Factors associated with the adoption of targeted therapy for human epidermal growth factor receptor 2 (HER 2) positive breast cancer_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Xin ¹ , WU Qiyou ¹ , LIAN Zhiwei ² ,  SUN Jing ¹ , WU Fan ² , ZHANG Gong ² , LIU Jian ² , CHEN Chuanben ²

1. School of Health Policy and Management, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100005, P. R. China;
2. Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou 350014, P. R. China;

Corresponding author：

SUN Jing, Email: sunjing@sph.pumc.edu.cn

Keywords：

Breast cancer; Human epidermal growth factor receptor 2; Targeted therapy; Influencing factor; Logistic regression

DOI：

10.7507/1672-2531.202208115

Video：

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Objective To analyze the factors associated with the adoption of targeted therapy in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer and to generate evidence to inform decision-making on public security policy regarding innovative anticancer medicines for the benefit of patients. Methods The study population comprised female patients diagnosed with HER2-positive breast cancer and treated at Fujian Cancer Hospital from 2014 to 2020. The patients were eligible for targeted therapy. The demographic and sociological characteristics and clinical information of patients were extracted from the hospital information system. We performed binary logistic regression analysis of factors associated with the adoption of targeted therapy in patients with HER2-positive breast cancer. We also divided the participants into two groups according to their tumor stage for subgroup analysis. Results A total of 1 041 female patients with HER2-positive breast cancer were included, among them, 803 received targeted therapy. In September 2017, molecular-targeted medicines for HER2-positive breast cancer began to be included in the local basic health insurance program. Only 282 (35.1%) patients adopted targeted therapy before September 2017, after which this number increased to 521 (64.9%). Among the patients who adopted targeted therapy, most were formally employed (45.8%) and enrollees of the urban employee health insurance program (66.0%). Among those who did not adopt targeted therapy, most were unemployed (42.4%) and enrollees of the resident health insurance program (50.0%). Binary logistic regression analysis revealed that patient occupation, gene expression of estrogen receptor, tumor stage, surgery or not, radiotherapy or not, and undergoing treatment before or after September 2017 were correlated with the adoption of targeted therapy (P<0.05). Conclusions Inclusion of targeted medicines for HER2-positive breast cancer in the health insurance program substantially increased the overall administration of these therapies. Individual affordability is a critical factor associated with the application of targeted therapy in eligible patients. Future policies should enhance the public security of patients with a relatively weak ability to pay and provide insurance coverage for innovative anti-cancer medicines.

Citation： WANG Xin, WU Qiyou, LIAN Zhiwei, SUN Jing, WU Fan, ZHANG Gong, LIU Jian, CHEN Chuanben. Factors associated with the adoption of targeted therapy for human epidermal growth factor receptor 2 (HER 2) positive breast cancer. Chinese Journal of Evidence-Based Medicine, 2023, 23(1): 7-13. doi: 10.7507/1672-2531.202208115 Copy

