ENZALUTAMIDE

The PBAC recommended the listing of enzalutamide (Xtandi®), for use 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). Patients with high-risk biochemical recurrence have a rapid increase in prostate-specific antigen following initial treatment indicating a greater risk of metastases and death from prostate cancer. The PBAC considered that for patients with m0HSPC enzalutamide plus ADT resulted in improved survival compared to the current treatment of ADT alone. The PBAC considered that the resubmission had largely addressed the key concerns it raised in relation to the previous November 2024 submission and accepted that enzalutamide was cost-effective at the price proposed in the resubmission. However, the PBAC considered that there remained some uncertainty in the estimated number of patients that would use enzalutamide. The PBAC advised that enzalutamide for the treatment of m0HSPC should join the current arrangement in place to manage financial risk of PBS-listed treatments for metastatic hormone sensitive prostate cancer (mHSPC) risk sharing arrangement (RSA) with an increase to the expenditure limits.