ApalutamideERLYAND
Treatment of castration-resistant non-metastatic prostate cancer (m0CRPC) and metastatic castration-sensitive prostate cancer (mHSPC) in patients undergoing concurrent androgen deprivation therapy.
Decisions on record
- Meeting Jul 2024 Recommended Non-metastatic castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer
- Meeting Jul 2022 Recommended Metastatic hormone-sensitive prostate cancer
- Meeting Nov 2021 Not recommended Prostate cancer (metastatic hormone-sensitive)
- Meeting Nov 2021 Recommended Prostate cancer (non-metastatic castration resistant)
- Meeting Nov 2020 Not recommended Treatment of patients with non- metastatic, castration-resistant prostate cancer.
- Meeting Jul 2019 Not recommended The treatment of non-metastatic, castration-resistant prostate cancer.
- Meeting Nov 2018 Not recommended Castration resistant prostate cancer
Access path
- TGA registered · ERLYAND
TGA label narrower than the PBS population
- Nov 2018Not recommended
vs watchful waiting (ongoing ADT, with or without secondary…
- Jul 2019Not recommended
Comparator changed: watchful waiting (ongoing ADT, with or without secondary hormonal…
- Nov 2020Not recommended
Comparator changed: watchful waiting (placebo with ongoing ADT) → watchful waiting…
- ↻ resubmittedNov 2021Recommended
Comparator changed: watchful waiting (ongoing ADT with or without secondary hormonal…
- Nov 2021Not recommended
Comparator changed: watchful waiting (ongoing ADT with or without secondary hormonal…
- ↻ resubmittedJul 2022Recommended
Comparator changed: ADT (androgen deprivation therapy) alone → ADT (androgen deprivation…
- Jul 2024Recommended · restricted
Comparator changed: ADT (androgen deprivation therapy) alone; docetaxel plus ADT for high…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended a General Schedule Authority Required (Telephone/Online) PBS listing of a new strength of apalutamide (tablet 240 mg) under the same conditions as the currently listed strength of apalutamide (tablet 60 mg) for the treatment of m0CRPC and mHSPC for patients undergoing concurrent androgen deprivation therapy.PSD · Jul 2024
6.2 The PBAC advised the equi-effective doses to be apalutamide 240 mg and apalutamide 4 x 60 mg.PSD · Jul 2024
5.8 The submission presented a cost-minimisation approach (CMA) of apalutamide 240 mg (30 pack) versus apalutamide 4 x 60 mg (120 pack).PSD · Jul 2024
5.9 The equi-effective dose proposed by the submission is apalutamide 240 mg = apalutamide 4 x 60 mg.PSD · Jul 2024
5.6 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of apalutamide 240 mg compared with apalutamide 4 x 60 mg.PSD · Jul 2024
5.7 The PBAC considered that, because the TGA determined bioequivalence, the claim of non-inferior comparative effectiveness and non-inferior comparative safety was reasonable.PSD · Jul 2024
5.2 The PBAC noted and welcomed the input from one organisation via the Consumer Comments facility on the PBS website. The comments from Rare Cancers Australia (RCA) described a range of benefits of treatment with apalutamide, including improved quality of life, where despite experiences with fatigue and hot flushes, patients stated that these side effects are significantly manageable.PSD · Jul 2024
5.18 The submission proposed that apalutamide 240 mg be subject to the existing Risk Sharing Arrangement (RSA) for mHSPC.PSD · Jul 2024
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as the submission presented a cost-minimisation approach with bioequivalent comparator.
Decision context
PopulationPatients with castration-resistant non-metastatic prostate cancer (m0CRPC) or metastatic castration-sensitive prostate cancer (mHSPC) undergoing concurrent androgen deprivation therapy.
Risk sharingApalutamide 240 mg proposed to be subject to the existing Risk Sharing Arrangement (RSA) for mHSPC.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2024 | Recommended · restricted | apalutamide 60 mg (4 x 60 mg tablets); also enzalutamide and darolutamide | — | Single-arm · Other |
| Jul 2022 | Recommended | ADT (androgen deprivation therapy) alone; docetaxel plus ADT for high volume chemotherapy-unsuitable patients | — | RCT · OS |
| Nov 2021 | Recommended | watchful waiting (ongoing ADT with or without secondary hormonal therapies); supplementary comparator: darolutamide | $35k–45k | RCT · MFS |
| Nov 2021 | Not recommended | ADT (androgen deprivation therapy) alone | — | RCT · OS |
| Nov 2020 | Not recommended | watchful waiting (ongoing ADT with or without secondary hormonal therapies) | — | RCT · MFS |
| Jul 2019 | Not recommended | watchful waiting (placebo with ongoing ADT) | — | RCT · PFS |
| Nov 2018 | Not recommended | watchful waiting (ongoing ADT, with or without secondary hormonal therapies) | — | RCT · MFS |
Clinical evidence
Consumer voice
Rare Cancers Australia described benefits of apalutamide treatment including improved quality of life and increased metastasis-free survival, noting that side effects like fatigue and hot flushes are manageable, and that the 240 mg formulation would improve convenience and treatment adherence.
The comments from Rare Cancers Australia (RCA) described a range of benefits of treatment with apalutamide, including improved quality of life, where despite experiences with fatigue and hot flushes, patients stated that these side effects are significantly manageable. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients undergoing concurrent androgen deprivation therapy; TGA label has no such requirement.