CabazitaxelCabazitaxel Accord
Treatment of castration resistant metastatic carcinoma of the prostate in patients previously treated with a docetaxel-containing regimen, in combination with prednisone or prednisolone.
Decisions on record
- Meeting Mar 2022 Recommended Prostate cancer
- Meeting Mar 2021 Recommended Castration resistant metastatic prostate cancer
- Meeting Mar 2012 Recommended Metastatic prostate cancer no PSD
- Meeting Nov 2011 Not recommended The proposed TGA indication is: Cabazitaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
- Meeting Jul 2011 Not recommended Anti-cancer drug
Access path
- TGA registered · Cabazitaxel Accord
TGA label narrower than the PBS population
- Jul 2011Not recommended
high and uncertain cost-effectiveness ratio, underestimation of costs due to omission of G-CSF and neutropenic…
- Nov 2011Not recommended
high and uncertain cost-effectiveness ratio, uncertain survival benefit especially beyond trial period (25%…
- Nov 2011Not recommended
high and uncertain cost-effectiveness ratio, high ICER unacceptably above threshold, survival benefit derived largely…
- ↻ resubmittedMar 2021Recommended · restricted
Comparator changed: docetaxel → Jevtana (cabazitaxel powder for injection)
- Mar 2022Recommended · restricted
Comparator changed: Jevtana (cabazitaxel powder for injection) → Jevtana, Cabazitaxel…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the Section 100 (Efficient Funding of Chemotherapy) listing of a new form of cabazitaxel, solution concentrate for I.V. infusion 60 mg in 3 mL (Cabazitaxel Accord®) under the same circumstances as the currently listed brands of cabazitaxel for treatment of castration resistant metastatic carcinoma of the prostate.PSD · Mar 2022
6.2 The PBAC noted that EFC medicines are governed by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 and subsection 33(1) allows the supplier of the infusion to use pharmaceutical benefits with the same chemotherapy drug but a different form to make the infusion, meaning different forms may be substituted.PSD · Mar 2022
5.3 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of Cabazitaxel Accord compared with Jevtana.PSD · Mar 2022
5.4 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable.PSD · Mar 2022
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. PBAC noted that cabazitaxel Accord is not expected to provide substantial and clinically relevant improvement in efficacy or reduction of toxicity over currently listed cabazitaxel brands.
The PBAC noted that its recommendation was on a cost-minimisation basis and advised that because cabazitaxel is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over the currently listed cabazitaxel, or not expected to address a high and urgent unmet clinical need given the presence of an alternative therapy, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009 for Pricing Pathway A were not met. PBAC · 2022
Decision context
PopulationAdults with castration resistant metastatic carcinoma of the prostate who have failed treatment with docetaxel due to resistance or intolerance, with WHO performance status of 2 or less, treated in combination with prednisone or prednisolone.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended · restricted | Jevtana, Cabazitaxel Ever Pharma, Cabazitaxel Juno | — | Cost-minimisation · Cost-minimisation |
| Mar 2021 | Recommended · restricted | Jevtana (cabazitaxel powder for injection) | — | Cost-minimisation · Cost-minimisation |
| Nov 2011 | Not recommended | — | $45k–75k | RCT · OS |
| Nov 2011 | Not recommended | docetaxel | $45k–75k | RCT · OS |
| Jul 2011 | Not recommended | mitozantrone | $75k–105k | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| TROPIC | Ph 3 | 755 | Overall Survival | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to WHO performance status ≤2 and specifies docetaxel failure due to resistance or intolerance; TGA label does not include these performance/tolerance criteria.