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

李雪; 贾才凤; 郑颖; 张森; 王美祺; 王明霞

doi:10.6039/j.issn.1001-0408.2024.19.11

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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

药物经济学 | 更新时间：2024-10-11

- 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
- Pharmacoeconomic evaluation of trastuzumab deruxtecan versus chemotherapy in the second-line treatment of advanced breast cancer with HER-2 low expression
- 中国药房 2024年35卷第19期页码：2383-2390
- 作者机构：
  
  1.河北医科大学第四医院药学部，石家庄　050011
  2.河北医科大学第四医院临床药理研究部，石家庄　050011
  3.河北医科大学第四医院乳腺中心，石家庄　050011
- 作者简介：
  
  主管药师，硕士研究生。研究方向：肿瘤药物的临床研究与评价。E-mail：lx15633081136@163.com
  主任药师，博士生导师，博士。研究方向：肿瘤药物的临床研究与评价。电话：0311-66696233。E-mail：46700792@hebmu.edu.cn
- 基金信息：
  
  河北省自然科学基金项目(H2021206432)
- DOI：10.6039/j.issn.1001-0408.2024.19.11
  中图分类号： R956;R737.9
- 纸质出版日期：2024-10-15，
  
  收稿日期：2024-02-10，
  
  修回日期：2024-07-22，
- 稿件说明：
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李雪,贾才凤,郑颖等.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 ^Δ[J].中国药房,2024,35(19):2383-2390.

LI Xue,JIA Caifeng,ZHENG Ying,et al.Pharmacoeconomic evaluation of trastuzumab deruxtecan versus chemotherapy in the second-line treatment of advanced breast cancer with HER-2 low expression[J].ZHONGGUO YAOFANG,2024,35(19):2383-2390.
李雪,贾才凤,郑颖等.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 ^Δ[J].中国药房,2024,35(19):2383-2390. DOI： 10.6039/j.issn.1001-0408.2024.19.11.

LI Xue,JIA Caifeng,ZHENG Ying,et al.Pharmacoeconomic evaluation of trastuzumab deruxtecan versus chemotherapy in the second-line treatment of advanced breast cancer with HER-2 low expression[J].ZHONGGUO YAOFANG,2024,35(19):2383-2390. DOI： 10.6039/j.issn.1001-0408.2024.19.11.

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1 045 655.76、906 404.99元/QALY，均高于WTP阈值（268 074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 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.

关键词

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

advanced breast cancerHER-2 low expressionsecond-line treatmentMarkov modelpharmacoeconomics

references

SUNG H，FERLAY J，SIEGEL R L，et al. Global cancer statistics 2020：GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin，2021，71（3）：209-249.

GIAQUINTO ANGELA N，HYUNA S，MILLER KIMBERLY D，et al. Breast cancer statistics，2022[J]. CA-Cancer J Clin，2022，72（6）：524-541.

CHEN S M，CAO Z，PRETTNER K，et al. Estimates and projections of the global economic cost of 29 cancers in 204 countries and territories from 2020 to 2050[J]. JAMA Oncol，2023，9（4）：465-472.

JrGUY G P，EKWUEME D U，YABROFF K R，et al. Economic burden of cancer survivorship among adults in the United States[J]. J Clin Oncol，2013，31（30）：3749-3757.

BAEZ-NAVARRO X，VAN BOCKSTAL M R，ANDRINOPOULOU E R，et al. HER2-low breast cancer：incidence，clinicopathologic features，and survival outcomes from real-world data of a large nationwide cohort[J]. Mod Pathol，2023，36（4）：100087.

ZHANG H，KATERJI H，TURNER B M，et al. HER2-low breast cancers[J]. Am J Clin Pathol，2022，157（3）：328-336.

中国抗癌协会国际医疗与交流分会，中国医师协会肿瘤医师分会乳腺癌学组. 人表皮生长因子受体2低表达乳腺癌临床诊疗共识：2022版[J]. 中华肿瘤杂志，2022，44（12）：1288-1295.

International Medical and Exchange Branch of China Anti-Cancer Association，Breast Cancer Group of Cancer Doctor Branch of China Medical Doctor Association. Consensus on clinical diagnosis and treatment of breast cancer with low expression of human epidermal growth factor receptor 2：2022 edition[J]. Chin J Oncol，2022，44（12）：1288-1295.

CORTÉS J，KIM S B，CHUNG W P，et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer[J]. N Engl J Med，2022，386（12）：1143-1154.

OGITANI Y，HAGIHARA K，OITATE M，et al. Bystander killing effect of DS-8201a，a novel anti-human epidermal growth factor receptor 2 antibody-drug conjugate，in tumors with human epidermal growth factor receptor 2 heterogeneity[J]. Cancer Sci，2016，107（7）：1039-1046.

MODI S N，JACOT W，YAMASHITA T，et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer[J]. N Engl J Med，2022，387（1）：9-20.

NARAYAN P，DILAWARI A，OSGOOD C，et al. US Food and Drug Administration approval summary：fam-trastuzumab deruxtecan-nxki for human epidermal growth factor receptor 2-low unresectable or metastatic breast cancer[J]. J Clin Oncol，2023，41（11）：2108-2116.

周挺，马爱霞，付露阳. 药物经济学评价Markov模型中转移概率计算的探讨[J]. 中国卫生经济，2017，36（12）：40-42.

