Abiraterone Acetate, Enzalutamide
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.
Access path
- Mar 2021Recommended
vs Not applicable — this is a restriction amendment to…
- PBS listing · Restricted
From the public summary
5.1 The PBAC recommended amending the listings of abiraterone and enzalutamide to allow their use in patients with metastatic castration-resistant prostate cancer (mCRPC) prior to receiving docetaxel. The PBAC considered that removal of the requirement for patients to have either received prior docetaxel or to have a predicted intolerance to docetaxel would better align the restrictions for abiraterone and enzalutamide with how these drugs are being used …PSD · Mar 2021
5.2 The PBAC noted that data provided by the DUSC Secretariat indicated that in 2020 69% of use of abiraterone and enzalutamide was in patients who had not received a prior supply of docetaxel.PSD · Mar 2021
Cost-effectiveness
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.
The PBAC noted that the prices of abiraterone and enzalutamide had reduced significantly since their previous considerations for this indication due to negotiated administrative priced reductions. The PBAC considered that both drugs would now likely be cost effective without prior use of docetaxel. PBAC · 2021
Decision context
PopulationAdults with metastatic castration-resistant prostate cancer (mCRPC) who have failed androgen deprivation therapy (ADT), including those without prior docetaxel exposure. WHO performance status ≤2.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2021 | Recommended | Not applicable — this is a restriction amendment to existing listings, not a new drug submission with comparative effica | — | RCT · OS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to pre-docetaxel mCRPC setting; TGA label includes post-docetaxel and asymptomatic/mildly symptomatic populations.