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2.	Siegel RL, Miller KD, Fuchs HE, et al. Cancer statistics, 2021. CA Cancer J Clin, 2021, 71(1): 7-33.
3.	Allemani C, Matsuda T, Di Carlo V, et al. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet, 2018, 391(10125): 1023-1075.
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7.	中华人民共和国人力资源和社会保障部. 人力资源社会保障部关于将36种药品纳入国家基本医疗保险、工伤保险和生育保险药品目录乙类范围的通知(人社部发〔2017〕54号). Available at: http://www.mohrss.gov.cn/SYrlzyhshbzb/shehuibaozhang/zcwj/201707/t20170718_274153.html.
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25.	Sruamsiri R, Wagner AK, Ross-Degnan D, et al. Expanding access to high-cost medicines through the E2 access program in Thailand: effects on utilisation, health outcomes and cost using an interrupted time-series analysis. BMJ Open, 2016, 6(3): e008671.
26.	Moye-Holz D, van Dijk JP, Reijneveld SA, et al. The impact of price negotiations on public procurement prices and access to 8 innovative cancer medicines in a middle-income country: the case of Mexico. Value Health Reg Issues, 2019, 20: 129-135.
27.	Sruamsiri R, Ross-Degnan D, Lu CY, et al. Policies and programs to facilitate access to targeted cancer therapies in Thailand. PLoS One, 2015, 10(3): e0119945.
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33.	Fwelo P, Yusuf ZI, Adjei A, et al. Racial and ethnic disparities in the refusal of surgical treatment in women 40 years and older with breast cancer in the USA between 2010 and 2017. Breast Cancer Res Treat, 2022, 194(3): 643-661.
34.	Diao Y, Lin M, Xu K, et al. Impact of public health insurance coverage of novel anticancer medication on medical expenditure and patient affordability in a provincial medical centre of China: a propensity score-matching analysis with the quasi-experimental design. BMJ Open, 2022, 12(2): e054713.
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39.	杨爽, 王艳, 徐伟, 等. 江苏省常州市特药保障政策实施成效评估研究: 以HER-2阳性乳腺癌为例. 中国卫生经济, 2017, 36(3): 43-45.
40.	罗仁夏, 吴彬. 福建省本级参保人员恶性肿瘤患病及医疗费用分析. 中国肿瘤, 2006, 15(6): 372-374.
41.	陈治水, 冷家骅, 高广颖, 等. 靶向药物纳入医保报销对医疗机构的影响评估: 以北京大学肿瘤医院为例. 中国卫生经济, 2018, 37(10): 30-34.
42.	夏云, 潘毅, 钱欣月, 等. 曲妥珠单抗纳入上海医保药品目录对乳腺癌患者靶向治疗的影响因素分析. 中国新药与临床杂志, 2021, 40(12): 826-829.
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1. Zeng H, Chen W, Zheng R, et al. Changing cancer survival in China during 2003-15: a pooled analysis of 17 population-based cancer registries. Lancet Glob Health, 2018, 6(5): e555-e567.
2. Siegel RL, Miller KD, Fuchs HE, et al. Cancer statistics, 2021. CA Cancer J Clin, 2021, 71(1): 7-33.
3. Allemani C, Matsuda T, Di Carlo V, et al. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet, 2018, 391(10125): 1023-1075.
4. Cao W, Chen HD, Yu YW, et al. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl), 2021, 134(7): 783-791.
5. 中国共产党中央委员会, 中华人民共和国国务院. “健康中国2030”规划纲要. Available at: http://www.gov.cn/zhengce/2016-10/25/content_5124174.htm.
6. 中华人民共和国政府. 国家卫生计生委办公厅关于公布国家药品价格谈判结果的通知(国卫办药政函〔2016〕515号). Available at: http://www.gov.cn/xinwen/2016-05/20/content_5075027.htm.
7. 中华人民共和国人力资源和社会保障部. 人力资源社会保障部关于将36种药品纳入国家基本医疗保险、工伤保险和生育保险药品目录乙类范围的通知(人社部发〔2017〕54号). Available at: http://www.mohrss.gov.cn/SYrlzyhshbzb/shehuibaozhang/zcwj/201707/t20170718_274153.html.
8. 国家医疗保障局. 国家医疗保障局关于将17种抗癌药纳入国家基本医疗保险、工伤保险和生育保险药品目录乙类范围的通知(医保发〔2018〕17号). Available at: http://www.nhsa.gov.cn/art/2018/10/10/art_37_1057.html.
9. 国家医疗保障局, 中华人民共和国人力资源和社会保障部. 国家医保局人力资源社会保障部关于将2019年谈判药品纳入《国家基本医疗保险、工伤保险和生育保险药品目录》乙类范围的通知(医保发〔2019〕65号). Available at: http://www.nhsa.gov.cn/art/2019/11/28/art_37_2050.html.
10. 国家医疗保障局, 中华人民共和国人力资源和社会保障部. 国家医保局人力资源社会保障部关于印发《国家基本医疗保险, 工伤保险和生育保险药品目录(2020年)》的通知(医保发〔2020〕53号). Available at: http://www.nhsa.gov.cn/art/2020/12/28/art_37_4220.html.
11. 国家医疗保障局, 中华人民共和国人力资源和社会保障部. 国家医保局人力资源社会保障部关于印发《国家基本医疗保险, 工伤保险和生育保险药品目录(2021年)》的通知(医保发〔2021〕50号). Available at: http://www.nhsa.gov.cn/art/2021/12/3/art_37_7429.html.
12. Harbeck N, Gnant M. Breast cancer. Lancet, 2017, 389(10074): 1134-1150.
13. Dean-Colomb W, Esteva FJ. Her2-positive breast cancer: herceptin and beyond. Eur J Cancer, 2008, 44(18): 2806-2812.
14. 张佩雯, 张辉, 李明爽, 等. 人表皮生长因子受体2阳性乳腺癌患者治疗后生存质量及影响因素研究. 中国循证医学杂志, 2021, 21(5): 532-538.
15. Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol, 2012, 13(1): 25-32.
