目的：本研究旨在评估美国和中国广泛期小细胞肺癌（ES-SCLC）患者的新批准的一线治疗（阿达席特联合化疗与单独化疗相比）的成本效益，并估算决策者对于阿达席特价格的合理范围。方法：构建了几个分割生存模型，比较了阿达席特联合化疗与单独化疗在10年时间范围内的成本和效益。临床疗效和安全性数据来自CAPSTONE-1试验。成本和效用来自先前发表的研究。进行了敏感性、情景和亚组分析以探索模型结果的不确定性。按照支付意愿（WTP）的三个阈值进行价格模拟，其中包括美国的WTP为10万美元，中国的WTP为37,422美元，美国的0.5WTP为5万美元，中国的0.5WTP为18,711美元，美国的1.5WTP为15万美元，中国的1.5WTP为56,133美元。发现：在阿达席特价格为1382.82美元/600mg的基础分析中，阿达席特联合化疗在美国的WTP阈值为10万美元时是具有成本效益的，但在中国的WTP阈值为37,422美元时不是具有成本效益的。如果考虑到支付能力保护（PAP），在中国给定的WTP下，该方案将具有成本效益。价格模拟结果表明，在美国，如果阿达席特价格低于8894.98美元/600mg（总质量调整的生命年[QALYs]是通过进展基础效用[PB-utility]计算的）或8912.51美元/600mg（总QALYs是通过死亡时间效用[TTD-utility]计算的），阿达席特联合化疗完全是首选治疗方案，当WTP阈值为10万美元时；如果阿达席特价格至少降低202.03美元/600mg（总QALYs是通过PB-utility计算的）或103.06美元/600mg（总QALYs是通过TTD-utility计算的），在中国没有PAP的WTP阈值下，该方案也具有成本效益。以上结果在敏感性分析中保持稳定。亚组分析发现，生存效益更好的亚组倾向于具有更高的成本效益概率，这也与阿达席特价格相关。意义：与单独化疗相比，一线阿达席特联合化疗在美国和在中国有PAP的情况下表示为优势治疗策略，在阿达席特价格1382.82美元/600mg时。决策者可以从本研究提供的定价策略中受益，以做出最佳决策。需要更多的证据来验证和改进这些结果。版权©2023 Gan, Shi, Zhu, Han and Li.

Purpose: The aim of this study was to evaluate the cost-effectiveness of a recently approved first-line therapy (adebrelimab plus chemotherapy vs. chemotherapy alone) for patients with extensive-stage small-cell lung cancer (ES-SCLC) in the US and China, and to estimate the reasonable range of adebrelimab price from the decision-makers. Methods: Several partitioned survival models were built to compare the cost and effectiveness of adebrelimab plus chemotherapy vs. chemotherapy alone over a 10-year time horizon. Clinical efficacy and safety data were extracted from the CAPSTONE-1 trial. Costs and utilities were obtained from previously published studies. Sensitivity, scenario and subgroup analyses were performed to explore the uncertainty of the model outcomes. Price simulation was conducted at three thresholds of willingness-to-pay (WTP), including WTP of $100,000 in the US and of $37,422 in China, 0.5WTP of $50,000 in the US and of $18,711 in China, and 1.5WTP of 150,000 in the US and of $56,133 in China. Findings: Base-case analysis at $1382.82/600 mg of adebrelimab price indicated that adebrelimab plus chemotherapy would be cost-effective in the US at the WTP threshold of $100,000, but not in China at the WTP threshold of $37,422. If PAP was taken into account, the regimen would be cost-effective in China at the given WTP. The results of price simulation indicated that adebrelimab plus chemotherapy was completely favored in the US if adebrelimab price was less than $8894.98/600 mg (total quality-adjusted life years [QALYs] were calculated with progression-based utility [PB-utility]) or $8912.51/600 mg (total QALYs were calculated with time-to-death utility [TTD-utility]) at the WTP threshold of $100,000; if adebrelimab price was reduced by at least $202.03/600 mg (total QALYs were calculated with PB-utility) or $103.06/600 mg (total QALYs were calculated with TTD-utility), the regimen was also cost-effective in China without PAP at the WTP threshold of $37,422. The above results were stable in the sensitivity analyses. Subgroup analysis found that the subgroup with better survival benefits tended to have a higher probability of cost-effectiveness, which was also associated with adebrelimab price. Implications: First-line adebrelimab plus chemotherapy represented a dominant treatment strategy comparing with chemotherapy alone in the US and also did in China with PAP at $1382.82/600 mg of adebrelimab price. Decision-makers could benefit from pricing strategy provided by this study in making optimal decisions. More evidences were needed to verify and improve the results.Copyright © 2023 Gan, Shi, Zhu, Han and Li.