PBAC's latest decision on Abiraterone acetate, enzalutamide: Recommended (2021). Considered for Amendment to existing listings for metastatic castration-resistant prostate cancer (mCRPC) to allow use prior to docetaxel treatment (pre-docetaxel setting), removing the requirement for patients to have failed prior docetaxel or have predicted intolerance to docetaxel.
PBAC outcome
Recommended
Restricted
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2021
Submissions
1
2021 → 2021
Eligible population
Adults with metastatic castration-resistant prostate cancer (mCRPC) who have failed androgen deprivation therapy (ADT), including those without prior docetaxel exposure. WHO performance status ≤2.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS
Pivotal trial size
1,401 patients
Key trials
PROSPER, COU-302
Comparator
Not applicable — this is a restriction amendment to existing listings, not a new drug submission with comparative efficacy evaluation.
Economic model
Not modelled
ICER note
This is a restriction amendment to align existing listings with current clinical practice; no new economic model or ICER calculation was performed. The PBAC noted that price reductions had occurred since previous considerations and that the drugs would 'likely be cost effective' but did not provide numeric ICER values.