全国胰岛素专项集中带量采购规则和中选成效分析

国家层面的药品集中带量采购由化学药扩展至生物药,胰岛素专项采购在秉承基本原则和有益经验的基础上,结合胰岛素特征对采购规则进行优化.系统介绍2021年国家组织的胰岛素专项采购的规则创新之处:合并通用名分组竞价,保证组内充分竞争;设置报价单元和代表品,保证同组公平竞争;医药机构按需求按厂牌报量和分量,尊重临床需求;设置更温...     

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。     

新形势下省级药品集中带量采购政策分析与完善建议*

目的：梳理我国省级药品集中带量采购政策,分析其特点和主要问题,提出优化建议。方法：采用政策文献分析和专家咨询法,分析省级药品集中带量采购政策。结果：省级药品集中带量采购已全面铺开,品类宽度大于国家药品集中带量采购,纳入了相当比例的注射剂。大多依据药品原创性划分质量层次,分组规则有待规范,少数不区分质量层次的省级药品集中带量采购面临更高的质控要求;采用多种采购方式相结合的采购模式、最低中标与谈判议价相结合的中选规则, 限价标准不一;采购量分配比例与国家药品集中带量采购接近,进行了按降幅分配采购量探索。结论：省级药品集中带量采购以借鉴国家经验为主,未来要明确采购目标,修正药品采购乱象;完善采购规则,推进方案制定规范化;完善医保支付标准制定条件,推动医保角色转变。     

药品集中带量采购政策对药品利用与支出的影响分析*

目的：分析药品集中带量采购政策对于药品利用与支出的影响。方法：利用2018—2019年的药品采购数据,采用双重差分模型比较了集采品种和同类替代非集采品种的价格、采购量、采购金额、质优药品的使用比例在药品集中带量采购政策实施后的变化。结果：药品集中带量采购试点政策实施后,与未实施试点政策的省份相比,实施试点政策或部分实施试点政策的省份集中采购试点品种的标化价格下降72.2%,标化采购量增加16.9%,采购费用下降55.3%,质优药品的使用比例增加15个百分点(均为P＜0.01)。尚未发现集采品种的采购向同类替代非集采品种转移的证据。结论：药品带量集采政策有利于药品支出的控制和用药质量水平的提升,有必要扩大药品带量集采的覆盖面,尽快将中成药和生物类似药纳入集采之中。     

药品带量采购的核心要素分析

明确药品带量采购的核心要素及相关理论,深入分析和比较我国实施的3批药品集中采购的相关政策,厘清我国药品带量采购模式的演进历程和发展趋势,以期为优化我国医药采购制度、增进人民群众健康福祉提供参考。     

带量采购对某公立医院口服降压药的价格、使用量的影响

目的：分析探讨国家药品集中带量采购政策对某公立医院口服降压药的价格、使用量以及销售金额等的影响。方法：本研究以某公立医院为样本，该院于2019年12月以及2020年4月参与实施了国家药品带量采购试点扩围和第二批药品集中带量采购工作。从医院信息系统（HIS）中提取带量采购前后一年的口服降压药使用数据，包括采购价格、销售金额、销售量等，为了避免疫情对本研究科学性及准确性的影响，最终选取2019年6月-11月以及2020年6月-11月的口服降压药品相关数据进行统计分析。结果：集中带量采购政策实施后，降压药品种中，除吲达帕胺价格不变外，其余降压药价格均显著下降；片数构成比和用药频度变化不大；降压药销售金额显著下降，日均治疗费用下降明显。结论：集中带量采购政策的实施，减轻了部分高血压患者群体用药经济负担，降低了医疗成本。     

药品带量采购政策的推进对我国药企的动态影响分析

目的:通过自2018年药品"4+7"带量采购试点至2020年第二批带量采购完成招标以来的政策,探讨政府和药企应如何应对,并对政策完善及我国药企发展提出针对性建议。方法:通过药品带量采购政策推进与深化进程中3次招标采购对我国药企的动态影响进行梳理和分析。结果:医药产业在成本控制及创新研发等方面深受该政策的影响,有利于推进采购流程科学化、一致性评价与新药研发。结论:该政策促使加快药企内部结构调整与转型,对建立与落实价格动态调整机制等具有重大意义,同时,对医药领域法律法规提出新要求。     

药品和耗材跨区域带量采购的实践与思考

目的比较我国药品和耗材跨区域带量采购的实践,厘清该模式的基本逻辑。方法比较分析国家组织集中采购(以下简称"国家集采")和非国家集采框架下我国药品和耗材跨区域带量采购的实践,总结实践的基本特点,分析采购内容、采购环境及采购规则的内在关系。结果我国药品和耗材跨区域采购的实践包括:以国家组织药品集中采购和使用试点(以下简称"‘4+7’试点"),"4+7"试点扩围,第二、第三批国家组织药品集中采购和使用,深圳药品集中采购组织(group purchasing organization,GPO)模式为代表的药品带量采购;以京津冀联盟及由其发展而来的"3+6"联合采购模式,黔滇豫渝4省(直辖市)联盟以及陕西省牵头的15省(自治区、兵团)省(自治区、兵团)际联盟为代表的耗材带量采购;以三明联盟为代表的药品和耗材带量采购。实践特点是平台统一、信息共享,允许多家企业中标和价格差异,价格联动。结论跨区域带量采购将成为药品和耗材带量采购的主要模式,而合作共享的信息平台和科学合理的质量评价体系是重要保障。     

