script.reportAU
Oncology

Palbociclib

Brand: Ibrance

PBAC's latest decision on Palbociclib: Recommended with restriction (2022). Considered for Treatment of patients with locally advanced (stage IIIB/IIIC) or metastatic (stage IV) hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have received previous endocrine therapy, in combination with fulvestrant.

PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
5
first 2017
PBS spend
$84M
19,853 scripts · 2024

Eligible population

Pre-/peri- or postmenopausal patients (but restricted to not premenopausal) with HR+/HER2- locally advanced inoperable or metastatic breast cancer who have received previous endocrine therapy, experienced disease progression, developed endocrine resistance, and have not previously been treated with a CDK4/6 inhibitor or developed intolerance to one necessitating withdrawal, with WHO ECOG status ≤2.

Therapy area
Oncology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
521 patients
Key trials
PALOMA-3, MONALEESA-3, MONARCH 2
Comparator
ribociclib in combination with fulvestrant
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis adopted; no ICER calculated by design.
ICER (historical)
$105k/QALY–$200k/QALY in an earlier submission (2018) — 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 — Extended listing would be included within the existing Risk Sharing Agreement that palbociclib currently shares with ribociclib and abemaciclib.

PBS expenditure

The Australian government paid $84M in PBS benefits for Palbociclib in 2024 across 19,853 scripts, at $4,216 per script.

Submission history

Similar precedents

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