仿制药价格将呈不稳定态势

据市场分析人士预测，仿制药价格正呈现出不稳定态势。从2001年到2003年，仿制药价格上涨速度是原研制药品价格上涨速度的两倍。由于许多畅销原研制药品专利到期，例如治疗糖尿病药物和过敏药物，专利药无法继续独占市场，因此仿制药制造商有了新的机会。     

我国某省原研药与仿制药价格差异与市场份额实证研究

目的:为完善国家原研药与仿制药管理工作提供科学参考。方法:根据某省药品招标采购中心数据库的数据,分析该省原研药与仿制药的价格差异与市场份额。结果:该省198个样本药品中,原研药与仿制药的价格差异倍数的均值为3.6倍,高于《药品政府定价办法》规定的差价率。结论:我国原研药与仿制药的价格差异高于国家规定。     

我国过期专利药与仿制药价格及使用现状分析

目的阐述我国过期专利药与仿制药价格及使用现状。方法通过分析过期药与专利药价格及使用现状,提出相应政策建议。结果与结论目前我国对专利药、过期专利药采取的定价法则,使市场上专利过期的药品价格为普通仿制药的2~5倍,两者存在一定的质量差异,其中专利药厂商通过各种渠道制造两者的产品差别化,加之患者药品信息的不对称、对药品的刚性需求等因素,诱导药品费用的不合理增长。     

对国内仿制药现状的一点看法

所谓仿制药是指与商品名药在剂量、安全性和效力(strength)(不管如何服用)、质量、作用(performance)以及适应症(intended use)上相同的一种仿制品(copy)。世界上每年都有总价值很高的专利药品保护到期,到期以后,其他国家和药厂即可进行仿制药。仿制药与专利药相比价格低廉,国际上认为具有提升医疗服务水平、降低医疗支出等经济效益和社会效益。同时,仿制药是世界贸易组织公认的一项巨大的社会公共财     

生物仿制药整装待发

生物制药和仿制药食业纷纷瞄准生物仿制药领域,随着2013年一些重量级治疗性蛋白质药物的专利到期,生物仿制药将迎来巨人的市场机遇.     

药品医保支付价格形成机制的国际经验及启示

目的:为我国制定合理的药品医保支付价格提供借鉴。方法:通过检索分析国内外正式发表的学术文章、官方网站和政府文件、新闻报道等资料和知情人访谈,总结国际主要药品医保支付价格形成机制,高值药可持续的公平可及的解决方式,为我国制定合理的药品价格政策提出建议。结果与结论:国际通用的医药支付价格的确定依据为内部参考定价法、增量成本-效果评价法、外部参考定价法。国际社会还采取以公平药价计划、药品专利池、开源药物研发组织等形式促进高值药可持续地公平可及。我国实现全民医保目标后,应积极探索制定合理的医保支付价格。可以在仿制药质量和临床疗效一致性评价后,采用内部参考定价法确定有仿制药竞争品种的支付标准,采用外部参考定价法或增量成本-效果评价法确定创新专利药品价格谈判的参考价格,对高值药物采用公平定价的理念。     

微话题

好生物探索V：【专利大面积到期首仿药申报数量剧增]随着全球专利药专利大范围到期,仿制药成为包括跨国公司在内所有药企重点关注的领域。首仿药物业已成为中国药物创新的重要领域;癌症、心脑血管等大病领域以及单抗药物依旧是首仿主要阵地。     

“一带一路”背景下我国与东盟国家仿制药注册制度对比研究

近年来,在"一带一路"的大背景下我国与东盟国家医药贸易往来不断加大,药品专利到期为仿制药提供了巨大的发展空间。为推动我国与东盟国家仿制药产业的合作发展,保障人民用药可及性,本文通过文献研究对东盟仿制药申请现状进行梳理,选取东盟中与我国医药贸易往来较大的3个国家(新加坡、泰国、马来西亚)与我国进行仿制药申请制度的对比,以期为我国与东盟国家展开仿制药产业合作提供有价值的科学信息。     

新医改大环境下树立仿制药品牌

贵刊83期《医改新政下抗生素品牌为王》一文指出仿制抗生素在医改和经济危机的大环境下机遇和挑战并存。其实我想在这样的大环境下不止抗生素命运如此，其他仿制药的命运也会受到很大影响。在国际上全球经济衰退使价格昂贵的专利药市场萎缩，且近两年部分专利药到期，使得仿制药市场竞争激烈。在竞争中品牌既成为竞争的要素，又成为竞争的结果。     

澳大利亚仿制药新"跳板"及给我国医药企业的启示

仿制药又称非专利药，与专利药相比，其最大的好处是价格低廉。仿制药早日上市，在保障人民群众的基本用药前提下，可显著减轻政府财政负担。所以，世界各国政府，无论是发达国家还是发展中国家，都在为专利到期后的仿制药顺利上市提供政策支持和法律保障，以平衡新药研发专利权人与社会公众的利益。     