我国药品集中带量采购政策执行情况分析

目的：分析各省(区、市)前四批国家组织药品集中带量采购的首年采购完成情况，为更好地执行政策提供参考。方法：根据首年采购数据，对比分析前四批带量采购药品的约定采购量完成率和中选产品采购占比。结果：随着带量采购批次的增加，医疗机构报量趋于准确且完成率的季度波动幅度逐步缩小，中选产品采购占比维持在80%左右且逐季递增。结论：前四批药品带量采购政策执行情况总体较好，但后续需完善医保基金结余留用机制，引导医疗机构准确报量；实时对接医疗机构信息系统，防止滥用非中选产品；关注非正常中选价格，消除可能的寻租空间；鼓励医疗机构积极开展过评仿制药的真实世界研究。     

分类分级采购格局正在成型

正2018年,国家医疗保障局成立后,开展了"4+7"城市药品集中采购和使用试点,开启了医保主导带量采购的新篇章。2019年,11个地区带量采购试点启动落地,9月扩围采购覆盖至25个地区,见证了药品采购机制创新和重大变革推进落实。2020年第二批集中采购全国覆盖,标志着药品集中采购机制创新的全面铺开。虽然实际的政策效果还需时间来验证,但其对于医疗机构和药品市场的影响已经可以预见。     

实施高值医用耗材带量采购的SWOT分析——以上海市为例

目的：分析实施高值医用耗材带量采购的优势、劣势、机遇和挑战,探讨政策实施的可行性、潜在风险以及解决思路。方法：基于上海高值医用耗材采购实证数据以及访谈,对上海开展高值医用耗材带量采购进行SWOT分析。结果：上海市拥有较为完善的阳光采购系统和模式,在国家政策的支持下,上海先前的药品带量和其他省市的耗材带量采购经验可以提供借鉴,这是上海的优势和机会;同时,上海阳光平台的功能也存在一些可能影响带量采购效果的劣势,面临耗材产品目录筛选困难、临床使用不规范、国内企业发展受阻等威胁。结论：上海开展高值医用耗材带量采购具备可行性,同时存在一些潜在风险,应在开展带量采购的过程中科学拟定计划,确保带量采购有效实行,同时兼顾各利益相关方。     

Essential drugs programmes in Africa

The essential drugs concept encompasses national drug policy, selection, quantification, quality assurance, procurement, inventory control and distribution, financing, rational drug use, and training. People from all sectors and levels were involved in developing Tanzania's national drug policy which was approved in 1991. The process developing a policy in Kenya continues. The policy will allow Kenya's Ministry of Health to implement various operational changes (e.g., improvements in hospital drug management). 40 sub-Saharan African (SSA) countries have a national essential drug list (EDL). A synergistic effect results when EDLs are merged with standard treatment guidelines (STGs) (e.g., in Tanzania and Zimbabwe) or constructed with STGs and a national formulary. The Federal Ministry of Health in Nigeria designated 209 drugs as essential drugs, while Nigerian states determined their own EDLs based on these 209 drugs. Spreadsheet models use morbidity patterns, past consumption, and population to help countries quantify drug needs which are then used to determine drug procurement. Various problems with quality assurance in regional and national quality control laboratories in SSA include staff turnover, limited equipment maintenance, and lack of reagents and laboratory standard solutions. A database, structured, flexible drug registration system allows countries (e.g., Zimbabwe) to monitor drug suppliers and agents. Drug procurement has improved in countries with established procurement systems. Computers help control and manage drug inventories. Kenya, Mozambique, Tanzania, and Uganda distribute ration kits of prepackaged drug selections. Cash and carry in Ghana, hospital fees in Kenya, and community insurance schemes in Guinea Bissau are some financing schemes in SSA. The International Network for the Rational Use of Drugs is operating in Ghana, Nigeria, the Sudan, and Tanzania. Training courses in drug supply management are held in Ghana, Tanzania, and Zimbabwe.     

A New Reimbursement System for Innovative Pharmaceuticals Combining Value-Based and Free Market Pricing

Sweden has experienced a national value-based pricing (VBP) system for innovative outpatient drugs operated by the Pharmaceutical Benefits Board - LFN (now called the Dental and Pharmaceutical Benefits agency - TLV) since 2002. VBP has the character of a monopoly system, leading to reimbursement decisions where usage of new medicines is limited to subgroups and not the population for which the drug is approved. VBP relies on a broad societal perspective, encouraging innovations by signaling to firms that value-adding treatments are demanded. However, the VBP system is operated without a drug budget responsibility. The budget responsibility lies at the regional level, not operating VBP, thus an intrinsic conflict is built into the system. The aim of this article is to suggest a modification to the current reimbursement system in Sweden where payment for pharmaceuticals is split between the regional and national levels. The system is expected to make new innovative pharmaceuticals accessible to a larger number of patients and provide more consumer surplus without reducing the producer surplus. In short, the county councils pay the marginal cost of production while the state pays for the innovation.     