ZHOU T，MA A X，FU L Y. Discussion on the calculation of Markov model transition probability in pharmacoeconomics evaluation[J]. Chin Health Econ，2017，36（12）：40-42.

国家统计局. 中华人民共和国2022年国民经济和社会发展统计公报[J]. 中国统计，2023（3）：12-29.

National Bureau of Statistics. Statistical bulletin on national economic and social development of the People’s Republic of China in 2022[J]. China Stat，2023（3）：12-29.

刘国恩. 中国药物经济学评价指南2020[M]. 北京：中国市场出版社，2020：27-46.

LIU G E. Guidelines for pharmacoeconomic evaluation in China 2020[M]. Beijing：China Market Publishing House，2020：27-46.

石丰豪，商叶，芮明军，等. R语言survHE程序包在卫生经济学评价中的应用[J]. 中国卫生经济，2020，39（9）：9-14.

SHI F H，SHANG Y，RUI M J，et al. Application of SurvHE package of R for health economic evaluation[J]. Chin Health Econ，2020，39（9）：9-14.

DJALALOV S，BECA J，EWARA E M，et al. A comparison of different analysis methods for reconstructed survival data to inform cost-effectiveness analysis[J]. Pharmacoeconomics，2019，37（12）：1525-1536.

国家卫生健康委员会. 中国居民营养与慢性病状况报告：2020年[J]. 营养学报，2020，42（6）：521.

National Health Commission. Report on nutrition and chronic diseases of residents in China：2020[J]. Acta Nutr Sin，2020，42（6）：521.

ZHU W T，ZHENG M M，XIA P P，et al. Cost-effectiveness of palbociclib plus fulvestrant as second-line therapy of women with HR+/HER2－ advanced breast cancer：a Chinese healthcare system perspective[J]. Front Oncol，2023，13：1068463.

孙蕾，周大创，陈平钰，等. 恩沙替尼一线治疗间变性淋巴瘤激酶阳性晚期非小细胞肺癌的药物经济学评价[J]. 中国药房，2022，33（12）：1479-1484.

SUN L，ZHOU D C，CHEN P Y，et al. Pharmacoeconomic evaluation of ensartinib in the first-line treatment of anaplastic lymphoma kinase-positive advanced non-small cell lung cancer[J]. China Pharm，2022，33（12）：1479-1484.

贾才凤，冯章英，张森，等. 阿贝西利联合氟维司群二线治疗激素受体阳性的晚期乳腺癌的药物经济学评价[J]. 中国现代应用药学，2023，40（12）：1609-1614.

JIA C F，FENG Z Y，ZHANG S，et al. Pharmacoeconomic evaluation of abemaciclib in combination with fulvestrant for second-line treatment of hormone receptor-positive advanced breast cancer[J]. Chin J Mod Appl Pharm，2023，40（12）：1609-1614.

ZHOU K X，JIANG C L，LI Q. Cost-effectiveness analysis of pembrolizumab monotherapy and chemotherapy in the non-small-cell lung cancer with different PD-L1 tumor proportion scores[J]. Lung Cancer，2019，136：98-101.

齐冉，聂旭阳，刘旭婷，等. 斯鲁利单抗联合化疗方案一线治疗广泛期小细胞肺癌的药物经济学评价[J]. 中国药房，2023，34（11）：1368-1373.

QI R，NIE X Y，LIU X T，et al. Pharmacoeconomic evaluation of serplulimab combined with chemotherapy regimens for the first-line treatment of extensive-stage small-cell lung cancer[J]. China Pharm，2023，34（11）：1368-1373.

WU Q J，LIAO W T，ZHANG M X，et al. Cost-effectiveness of tucatinib in human epidermal growth factor receptor 2-positive metastatic breast cancer from the US and Chinese perspectives[J]. Front Oncol，2020，10：1336.

ZHANG B N，LONG E F. Cost-effectiveness analysis of palbociclib or ribociclib in the treatment of advanced hormone receptor-positive，HER2-negative breast cancer[J]. Breast Cancer Res Treat，2019，175（3）：775-779.

LANG Y T，CHAI Q Q，TAO W Q，et al. Cost-effectiveness of sacituzumab govitecan versus chemotherapy in advanced or metastatic triple-negative breast cancer[J]. Breast，2023，68：173-180.

ZHU Y W，LIU K，WANG M，et al. Trastuzumab deruxtecan versus trastuzumab emtansine for patients with human epidermal growth factor receptor 2-positive metastatic breast cancer：a cost-effectiveness analysis[J]. Breast，2022，66：191-198.

HURWITZ J，HAGGSTROM L R，LIM E. Antibody-drug conjugates：ushering in a new era of cancer therapy[J]. Pharmaceutics，2023，15（8）：2017.

ZHU Y W，LIU K，ZHU X L，et al. Trastuzumab deruxtecan versus chemotherapy for patients with HER2-low advanced breast cancer：a US-based cost-effectiveness analysis[J]. Front Pharmacol，2022，13：1025243.

ZHAN M，HUANG Z J，XU T，et al. Cost-effectiveness analysis of trastuzumab deruxtecan in patients with HER2-low advanced breast cancer based on DESTINY-Breast04[J]. Front Public Health，2023，11：1049947.

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