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塞普鲁单抗联合化疗对比化疗治疗美国和中国广泛期小细胞肺癌患者的成本效果分析:为药物定价提供信息。

Serplulimab Plus Chemotherapy vs Chemotherapy for Treatment of US and Chinese Patients with Extensive-Stage Small-Cell Lung Cancer: A Cost-Effectiveness Analysis to Inform Drug Pricing.

机构信息

Center for Pharmacoeconomics and Outcomes Research, China Pharmaceutical University, 639 Longmian Road, Jiangning District, Nanjing, 211198, China.

Department of Public Affairs Management, School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, 211198, China.

出版信息

BioDrugs. 2023 May;37(3):421-432. doi: 10.1007/s40259-023-00586-6. Epub 2023 Feb 25.

Abstract

BACKGROUND

Serplulimab is a potential valuable therapy, while patients, physicians, and decision-makers are uncertain about the cost-effectiveness of this novel drug and its corresponding reasonable price. This study aimed to simulate the price at which serplulimab was cost-effective as first-line therapy for United States (US) and Chinese extensive-stage small-cell lung cancer (ES-SCLC) patients.

METHODS

In this economic evaluation, a partitioned survival model was constructed from the perspective of US and Chinese payers. Baseline characteristics of patients and critical clinical data were obtained from ASTRUM-005. Costs and utilities were collected from open-access databases and published literature. Cumulative costs (in US dollars), life years, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were measured and compared. Price simulation was conducted to inform the pricing strategy at the given willingness-to-pay (WTP) threshold. The robustness of the model was assessed via sensitivity analyses and scenario analyses; subgroup analyses were also included.

RESULTS

Base-case analysis indicated that serplulimab ($818.16/100 mg) would be cost-effective in the US at the WTP threshold of $150,000, with improved effectiveness of 0.61 QALYs and an additional cost of $64,918 (ICER $106,757). Serplulimab ($818.16/100 mg, patient assistance program considered) was cost-effective in China, with improved effectiveness of 0.58 QALYs and an increased overall cost of $19,369 (ICER $33,392). The price simulation results indicated that serplulimab was favored in the US when the price was less than $762.11/100 mg and $1261.57/100 mg at the WTP threshold of $100,000 and $150,000, respectively; it was cost-effective at the WTP threshold of $38,184 when the price was less than $373.37/100 mg in China. Sensitivity analyses revealed that the above results were stable. Subgroup analysis results indicated an overall trend for subgroups with better survival advantages to have a higher probability of cost-effectiveness, despite serplulimab not being cost-effective in some subgroups.

CONCLUSIONS

Serplulimab might be a valuable and cost-effective therapy in both the US and China. The evidence-based pricing strategy provided by this study could benefit decision-makers in making optimal decisions and clinicians in general clinical practice. More evidence about the budget impact and affordability for patients is needed.

摘要

背景

赛普丽珠是一种有潜力的有价值的治疗方法,然而,患者、医生和决策者不确定这种新型药物的成本效益,也不确定其合理价格。本研究旨在模拟赛普丽珠作为美国(US)和中国广泛期小细胞肺癌(ES-SCLC)患者一线治疗的成本效益价格。

方法

本经济学评价从美国和中国支付者的角度构建了一个分割生存模型。患者的基线特征和关键临床数据来自 ASTRUM-005 研究。成本和效用数据来自开放获取数据库和已发表的文献。测量和比较了累计成本(美元)、生命年、质量调整生命年(QALY)和增量成本效益比(ICER)。进行了价格模拟,以在给定的支付意愿(WTP)阈值下为定价策略提供信息。通过敏感性分析和情景分析评估模型的稳健性;还进行了亚组分析。

结果

基础案例分析表明,赛普丽珠(818.16 美元/100mg)在美国的支付意愿阈值为 150000 美元时具有成本效益,其有效性提高了 0.61 QALY,额外成本为 64918 美元(ICER 为 106757 美元)。考虑到患者援助计划,赛普丽珠(818.16 美元/100mg)在中国具有成本效益,其有效性提高了 0.58 QALY,总费用增加了 19369 美元(ICER 为 33392 美元)。价格模拟结果表明,在美国,当价格低于 762.11 美元/100mg 和 1261.57 美元/100mg 时,赛普丽珠在支付意愿阈值为 100000 美元和 150000 美元时具有优势;在中国,当价格低于 373.37 美元/100mg 时,赛普丽珠在支付意愿阈值为 38184 美元时具有成本效益。敏感性分析结果表明,上述结果是稳定的。亚组分析结果表明,尽管赛普丽珠在某些亚组中不具有成本效益,但总体趋势是生存优势更好的亚组具有更高的成本效益概率。

结论

赛普丽珠在美国和中国可能是一种有价值且具有成本效益的治疗方法。本研究提供的基于证据的定价策略可以使决策者做出最佳决策,并使临床医生在一般临床实践中受益。需要更多关于患者预算影响和负担能力的证据。

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