16. Uriarte-Pinto M, Escolano-Pueyo Á, Gimeno-Ballester V, et al. Trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel in the neoadjuvant setting of HER-2 positive breast cancer. Int J Clin Pharm, 2016, 38(2): 446-453.
17. 武正炎. NCCN乳腺癌临床实践指南(2006版)简介. 实用临床医药杂志, 2006, 10(3): 34-35.
18. 许凤锐. 乳腺癌NCCN指南中国历程: 2006-2016. 第19届全国临床肿瘤学大会暨2016年CSCO学术年会论文集, 2016.
19. 中国抗癌协会乳腺癌专业委员会. 中国抗癌协会乳腺癌诊治指南与规范(2021年版). 中国癌症杂志, 2021, 31(10): 954-1040.
20. Li J, Wang S, Wang Y, et al. Disparities of trastuzumab use in resource-limited or resource-abundant regions and its survival benefit on HER2 positive breast cancer: a real-world study from China. Oncologist, 2017, 22(11): 1333-1338.
21. 张文婷, 桂玲, 刘东. 2009~2011年武汉地区抗肿瘤分子靶向治疗药物应用分析. 药物流行病学杂志, 2013, 22(1): 32-34.
22. 方欣, 田梦媛, 张欲晓, 等. 药品不同准入价格对医保基金及个人可负担性的影响——以部分抗肿瘤靶向药物为例. 中国卫生政策研究, 2016, 9(11): 40-44.
23. 国家医疗保障局. 国家医疗保障局对十三届全国人大二次会议第6795号建议的答复(医保函〔2019〕72号). Available at: http://www.nhsa.gov.cn/art/2019/8/14/art_110_6689.html.
24. 王煜昊, 徐伟, 路娜娜, 等. "4+7"集中带量采购实施效果分析—基于9试点地区药品销售数据. 中国卫生政策研究, 2021, 14(2): 36-43.
25. Sruamsiri R, Wagner AK, Ross-Degnan D, et al. Expanding access to high-cost medicines through the E2 access program in Thailand: effects on utilisation, health outcomes and cost using an interrupted time-series analysis. BMJ Open, 2016, 6(3): e008671.
26. Moye-Holz D, van Dijk JP, Reijneveld SA, et al. The impact of price negotiations on public procurement prices and access to 8 innovative cancer medicines in a middle-income country: the case of Mexico. Value Health Reg Issues, 2019, 20: 129-135.
27. Sruamsiri R, Ross-Degnan D, Lu CY, et al. Policies and programs to facilitate access to targeted cancer therapies in Thailand. PLoS One, 2015, 10(3): e0119945.
28. Moye-Holz D, Soria Saucedo R, van Dijk JP, et al. Access to innovative cancer medicines in a middle-income country - the case of Mexico. J Pharm Policy Pract, 2018, 11: 25.
29. Bazargani YT, de Boer A, Schellens JH, et al. Selection of oncology medicines in low- and middle-income countries. Ann Oncol, 2014, 25(1): 270-276.
30. Exarchakou A, Rachet B, Belot A, et al. Impact of national cancer policies on cancer survival trends and socioeconomic inequalities in England, 1996-2013: population based study. BMJ, 2018, 360: k764.
31. Kumachev A, Trudeau ME, Chan KK. Associations among socioeconomic status, patterns of care and outcomes in breast cancer patients in a universal health care system: Ontario's experience. Cancer, 2016, 122(6): 893-898.
32. Doshi JA, Li P, Huo H, et al. Association of patient out-of-pocket costs with prescription abandonment and delay in fills of novel oral anticancer agents. J Clin Oncol, 2018, 36(5): 476-482.
33. Fwelo P, Yusuf ZI, Adjei A, et al. Racial and ethnic disparities in the refusal of surgical treatment in women 40 years and older with breast cancer in the USA between 2010 and 2017. Breast Cancer Res Treat, 2022, 194(3): 643-661.
34. Diao Y, Lin M, Xu K, et al. Impact of public health insurance coverage of novel anticancer medication on medical expenditure and patient affordability in a provincial medical centre of China: a propensity score-matching analysis with the quasi-experimental design. BMJ Open, 2022, 12(2): e054713.
35. Diao Y, Lin M, Xu K, et al. How government health insurance coverage of novel anti-cancer medicines benefited patients in China - a retrospective analysis of hospital clinical data. BMC Health Serv Res, 2021, 21(1): 856.
36. 李明爽, 刁一凡, 叶建春, 等. 国家谈判靶向抗乳腺癌药物纳入基本医疗保险政策患者惠及研究. 药物流行病学杂志, 2021, 30(6): 398-403,428.
37. Li M, Diao Y, Ye J, et al. The public health insurance coverage of novel targeted anticancer medicines in China-in favor of whom. A retrospective analysis of the insurance claim data. Front Pharmacol, 2021, 12: 778940.
38. 罗格莲, 林瑾文, 林永顺, 等. 福建省乳腺癌靶向药物治疗现状及其治疗费用分析. 药学研究, 2016, 35(11): 673-676.
39. 杨爽, 王艳, 徐伟, 等. 江苏省常州市特药保障政策实施成效评估研究: 以HER-2阳性乳腺癌为例. 中国卫生经济, 2017, 36(3): 43-45.
40. 罗仁夏, 吴彬. 福建省本级参保人员恶性肿瘤患病及医疗费用分析. 中国肿瘤, 2006, 15(6): 372-374.
41. 陈治水, 冷家骅, 高广颖, 等. 靶向药物纳入医保报销对医疗机构的影响评估: 以北京大学肿瘤医院为例. 中国卫生经济, 2018, 37(10): 30-34.
42. 夏云, 潘毅, 钱欣月, 等. 曲妥珠单抗纳入上海医保药品目录对乳腺癌患者靶向治疗的影响因素分析. 中国新药与临床杂志, 2021, 40(12): 826-829.
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