Impact of National Centralized Drug Procurement Policy on Antiviral Utilization and Expenditure for Hepatitis B in China

Background and Aims:The National Centralized Drug Procurement(NCDP)policy was launched in China's Mainland in April 2019,with entecavir(ETV)and tenofovir disoproxil fumarate(TDF)being included in the procurement list.We conducted the current study to investigate the impact of the NCDP policy on the utilization and expenditures of antiviral therapy for chronic hepatitis B(CHB)in China.Methods:Procurement records,including monthly purchase volume,expenditure,and price of nucleos(t)ide analogs(NAs),were derived from the National Healthcare Security Administration from April 2018 to March 2021.The changes in volumes and expenditures of the first-line NAs and bid-winning products were calculated.The effects of price,volume,and structure related to drug expenditure were calculated by the Addis and Magrini(AM)Index System Analysis.Results:The purchase volume of NAs significantly increased from 134.3 to 318.3 million DDDs,whereas the expenditure sharply decreased from 1,623.41 to 490.43 million renminbi(RMB)or 241.94 to 73.09 million US dollars(USD).The proportions of firstline NAs rose from 72.51%(ETV:69.00%,TDF:3.51%)to 94.97%(ETV:77.42%,TDF:17.55%).AM analysis showed that the NCDP policy decreased the expenditure of all NAs(S=0.91)but increased that of the first-line NAs in the bidwinning list(S=1.13).Assuming the population size of CHB patients remains stable and a compliance rate of≥75%,the proportion of CHB patients receiving first-line antiviral therapy would increase from 6.36–8.48%to 11.56–15.41%.Conclusions:The implementation of the NCDP policy significantly increased the utilization of first-line NAs for CHB patients at a lower expenditure.The findings provided evidence for optimizing antiviral therapy strategy and allocating medical resources in China.

Effects of drug procurement under cap price policy in Sanming

To study the effects of drug procurement under cap price policy (DPUCP)in Sanming,changes in drug category,price, availability and corporate structure were analyzed using purchasing data of the 7th and 8th centralized drug procurement in Fujian Province and the 1st drug procurement under cap price in Sanming,and a field investigation was conducted.(1)The amounts of bid-winning drugs and pharmaceutical makers decreased sharply,leading to optimization of drug category and supplier structure. (2)The procurement could meet clinical demands,though a small percentage of drugs were out of stock.(3)Drug prices fell in general,with 10%decline in domestic drugs with a unit package price over RMB 5yuan,a slight price reduction in imported drugs,and some price increase in cheap domestic drugs with a unit package price under RMB 3yuan.DPUCP policy in Sanming optimized procurement drug category and supplier structure,reduced price,and improved industrial structure.However,problems still existed,such as shortage of some drugs and little price reduction in imported and brand-name drugs.

Strategic Research on Pharmaceutical Enterprises’ Participation in National Drug Centralized Procurement

Objective To study the influence of national drug centralized procurement policy on pharmaceutical enterprises manufacturing generic drugs and original drugs,so as to provide a reference for them to make different strategic choices.Methods Through the literature research on the related policies and the bidding data,the national drug centralized policies were studied systematically.Combined with the bid-winning price and price reduction range of the winning enterprises in the three rounds of centralized procurement,their difficulties,strategic choices and the winning factors were investigated.Besides,a model was established to clarify the optimal price of enterprises in the process of drug procurement.Results and Conclusion The strategic choices of enterprises in participating national drug centralized procurement are influenced by many factors such as the market share of the original varieties,active pharmaceutical ingredients(APIs)and cost.Therefore,corresponding strategies should be formulated according to the characteristics and interests of enterprises.

药品集中带量采购对糖尿病患者住院费用的影响

目的评价药品集中带量采购对糖尿病患者住院总费用及各类构成费用的影响。方法基于研究医院的9852份糖尿病患者病案首页数据,整理患者基本信息、医疗服务利用信息及各项医疗费用信息,综合运用普通最小二乘法(ordinary least square,OLS)和倾向性得分匹配法(propensity score matching,PSM)进行数据分析。结果集中带量采购政策确实能够降低糖尿病住院患者的药品费用(t=-2.27,P<0.05),但是对住院总费用、医疗服务性费用影响不显著。OLS回归低估了药品集中带量采购对患者检查化验耗材费用的增费效应(t=2.26,P<0.05)。结论在进一步加强宣传教育的同时,要有序扩大药品集中带量采购,系统推动医药领域集约式改革,持续放大改革红利,实现患者总体医疗负担减轻,让政策福利遍及更多患者。

