Effect of the Policies to Prevent Drug Shortage and Stabilize Drug Prices in Medical Institutions

Objective To evaluate the effect of some policies to prevent drug shortage and stabilize drug prices,and to provide reference for improving relevant policies.Methods With a combination of random stratified sampling and quota sampling,532 medical institutions in 20 provinces were selected to carry out questionnaire surveys.Then,a comparative analysis was made to study the changes of drugs on the shortage list and drugs on non-shortage list before and after the release of the policy of ensuring supply and stabilizing prices.Results and Conclusion The policy played an important role in curbing the growth of drug shortage in the medical institutions,but it did not curb the growth of drugs on non-shortage list.Besides,the drugs on non-shortage list showed an overall fluctuation and upward trend.Meanwhile,from the perspective of drug prices,the price stability problem of drugs on the shortage list and on the non-shortage list became more serious,and the average price increase was 256% and 239%,respectively.The implementation of policies related to the supply and price stability of drugs prevents the growth trend of drug shortages in the list of medical institutions,which has been recognized by most medical institutions.However,there is an increasing trend in the number of drugs on non-shortage list.In addition,the price increase of drugs on both the shortage list and non-shortage list is severe.Some medical institutions report that they have difficulties in using the information reporting system of drug shortage and the classification,grading and the alternative use of drug shortages.It is recommended to strengthen the management of price stabilization of drugs on the shortage list.Further attention should be paid to the supply and price stabilization of drugs on non-shortage list.At the same time,trainings in the classification and substitution of drug shortage and information reporting system should be actively organized,thus comprehensively improving the capabilities of medical institutions at all levels to deal with the problem of drug shortage.

Who Raised My Drug Price?

The prices of some drugs have surged up recently with a cardiac medicine, for instance, costing 10 times more. Some consumers are linking it to the latest reform in China＇s drug regulation history. In May, the National Development and Reform Commission （NDRC）, China＇s top economic regulator, announced the price ceiling imposed by the government on over 2,700 pharmaceutical drugs would be removed from June 1 onward.

Drug Regulatory Science in EU and Its Enlightenment to China

Objective To analyze the current situation of research and application of drug regulatory science in EU,and provide suggestions for policy-making of drug regulatory in China.Methods The policy guidelines issued by European Medicines Agency(EMA)and domestic and foreign literature were retrieved to summarize how to carry out drug regulation science in Europe.Results and Conclusion A strategic plan was formulated by the EMA for the implementation of drug regulatory science,and the construction of academic system and discourse system of regulatory science were improved,which played a role in promoting the progress of European drug regulatory science.It is suggested that a phased strategic plan of regulatory science should be established to clarify strategic objectives and main tasks in China as soon as possible.Besides,the construction of discipline system and discourse system should be strengthened to realize the scientific supervision of drugs.

EU Real-World Evidence Supporting Drug Regulatory Decision and Its Enlightenment to China

Objective To provide references and suggestions for the application of real-world evidence in the decision-making of drug regulation in China.Methods The application of EU real-world evidence in drug regulatory decision support was analyzed through literature research and other methods,and the specific operation of its application was demonstrated by case studies.Results and Conclusion The application of EU real-world evidence in drug regulatory decision-making has achieved certain results and is in a stable development stage.The application of real-world evidence in China’s drug regulation is feasible.The successful application of EU real-world evidence can provide reference for China.

Management of Orphan Drug Reimbursement Abroad and Its Enlightenment to China

Objective To analyze relevant policies and measures on the management of orphan drug reimbursement in foreign countries to provide a reference for future reimbursement management in China.Methods According to the percentage of health care expenditure in GDP,the completeness of rare disease policies,and the total population,Russia,Australia,and India were selected as the reference.Based on the existing literature,the main content and characteristics of the reimbursement of rare disease drugs were analyzed.Results and Conclusion Russia manages rare diseases in the form of lists.Special rare diseases are reimbursed by federal or regional finances,and ordinary rare diseases are reimbursed by statutory medical insurance funds.Orphan drugs in Australia are included in the pharmaceutical benefits scheme(PBS)and the lifesaving drugs program(LSDP),LSDP provides fully reimbursed drugs for eligible rare disease patients.India’s proposal takes health system sustainability into consideration.China should carry out epidemiological research to legally determine the rare diseases,establish reasonable reimbursement standards,and improve the multi-level reimbursement system.

