Abiraterone Acetate And MethylprednisoloneYONSA MPRED
Metastatic castration-sensitive (hormone-sensitive) prostate cancer in combination with androgen deprivation therapy, for treatment initiation within 6 months of commencing ADT.
Decisions on record
- Meeting Jul 2023 Recommended Metastatic hormone sensitive prostate cancer
- Meeting Nov 2022 Recommended Metastatic castration-resistant prostate cancer
- Meeting Mar 2022 Not recommended Metastatic castration resistant prostate cancer
Access path
- TGA registered · YONSA MPRED
TGA label narrower than the PBS population
- Mar 2022Not recommended
vs originator abiraterone acetate (OAA) 1000 mg once daily…
- ↻ resubmittedNov 2022Recommended · restricted
Comparator changed: originator abiraterone acetate (OAA) 1000 mg once daily with…
- Jul 2023Recommended
Comparator changed: originator abiraterone acetate (OAA) 1000 mg once daily with…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of the composite pack of abiraterone acetate and methylprednisolone (SAA+MPRED) tablets for the treatment of metastatic hormone sensitive prostate cancer (mHSPC) on a CMA versus apalutamide.PSD · Jul 2023
7.2 The PBAC noted the input from the Medical Oncology Group of Australia (MOGA) which strongly supported the listing of SAA+MPRED on the PBS for the treatment of mHSPC.PSD · Jul 2023
6.27 The submission presented a CMA to compare costs of treatment with SAA+MPRED to apalutamide (see Table 7).PSD · Jul 2023
6.28 Based on the established bioequivalence to OAA+P the submission proposed SAA 500 mg + MPRED 4 mg daily to be equi-effective to apalutamide 240 mg once daily.PSD · Jul 2023
6.24 Based on i) indirectly comparable evidence presented for OAA+P + ADT and apalutamide + ADT via ADT as common comparator, and ii) assuming bioequivalence of OAA+P + ADT and SAA+MPRED + ADT, the submission described SAA+MPRED + ADT as non-inferior in terms of effectiveness compared with apalutamide + ADT and inferior in terms of safety. The ESC considered that these claims were reasonable. The results of ITCs showed that OAA+P + ADT vs.PSD · Jul 2023
6.25 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable. 17PSD · Jul 2023
6.2 The PBAC noted and welcomed the input from The Medical Oncology Group of Australia (MOGA) via the Consumer Comments facility on the PBS website. The MOGA expressed its strong support for the abiraterone and methylprednisolone submission, categorising it as one of the therapies of “highest priority for PBS listing”.PSD · Jul 2023
6.43 The submission stated that the Sponsor expects to join the same RSA as apalutamide for use beyond the annual subsidisation caps upon listing. For apalutamide, the PBAC considered that a RSA with a rebate for use beyond annual subsidisation caps, which were based on the estimated PBS/RPBS expenditure would be reasonable to mitigate the risk that patients would remain on apalutamide for longer than estimated from the TITAN trial and the risk that use …PSD · Jul 2023
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The ESC considered for the purpose of Section 101(3B) of the National Health Act 1953, that SAA+MPRED was an alternative therapy to apalutamide, enzalutamide and darolutamide for the treatment of mHSPC, and that SAA+MPRED does not provide a significant improvement in efficacy over these drugs. PSD · 2023
Decision context
PopulationPatients with newly diagnosed metastatic castration-sensitive prostate cancer in combination with androgen deprivation therapy, treatment initiated within 6 months of commencing ADT.
Risk sharingSponsor expects to join the same risk sharing arrangement (RSA) as apalutamide upon listing.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2023 | Recommended | apalutamide | — | RCT · OS |
| Nov 2022 | Recommended · restricted | originator abiraterone acetate (OAA) 1000 mg once daily with prednisone 5 mg twice daily | — | RCT · Surrogate |
| Mar 2022 | Not recommended | originator abiraterone acetate (OAA) 1000 mg once daily with concomitant prednisolone (PRED) 5 mg twice daily | — | RCT · Surrogate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| STAMPEDE | Ph 2, PHASE3 | 11,992 | Overall survival | active not recruiting |
| PEACE-1 | Ph 1, PHASE2 | 12 | PSA response | completed |
| STAAR | Ph 2 | 53 | Testosterone Levels | completed |
| Study 301 (COU-AA-301) | Ph 3 | 1,195 | Overall Survival | completed |
| Study 302 (COU-AA-302) | Ph 3 | 1,088 | Overall Survival | completed |
Consumer voice
The Medical Oncology Group of Australia (MOGA) expressed strong support for abiraterone and methylprednisolone submission, categorising it as a therapy of highest priority for PBS listing, and presented an ESMO-MCBS score of 4 out of 5.
The MOGA expressed its strong support for the abiraterone and methylprednisolone submission, categorising it as one of the therapies of "highest priority for PBS listing". Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to treatment initiation within 6 months of ADT commencement; TGA label has no timing requirement.