastuzumab plus capecitabine is $75,000 to <$95,000 per QALY gained (published in footnote 1 as redacted in main tables)
Submission history
Mar 2021: Recommended with restriction · Authority Required
Nov 2025: Recommended with restriction · Authority Required — ICER $95k/QALY