PBAC's latest decision on Capivasertib: Recommended with restriction (2024). Considered for Treatment of locally advanced or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer with a confirmed AKT pathway alteration (PIK3CA, AKT1, or PTEN) following recurrence or progression on or after aromatase inhibitor (AI) therapy, with or without a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor.
PBAC outcome
Recommended with restriction
2024
ICER (AUD/QALY)
—
ICER not stated
Submissions
1
first 2024
Submissions
1
2024 → 2024
Eligible population
patients with newly diagnosed locally advanced or progression to metastatic HR+/HER2- breast cancer
Therapy area
Oncology
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
708 patients
Key trials
CAPItello-291
Comparator
fulvestrant monotherapy
Economic model
CUA
Eligible patients/year
20,672
ICER note
ICER not stated in document. Economic analysis versus fulvestrant monotherapy was conducted but no numeric ICER value or band is presented in the PSD.