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Abstract：
Background: The Pilot Plan of National Centralized Volume-Based Procurement (NCVBP) was adopted to cope with the rapid increase in drug expenditures. This research aimed to quantitatively evaluate the impact of the NCVBP on antiviral medications for the hepatitis B virus. Methods: Data on nucleoside analogs (NAs) medications of hepatitis B virus monthly procurement records in the pilot cities from January 2018 to December 2019 were extracted from the China Drug Supply Information Platform (CDSIP). The impacts of the NCVBP on purchased volumes, expenditures, and pre-defined daily dose costs were evaluated by interrupted time-series (ITS) analysis using Stata 16.0. We constructed two segments with one interruptive point (March 2019). Results: Compared to the same period between pre-and post-intervention, the purchased volume of NAs medications were increased by 92.85%, and selected medications were increased by 119.09%. Analysis of changes in the level of NAs medication followed a decrease in purchased expenditure (coefficient: 5364.88, p < 0.001), meanwhile, the purchased volume was increased with statistical significance (coefficient:605.49, p < 0.001). The Defined Daily Dose cost (DDDc) of NAs medication followed a decrease (coefficient: 8.90, p < 0.001). The NCVBP reform was followed by an increase of 618.41 ten thousand Defined Daily Dose (DDD) (p < 0.001) in purchased volume and a reduction of 5273.84 ten thousand Chinese Yuan (CNY) (p < 0.001) in the purchased expenditure of selected medications in the level. The DDDc of selected medications decreased in the level (coefficient: 9.87, p < 0.001), while the DDDc of alternative medications increased in the slope (coefficient:0.07, p = 0.030). The purchased volume and expenditure of bid-winning products increased by 964.08 ten thousand DDD and 637.36 ten thousand CNY in the level (p < 0.001). An increase of 633.46 ten thousand DDD (p < 0.001) in purchased volume and a reduction of 4285.32 ten thousand CNY (p < 0.001) in the purchased expenditure of generic drugs in the level was observed. Conclusion: The NCVBP reduced the DDDc of NAs medication, improved the utilization of the selected medications, and promoted the usage of generic products.
摘要：
背景：采用了国家集中批量采购（NCVBP）试点计划，以应对药品支出的快速增长。本研究旨在定量评估NCVBP对乙型肝炎病毒抗病毒药物的影响。方法:从中国药品供应信息平台(CDSIP)提取2018年1月至2019年12月各试点城市乙型肝炎病毒核苷类似物(NAs)药品月度采购记录数据。NCVBP对购买量的影响，支出,使用Stata16.0通过中断时间序列（ITS）分析评估预定义的日剂量成本。我们构建了两个具有一个中断点的部分（2019年3月）。结果：与干预前和干预后的同期相比，NAs药物的购买量增加了92.85%，和选定的药物增加了119.09%。对NAs药物水平变化的分析跟随购买支出的减少（系数：5364.88，p<0.001），同时,购买量增加有统计学意义(系数:605.49,p<0.001)。NAs药物的定义每日剂量成本（DDDc）随后下降（系数：8.90，p<0.001）。NCVBP改革后，购买量增加了618.41万定义每日剂量（DDD）（p<0.001），购买量减少了5273.84万元人民币（CNY）（p<0.001）。该水平的选定药物。所选药物的DDDc水平下降（系数：9.87，p<0.001），而替代药物的DDDc斜率增加（系数：0.07，p=0.030）。中标产品的采购量和支出增加了964.08万DDD和637.36万CNY（p<0.001）。观察到购买量增加633.46万DDD（p<0.001），购买水平的仿制药支出减少4285.32万元人民币（p<0.001）。结论:NCVBP降低了NAs用药的DDDc,改善了所选药物的利用率，并推广了通用产品的使用。
