Cost-effectiveness analysis of second-generation androgen receptor antagonists for the treatment of metastatic hormone-sensitive prostate cancer.

[OBJECTIVE] The combination of second-generation androgen receptor (AR) antagonists with androgen deprivation therapy (ADT) has shown good efficacy and safety in advanced prostate cancer. This study aims to evaluate the cost-effectiveness of three second-generation AR antagonists in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in China, providing pharmacoeconomic evidence for clinical drug selection.

[METHODS] A Markov model was constructed based on data from the ARCHES, TITAN, and ARANOTE phase III clinical trials, with a 28-day cycle period. Direct medical costs and quality-adjusted life years (QALYs) were simulated over a 15-year horizon. The incremental cost-effectiveness ratio (ICER) was used as the primary outcome, and a willingness-to-pay (WTP) threshold of three times the 2024 per capita GDP of China was set for cost-utility analysis. Sensitivity analysis was conducted to validate the model's influencing factors and the robustness of the results.

[RESULTS] The cumulative cost of the apalutamide regimen was ¥776,807, resulting in 4.95 QALYs. Compared to apalutamide, the ICER for enzalutamide was ¥643,309/QALY, while for darolutamide, the ICER was -¥40,625/QALY.

[CONCLUSION] For Chinese mHSPC patients, darolutamide is the most cost-effective treatment at a WTP threshold of ¥287,391/QALY, followed by apalutamide, with enzalutamide being less favorable.