目的:探究国家药品集中带量采购政策下抗肿瘤药品的使用特征,为进一步规范可替代品种使用监测、优化药品集采政策提供建议.方法:利用2019年-2020年国家药品供应保障综合管理信息平台的药品采购数据,采用描述性统计方法分析政策实施前后抗肿瘤药品采购金额、用药频度(DDDs)与日均费用(DDDc)的变化情况.结果:政策实施后抗肿瘤集采品种的采购金额与DDDc分别下降了 31.87％和51.55％,DDDs上升了 40.61％;可替代品种的采购金额与DDDs分别上升了 49.20％与41.62％,DDDc变化不明显.从注册评价类型来看,政策实施后集采品种中的仿制药DDDs增幅高于原研药,药品费用下降明显;可替代品种中原研药的采购金额与DDDs的增长率高于仿制药.从可替代程度来看,可替代品种的采购金额、DDDs与DDDc增幅在政策实施后均高于基本可替代品种.结论:国家药品集采政策对抗肿瘤集采品种的降价省费效应显著,使用中选产品逐渐成为患者的一致选择;集采品种对可替代品种的替代效应并不明显,应采用信息化手段开展高替代程度品种的使用限额与用量监测,加快过评仿制药对高价原研药的替代使用.

目的:分析集中带量采购对公立医疗机构约定采购周期及续约期药品采购的影响,以期为政策协同提供科学依据.方法:基于两干预点间断时间序列模型,分析2018年1 月—2020年12月7个试点城市公立医疗机构药品采购量、采购金额及日均费用的变化特征.结果:集中带量采购品种中原研药、未过评仿制药试点期采购量及其占比水平变化均为下降(P＜0.05).集中带量采购品种中原研药(β2=-0.58,P= 0.043)、过评仿制药(β2=-3.18,P＜0.001)、未过评仿制药(β2= 5.83,P＜0.001)试点期日均费用水平变化均具有统计学意义.可替代品种中过评仿制药在试点期政策干预后采购量(β3= 19.69,P= 0.025)及采购量占比均呈上升趋势,但在续约期政策干预后采购量及采购量占比均呈下降趋势.抗感染药、抗肿瘤药及免疫用药试点期采购量水平变化均具有统计学意义(P＜0.05).结论:加强药品使用监测和合理用药管理,制定并完善挂网采购审核、价格监测、医保支付标准调整等相关配套措施.

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.

目的 调查内分泌科医师对胰岛素类药品临床转换替代的态度,为完善胰岛素集中带量采购方案提供依据.方法 采用问卷调查法,以南昌市三级甲等综合医院的内分泌科医师为调查对象,从代际层面、议价组层面、通用名层面和厂牌/规格层面4个维度调查内分泌医师认可的胰岛素可转换替代比例.结果 共成功发放问卷89份,占南昌市三级甲等综合医院在岗内分泌科医师(共111名)的80.2％;回收89份问卷,其中1份为无效问卷,有效率为98.9％.调查结果显示,在代际层面,93.2％的内分泌科医师会首选胰岛素类似物.在议价组层面,医师认可的组三与组四药品间相互转换替代比例的加权平均数为63.9％.在通用名、厂牌/规格层面,医师认可的各组药品间相互转换替代比例的加权平均数均在70％以上.结论 武汉市胰岛素分组办法较为合理,能实现组内胰岛素安全临床转换替代,建议取消长效人胰岛素竞价组;组内药品间可转换替代比例的加权平均数均较高,建议提高胰岛素约定采购量,并进行"量价挂钩"谈判;受访医师选用胰岛素起始治疗方案时更注重疗效、安全等因素,故胰岛素的替换要以临床疗效、用药安全为前提.

Objectives: The purpose of this study was to quantitatively evaluate the impacts of the”4 + 7” pilot policy on purchase volume, purchase expenditures, and daily cost and to find the changes in the use of SSRIs.Methods: Data was collected covering 31 months, before, during, and after the “4 + 7” pilot policy was implemented in Shenzhen. Interrupted time-series (ITS) analysis was used to examine whether there had been a significant effect with the onset of the “4 + 7” pilot policy in March 2019.Findings: The daily cost of policy-related drugs had a substantial drop of 2.93 yuan under the “4 + 7” pilot policy. The result has shown a 76.70% increase in volume and a 3.39% decrease in the expenditure on policy-related drugs. This study found that the “4 + 7” pilot policy increased the proportion of purchasing winning drugs, with an increment of 85.60 percent. After the implementation of the “4 + 7” pilot policy, policy-related drugs decreased by 443.55thousand Chinese yuan. The study indicated that volume of winning products significantly increased as shown in the regression with a level coefficient (β2) of -224.17 (p < 0.001) and trend coefficient (β3) of 15.74 (p < 0.001). The result revealed that both volume and expenditures on branded products showed a significant decrease in the regression in the post-intervention period (level coefficient of volume: β2 = -57.65, p < 0.01, trend coefficient of volume: β3 = -3.44, p < 0.01; level coefficient of expenditure: β2 = -712.98, p < 0.01, trend coefficient of expenditure: β3 = -40.10, p < 0.01).Conclusion: The volume-based procurement has successfully led to price reductions and improved the affordability of medicines, especially for those with chronic diseases. The volume-based procurement has demonstrated initial success in reshaping the composition of the Chinese pharmaceutical market in favor of generics with high quality and low prices.