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.

Suggestions on Foreign Pharmaceutical Enterprises Dealing with China’s Drug Centralized Procurement - Taking the First Batch of Implementation Results as an Example

Objective To analyze the impact of the first batch of centralized drug procurement on foreign pharmaceutical enterprises since the national centralized drug procurement policy has brought great impact on pharmaceutical market,and put forward some suggestions on their marketing transformation in China.Methods Firstly,the documents of the drug centralized procurement were studied,and then the sales figures before and after the implementation of the policy were retrieved from MiNET.At the same time,the relevant business adjustment information of foreign pharmaceutical enterprises was collected for analysis.Results and Conclusion The sales of related products of foreign pharmaceutical enterprises have dropped sharply,so they have stripped off these products and reduced their staff.It is suggested that foreign pharmaceutical enterprises should adjust the structure of sales team,strengthen the layout of the market in the county,and accelerate the introduction of innovative drugs to cope with centralized drug procurement.

Discussion on Drug Procurement with Target Quantity in China and Its Problem

Objective To provide reference for improving drug procurement with target quantity in China.Methods Documents on drug centralized procurement such as the “Guidance on Drug Procurement with Target Quantity for 4+7 Cities” issued by National Healthcare Security Administration in November 2018 and “Notice on the National Organization of the Pilot Program for Drug Centralized Procurement and Use of Bidding Drugs” issued by the State Council were studied to summarize the mode and result of drug procurement with target quantity.Results and Conclusion Drug procurement with target quantity led by National Healthcare Security Administration solved some problems in the previous centralized drug procurement.For instance,quantity could not determine drug price,and medical institutions didn’t pay to pharmaceutical companies on time.However,this new mode may also arouse new problems such as procurement monopoly,drug shortage,drug quality and inhibition of innovation.

Analysis of Drug Purchase and Pricing Decision under the Mode of Procurement with Target Quantity

Objective To study the reasonable pricing strategy to effectively reduce the risk of drug supply disruption.This paper studies the vertical competition between drug purchasers and pharmaceutical enterprises,and the horizontal competition between different pharmaceutical enterprises.Based on the wholesale price of drugs made by pharmaceutical enterprises,drug purchasers adopt different procurement strategies.Methods A multi-stage game model was used to analyze the collusion and competition between two drug procurement parties.Results and Conclusion(1)Enterprise B can choose the optimal game strategies according to the stability of enterprise A;(2)Two procurement parties should choose collusion when the risk of supply interruption is low;(3)Emergency dual sourcing strategy is better than single sourcing strategy;(4)The optimal procurement quantity is irrelevant to the monotonicity of the stability of enterprise A in Cournot game.Through numerical analysis,the optimal decisions of pharmaceutical enterprises and drug purchasers are obtained respectively.

Current Effect of“4+7”Drug Centralized Volume Procurement and Suggestions for Future Improvement

Objective To explore the impact of the“4+7”city drug centralized procurement policy implemented from April 1st,2019 on China’s pharmaceutical market and the differences between this pilot scheme and the first volume procurement,so as to put forward some suggestions for this policy and improve the drug price formation mechanism.Methods The characteristics of the“4+7”volume procurement policy and its improvements were summarized through literature research,and the distribution of the winning enterprises in volume procurement was shown by the chart.Then the overall situation of pharmaceutical enterprises in China was analyzed.Results and Conclusion According to the main distribution of enterprises in the alliance region,we can see that the first round of bid-winning enterprises with 25 varieties are mainly distributed in the eastern coastal cities of Jiangsu,Zhejiang,Shandong,and Guangdong,which shows a trend of developing to provinces of Sichuan,Hubei,and Hunan.With the increase of volume procurement inland cities will be included in the future.This pilot scheme of volume procurement is a reform of the entire pharmaceutical industry.It has improved the market structure and promoted the transformation and upgrading of regional medicine representatives.The most important thing is to enable the public to better enjoy the benefits brought by the low-priced drugs.However,for some pharmaceutical enterprises and drug retail industry,it is a challenge.Therefore,it is necessary to improve the policy and strengthen market supervision and management.

Analysis on the Development Strategy of China’s Pharmaceutical Enterprises under the Background of Volume Procurement

Objective To provide reference for the development strategy of China’s enterprises under the current policy background of generic drug consistency evaluation and volume procurement.Methods China’s current policies on generic drugs and market environment were analyzed and the development paths of international top pharmaceutical enterprises were studied as well.Results and Conclusion There are four transformation and upgrading paths for China’s pharmaceutical enterprises.First,they should invest more in innovation to realize the globalization of new drugs.Second,overseas patented new drugs should be introduced actively.Third,they must focus on the research and development of high-end generic drugs.Lastly,the transformation from active pharmaceutical ingredients into pharmaceutic preparation should be carried out quickly.Under the background of volume procurement,the pharmaceutical market pattern will be completely changed.The research and development capability and patented drugs will become the core competitive advantages of enterprises.

