Abiraterone Acetate And PrednisoloneAndriga-10
Treatment of patients with metastatic castration resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) or patients with mCRPC who have received prior chemotherapy containing a taxane.
Decision on record
- Meeting Jul 2025 Recommended Metastatic castration-resistant prostate cancer (mCRPC)
Access path
- TGA registered · Andriga-10
TGA label narrower than the PBS population
- Jul 2025Recommended · restricted
vs abiraterone acetate 500 mg tablets (Zytiga) and…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the General Schedule Authority Required (Telephone/Online) listing of a composite pack containing abiraterone acetate 500 mg tablets and prednisolone 5 mg tablets (ANDRIGA-10) for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).PSD · Jul 2025
6.2 The PBAC considered the claim of noninferior effectiveness and safety of ANDRIGA-10 to abiraterone and prednisolone was reasonable. However, the PBAC considered for the purposes of satisfying Section 101(3B) of the National Health Act 1953, any treatments for mCRPC are relevant alternative therapies.PSD · Jul 2025
5.9 As a Category 3 submission, the economic analysis was not independently evaluated.PSD · Jul 2025
5.10 The proposed AEMP of ANDRIGA-10 is $821.06 for a 28-day supply which is the same cost per day ($29.32) as abiraterone acetate and prednisolone used concomitantly.PSD · Jul 2025
5.7 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of ANDRIGA-10 compared with Zytiga 500 mg tablets and prednisolone 5 mg tablets.PSD · Jul 2025
5.8 The PBAC considered that the claim of noninferior comparative effectiveness and safety was reasonable.PSD · Jul 2025
5.3 Rare Cancers Australia noted that mCRPC can significantly impact patients’ physical health which can lead to social isolation and financial hardship due to loss of income 4PSD · Jul 2025
5.4 The Medical Oncology Group of Australia (MOGA) expressed its support for the ANDRIGA-10 submission and its listing on the PBS.PSD · Jul 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The submission presented a cost-minimisation approach of ANDRIGA-10 compared with Zytiga and prednisolone used concomitantly. PSD · 2025
Decision context
PopulationPatients with metastatic castration resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) or patients with mCRPC who have received prior chemotherapy containing a taxane, with WHO performance status of 2 or less, not in combination with chemotherapy, and not having experienced disease progression on prior novel hormonal drugs.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | abiraterone acetate 500 mg tablets (Zytiga) and prednisolone 5 mg tablets (Panafcortelone) used concomitantly | — | Cost-minimisation · Cost-minimisation |
Consumer voice
Rare Cancers Australia noted that mCRPC significantly impacts patients' physical health, social isolation and financial hardship, and stated that ANDRIGA-10 is well tolerated and offers a convenient oral option to help maintain normal daily life. The Medical Oncology Group of Australia expressed support for PBS listing.
mCRPC can significantly impact patients' physical health which can lead to social isolation and financial hardship due to loss of income and ability to work. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to WHO performance status ≤2, excludes chemotherapy combinations, and excludes prior novel hormonal drug progression.