PBAC's latest decision on Zoledronic acid: Recommended with restriction (2023). Considered for Adjuvant management of breast cancer in post-menopausal women. Treatment duration of up to 3 years at a dose of 4 mg IV every six months.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$5k/QALY
Range: $690/QALY–$5k/QALY
Submissions
5
first 2008
Submissions
5
2008 → 2023
Eligible population
Post-menopausal women with early breast cancer (adjuvant setting). The population includes all-comers, node-positive, and specifically post-menopausal subgroups. Treatment duration up to 3 years.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
Meta-analysis
Primary endpoint
OS
Pivotal trial size
18,766 patients
Key trials
EBCTCG 2015 IPD meta-analysis (18,766 women across 26 RCTs), NICE 2018 systematic review
Comparator
no treatment
Economic model
CUA
ICER note
ICER range calculated from NICE QALYs applied to Australian drug costs. Node-positive group: $690/QALY; all-comers: $5444/QALY; post-menopausal: $2722/QALY. Actual ICER for restricted post-menopausal population likely lower due to excluded fracture reductions and cost offsets.
Submission history
Jul 2008: Recommended with restriction · Authority Required
Nov 2008: Recommended with restriction · Authority Required
Nov 2012: Recommended with restriction · Authority Required (STREAMLINED)
Jul 2018: Recommended with restriction · Authority Required