中国医保药品价格谈判回顾和展望

目的:总结2018—2023年中国医保药品价格谈判的实践经验,对未来的工作提出建议。方法:通过文献回顾、收集官方公布的数据和网络报道资料,对当前医保药品价格谈判的政策和实践进行总结分析。结果:谈判药品平均降价50%~60%,但也存在有待解决的问题。未来医保药品价格谈判工作需要更加关注价值谈判组织体系、标准和方法的建立,重视价值谈判的立法和规制,使价格谈判工作更加公正、公平和透明化。结论:我国的药品价格谈判成绩斐然,充分发挥了政府主导和市场机制的作用,通过价值谈判保障了创新药物的可得性和可及性,在新药需求无限性和医保基金有限性之间找到了平衡点。

基于德尔菲法构建集采中选药品管理敏感指标

目的:构建集采中选药品管理敏感指标。方法:通过循证初步建立集采中选药品管理敏感指标,再通过德尔菲专家函询法对30名药学人员进行2轮函询,并统计整理函询结果。结果:构建的集采中选药品管理敏感指标包括一级指标3项,二级指标11项和三级指标22项。两轮专家函询有效回收率分别为91%和100%。第二轮权威系数为0.82,总体协调系数0.434,检验具有统计学意义(P<0.01)。结论:本研究构建的集采中选药品管理敏感指标满足专家积极程度、权威程度和一致性标准等各项标准。

国家集采左氧氟沙星氯化钠注射液仿制药疗效和安全性评价

目的:比较国家集中带量采购左氧氟沙星氯化钠注射液和原研药品治疗社区获得性肺炎的临床疗效与安全性。方法:回顾性收集福建省某大型三甲医院2020年10月20日至2022年10月20日诊断为CAP并使用左氧氟沙星氯化钠注射液的患者相关临床信息,采用倾向性评分匹配法调整组间差异,比较两组的有效性和安全性。结果:倾向评分匹配后,集采组纳入患者117例,原研组纳入患者117例。两组用药第七天临床治疗有效率、白细胞、中性粒细胞百分数、C反应蛋白、降钙素原、体温、给药疗程(天)比较,无统计学差异。两组用药后肝肾功能异常比较,无统计学差异。结论:国家集中带量采购左氧氟沙星氯化钠注射液与原研药品治疗CAP的效果与安全性相当。

典型国家和地区原研药医保支付标准设计对我国的启示

目的:为国家药品集中采购政策背景下的药品医保支付标准管理提供参考。方法:对典型国家和地区的药品医保支付标准管理经验进行研究。结果:选取的典型国家和地区具有较为完备的药品医保支付标准管理体系,参考市场实际交易价格等多重因素,仿制药与原研药医保支付标准存在差异。建议:完善相关政策文件,建立科学的药品医保支付标准管理体系,通过药品市场价格交易监测机制,构建以市场为导向的医保支付标准形成机制,根据仿制药与原研药等不同药品的不同属性进行精细化分类管理;同时,在当前国家药品集中采购品种同通用名实行同一医保支付标准的政策前提下,继续推进并优化仿制药一致性评价工作,实现仿制药与原研药临床疗效一致,以符合当前仿制药与原研药实行同一医保支付标准的政策导向。

广西医疗机构落实国家药品集中带量采购政策的效果分析

目的探讨国家药品集中带量采购政策(后文简称“国家集采政策”)在广西壮族自治区的实施效果,为医疗机构后续开展集采药品相关工作提供参考。方法选取广西壮族自治区医疗机构国家集采政策实施前后的药品采购数据,以政策目标、利益相关方关注的问题等为导向,引入并研究6个二级指标(如可获得性、可负担性、药品安全性等)、18个三级指标(如约定采购量完成率、负担水平、药占比等)。采用描述性统计方法对国家集采政策实施前后(2019年和2020年)的数据进行差异性、变化趋势等分析。结果在可获得性方面:广西壮族自治区医疗机构参与度为92.55%,疾病覆盖率为40.16%,整体约定采购量完成率中值为287.82%,总体配送率为97.20%。在可负担性方面:2019-2022年药品价格总体的降幅为74.80%,人均住院药品费用、门诊药占比、住院药占比降幅依次为17.61%、10.22%、20.10%,除慢性病、抗肿瘤用药外,药品可负担水平均低于1。对医药的影响:2022年药品不良反应事件占比为66.00%,相比执行国家集采政策前增幅为1.29%,广西壮族自治区通过一致性评价的药品共12个品规,前8名的制药企业的市场集中度小于20.00%。对医疗医保的影响:直至2022年基本实现仿制药替代原研药,同类非中选药品使用比约为9.12%,未提出二次换药的人数占63.39%;药品费用支出减少共24.59亿元。结论国家集采政策在广西壮族自治区取得了显著的效果,但同时还需重点关注扩大专科病种用药覆盖面、中选药品的临床综合评价、优化待分配量选择方案等问题。

