School of Public Health, Peking University Health Science Center, Beijing, China.
Public Policy Research Center, Peking University, Beijing, China.
BMJ Open. 2023 Jul 5;13(7):e064199. doi: 10.1136/bmjopen-2022-064199.
In December 2018, China launched national volume-based procurement (NVBP) to negotiate drug prices with manufacturers. Gefitinib was one of the 25 pilot drugs, which is used for treatment of non-small cell lung cancer. Lung cancer is the most common type of cancer in China and targeted drugs like gefitinib have been proven to provide clinical benefits to patients. This study aims to explore the impact of NVBP policy on the usage and expenditure of anticancer drugs.
Gefitinib and alternative drugs (icotinib and erlotinib) were used as objects of study. Quarterly data from the China Hospital Pharmaceutical Audit database in 9454 hospitals in China were used for analysis. Descriptive analysis was conducted using purchase volume and expenditure as variables. Interrupted time-series (ITS) analysis was applied to further analyse the effect of NVBP policy on the medicines under study.
During the 12-month period before (2018Q2-2019Q1) and after (2019Q2-2020Q1) the NVBP policy, the total purchase volume of medicines rose from 4.48 million defined daily dose (DDD) to 7.02 million DDD, with an increase of 56.66%. Purchase volume of gefitinib and alternative drugs increased 100.61% and 14.88%, respectively. After the implementation of NVBP policy, procurement volume of alternative drugs decreased by 72 051 DDD (p value=0.044) and trend change decreased by 56 738 DDD (p value<0.01). The overall expenditure reduction was 14.7%, with the expenditure of gefitinib reducing by 38.47% and alternative drugs increasing by 10.70%. ITS analysis indicated statistically significant differences in level and trend changes for expenditure of total drugs and gefitinib.
The evidence provided in this study indicated that the implementation of NVBP policy was related to the expenditure reduction of the first generation of anti-EGFR lung cancer drugs. The policy effectively controlled the increase in expenditures for corresponding drugs while ensuring the use of drugs.
2018 年 12 月,中国启动了以药品用量为基准的国家集中采购(NVBP),与药品生产企业进行药品价格谈判。吉非替尼是 25 种试点药物之一,用于治疗非小细胞肺癌。肺癌是中国最常见的癌症类型,已证明靶向药物如吉非替尼能为患者带来临床获益。本研究旨在探讨 NVBP 政策对癌症药物使用和支出的影响。
以吉非替尼和替代药物(厄洛替尼和埃克替尼)为研究对象。使用中国医院药品采购审计数据库中来自中国 9454 家医院的季度数据进行分析。以购买量和支出为变量进行描述性分析。采用中断时间序列(ITS)分析进一步分析 NVBP 政策对研究药物的影响。
在 NVBP 政策实施前(2018 年第 2 季度至 2019 年第 1 季度)和实施后(2019 年第 2 季度至 2020 年第 1 季度)的 12 个月期间,药物总购买量从 448 万用药日剂量(DDD)增加到 702 万 DDD,增加了 56.66%。吉非替尼和替代药物的购买量分别增长了 100.61%和 14.88%。NVBP 政策实施后,替代药物的采购量减少了 72051DDD(p 值=0.044),趋势变化减少了 56738DDD(p 值<0.01)。总支出减少了 14.7%,吉非替尼支出减少了 38.47%,替代药物支出增加了 10.70%。ITS 分析表明,药物总支出和吉非替尼的支出水平和趋势变化存在统计学差异。
本研究提供的证据表明,NVBP 政策的实施与第一代抗 EGFR 肺癌药物支出的减少有关。该政策在确保药物使用的同时,有效控制了相关药物支出的增长。