Real-World Evidence Supporting New Drug Review and Approval in European Union and Its Enlightenment to China

Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European Medicines Agency(EMA)and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE.Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun.The decision-making process includes three stages such as new drug research and development,review,and approval.However,there are some challenges in data quality,research methods,evidence sufficiency,and research process of RWE supporting the European Union in reviewing and approving new drugs.At present,RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs.At the same time,RWE also can promote the development and application of Traditional Chinese Medicine(TCM)and help find out the potential value of TCM such as new indications.

Research on the Price Level of Drugs in Short Supply in China

Objective To determine the price level of drugs in short supply and conduct affordability evaluations,thus putting forward countermeasures and suggestions for the management of prices of these drugs.Methods Taking the national list of drugs in short supply and the national key monitoring list of clinically essential drugs in short supply as the research objects,the bid-winning prices were searched through various bidding websites across the country,and the price levels of the varieties in the list were evaluated through fixed base price index,median price ratio and other indicators.The per capita income evaluation method was used to evaluate the affordability of the drugs on the list.Results and Conclusion Among the 30 varieties with valid international reference prices,25 are higher than the international reference prices.The prices of 14 kinds of drugs are 1-5 times higher than the international reference prices.The prices of 10 kinds of drugs are 6-35 times higher than the international reference prices.In rural and urban areas,50%and 73%of the drugs in short supply cost more than two times of the daily income for each course of treatment.The current price levels of selected drugs in short supply are generally high.It is recommended that these drugs should be classified and managed.Besides,the shortage of drugs should be included in the centralized procurement organized by the state to solve the unstable supply in the market.

Analysis of Drug Medical Insurance Access Pricing Based on the Perspective of Binary Equilibrium

Objective To study the influencing factors in the process of national medical insurance negotiation and drug pricing from the dualistic equilibrium perspective,and to provide reference for the harmonious management of drug pricing in China.Methods Through the literature analysis and policy review,the pricing subject,pricing basis and price control system in the pricing process of medical-accessed medicines were analyzed from the perspective of binary equilibrium and harmonious management.Results and Conclusion It is found that four balances in the drug pricing process,two balances in pricing basis and three balances in price control system need to be considered,respectively.Drug pricing is the key content of national medical insurance access,which is also the hotspot of the policy in the pharmaceutical fields in recent years.Drug pricing not only reflects the value of drugs,but also reflects a lot of top-level designs of binary equilibriums in medical insurance policy.While the rational design of drug pricing requires the joint efforts of the government,pharmaceutical companies and relevant experts to comprehensively consider many equilibriums,so as to improve the relevant systems.

Research on the sharing mechanism of drug price information in China-from the perspective of intergovernmental information sharing

Establishment of sharing mechanism for drug price information to guarantee the construction of a unified cross-departmental price information platform is a new national policy after Chinese government abandoned drug price control. Based on the theory of intergovernmental information sharing, this study aimed to investigate the drug price information sharing mechanism in China through literature research and stakeholder interviews, which included institution guarantee mechanism, department coordination mechanism and technical support mechanism.

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.

The Impacts of Drug Price Regulations in China

To lower pharmaceutical expenditure,the Chinese government has replaced the Fixed Percent Markup (FPM) policy with the policies of the Separation of Outpatient Pharmacies from Hospitals (SOPH) and the Zero Markup Drug (ZMD).We build a multistage game theoretic model comprising a hospital and a drugstore to analyze the policies' impacts on the providers' drug selection and pricing behaviors.By comparing the equihibrium outcomes,we draw the following conclusions:(i) FPM,especially for one imposing a strict margin ceiling,actually induces an expensive prescription given patients' great compliance.(ii) Both SOPH and ZMD can conditionally lower patients' expenditure,and their performances rely on the hospital's selection.(iii) A proper rate of insurance coverage and a removal of drug rebate are helpful to improve the policies' performance.

Effect improvement of drug pricing reform based on multi-channel coordination

To improve the effect of the drug pricing reform,a business model of pharmaceutical e-commerce is introduced into the pharmaceutical supply chain.First,based on the measures of the drug pricing reform,a dual-channel model is established,consisting of a drugstore and a hospital.The analysis of the model indicates that the reform leads to higher costs for patients.Then,an e-pharmacy is added to the dual-channel supply chain.Meanwhile,to reduce the home-delivery cost of the e-pharmacy,a multi-channel coordination strategy called“order online,delivery by drugstore”is proposed.By comparing the optimal values under the two models with and without coordination strategy,respectively,the results show that the profits of the e-pharmacy and the drugstore increase while the retail prices of drugs drop,and a large number of patients are diverted from the hospital.Therefore,the business model of pharmaceutical e-commerce with multi-channel coordination can greatly improve the effect of the drug pricing reform.