抗菌药物集采对妇产科及小儿骨科围手术期预防用药的影响——以某三甲医院为例

目的:评价抗菌药物集采对妇产科和小儿骨科围手术期预防用药的影响,为推进和完善抗菌药物药品集中采购提供参考。方法:以临沂市某三甲医院为例,采用回顾性方法收集第五批国家药品集中采购中选药品(注射用头孢呋辛钠)集采前半年(2021年1月1日至2021年6月30日)和集采后半年(2022年1月1日至2022年6月30日)药品消耗量、销售金额、用药频度(DDDs)、日均费用(DDDc)、可负担性等数据,并进行对比分析。结果:集采政策实施后,妇产科平均住院日由6.98天降至6.21天,降幅为14.29%,例均药品费用、例均药占比、头孢呋辛钠例均费用、DDDc分别降幅30.70%、19.26%、7.5%和12.43%;小儿骨科平均住院日由9.76天降至8.50天,降幅为12.91%,头孢呋辛钠例均费用、DDDc降幅分别为1.17%和13.69%。结论:集采政策的有效实施降低了注射用头孢呋辛钠的价格,提高了患者的可负担性、医保基金的使用效率,降低了医院运营成本。

基于联合库存的公立医院多院区药品采购模式分析

目的 评价联合库存管理(JMI)方法在医院多院区药品采购与控制管理中的应用效果。方法 基于JMI模式,运用合理的数据处理方法从某集团医院筛选出4种试点药品进行研究,从库存成本、周转情况、供应情况等方面对比、分析应用后的效果。结果 某集团医院在应用中心医院主导的JMI模式后,3家分院试点药品库存量和库存金额显著降低,库存量较实施前减少31.93%,平均库存金额减少16.23%;库存周转天数显著减少,3家分院周转天数均减少1 d以上;药品缺货率显著降低,试点药品中变化最明显的多柔比星脂质体注射液,缺货率下降6.7%;各组数据的比较结果均具有统计学意义(P<0.05)。结论 医院多院区采用中心医院主导的JMI模式,可以明显改善药品采购管理和库存管理的效果,从而提升医院资金的使用效率。

我国药品集中带量采购制度理论与实践浅析

我国药品集中带量采购(以下简称集采)是发挥医保战略性购买功能、重构医药价格形成机制、规范药品流通秩序、降低患者药费负担、促进合理安全用药的制度创举。本文从制度创建的视角,系统性回顾了我国开展药品集采工作五年以来的制度内涵、运行效果和多方影响。制度运行的核心机制包括政府组织、联盟采购、平台操作的工作机制,质量优先、保障供应、为用而采的规则机制,以及集采与使用的运行维护机制;药品价格形成的核心机制包括量价挂钩的市场交换机制和“四个确保”的市场契约机制;制度实施涉及招标采购、供应配送、配备使用、接续工作4个关键环节和18个核心要素。集采政策实施后,临床用药替代效应明显、药品可及性提高、药品费用显著下降且主要惠及患者、药品市场集中度提高和产业格局逐步重塑。

DIP支付方式下医保供给侧政策协同对费用控制的影响研究

目的:本研究旨在探索DIP支付方式与其他医保供给侧政策间的协同效果。方法:以全国DIP改革试点城市A市为处理组,未改革城市B市为对照组进行比较研究。收集2019—2022年共1120个公立医疗机构样本,采用双重差分法对住院医疗总费用及部分费用结构进行分析。结果:A市DIP改革对医疗机构住院医疗总费用、住院检查化验总费用产生显著的抑制效应,对住院药品总费用和住院材料总费用未产生影响。结论:DIP支付方式发挥显著控费效果,住院医疗总费用得到有效控制;单纯采取调价政策与集采政策的控费效果尚有不足;DIP与其他供给侧政策协同,促进医疗费用结构更加合理。建议医保部门注重发挥供给侧政策协同作用,共同推动医保基金使用效率提升。

