PBAC's latest decision on Olaparib: Recommended with restriction (2024). Considered for Treatment of HER2-negative metastatic breast cancer in patients with a confirmed germline BRCA1 or BRCA2 mutation who have received prior chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
15
first 2016
Submissions
15
2016 → 2024
Eligible population
Adult patients with HER2-negative metastatic breast cancer with a confirmed germline BRCA1 or BRCA2 mutation (class 4 or 5 variant) who have received prior chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, with WHO performance status 0-2.
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
OlympiAD
Comparator
chemotherapy
Economic model
CUA
ICER note
ICER values are redacted in the public document; economic analysis performed but commercially sensitive.
ICER (historical)
$45k/QALY–$75k/QALY across 2 submissions (2016) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Mar 2016: Recommended with restriction · Restricted
Jul 2016: Recommended with restriction · Restricted — ICER $75k/QALY
Nov 2016: Recommended with restriction · Authority Required — ICER $75k/QALY
Mar 2018: Recommended with restriction · Authority Required
Nov 2019: Recommended with restriction · Restricted
Mar 2020: Recommended with restriction · Authority Required
Jul 2020: Not recommended · Authority Required
Mar 2021: Recommended with restriction · Authority Required
Nov 2021: Recommended with restriction · Authority Required
Jul 2022: Recommended with restriction · Authority Required
Nov 2022: Not recommended · Authority Required
Mar 2023: Recommended with restriction · Authority Required
Nov 2023: Not recommended · Authority Required
Nov 2023: Recommended with restriction · Authority Required
Jul 2024: Recommended with restriction · Authority Required