帕博利珠单抗联合化疗一线治疗晚期三阴性乳腺癌的成本-效果分析

doi:10.5246/jcps.2023.07.049

摘要/Abstract

摘要：

本文旨在从中国卫生体系角度评价帕博利珠单抗联合化疗治疗晚期TNBC的成本-效果。建立具有三种健康状态的Markov模型, 该模型的模拟时限为10年, 循环周期为21天。通过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, 进行情景分析来探讨中国患者援助计划(PAP)下帕博利珠单联合化疗治疗晚期TNBC的经济性。基础分析结果表明, 帕博利珠单抗联合化疗可多获得0.67 QALYs, 增量成本为\$ 77 096.78, ICER为115 896.30 \$/QALY。单因素敏感性分析结果显示, 帕博利珠单抗成本对结果的影响最大。概率敏感性分析结果显示, 在中国的意愿支付阈值下(33 782.23 \$/QALY), 帕博利珠单抗联合化疗具有经济性的概率为0。从中国卫生体系角度来看, 与安慰剂联合化疗相比, 帕博利珠单抗联合化疗一线治疗晚期TNBC不具有成本-效果优势。如果考虑帕博利珠单抗纳入PAP, 虽仍然不具有经济性, 但是ICER更加接近于中国3倍人均GDP。

关键词: 成本-效果, 帕博利珠单抗, 化疗, 晚期三阴性乳腺癌, 马尔科夫模型

Abstract:

The purpose of this study was to assess the cost-effectiveness of using pembrolizumab plus chemotherapy for advanced triple-negative breast cancer (TNBC) in the context of China’s healthcare system. To achieve this, we developed a Markov model with three health states, a time horizon of 10 years, and a cycle length of 21 days. Additionally, we conducted one-way sensitivity analyses and probabilistic sensitivity analyses to test the model’s stability. Scenario analyses were also performed to explore the cost-effectiveness of pembrolizumab plus chemotherapy based on the Patient Assistance Program (PAP). The base-case analysis demonstrated that pembrolizumab plus chemotherapy provided an additional 0.67 QALYs, with an incremental cost of \$ 77 096.78, resulting in an ICER of \$ 115 896.30/QALY. One-way sensitivity analyses revealed that pembrolizumab cost had the greatest impact on the results. In probabilistic sensitivity analyses, pembrolizumab plus chemotherapy was found to be cost-effective in 0% of cases at willingness-to-pay thresholds of \$ 33 782.23/QALY. Considering China’s healthcare system, pembrolizumab plus chemotherapy as first-line treatment for advanced TNBC was unlikely to be cost-effective when compared to placebo plus chemotherapy. Even if pembrolizumab was to be included in the PAP, it would still not be considered cost-effective, although the ICER would be much closer to three times China’s GDP per capita (\$ 33 782.23/QALY).

Key words: Cost-effectiveness, Pembrolizumab, Chemotherapy, Advanced triple-negative breast cancer, Markov model

Supporting:

朱文涛, 洪望龙, 郑淼淼, 马国强, 沈爱宗. 帕博利珠单抗联合化疗一线治疗晚期三阴性乳腺癌的成本-效果分析[J]. 中国药学(英文版), 2023, 32(7): 587-597.

Wentao Zhu, Wanglong Hong, Miaomiao Zheng, Guoqiang Ma, Aizong Shen. Combination of pembrolizumab and chemotherapy as first-line treatment in advanced triple-negative breast cancer: a cost-effectiveness analysis[J]. Journal of Chinese Pharmaceutical Sciences, 2023, 32(7): 587-597.

图/表 11

Figure 1. The Markov model.

Table 1. The optimal fitting distribution and parameters of the survival curve.

Table 2. Comparison of the incidence of AEs (grade ≥ 3).

Table 3. Key model parameters.

Table 4. Basic analysis results.

Figure 2. One-way sensitivity analyses tornado diagram. PC arm, Pembrolizumab plus chemotherapy arm; CP arm, Placebo plus chemotherapy arm; QALY, Quality-adjusted life year; ICER, Incremental cost-effectiveness ratio.

Figure 3. Cost-effectiveness scatter plot WTP, Willingness-to-pay; QALYs, Quality-adjusted life year.

Figure 4. Cost-effectiveness acceptability curve PC arm, Pembrolizumab plus chemotherapy arm; CP arm, Placebo plus chemotherapy arm; QALY, Quality-adjusted life year.

Figure 5. One-way sensitivity analyses tornado diagram of the scenario analysis. PC arm, Pembrolizumab plus chemotherapy arm; CP arm, Placebo plus chemotherapy arm; QALY, Quality-adjusted life year; ICER, Incremental cost-effectiveness ratio.

Figure 6. Cost-effectiveness scatter plot of the scenario analysis. WTP, Willingness-to-pay; QALYs, Quality-adjusted life year.

Figure 7. Cost-effectiveness acceptability curve of the scenario analysis. PC arm, Pembrolizumab plus chemotherapy arm; CP arm, Placebo plus chemotherapy arm; QALY, Quality-adjusted life year.

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