Abstract
BACKGROUND: Novel androgen receptor inhibitors (ARIs) have been recommended for patients with high-risk nonmetastatic castration-resistant prostate cancer (nmCRPC). OBJECTIVE: The present study aims to evaluate the cost-effectiveness of darolutamide, enzalutamide, apalutamide, and bicalutamide when combined with androgen deprivation therapy (ADT) for treating nmCRPC in the context of national drug price negotiations in China. DESIGN: A cost-effectiveness analysis. METHODS: A Markov model was developed to assess the cost-effectiveness of first-line therapy (darolutamide, enzalutamide, apalutamide, and bicalutamide) combined with ADT in nmCRPC patients, as well as second-line treatment options receiving chemotherapy after disease progression. The model included three health states: progression-free survival, progression survival, and death. The transfer probability per period was calculated using a Log-normal distribution. Drug costs were obtained from national price negotiations and relevant medical institutions, and health state utility values were obtained from the literature. Uncertainty was addressed through one-way sensitivity, probabilistic sensitivity, and scenario analyses. RESULTS: Compared with bicalutamide plus ADT, apalutamide, darolutamide, and enzalutamide provided incremental benefits of 3.52, 4.96, and 3.86 quality-adjusted life years (QALYs), respectively. This resulted in incremental cost-effectiveness ratios (ICERs) of $117,261, $166,618, and $238,170 in nmCRPC patients. Specifically, the ICERs of apalutamide, darolutamide, and enzalutamide were $33,357/QALY, $33,600/QALY, and $61,740/QALY, respectively. CONCLUSION: Compared with bicalutamide plus ADT, apalutamide plus ADT and darolutamide plus ADT are more cost-effective under the willingness-to-pay threshold of $38,223/QALY. Nonetheless, enzalutamide plus ADT is not cost-effective compared with bicalutamide plus ADT.