PBAC's latest decision on Apalutamide: Recommended with restriction (2024). Considered for Treatment of castration-resistant non-metastatic prostate cancer (m0CRPC) and metastatic castration-sensitive prostate cancer (mHSPC) in patients undergoing concurrent androgen deprivation therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
7
first 2018
Submissions
7
2018 → 2024
Eligible population
Patients with castration-resistant non-metastatic prostate cancer (m0CRPC) or metastatic castration-sensitive prostate cancer (mHSPC) undergoing concurrent androgen deprivation therapy.
Therapy area
Oncology
Line of therapy
Not applicable
Evidence base
Single-arm
Primary endpoint
Other
Key trials
56021927PCR1028
Comparator
apalutamide 60 mg (4 x 60 mg tablets); also enzalutamide and darolutamide
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated as the submission presented a cost-minimisation approach with bioequivalent comparator.
ICER (historical)
$35k/QALY–$45k/QALY in an earlier submission (2021) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Risk sharing
Risk-sharing arrangement in place — Apalutamide 240 mg proposed to be subject to the existing Risk Sharing Arrangement (RSA) for mHSPC.
Submission history
Nov 2018: Recommended with restriction · Authority Required
Jul 2019: Recommended with restriction · Restricted
Nov 2020: Recommended with restriction · Authority Required
Nov 2021: Recommended with restriction · Authority Required — ICER $45k/QALY
Nov 2021: Recommended with restriction · Authority Required
Jul 2022: Noted · Authority Required
Jul 2024: Recommended with restriction · Authority Required