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德曲妥珠单抗对比化疗方案二线治疗HER-2低表达晚期乳腺癌的经济学评价
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| 篇名： | 德曲妥珠单抗对比化疗方案二线治疗HER-2低表达晚期乳腺癌的经济学评价 |
| TITLE： | Pharmacoeconomic evaluation of trastuzumab deruxtecan versus chemotherapy in the second-line treatment of advanced breast cancer with HER-2 low expression |
| 摘要： | 目的 从我国卫生体系角度出发，评价德曲妥珠单抗方案对比医生选择化疗（TPC）方案二线治疗人表皮生长因子受体2（HER-2）低表达晚期乳腺癌的经济性。方法基于DESTINY-Breast04临床试验数据构建动态Markov模型，模拟时限为10年，循环周期为3周。以成本、质量调整生命年（QALY）、增量成本-效果比（ICER）作为模型产出指标，采用5%的贴现率，以3倍2023年我国人均国内生产总值（GDP）作为意愿支付（WTP）阈值，采用成本-效用分析法分析激素受体阳性队列和所有患者队列中两种治疗方案的经济性，再通过不确定性分析验证基础分析结果的稳健性。结果基础分析结果显示，德曲妥珠单抗方案与TPC方案相比，在激素受体阳性队列和所有患者队列中的ICER值分别为1045655.76、906404.99元/QALY，均高于WTP阈值（268074元/QALY）。单因素敏感性分析结果显示，疾病无进展状态效用值、德曲妥珠单抗价格、疾病进展状态效用值等参数对模型结果影响较大。概率敏感性分析结果显示，当WTP阈值为3倍2023年我国人均GDP时，德曲妥珠单抗方案具有经济性的概率为0。情境分析结果显示，在考虑援助计划时，德曲妥珠单抗方案具有经济性的概率为0；当德曲妥珠单抗价格降低70%时，该方案具有经济性的概率显著提高至82.80%。结论在以3倍2023年我国人均GDP作为WTP阈值时，德曲妥珠单抗方案相对于TPC方案二线治疗HER-2低表达晚期乳腺癌不具有经济性；按地区适当降低德曲妥珠单抗的价格，可以提高其经济性。 |
| ABSTRACT： | OBJECTIVE To evaluate the economics of trastuzumab deruxtecan versus the physician-selected chemotherapy （TPC） regimen in the second-line treatment of advanced breast cancer with epidermal growth factor receptor 2 （HER-2） low expression from the perspective of the Chinese healthcare system. METHODS Based on the data of DESTINY-Breast04 clinical trial， the dynamic Markov model was constructed. The time frame of the model simulation was 10 years， and the cycle was 3 weeks. Taking cost， quality-adjusted life year （QALY） and incremental cost-effectiveness ratio （ICER） as the model output indicators， the discount rate of 5% was applied， and 3 times China’s per capita gross domestic product （GDP） in 2023 was taken as the willingness-to-pay （WTP） threshold value. Cost-utility analysis was used to evaluate the economics of the two treatment regiments in the hormone receptor-positive cohort and all patient cohorts， and uncertainty analysis was used to verify the robustness of the basic analysis result. RESULTS The results of the basic analysis showed that compared with the TPC regimen， the ICER value of trastuzumab deruxtecan regimen edu.cn were 1 045 655.76 and 906 404.99 yuan/QALY in the hormone receptor-positive cohort and all patients， respectively， both exceeding the WTP threshold （268 074 yuan/QALY）. The results of single factor sensitivity analysis showed that progression-free survival utility value， the price of trastuzumab deruxtecan and progression disease utility had a significant influence on the model results. The results of probability sensitivity analysis showed that when the WTP threshold was 3 times China’s per capita GDP in 2023， the probability of economic viability of trastuzumab deruxtecan was 0. The results of scenario analysis showed that when the patient assistance program for trastuzumab deruxtecan was considered， the probability of trastuzumab deruxtecan regimen being economical was 0. However， when the price of trastuzumab deruxtecan was reduced by 70%， the probability of its being cost-effective was significantly increased to 82.80%. CONCLUSIONS At a WTP threshold of 3 times China’s per capita GDP in 2023， the trastuzumab deruxtecan regimen is not cost-effective compared to TPC regimen for the second-line treatment of advanced breast cancer with HER-2 low expression. Reducing the price of trastuzumab deruxtecan by region can improve its cost-effectiveness. |
| 期刊： | 2024年第35卷第19期 |
| 作者： | 李雪；贾才凤；郑颖；张森；王美祺；王明霞 |
| AUTHORS： | LI Xue，JIA Caifeng，ZHENG Ying，ZHANG Sen，WANG Meiqi，WANG Mingxia |
| 关键字： | 德曲妥珠单抗；晚期乳腺癌；HER-2低表达；二线治疗；Markov模型；药物经济学 |
| KEYWORDS： | trastuzumab deruxtecan； advanced breast cancer； HER-2 low expression； second-line treatment； Markov model； |
| 阅读数： | 6 次 |
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