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Abstract：
BACKGROUND: National Volume-Based Procurement (NVBP) program has been carried out in China to lower drug prices and reduce patients\' medication burden. This study aims to evaluate its impact on drug purchasing in Tianjin city, one of the first 11 cities piloting NVBP in China.
METHODS: Using monthly drug procurement data from Tianjin Medical Purchasing Center between 2018 and 2020, this study identified bid-winning drugs and their alternative drugs in the pilot NVBP, and evaluated the policy impacts on their procurement price (cost of defined daily dose, DDDc), volume (the number of defined daily dose, DDDs), and expenditure, during the first (initiated at April 1, 2019) and second (initiated at April 25, 2020) procurement cycles of pilot NVBP, applying interrupted time series (ITS) analysis. Included drugs were classified into 12 pharmacological subgroups for further analysis.
RESULTS: Decrease in DDDc of NVBP-covered drugs (bid-winning and non-winning drugs) were observed in the first (level change: -CNY 3.878/DDD, P<.001; trend change: -CNY 0.068/DDD, P=.001; relative change: -61.55%) and second (level change: -CNY 0.356/DDD, P=.049) procurement cycles of pilot NVBP, while no significant change was observed for the DDDc of alternative drugs, except for the increase in antidiarrheic and anti-inflammatory/antirheumatic subgroups as more expensive drugs were purchased from new suppliers in the second procurement cycle. The DDDs of bid-winning drugs significantly increased, while decreased for the non-winning original and generic drugs. Procurement expenditure was saved for NVBP-covered drugs (level change: -CNY 7.29×107, P<.001; trend change: -CNY 5.62×106, P<.001; relative change: -62.60%). However, during the second procurement cycle, procurement volume and expenditure of alternative drugs increased significantly in 7 out of 12 subgroups.
CONCLUSIONS: The pilot NVBP policy in China reduced procurement price, promoted generic substitution, and saved procurement expenditure. However, the increase in procurement price, volume and expenditure of alternative drugs may reveal the significance of regulating healthcare institutions\' drug purchasing behavior.
METHODS: Using monthly drug procurement data from Tianjin Medical Purchasing Center between 2018 and 2020, this study identified bid-winning drugs and their alternative drugs in the pilot NVBP, and evaluated the policy impacts on their procurement price (cost of defined daily dose, DDDc), volume (the number of defined daily dose, DDDs), and expenditure, during the first (initiated at April 1, 2019) and second (initiated at April 25, 2020) procurement cycles of pilot NVBP, applying interrupted time series (ITS) analysis. Included drugs were classified into 12 pharmacological subgroups for further analysis.
RESULTS: Decrease in DDDc of NVBP-covered drugs (bid-winning and non-winning drugs) were observed in the first (level change: -CNY 3.878/DDD, P<.001; trend change: -CNY 0.068/DDD, P=.001; relative change: -61.55%) and second (level change: -CNY 0.356/DDD, P=.049) procurement cycles of pilot NVBP, while no significant change was observed for the DDDc of alternative drugs, except for the increase in antidiarrheic and anti-inflammatory/antirheumatic subgroups as more expensive drugs were purchased from new suppliers in the second procurement cycle. The DDDs of bid-winning drugs significantly increased, while decreased for the non-winning original and generic drugs. Procurement expenditure was saved for NVBP-covered drugs (level change: -CNY 7.29×107, P<.001; trend change: -CNY 5.62×106, P<.001; relative change: -62.60%). However, during the second procurement cycle, procurement volume and expenditure of alternative drugs increased significantly in 7 out of 12 subgroups.
CONCLUSIONS: The pilot NVBP policy in China reduced procurement price, promoted generic substitution, and saved procurement expenditure. However, the increase in procurement price, volume and expenditure of alternative drugs may reveal the significance of regulating healthcare institutions\' drug purchasing behavior.
摘要：
背景：为了降低药品价格和减轻患者用药负担，中国已经实施了国家批量采购（NVBP）计划。本研究旨在评估其对天津市药品采购的影响，中国首批11个试点NVBP的城市之一。
方法：使用2018年至2020年天津市医药采购中心的月度药品采购数据，本研究确定了试点NVBP中的中标药品及其替代药品，并评估了政策对其采购价格的影响(定义的每日剂量成本，DDDc),体积(定义的每日剂量数量，DDDs),和支出，在试点NVBP的第一个(于2019年4月1日启动)和第二个(于2020年4月25日启动)采购周期期间，应用中断时间序列(ITS)分析。将包括的药物分为12个药理学亚组用于进一步分析。
结果：第一次观察到NVBP覆盖药物（中标和非中标药物）的DDDc下降（水平变化：-CNY3.878/DDD，P<.001；趋势变化：-0.068元/DDD，P=.001；相对变化：-61.55%）和第二（水平变化：-CNY0.356/DDD，P=.049)试点NVBP的采购周期，虽然替代药物的DDDc没有观察到显著变化，除了止泻药和抗炎/抗风湿亚组的增加,因为在第二个采购周期从新供应商处购买了更昂贵的药物.中标药品的DDDs明显增加,而非获奖原研药和仿制药有所下降。NVBP覆盖药品节省采购支出（水平变化：-7.29×107元，P<.001；趋势变化：-5.62×106元，P<.001；相对变化：-62.60%）。然而,在第二个采购周期中，12个亚组中有7个替代药物的采购量和支出显着增加。
结论：在中国试点的NVBP政策降低了采购价格，促进的通用替换，并节约了采购支出。然而,采购价格的上涨，替代药物的数量和支出可能揭示规范医疗机构药品购买行为的重要性。
方法：使用2018年至2020年天津市医药采购中心的月度药品采购数据，本研究确定了试点NVBP中的中标药品及其替代药品，并评估了政策对其采购价格的影响(定义的每日剂量成本，DDDc),体积(定义的每日剂量数量，DDDs),和支出，在试点NVBP的第一个(于2019年4月1日启动)和第二个(于2020年4月25日启动)采购周期期间，应用中断时间序列(ITS)分析。将包括的药物分为12个药理学亚组用于进一步分析。
结果：第一次观察到NVBP覆盖药物（中标和非中标药物）的DDDc下降（水平变化：-CNY3.878/DDD，P<.001；趋势变化：-0.068元/DDD，P=.001；相对变化：-61.55%）和第二（水平变化：-CNY0.356/DDD，P=.049)试点NVBP的采购周期，虽然替代药物的DDDc没有观察到显著变化，除了止泻药和抗炎/抗风湿亚组的增加,因为在第二个采购周期从新供应商处购买了更昂贵的药物.中标药品的DDDs明显增加,而非获奖原研药和仿制药有所下降。NVBP覆盖药品节省采购支出（水平变化：-7.29×107元，P<.001；趋势变化：-5.62×106元，P<.001；相对变化：-62.60%）。然而,在第二个采购周期中，12个亚组中有7个替代药物的采购量和支出显着增加。
结论：在中国试点的NVBP政策降低了采购价格，促进的通用替换，并节约了采购支出。然而,采购价格的上涨，替代药物的数量和支出可能揭示规范医疗机构药品购买行为的重要性。
