PBAC's latest decision on Sacituzumab govitecan: Not recommended (2025). Considered for Treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have progressive disease following two or more prior systemic therapies, at least one in the locally advanced or metastatic setting.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
5
first 2021
Submissions
5
2021 → 2025
Eligible population
Adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (HER2-negative defined as IHC 0, or HER2-low defined as IHC 1+ or IHC 2+ with negative ISH result) who have progressive disease following two or more prior systemic therapies (at least one in the locally advanced or metastatic setting) and ECOG performance status ≤1
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
Other
Key trials
ASCENT, DESTINY-Breast04
Economic model
not-modelled
ICER note
Category 3 submission; no economic modelling undertaken or required. Submission claimed no change to cost-effectiveness or uptake.
ICER (historical)
$95k/QALY–$115k/QALY in an earlier submission (2023) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Why PBAC said no
Reasons cited in the latest PSD: PBAC did not support the claim that current restriction wording would be misinterpreted by prescribers; considered current wording with treatment guidelines sufficient for clinical discretion; noted the mechanism of action of SG does not target HER2 the same way as T-DXd, making the populations not equivalent
Submission history
Nov 2021: Recommended with restriction · Authority Required
Mar 2022: Recommended with restriction · Restricted
Jul 2023: Recommended with restriction · Authority Required
Nov 2023: Recommended with restriction · Restricted — ICER $115k/QALY