Longer patents for increased generic competition in the US. The Waxman-Hatch Act after one decade

The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost during the lengthy FDA regulatory process. In this paper, we consider whether these twin objectives have been realised during the first decade of the Act's existence. First, we investigate the pattern of generic and brand name prices and market shares for the major products whose patents expired between 1984 and 1993. A regression model indicates that generic competition has been intensifying significantly in recent periods. Major brand name products now typically lose more than half their market share within the first year after patent expiration. In addition, we examine changes in patent protection for new chemical entities introduced over the period 1984 to 1993. For 1991 to 1993 new drug introductions, the average effective patent life was 11.8 years with 2.3 years resulting from Waxman-Hatch extensions. In the final section of the paper, we consider how the US law compares with that in Europe and discuss possible legislative improvements in the 1984 Act.     

Pharmaceutical policy regarding generic drugs in Belgium

Pressure to control pharmaceutical expenditure and price competition among pharmaceutical companies are fuelling the development of generic drug markets in EU countries. However, in Belgium, the market for generic drugs is underdeveloped compared with other countries. To promote the use of generic drugs, the government introduced a reference pricing (RP) scheme in 2001. The aim of this paper is to discuss Belgian pharmaceutical policy regarding generic drugs and to analyse how the Belgian drug market has evolved following initiation of the RP scheme.The market share held by generic drugs increased following implementation of the RP scheme. Focusing on volume, average market share (by semester) for generic drugs amounted to 2.05% of the total pharmaceutical market from January 1998 to June 2001, compared with 6.11% from July 2001 to December 2003. As new generic drugs are introduced, their market share tends to increase in the first couple of months, after which it levels off. Faced with increasing generic competition, some manufacturers have launched new variants of their original drug, thereby effectively extending the period of patent protection. Strategies consisting of price reductions in return for the abolition of prescribing conditions and the launch of new dosages or formulations appear to have been successful in maintaining the market share of original drugs. Nevertheless, the introduction of the RP scheme was associated with savings amounting to 1.8% of pharmaceutical expenditure by the third-party payer in 2001 and 2.1% in 2002.The findings of this paper indicate that the RP scheme has stimulated the Belgian generic drug market. However, existing policy has largely failed to take into account the role that physicians and pharmacists can play in stimulating generic drug use. Therefore, further development of the Belgian generic drug market seems to hinge on the creation of appropriate incentives for physicians to prescribe, and for pharmacists to dispense, generic drugs. With respect to incentives to advance generic drug use, EU countries have experimented with various forms of budget constraints for physicians, generic substitution by pharmacists and RP schemes, although more evidence is needed of their impact on consumption and prices of generic drugs, pharmaceutical expenditure and health outcomes.     

Pricing and reimbursement of pharmaceuticals in Sweden

Significant changes in the Swedish reimbursement system for drugs were introduced on January 1, 1993. A reference price system was introduced and price control became the responsibility of the National Social Insurance Board (NSIB). If a drug is to be reimbursed when prescribed, the price must be approved by the NSIB. The prices for drugs included in the reference price system do not have to be approved by the NSIB, as the reimbursement level is fixed at 10% above the price of the cheapest generic. Several pricing strategies were developed by pharmaceutical companies after these changes. For original products within the reference price system, the price, with few exceptions, was dropped to the reimbursement price. Total sales for compounds with reference prices decreased in value and the market share for generic products increased. Some products and package sizes, mainly with regard to hospital drugs, were withdrawn from reimbursement and the prices increased. The total sales of drugs for human use increased by about 6.5% during the first 6 months of 1993 when compared with the same period the previous year. There was a slight decrease (1.6%) in total expenditure for the reimbursement scheme (NSIB), but an increase of 14% for patient copayments during the first 3 months compared with the same period the year before. Cost containment has become a major priority for all publically financed programmes. However, the changes in the Swedish drug reimbursement system have not produced significant savings in public expenditure and further changes may be expected.     

Switch patterns before and after patent expiry of omeprazole: a case study in The Netherlands

BACKGROUND: An increase of therapeutic substitution after patent expiry might have a negative effect on cost-savings generated with newly introduced generic drugs. To evaluate influences of patent expiry on therapeutic substitution, switch behaviour before and after patent expiry was investigated. AIM: To describe proton pump inhibitor use and investigate substitution patterns from omeprazole before and after patent expiry. METHODS: Data were obtained from the InterAction DataBase. Proportional proton-pump inhibitor use was identified per quarter during the study period 2000-2003. For the second part two cohorts--one before and one after patent expiry--were defined. The number of switchers was quarterly identified during 2-year follow-up period. For statistical analyses the chi-square test and hazard ratio were used. RESULTS: In proportional use, a downward trend for omeprazole was found. After patent expiry, significantly more patients switched to other proton pump inhibitors (P < 0.001). The hazard ratio of 0.62 (95% CI: 0.57-0.69), indicates that for every six patients switching before patent expiry, 10 patients switch after patent expiry. CONCLUSION: After patent expiry more patients switch to another proton pump inhibitor. In light of the total savings achieved with generic omeprazole, the importance of this negative impact on total cost-savings on proton pump inhibitors is unclear.     

