AbirateroneAbiraterone-Teva 250mg
for the treatment of metastatic advanced prostate cancer (castration resistant prostate cancer) in patients who have received prior chemotherapy containing a taxane.
Decisions on record
- Meeting Jul 2021 Not recommended Castration resistant prostate cancer
- Meeting Jul 2017 Recommended Castration resistant metastatic carcinoma of the prostate
- Meeting Jul 2014 Not recommended Janssen-Cilag Pty Ltd Change to listing (Major submission) Prostate Cancer Section 85 Authority required listing for abiraterone for the treatment of metastatic castration resistant prostate cancer (mCRPC) to include patients who have progressed following treatment with androgen deprivation therapy
- Meeting Nov 2012 Recommended Prostate cancer
- Meeting Mar 2012 Recommended Metastatic prostate cancer
- Meeting Nov 2011 Not recommended Anti-cancer drug
Access path
- TGA registered · Abiraterone-Teva 250mg
TGA label equal than the PBS population
- Nov 2011Not recommended
unacceptably high incremental cost-effectiveness ratio, uncertainty regarding the clinical place in therapy, unclear…
- Mar 2012Not recommended
unacceptably high incremental cost-effectiveness ratio, uncertainty regarding clinical place in therapy, potential for…
- Mar 2012Not recommended
Comparator changed: best supportive care (placebo; prednisone/prednisolone plus other…
- Jul 2012Not recommended
unacceptably high incremental cost-effectiveness ratio, uncertainty regarding the clinical place in therapy…
- ↻ resubmittedNov 2012Recommended · restricted
ICER dropped $200,000 → $75,000 (-62%)
- PBS listing · Authority Required
From the public summary
A revised base-case estimate of the incremental cost-effectiveness of abiraterone was presented. No structural changes were made to the model used in the November 2011 submission, however a number of inputs were varied. The ICER in the revised base-case was between $45,000 and $75,000.PSD · Jul 2012
Cost-effectiveness
The PBAC noted the re-submission’s argument that best supportive care should be a relevant comparator, and that abiraterone be listed on a cost-effectiveness basis compared with best supportive care (superior effectiveness and equivalent safety; 50%) and a cost-minimisation basis with cabazitaxel (non-inferior effectiveness and superior safety; 50%). However, the PBAC considered that estimating the number of patients unsuitable for cabazitaxel following treatment with docetaxel remained a source of much uncertainty, and that the exact proportion of comparator split is therefore unclear due the current changing market. PBAC · 2012
Decision context
Populationpatients with metastatic castrate resistant prostate cancer who have progressing disease after treatment with docetaxel
Risk sharinga risk share agreement would be required to mitigate the financial risk to Government of treatment beyond progression and use in patients who had not previously been treated with docetaxel.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2012 | Recommended · restricted | 50% best supportive care and 50% cabazitaxel | $45k–75k | Cost-minimisation |
| Jul 2012 | Not recommended | best supportive care (placebo; prednisone/prednisolone plus other care), mitozantrone (mitozantrone plus prednisone/pred | $105k–200k | RCT, indirect comparisons · OS |
| Mar 2012 | Not recommended | placebo (prednisone/prednisolone plus other care) and mitozantrone (mitozantrone plus prednisone/prednisolone plus other | $105k–200k | RCT, indirect comparisons · OS |
| Mar 2012 | Not recommended | placebo (prednisone/prednisolone plus other care), mitozantrone (mitozantrone plus prednisone/prednisolone plus other ca | $105k–200k | RCT · OS |
| Nov 2011 | Not recommended | best supportive care (placebo; prednisone/prednisolone plus other care), mitozantrone (mitozantrone plus prednisone/pred | $105k–200k | RCT, indirect comparisons · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| COU-AA-301 | Ph 3 | 1,195 | Overall Survival | completed |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC recommendation specify metastatic CRPC patients with prior taxane chemotherapy; PBAC clarifies docetaxel and later-line status, which aligns with the label.