Abiraterone AcetateAbiraterone-Teva 250mg
Treatment of metastatic castration-resistant carcinoma of the prostate in combination with a corticosteroid.
Decision on record
- Meeting Mar 2017 Recommended Metastatic castration- resistant prostate cancer
Access path
- TGA registered · Abiraterone-Teva 250mg
TGA label narrower than the PBS population
- Jul 2014Not recommended
Uncertain overall survival benefit (did not meet pre-specified statistical significance criteria at O'Brien-Fleming…
- ↻ resubmittedMar 2017Recommended · restricted
Evidence: RCT → Other
- Jul 2017Recommended · restricted
Evidence: Other → Cost-minimisation
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the Authority Required (STREAMLINED) listing of abiraterone acetate 500 mg tablets for use in combination with prednisone or prednisolone for the treatment of metastatic castration-resistant carcinoma of the prostate.PSD · Jul 2017
6.2 The PBAC noted that the proposed maximum quantity and number of repeats provides an equivalent amount of abiraterone acetate as the current PBS listed 250 mg strength.PSD · Jul 2017
5.4 As a minor submission, there was no economic comparison presented.PSD · Jul 2017
6.10 The submission describes abiraterone as superior in terms of comparative effectiveness and non-inferior in terms of comparative safety over “watchful waiting (placebo)”. The claim regarding safety is adequately supported. There were differences in the rates of hypokalemia, hypertension and hepatotoxicity. However, with the exception of the increase in hepatotoxicity, these did not reach statistical significance after adjusting for treatment exposure.PSD · Jul 2014
6.11 Although a statistically significant difference in overall survival was observed in the trial’s ‘PBS subgroup’ (BPI-SF Q3 score of 0-1, baseline PSA <114ng/mL and ECOG ≤1), this result may not apply to the likely PBS population. A comparison versus placebo (watchful waiting) may not be the only relevant comparison. Also, the PBS subgroup analysis was post-hoc and there was no statistically significant difference in the ITT population.PSD · Jul 2014
6.2 The PBAC noted and welcomed the input from individuals (66), health care professionals (2) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with abiraterone including the ability to improve quality of life, postpone chemotherapy, and remain active in family life.PSD · Jul 2014
Cost-effectiveness
Minor submission; no economic comparison presented.
The PBAC noted that the listing of the 500 mg strength would be cost neutral to the PBS as the proposed AEMP is the same as the price of the current listed 250 mg strength. PBAC · 2017
Decision context
PopulationPatients with metastatic castration-resistant prostate cancer who have failed or are unsuitable for docetaxel treatment, with WHO performance status of 2 or less, and not previously treated with enzalutamide (or intolerant).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Recommended · restricted | — | — | Cost-minimisation |
| Mar 2017 | Recommended · restricted | — | — | Other |
| Jul 2014 | Not recommended | watchful waiting (placebo) | — | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| COU-AA-302 | Ph 3 | 1,088 | Overall Survival | completed |
Consumer voice
Consumer input from individuals, healthcare professionals, and organisations described multiple benefits of abiraterone treatment, including improved quality of life, ability to postpone chemotherapy, and maintenance of active family involvement.
The comments described a range of benefits of treatment with abiraterone including the ability to improve quality of life, postpone chemotherapy, and remain active in family life. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to castration-resistant disease, docetaxel-failure/unsuitability, specific performance status, and no prior enzalutamide—not in TGA label.