EnzalutamideXtandi
Treatment of non-metastatic hormone sensitive prostate cancer (m0HSPC) with high-risk biochemical recurrence (PSA doubling time ≤9 months) in combination with androgen deprivation therapy.
Decisions on record
- Meeting Mar 2026 Recommended Non-metastatic hormone sensitive prostate cancer (nmHSPC) with biochemical recurrence at high-risk for metastasis
- Meeting Nov 2024 Not recommended Non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence
- Meeting Mar 2023 Recommended Prostate cancer; metastatic hormone-sensitive prostate cancer (mHSPC)
- Meeting Mar 2022 Recommended Prostate cancer
- Meeting Jul 2021 Not recommended Castration resistant prostate cancer
- Meeting Jul 2017 Deferred Prostate cancer
- Meeting Mar 2017 Deferred Prostate cancer
- Meeting Nov 2015 Not recommended Metastatic castration resistant prostate cancer
1 earlier decision
- Jul 2014 Recommended Xtandi® Astellas Pharma Australia Pty Ltd New listing (Major submission) Prostate cancer Authority required (Streamlined) listing for the treatment of patients with metastatic castration resistant prostate cancer who have previously received docetaxel and who meet certain criteria. On the basis of i
Access path
- TGA registered · Xtandi
TGA label narrower than the PBS population
- Jul 2014Recommended · restricted
vs abiraterone
- Nov 2015Not recommended
Comparator changed: abiraterone → watchful waiting, abiraterone, and docetaxel
- Mar 2017Deferred
Comparator changed: watchful waiting, abiraterone, and docetaxel → watchful waiting…
- Jul 2017Deferred
Comparator changed: watchful waiting (active surveillance) → watchful waiting…
- Mar 2022Recommended · restricted
Comparator changed: watchful waiting (post-docetaxel treatment continuation) →…
- Mar 2023Recommended · restricted
Comparator changed: darolutamide → ADT alone
- Nov 2024Not recommended
Comparator changed: ADT alone → ADT alone (Leuprorelin + Placebo in EMBARK trial)
- ↻ resubmittedMar 2026Recommended · restricted
Comparator changed: ADT alone (Leuprorelin + Placebo in EMBARK trial) → ADT (leuprorelin…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC did not recommend enzalutamide, for use with or without androgen deprivation therapy (ADT), for the treatment of patients who have non-metastatic hormone sensitive prostate cancer (m0HSPC) with high-risk biochemical recurrence (BCR).PSD · Nov 2024
7.2 The primary reason for this outcome was due to the economic evaluation.PSD · Nov 2024
6.33 The submission presented stepped economic evaluations of enzalutamide therapies (enzalutamide plus ADT, and enzalutamide monotherapy), versus ADT alone for patients who have m0HSPC with high-risk BCR based on the EMBARK randomised trial.PSD · Nov 2024
6.34 The type of economic evaluations presented were cost-utility analyses using a semi- Markov model. The model used a combined partitioned survival and Markov model approach to estimate movement between seven health states: (i) m0HSPC prior to or without treatment suspension, (ii) m0HSPC during treatment suspension, (iii) m0HSPC post-treatment suspension, (iv) mHSPC, (v) m0CRPC, (vi) mCRPC and (vii) dead.PSD · Nov 2024
Table 1: Key components of the clinical issue addressed by the submission Component Description Population Non-metastatic hormone sensitive carcinoma of the prostate (m0HSPC) Intervention Enzalutamide with or without androgen deprivation therapy For enzalutamide with ADT: ADT alone (Leuprorelin + Placebo in EMBARK)PSD · Nov 2024
profile compared to ADT alone. Source: Table 1-1, p2 of the submission.PSD · Nov 2024
6.3 MOGA also expressed its strong support for the enzalutamide submission, categorising it as one of the therapies of “high priority for PBS listing” on the basis of the EMBARK trial. The PBAC noted that the MOGA presented a European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) for enzalutamide with or without ADT, which was limited to 3 (out of a maximum of 5, where 5 and 4 represent the grades with substantial …PSD · Nov 2024
6.4 The submission was based on one head-to-head randomised trial, EMBARK, comparing enzalutamide plus ADT and enzalutamide monotherapy to placebo plus ADT in patients with m0HSPC and high-risk BCR after prostatectomy or radiotherapy or both who were not candidates for salvage radiotherapy. ADT treatment was leuprorelin (also known as leuprolide acetate) administered as an intramuscular or subcutaneous injection.PSD · Nov 2024
Cost-effectiveness
ICER values are redacted in the public document; economic model details are present but specific ICER figures are not stated in the publicly available text.
The PBAC deferred a recommendation on the proposal for an extended PBS listing for enzalutamide for the treatment of metastatic castrate-resistant prostate cancer (mCRPC) prior to docetaxel, on the basis that the proposal to achieve a cost-effective listing was unacceptable. PBAC · 2017
Decision context
PopulationAdult patients with non-metastatic hormone sensitive prostate cancer with high-risk biochemical recurrence (PSA doubling time ≤9 months) who have undergone radical prostatectomy and/or radiation therapy, treated with enzalutamide in combination with androgen deprivation therapy.
Risk sharingRisk-sharing arrangement (RSA) proposed, which combines m0HSPC with the currently existing mHSPC restriction.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | ADT (leuprorelin + placebo) | — | RCT · MFS |
| Nov 2024 | Not recommended | ADT alone (Leuprorelin + Placebo in EMBARK trial) | — | RCT · PFS |
| Mar 2023 | Recommended · restricted | ADT alone | — | RCT · OS |
| Mar 2022 | Recommended · restricted | darolutamide | — | Meta-analysis · MFS |
| Jul 2017 | Deferred | watchful waiting (post-docetaxel treatment continuation) | $45k–75k | RCT · OS |
| Mar 2017 | Deferred | watchful waiting (active surveillance) | $45k–75k | RCT · PFS |
| Nov 2015 | Not recommended | watchful waiting, abiraterone, and docetaxel | — | RCT · OS |
| Jul 2014 | Recommended · restricted | abiraterone | — | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ARCHES | Ph 3 | 1,150 | Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of… | completed |
| ENZAMET | Ph 3 | 1,125 | Overall Survival Time | active not recruiting |
| AFFIRM | Ph 3 | 1,199 | Overall Survival | completed |
| PREVAIL | Ph 3 | 1,717 | Overall Survival | completed |
| PROSPER | Ph 3 | 1,401 | Metastasis Free Survival (MFS) | completed |
Consumer voice
The Medical Oncology Group of Australia expressed strong support for enzalutamide listing, categorising it as a therapy of highest priority for PBS listing based on the ARCHES and ENZEMET trials, and presented an ESMO-MCBS score of 4 out of 5.
strong support for the enzalutamide 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 m0HSPC with PSADT ≤9 months after failed primary treatment, excluding salvage radiotherapy candidates; TGA label lacks these clinical criteria.