表皮生长因子受体酪氨酸激酶抑制剂的消费和成本趋势：报销和国家价格谈判的影响。
Consumption and cost trends of EGFR TKIs: influences of reimbursement and national price negotiation.
机构信息
Department of Pharmacy, The First Affiliated Hospital of Nanjing Medical University, No 300 Guangzhou Road, Nanjing City, Jiangsu Province, 210029, People's Republic of China.
Department of Pharmacy, Jiangsu Medicine Information Institute, Nanjing, 210029, China.
出版信息
BMC Health Serv Res. 2022 Apr 1;22(1):431. doi: 10.1186/s12913-022-07868-9.
BACKGROUND
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) have been widely used in the treatment of EGFR mutation non-small-cell lung cancer. The Chinese government has made great efforts to improve the availability and affordability of these drugs. The aim of this study was to investigate the trends in the consumption and cost of EGFR TKIs in Nanjing, a developed city in China, and evaluate the influence of health insurance coverage and national price negotiation on drug consumption.
METHODS
Data about EGFR TKIs applications in 2010-2019 were extracted from Jiangsu Medicine Information Institute. Five types of EGFR TKIs were included. Consumption was expressed in defined daily doses (DDDs) and expenditure. The correlation between defined daily cost (DDC) and DDDs was analyzed by Pearson's correlation test.
RESULTS
The DDC, number of DDDs and expenditure of EGFR TKIs changed little from 2010 to 2015. National price negotiation was initiated as a policy and low-price generic gefitinib came into the market in 2016. Three types of EGFR TKIs moved into the coverage of the national health insurance since 2017. Hence, the DDC decreased, and the number of DDDs increased significantly year by year since 2016. The first generation TKIs always made up of comprised the majority of the total consumption. The predominantly prescribed TKIs were gefitinib and icotinib. DDC was negatively correlated with the number of DDDs. The number of DDDs increased significantly after health insurance enrollment, price negotiation and generic drug replacement.
CONCLUSION
The consumption of EGFT TKIs has increased and the DDC of EGFR TKIs has decreased since 2016. These trends may be attributed to drug reimbursement, price negotiation and generic drug replacement. Further efforts are needed to translate the high consumption of EGFR TKIs into clinical benefits.
背景
表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）已广泛用于 EGFR 突变非小细胞肺癌的治疗。中国政府为提高这些药物的可及性和可负担性做出了巨大努力。本研究旨在探讨中国发达城市南京 EGFR TKI 的使用量和费用趋势，并评估医保覆盖范围和国家价格谈判对药物使用量的影响。
方法
从江苏省医药信息研究所提取了 2010 年至 2019 年 EGFR TKI 的应用数据。纳入了 5 种 EGFR TKI。消耗量用限定日剂量（DDD）和支出表示。通过 Pearson 相关检验分析 DDC 与 DDDs 的相关性。
结果
2010 年至 2015 年，EGFR TKI 的 DDC、DDD 数和支出变化不大。2016 年，国家价格谈判作为一项政策启动，低价仿制药吉非替尼进入市场。自 2017 年以来，三种 EGFR TKI 被纳入国家医疗保险覆盖范围。因此，自 2016 年以来，DDC 下降，DDD 数逐年显著增加。第一代 TKI 一直占总消耗量的大部分。主要处方 TKI 是吉非替尼和埃克替尼。DDC 与 DDD 数呈负相关。医保参保、价格谈判和仿制药替代后，DDD 数显著增加。
结论
自 2016 年以来，EGFT TKI 的使用量增加，EGFR TKI 的 DDC 下降。这些趋势可能归因于药物报销、价格谈判和仿制药替代。需要进一步努力将 EGFR TKI 的高消耗量转化为临床获益。
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