Access to essential drugs in Guyana: a public health challenge

Guyana's pharmaceutical sector faces major challenges that limit access to essential drugs. This study analyzes Guyana's drug policy and regulation, public financing, and drug procurement and delivery. The study also identifies main barriers to drug access and proposes alternatives to strengthen the country's public health functions. Data were collected from the country's regulatory agencies, public procurement agency, pharmacies, wholesalers, and pharmaceutical companies. The information was supplemented with interviews with a convenient sample of Guyanese health authorities and stakeholders. Data were also compiled from scientific databases, and web pages of the country's Ministries of Health, Commerce and Finance, the Bureau of Statistics, and international organizations. Major barriers to drug access include: (1) lack of national drug policy and regulation, and limited role of the regulatory authority; (2) inefficient drug selection and irrational drug use; (3) insufficient financial resources and lack of drug pricing policy; (4) inefficient planning and managing public supply system; (5) deficient epidemiological and information systems; and (6) inadequate infrastructures and human resources shortage. Improving drug access in Guyana requires the strengthening of the country's public health functions and the implementation of a national drug policy and pricing policy, streamlining the drug financing, procurement, and planning and managing drug supply; and adequate infrastructures and human resources.     

Development of an essential drugs list for Bosnia and Herzegovina.

Part of the impact of the war in ex-Yugoslavia and especially Bosnia and Herzegovina was to limit the supply of therapeutic drugs they had used before the war. The difficulties encountered made the health care system temporarily dependent on humanitarian assistance agencies which applied the concept of essential drugs; and, after initial difficulties, national health staff adapted to the need to prescribe from a very limited range of drugs. Meanwhile, national drug policy and procurement and prescribing practices were reviewed by working groups and a national List of Essential Drugs was drawn up by national experts with international support. This list has now been passed into legislation.     

中国药品集中采购的演变以及与医保支付的逻辑关系

本文主要通过政策梳理和文献回顾的方法,详细阐述了药品集中采购政策的发展演变及其与医保支付的逻辑关系。文章首先梳理了药品集中采购的三个发展阶段,并分析了当前药品集中招标采购的特点和趋势;进而重点探讨了药品集中采购与医保支付体系的关系以及两者配套改革对于解决药品问题的现实可行性。研究认为,药品集中招标采购已经演变为省级平台限价下的议价、最低价联动采购方式;药品集中招标采购可为医保支付标准的形成提供依据,但国家药品谈判以及省级医保特药谈判存在功能重叠;药品招标采购、医保支付等制度安排可助推医药分开,配套相关改革可为解决"药价虚高"提供一种思路。     

金砖五国药物政策比较及对我国的启示

目的:比较巴西、俄罗斯、印度、中国和南非五个金砖国家的药物政策,为进一步完善我国的基本药物制度提供借鉴.方法:采用系统评价的方法,对比研究和系统总结这些国家药物政策及部分国家实施基本药物制度的经验.结果:巴西实施基本药物制度,并开办大众药店;俄罗斯实施医药分离制度;印度德里的基本药物制度模式具有典型代表性;南非政府集中采购与配送等.这些金砖国家的药物政策各有其特点,但目的一致,即增加大众对低价、高质量药品的可获得性.结论:金砖国家药物政策改革成效显著,但各国政府在深化医药改革中依然面临着严峻的挑战,还需要根据本国国情不断地探索,同时借鉴发达国家的经验,进一步巩固与完善本国的药物政策.     

上海市药品带量采购分析和思考

本文通过对上海市药品带量采购相关文件资料进行分析,结合实地调研和访谈,从药品集中采购基本情况、带量采购试点药品范围和品种、企业资质认定、中标企业确定、药品配送和药款结算六个方面对上海市药品带量采购做法进行梳理总结,分析认为上海市真正实现了药品带量采购,通过建立科学的质量综合评价指标、设立药品采购专用账户、预付药品采购货款、加强平台服务和监管能力,有效保障带量采购机制运行。由此得出以下启示与建议:事权统一的职能部门是实现药品带量采购的重要保障,技术手段和平台建设是实现药品带量采购的基础条件,经济技术标的设置应当关注通用名药品个体属性,推进三医联动将有助于进一步扩大带量采购药品的范围。     

2012-2018年甘肃省药品集中采购情况分析

目的:评价甘肃省药品集中采购政策实施的效果,总结药品集中采购取得的成绩和不足,为甘肃省进一步完善药品集中采购政策提供参考。方法:从甘肃省药品集中招标采购平台上导出2012-2018年药品采购相关统计数据,使用Ex-cel软件进行描述性统计分析。使用指标主要有均数、百分比、集中度等。结果:2012-2018年甘肃省药品集中采购的药物金额总体上逐年增加、药品价格以中低价格为主、市场集中度较低,各级医院基本药物的采购金额大体上呈增加趋势。结论:甘肃省药品集中采购政策总体上实施效果良好,但还应有针对性地规范完善。