EnzalutamideXtandi

7.1 The PBAC recommended the PBS listing of enzalutamide, in combination with androgen deprivation therapy (ADT), for the treatment of patients who have non- metastatic hormone sensitive prostate cancer (m0HSPC) with high-risk biochemical recurrence (BCR). The PBAC considered that enzalutamide plus ADT was superior compared to the nominated comparator of ADT in terms of metastases free survival (MFS) and overall survival (OS).PSD · Mar 2026

7.2 The PBAC acknowledged the input received from individuals, health care professionals and organisations in support of the resubmission, noting that the input highlighted the survival benefit associated with early treatment of prostate cancer. The PBAC also noted that enzalutamide plus ADT was the recommended treatment for m0HSPC in the NCCN and ESMO clinical guidelines.PSD · Mar 2026

6.30 The resubmission presented an updated modelled economic evaluation comparing enzalutamide with ADT to ADT. At the November 2024 PBAC meeting, concerns were raised about structural uncertainties in the modelling approach, which manufactured a large treatment benefit and survival gain for enzalutamide with ADT over ADT.PSD · Mar 2026

OFFICIAL Public Summary Document - March 2026 PBAC Meeting Table 9: Key components of the economic evaluation Component November 2024 submission March 2026 resubmission Justification/comments Type of analysis Cost-utility Unchanged - Outcomes LYs, QALYs Unchanged - Time horizon 30 years vs median follow up 60.7 20 years vs median follow In EMBARK, the mean age at months in EMBARK.PSD · Mar 2026

Table 1: Key components of the clinical issue addressed by the resubmission Component Description Population Non-metastatic hormone sensitive carcinoma of the prostate (m0HSPC) Intervention Enzalutamide with ADTaPSD · Mar 2026

safety profile compared to ADT. Blue shading indicates data previously seen by the PBAC. Source: Table 1.1.2, p48 of the resubmission.PSD · Mar 2026

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