Inspiration of Foreign Innovative Drug Pricing Methods and Medical Insurance Payment Standards to China

Objective To study the innovative drug pricing methods and medical insurance payment standards in foreign countries and to provide reference for China’s government.Methods The official websites were searched for information and related literature,and literature review was used.Results and Conclusion In foreign countries,the clinical value of innovative drugs and their impact on medical insurance funds were comprehensively evaluated based on factors such as quality-adjusted life years,clinical benefit,and improvement of clinical benefit.Then,the evaluation results were taken as an important basis for whether innovative drugs were admitted to the medical insurance catalog and establishing medical insurance payment standards.By using international experience for reference,innovative drug pricing methods and medical insurance payment standards for China’s national conditions can be improved by establishing a basic database of clinical value and drug economic evaluation of innovative drugs,as well as innovative drug payment models based on decision thresholds.

Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed,including the process of approval for generic drugs,bioequivalence issues including“switchability”,bioequivalence for complicated dosage forms,patent extension,generic drug safety,generic substitution and low-cost generics.The backlog in generic review,generic drug user fees,and“quality by design”for generic drugs is also discussed.The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.

DrugAbacus方法在抗肿瘤药物定价方面的应用

目的我国在抗肿瘤药物价值评估方面尚处于初级阶段,缺乏成熟的药物价值评估体系,通过对DrugAbacus交互式计算器的分析和探讨,为我国建立基于价值评估的药物经济学模型提供参考,为临床医生和患者选择治疗方案提供有价值的参考意见。方法通过文献检索、数据查询等对DrugAbacus交互式计算器的价值构成因素和数据来源进行分析,并根据基线数值对抗肿瘤药物进行价格评估。结果抗肿瘤药物Afinitor,用于治疗肾癌、胰腺癌以及乳腺癌时,实际价格均高于建议价格;抗肿瘤药物Avastin用于结肠癌的治疗时,实际价格与建议价格相差不大;Halaven的建议价格始终是高于实际价格的,即该药物的价格至少是合理的甚至价格偏低,Ixempra的价格偏高,所以认为使用药物Halaven比使用药物Ixempra能节省更多的费用。结论DrugAbacus方法对药品定价所应该考虑的因素进行了复杂的分析,虽然存在局限性,但是该方法在很大程度上反映了社会对创新型药物价值的评估,可以为我国药品定价提供参考。

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。

新上市药品首发价格形成机制与鼓励高质量创新的经济学理论分析

目的:本研究旨在探究新上市药品首发价格形成机制的经济学本质,及其面临的挑战与待解决的问题。方法:从药品价格形成机制的基本原理出发,本文引入了内生与外生价格、非对称信息博弈、创新药品市场竞争以及新制度经济学的相关理论,探索药品首发价格形成机制的经济学理论基础。结论及建议:建立合理的药品首发价格形成机制,是发挥市场在资源配置中起决定性作用的同时更好发挥政府作用的举措。以鼓励高质量创新为目标的药品首发价格形成机制,应当以降低制度性交易成本为核心目标。建议以创新价值、竞争情况等相关信息披露为基础,对新上市药品合理分类,降低信息不对称程度,治理当前新药市场的逆向选择问题。在保证高质量创新药定价权最大化的同时约束同质化创新的垄断定价权,兼顾效率和公平。

药品价格指数的构建与应用

目的基于药品零售价格大数据构建药品价格指数,描述其波动特征,发挥其药品价格宏观监管作用,促进药品价格保持合理水平。方法运用链式拉氏指数构建原理建立药品价格指数模型,运用时间序列模型描述指数波动特征,识别并分析药品价格波动异常状况。结果2015年1月—2020年12月,药品价格总指数小幅上涨,累计涨幅为14.43%,年均涨幅约2.40%,市场化改革成效较为显著。通过基于局部加权回归的季节趋势分解(seasonal-trend decomposition using loess,STL)方法对获得的药品价格总指数时间序列进行分析,指数呈长期平缓上升趋势,不规则波动值为-1.41~2.03,说明药品价格受外因影响较小,周期性特征仍有待进一步研究。2015年1月—2020年12月,根据药品价格指数共监测到价格异常风险32次。结论药品价格指数较全面地反映药品价格走势,对于药品价格异常波动具有一定的预警作用,能够为我国药品价格监管提供有效工具。

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。

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。