Cost-effectiveness of fuzuloparib, with or without apatinib, for BRCA mutation HER2-negative metastatic breast cancer in China

Background: The FABULOUS trial showed that fuzuloparib, with or without apatinib, significantly improved progression-free survival (PFS) in patients with human epidermal growth factor receptor 2-negative metastatic breast cancer with germline breast cancer susceptibility genes 1 or 2 mutations compared to standard chemotherapy. The study assessed the cost-effectiveness of three treatment options from the perspective of China's healthcare system. Methods: A partitioned survival model was created to evaluate cost-effectiveness. The model incorporated direct medical costs, with drug prices derived from local charges and other costs as well as utility data from published literature. Both costs and utility values were discounted at an annual rate of 4.5%. The incremental cost-effectiveness ratio (ICER) served as the primary outcome. The treatment regimen was determined to be cost-effective if the ICER was below the willingness-to-pay (WTP) threshold of $26,083/quality-adjusted life year (QALY). One-way sensitivity, probabilistic sensitivity and scenario analyses were also conducted. Results: The ICERs for fuzuloparib versus chemotherapy, fuzuloparib versus fuzuloparib-apatinib, and fuzuloparib-apatinib versus chemotherapy were calculated as $141,912.74/QALY, $285,196.26/QALY, and $90,074.03/QALY, respectively. Accordingly, neither fuzuloparib plus apatinib nor fuzuloparib monotherapy was found to be cost-effective compared with standard chemotherapy at the WTP threshold of $26,083/QALY. Moreover, fuzuloparib monotherapy was not cost-effective compared with fuzuloparib plus apatinib. Sensitivity and scenario analyses affirmed the robustness of the model. One-way sensitivity analysis showed that utility for PFS, utility for progressive disease, and costs associated with subsequent treatment exerted the most substantial influence on the outcomes. Conclusion: Although fuzuloparib, with or without apatinib, has shown substantial clinical benefits, it has not proven to be cost-effective when compared to standard chemotherapy. Further global multicenter or population-specific clinical trials involving breast cancer patients are necessary to enhance the understanding of the application scope and cost-effectiveness of fuzuloparib.