常州市各级医院带量采购政策实施效果差异研究

目的评价第二批国家集中带量采购(以下简称“集采”)政策在常州市不同等级医院的实施效果。方法基于双组间断时间序列模型和描述性统计,依托江苏省常州市医疗机构药品采购数据,分析第二批国家集采政策实施对江苏省常州市二级及以上医院和基层医疗卫生机构用药影响差异。结果第二批国家集采政策实施后,常州市二级及以上医院和基层医疗卫生机构集采品种均呈现不同程度药品使用频度(defined drug dose numbers,DDDs)上升、采购金额下降和药品日均费用(defined daily dose cost,DDDc)下降的现象,其中对于基层医疗卫生机构集采中选品种使用增长效果更明显,在具体药物种类上,心血管系统类、消化系统类药物受政策影响更明显。结论政府应该根据不同医院的用药特点制定更为灵活、有针对性的集采品种使用考核标准,并将考核细化到不同种类药品的使用情况。此外,政府相关部门应持续性检测各级医院的合理用药情况,并通过奖惩制度提高医疗机构使用集采品种的积极性。

Policy Comparison between Shenzhen GPO and Guangdong Medicine Exchange Center

Objective To put forward some suggestions for improving the procurement policy of Shenzhen Pharmaceutical Group.Methods The literature research and comparative research were used to compare the policies between Guangdong’s centralized drug procurement and Shenzhen Pharmaceutical Group’s procurement so as to analyze their advantages and disadvantages.Results and Conclusion The purchasing model of Shenzhen group purchasing organization(GPO)can ensure the timely supply of medicines.Besides,the cross-regional alliance system helps to achieve a true price-for-quantity exchange,and a market-based price linkage mechanism can effectively reduce drug prices.However,the online drug catalogue of Shenzhen GPO cannot fully cover the actual needs of hospitals for procurement.The market-based price linkage may lead to problems of drug quality or shortage of drugs.Therefore,the number of batches of drugs should be increased online appropriately.Meanwhile,a mechanism must be established to guarantee the supply and quality of low-priced drugs.

我国非国家组织药品集中采购模式比较

目的比较分析我国各省市的药品集中采购方案及相关政策,探讨各地非国家组织药品集中采购模式的特点。方法围绕采购内容、采购规则等比较分析各地的非国家组织药品集中采购模式的特点,以及采购内容、采购环境、采购规则之间的内在关系。结果我国目前的非国家组织药品集中采购模式可划分为药品集中采购组织(group purchasing organization,GPO)、非过评仿制药带量采购、专项药品带量采购、带量议价以及分类采购框架下的带量采购5种。我国非国家组织药品集中采购的特点是分品种、分批次,以政府主导为主,执行机构主要为医疗保障局。结论目前,各地的非国家组织药品集中采购仅覆盖了部分品种的药品,对非过评仿制药进行集中采购是未来的重要趋势,建立公平、科学的质量分组规则是非国家组织药品集中采购亟待解决的重要技术问题。

The effects of the National Drug Pooled Procurement(NDPP)pilot program in China

In 2018,the Chinese government identified four municipalities and seven sub-provincial cities for the implementation of the National Drug Pooled Procurement(NDPP)pilot program(the“4+7”policy).In the present study,we analyzed the effects of the“4+7”policy with data of 25 pilot drugs from the National Healthcare Security Administration(NHSA)from the aspects of drug price,volume,and expenditure.After the implementation of the policy,the average price of total and winning drugs was decreased by 54.47%and 73.82%,respectively,while the DDDc of non-winning drugs was decreased by only 1.54%,and the DDDc of uncertificated generic drugs was increased 83.18%.The DDDs indicating the volume of total and winning drugs was increased by 21.18%and 353.98%,respectively,and the DDDs of non-winning drugs was decreased by 61.35%.The costs of total and non-winning drugs were decreased by 44.83%and 61.94%,respectively,and the cost of winning drugs was increased by 18.87%.The“4+7”policy reduced the price and cost of pilot drugs and improved the affordability and accessibility of drugs.However,there were also problems with unexpected excessive price increases of uncertificated generic drugs and relatively high prices of non-winning products.Therefore,we highly suggested promoting the normalization and institutionalization of pooled drug procurement,enhancing the administrative capacity of local procurement platforms,and strengthening monitoring the price of non-winning,especially for the uncertificated generic drugs.