PBAC's latest decision on Niraparib: Recommended with restriction (2023). Considered for Maintenance therapy in patients with newly diagnosed advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that is HRD positive and BRCA wild type, who are in response to first-line platinum-based chemotherapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
4
first 2021
Submissions
4
2021 → 2023
Eligible population
Patients with newly diagnosed advanced (Stage III-IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are HRD positive and BRCA wild type, and in complete or partial response to first-line platinum-based chemotherapy.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
PRIMA
Comparator
standard medical management
Economic model
CEA
ICER note
Redacted: prices and ICER values are commercially sensitive and shown as $ or blank in the document. The submission was based on a cost-effectiveness analysis, but specific ICER values are not disclosed in the public summary.
Risk sharing
Risk-sharing arrangement in place — Special Pricing Arrangements apply; financial cap proposed by sponsor to address clinical uncertainty in HRD negative subgroup.
Submission history
Mar 2021: Recommended with restriction · Authority Required
Jul 2021: Recommended with restriction · Authority Required
Mar 2022: Recommended with restriction · Authority Required
Mar 2023: Recommended with restriction · Authority Required