PBAC's latest decision on Talazoparib: Recommended with restriction (2024). Considered for First-line treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients with BRCA1/2 pathogenic variants who have not received prior treatment with a novel hormonal agent.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$75k/QALY
Range: $55k/QALY–$75k/QALY
Submissions
3
first 2019
Submissions
3
2019 → 2024
Eligible population
Adult patients diagnosed with mCRPC with BRCA1/2 pathogenic variants who have not been previously treated with a novel hormonal agent, with ECOG performance score ≤1.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
TALAPRO-2
Comparator
enzalutamide monotherapy
Economic model
CUA
Risk sharing
Risk-sharing arrangement in place — Risk sharing arrangement (RSA) — agreed in principle to join the current olaparib monotherapy RSA.
Submission history
Nov 2019: Recommended with restriction · Authority Required
Mar 2024: Recommended with restriction · Authority Required