Zhu Jiaming, Li Zhengxiong, Ding Ye, Xu Qiaoping
Fourth Clinical Medical College of Zhejiang Chinese Medical University, Affiliated Hangzhou First People's Hospital, Hangzhou, P.R. China.
Department of Clinical Pharmacology, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Cancer Center, Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine, Hangzhou, P.R. China.
Ther Adv Med Oncol. 2025 Aug 25;17:17588359251367329. doi: 10.1177/17588359251367329. eCollection 2025.
The phase III TALAPRO-2 trial established that combining talazoparib (TALA) with enzalutamide significantly extends progression-free survival (PFS) and overall survival in metastatic castration-resistant prostate cancer (mCRPC) patients. Given the substantial cost implications of novel targeted therapies, economic evaluation is essential to determine whether the clinical benefits of this regimen justify its expense in the first-line mCRPC setting.
To evaluate the cost-effectiveness of talazoparib plus enzalutamide versus enzalutamide monotherapy as first-line treatment for mCRPC, informing clinical decision-making and healthcare resource allocation.
A Markov model-based cost-effectiveness analysis.
Based on data from the TALAPRO-2 trial, a dynamic Markov model was constructed to simulate disease progression in mCRPC patients. From the perspectives of U.S. and Chinese payers, total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICER) were considered as the primary outputs in the model. One-way sensitivity analysis and probabilistic sensitivity analysis were used to validate the robustness of the model. Price reduction analysis provided an evidence-based basis for drug pricing and health insurance negotiations by quantifying the impact of price adjustments on economics.
In the base-case analysis, the ICERs for talazoparib plus enzalutamide were $646,743.72/QALY and $57,635.76/QALY from the U.S. and China perspectives, respectively, which were above the willingness-to-pay thresholds ($150,000 in the U.S. and $40,334 in China). Sensitivity analyses showed that the utility of PFS and drug prices impacted the results most. Price adjustment scenarios showed that China needed a 34.5% price reduction to achieve affordability, whereas the U.S. remained unaffordable even with an 80% price reduction.
At current pricing, talazoparib plus enzalutamide as first-line treatment of patients with mCRPC is not cost-effective in either the U.S. or China. The study supports differentiated pricing strategies to balance clinical benefits with the rational allocation of healthcare resources.
III期TALAPRO-2试验证实，他拉唑帕尼（TALA）与恩杂鲁胺联合使用可显著延长转移性去势抵抗性前列腺癌（mCRPC）患者的无进展生存期（PFS）和总生存期。鉴于新型靶向治疗药物成本高昂，进行经济学评估对于确定该方案在一线mCRPC治疗中的临床获益是否足以证明其成本投入至关重要。
评估他拉唑帕尼联合恩杂鲁胺与恩杂鲁胺单药治疗作为mCRPC一线治疗方案的成本效益，为临床决策和医疗资源分配提供依据。
基于马尔可夫模型的成本效益分析。
基于TALAPRO-2试验的数据，构建动态马尔可夫模型以模拟mCRPC患者的疾病进展。从美国和中国支付方的角度，将总成本、质量调整生命年（QALY）和增量成本效益比（ICER）作为模型的主要输出指标。采用单因素敏感性分析和概率敏感性分析来验证模型的稳健性。降价分析通过量化价格调整对经济学的影响，为药品定价和医保谈判提供循证依据。
在基础病例分析中，从美国和中国的角度来看，他拉唑帕尼联合恩杂鲁胺的ICER分别为646,743.72美元/QALY和57,635.76美元/QALY，均高于支付意愿阈值（美国为150,000美元，中国为40,334美元）。敏感性分析表明，PFS的效用和药品价格对结果影响最大。价格调整方案显示，中国需要降价34.5%才能实现可承受性，而美国即使降价80%仍难以承受。
按照当前定价，他拉唑帕尼联合恩杂鲁胺作为mCRPC患者的一线治疗方案在美国和中国均不具有成本效益。该研究支持差异化定价策略，以平衡临床获益与医疗资源的合理分配。