国家组织药品集采对医药上市公司股价的影响

目的:探究国家组织药品集采对医药上市公司股价的影响。方法:运用事件研究法,以九批药品集采政策为研究对象,从中选企业和医药行业两个角度,分别探究药品集采政策对股价的影响效果。结果:研究发现,各批药品集采事件发生后,中选企业股票和医药行业指数股均产生了显著的异常收益率;就股价而言,短期内,政策对中选企业产生一定的消极影响而对医药行业总体将产生积极影响。但本研究并未与未中选的、不参与集采的品种进行对比,也未与资本市场其他行业股价变化进行对比分析。结论:研究认为,中选企业股价与医药行业指数的反向变动引致了一定的套利空间,或是长期价值投资者的建仓良机。建议政府部门坚持药品集采制度常态化,医药上市公司加强质量管理与成本控制,证券市场投资者培养理性的价值投资观念。

WTO药品报销“第一案”——“土耳其药品案”及其对中国的启示

2022年7月25日公布仲裁裁决的土耳其药品案,是DSU第25条上诉仲裁“第一案”,也是涉及药品报销制度的WTO“第一案”。该案专家组和上诉仲裁庭裁定土耳其政府报销私人药店所售药品不构成政府采购,本地化措施也不符合GATT1994第20条(b)项公共健康例外。上诉仲裁庭纠正了专家组的一项错误法律解释,尊重专家组的事实认定,但本案仍有许多法律解释和适用问题有待澄清和完善。土耳其药品案给中国带来如下启示:关注WTO规则对医疗体制改革的规制和影响;供应链韧性建设必须遵守WTO规则;可以合理利用WTO政府采购豁免确保国内供应链安全,但应避免设置超出豁免范围的歧视性附加条件。

“4+7”注射类带量采购药品在我院的实施现状

目的分析某三级医院自2021年5月29日常量采购执行后一年内注射类药品的使用情况,为临床药事管理提供参考。方法采用药物经济学方法回顾性分析,对第四批带量采购药品3种大品种注射液执行后一年的使用数量、使用金额、用药频度、日均费用等进行分析。结果3种注射液均100%完成任务量,并且除盐酸氨溴索注射液外,其他中选药品的用药频度均大于原研药品,3种注射液的日均费用远低于原研药品。结论“4+7”带量采购药品在临床具有较高选择性,并且能够显著降低患者的就医压力,同时能够促进仿制药的发展和药物的合理使用。

集采政策对医疗机构心血管药品采购的影响研究

目的:分析药品集采政策对不同等级医疗机构心血管药品采购的影响,为药品集采政策的调整与优化提供参考。方法:分析心血管药品在各级医疗机构的采购量变化情况,采用Mann-Kendall(M-K)趋势性检验判断心血管药品采购量的长期变化趋势。结果:药品集采政策实施后,心血管药品中选产品采购量大幅增长;各级医疗机构集采品种采购量增幅随采购周期的延长而降低;试点地区基层医疗机构中选产品采购量显著增长,联盟地区仅基层医疗机构非中选产品采购量显著下降,基层医疗机构可替代品种采购量呈下降趋势。结论:药品集采政策效应可能存在滞后性,且随采购周期的延长而逐渐弱化,可替代品种的采购量增长值得进一步关注。

首批药品集采品种采购量变化的影响因素分析

目的探讨首批药品集中带量采购(简称“集采”)品种采购量变化的影响因素。方法选取“4+7”政策的25个集采品种为研究对象,对“4+7”试点、续约、扩围政策实施前后上述集采品种的采购量变化进行分析,并从药品、医疗机构、地区3个层面确定影响因素,采用多元线性回归模型分析集采品种采购量变化的影响因素。结果“4+7”试点、续约、扩围政策干预期的采购量较基期平均分别增长52.1万DDDs、-0.2万DDDs、85.8万DDDs。在试点、续约、扩围期,集采品种的DDDc降幅都与集采品种的采购量增量呈显著正相关(P<0.01)。在试点和续约期,完全可替代药品品种数与集采品种的采购量增量呈显著正相关(P<0.1);在试点和扩围期,一定程度可替代药品品种数与集采品种的采购量增量呈显著负相关(P<0.05)。在续约期,三级医院集采品种的采购量增量显著小于基层医疗机构(P<0.05)。结论集采品种采购量的变化幅度与DDDc降幅相关,集采后药品价格降幅越大,其采购量的增幅就越大;集采品种的可替代药品品种数对其采购量变化有影响,但不稳定;随着政策实施,基层医疗机构的“放量”效果逐渐超过三级医院,提示集采品种的用量在向基层医疗机构转移,集采政策推动了分级诊疗制度的实施。