Effects of reference pricing in pharmaceutical markets: a review

This work aims to provide a systematic and updated survey of original scientific studies on the effect of the introduction of reference pricing (RP) policies in Organisation for Economic Co-operation and Development (OECD) countries. We searched PubMed, EconLit and Web of Knowledge for articles on RP. We reviewed studies that met the inclusion criteria established in the search strategy. From a total of 468 references, we selected the 35 that met all of the inclusion criteria. Some common themes emerged in the literature. The first was that RP was generally associated with a decrease in the prices of the drugs subject to the policy. In particular, price drops seem to have been experienced in virtually every country that implemented a generic RP (GRP) policy. A GRP policy applies only to products with expired patents and generic competition, and clusters drugs according to chemical equivalence (same form and active compound). More significant price decreases were observed in the sub-markets in which drugs were already facing generic competition prior to RP. Price drops varied widely according to the amount of generic competition and industrial strategies: brand-named drugs originally priced above RP values decreased their prices to a greater extent. A second common theme was that both therapeutic RP (TRP) and GRP have been associated with significant and consistent savings in the first years of application. A third general result is that generic market shares significantly increased whenever the firms producing brand-named drugs did not adopt one of the following strategies: lowering prices to RP values; launching new dosages and/or formulations; or marketing substitute drugs still under patent protection. Finally, concerning TRP, although more evidence is needed, studies based on a large number of patient-level observations showed no association between the RP policy and health outcomes.     

试述“复关”和知识产权保护对我国医药业的影响

本文根据近年来药品市场进口药的占有情况,分析了我国实行“药品专利保护”和恢复“关贸总协定”缔约国地位后国内药品市场的状况。过去是国内企业和产品的竞争,实施“药品专利保护”和“复关”后则是国内产品和进口产品的竞争。随着进口药品的大量涌入,专利药品的昂贵与全民医疗制度的冲突更加尖锐。但只要充分利用“药品专利”和“关贸总协定”有利于我国的一面,国内医药工业的前景还是乐观的。     

Potential Association between Drug Shortages and High‐Cost Medications

Shortages and sudden price increases of certain drugs may both occur emergently, with little to no warning, and they can have a dramatic impact on patient care. Little data are available linking drug shortages and price increases. Many of the same characteristics that may make medications susceptible to shortages can also place them at risk for sudden price increases. These characteristics include unapproved drugs, off‐patent sole‐source medications, and infrequently used medications. We reviewed drug shortage data from the University of Utah Drug Information Service to demonstrate how frequently these characteristics occurred and resulted in higher drug prices. Clinicians can use drug shortage management principles to mitigate the impact of sudden price increases for patients and health care organizations.     

Patent cliff mitigation strategies: giving new life to blockbusters

With several blockbuster drugs on the brink of another significant patent expiry cliff, innovator pharmaceutical firms are at risk of losing billions of dollars in sales to generic competition. With issues such as staggering R&D costs, reduced productivity and increasing governmental emphasis on pharmacoeconomics, timely planning and implementation of product lifecycle management strategies is becoming indispensable. A variety of strategies designed to mitigate the post-patent expiry revenue loss exist. These approaches range from fairly straightforward measures, such as strategic price cuts and launching own or authorized generics, to complex and lengthy ones, such as new formulations and indications that require companies to reinvent their pharmaceuticals. As patent expiries loom and product pipelines continue to remain thin, proactive planning for generic entry will be critical for pharma companies to drive growth and earnings in a sustainable manner.     

基本药物价格上涨的现况调查及因素分析-基于合肥某三级综合医院的调查

目的：探索公立医疗机构基本药物供应价格现状,分析药品价格上涨原因,为该领域的相关研究提供参考。方法：收集安徽省某三级综合性医院2016年1月1日-2017年9月30日期间内价格上涨的基本药物,用DDDc（药品日均费用）反映涨价药品对患者负担的影响,并通过咨询采购主管及联系药品经营商来调查药品涨价原因。结果：样本点在调查期间共使用1243种药品、366种国家基本药物及840种省基本药物。调查发现共有91种省基本药物（包括64种国家基本药物）在调查期间发生价格增长;DDDc涨幅为1.30元人民币,涨幅前20名的基本药物有17种为针剂,DDDc涨幅均大于7元人民币。导致药品涨价的主要原因有原辅料价格上涨、生产成本上涨、原供应生产企业无法供应、生产厂家供应价格上涨、配送企业供应价格上涨、配送企业无法供应和原配送企业无法满足“两票制”要求。结论：我国正致力解决人民群众用药贵的问题;但是,药品价格在招标后的上涨与我国医疗卫生体制改革及基本药物制度的目的相悖。因此,本研究建议我国继续完善药品招标制度,制定合理的定价机制及科学的补偿机制,充分发挥基本药物在使用中价格相对低廉的作用。