药物经济性评价下的中国药企变革

卫生政策和制度的导向无疑会对制药企业的行为产生重要的影响。在中国医药体制改革不断深入的过程中,为了解决民众"看病贵"问题,建立科学合理的医药价格形成机制尤为重要。现行医药市场环境中,存在着药企创新乏力,药品定价虚高、药品质量降低、小规模药企无序竞争、过度营销等乱象,限制和阻碍着我国医药企业的健康发展。随着国内药物经济学的引入和推广,药物经济性评价方法逐步被卫生领域所接受,逐渐成为药品价格管理的制度依据。药物经济性评价的推行,可以促进药品科学合理定价,从而引发中国制药企业陆续的改革。引入药物经济性评价,可以促使制药企业规范化发展,扭转制药企业的不良形象。     

欧洲11国药物经济学评估活动调查

近年来,在医疗保健计划中,管理者不得不面对不断涌现的新型药品和不断增长的控费压力之间的矛盾。为此,许多经济合作发展组织(OECD)国家开始采用药物经济学评估技术,以帮助选择合适的药品报销目录或者帮助进行药品定价。本文分析了11个OECD国家中药物经济学评估的开展状况,对其开展评估活动的目标、程序和所产生的影响进行了综述。本文的研究方法包括文献研究和一个探索性的实证调查。本研究所得的主要结论概况如下:(1)从被调查各国的开展情况看,药物经济学评估已经在OECD国家中获得了广泛的应用。无论是对于公立保健计划还是私立保险机构,药物经济学评估都已经成为一个有效的决策支持工具。(2)从调查结果看,各国开展药物经济学评估的最主要意图,是为了保证在卫生服务中使用的药品能够"物有所值"。在部分国家中,主要是评判新药的投入产出比是否能达到一个满意的值;在另一些国家,则主要是把经济学评估结果应用在药品定价协商中,以保证新药具有经济学优势。医药厂商对药物经济学评估存在一定顾虑,包括担心政府的目的是单纯的抑制药品费用,以及采用这项技术可能会阻碍创新。从本调查结果看,单纯的抑制药品费用并非政府的主要目的。当然,对药品费用水平及其增长率的影响,是开展药物经济学评估的一个自然结果。而对于创新问题,如果药物经济学评估能够促使厂商开发出价值更精准的新药,那自然会对公众有益。(3)药物经济学评估是正在发展的技术,它还有很大的改善空间。需要注意的是,开展经济学评估本身就是增加了成本,并且经济学评估也延缓了新药投入使用的时间。所以,对这项技术的运用必须注意平衡:提高药品投入产出比所产生的利益与开展研究所增加的成本与所导致的延迟之间。当然,有效地保持这种平衡并不容易。(4)调查中发现,各国对于加强国际交流均非常感兴趣,这可能是因为各国都希望通过技术交流提高药物经济学评估的质量并节约研究成本。     

药品定价浅析

目的:探索我国药品定价的合理模式。方法:对现行药品价格管理模式的现状进行分析。结果与结论:加强政府对药品价格的宏观调控,应用药物经济学方法与成果,提高政府定价的科学性和透明度,使药品定价更加趋于科学与合理。     

药物经济学在欧盟的研究与应用

本文根据意大利Padova大学的Patrizia Berto教授在2008中国药学会学术年会暨第八届中国药师周药物经济学分会上的讲座整理。讲座主要涵盖了以下三方面的内容:(1)卫生技术评估及卫生经济学分析在欧洲药品定价及医疗保险政策决策中的作用;(2)药物经济学在欧洲国家的应用;(3)药品定价及医疗保险对制药企业影响的展望。由于篇幅所限,我们只节选了部分内容在此刊登。     

中国制药企业药物经济学应用现状调查

目的：通过对中国制药企业药物经济学的应用现状进行调查,了解目前药物经济学在中国制药企业中的应用情况,为卫生决策部门提供药物经济学相关决策依据,并提高企业对药物经济学的认知度。方法：以自设问卷,采用上门走访等方式对中国制药企业开展药物经济学研究的情况进行调查。结果：在访问成功的247家制药企业中,有212家（占85.83%）未开展过药物经济学研究,有35家（占14.17%）曾有过药物经济学研究经历。结论：药物经济学在中国制药企业中应用的不多,还未得到普及。     

澳大利亚经验对中国建立药物经济性评价指南的启示

目前,中国政府正在制定药物安全有效和经济性评价指南(SE／CEAP,以下简称评价指南)评价指南是政府制定医疗卫生补偿政策的依据之一,是由澳大利亚药物管理局(TGA),药物收益咨询委员会(PBAC),以及经济小组委员会(ESC)共同开发的一门国际认证的专业技术。药品福利计划(PBS)药品目录是纳税人获得低廉药品的保证,而药物收益咨询委员会通过药物评价工作对政府制定合理的PBS药品目录起到关键作用。澳大利亚通过税收和政府机构推动药物政策制定,同时,最大化公众和私人利益,树立了一个国际范例。在当前的老龄化社会环境下,该政策为政府提供了有效的财政杠杆,缩短了技术垄断权(IMPs)的保护期但又不限制本国企业创新的能力。目前,跨国制药产业正对药物经济学评价指南(CEAP)的评价程序进行详细审查,制药产业希望降低买家垄断的集中程度,把药物经济学评价指南的评估角度从全社会角度替换为市场角度,即把药物经济学评价指南中对成本的界定替换为产品的隐性边际成本,企业与医师和政府沟通以及广告的成本。     

药品专利制度的现实困境及反思

药品研发及市场化具有高风险、高投入特征，药品专利制度通过为制药企业提供专利期内垄断市场激励,促进药物创新。TRIPS协议在全球范围内建立了对药品专利的高标准保护，然而这一药品专利国际保护制度突出了药品专利私权属性以及对利润的过分追求，在现实中引发了药品创新悖论与药品获得困难两方面问题。借鉴并完善国际社会已有的药物研发多元融资措施、税收优惠机制以及公私合作模式，有助于纾解药品专利制度面临的现实困境。     

用药物经济学引领新药研究开发

医药企业在进行新药和仿制药研究开发时,于立项前可以首先收集目标药品的疗效、价格以及竞争药品的相关数据进行药物经济学分析。选择具有药物经济学优势的药品进行研制。成功后,使其更具竞争优势,并可以获得更大的市场机会和利益。     

在我国药品定价中应用药物经济学评价的技术性障碍分析

目的:探讨在我国药品定价中应用药物经济学评价方法的技术性障碍。方法:根据卫生经济学和药物经济学理论,采用理论推导和论证的方法。结果:我国的药物经济学评价方法在许多环节上尚不成熟和完善,存在许多技术性障碍,需要进行有效改进,增加可操作性和可信度,才能获得有效的应用。     

药物经济学在制药行业的运用和展望

药物经济学作为一门新型的边缘学科,受到了广泛的关注。许多制药企业已经开始在新药的筛选、研发、新药上市后再评价,以及营销战略的制定上,积极采用药物经济学的评价和分析方法,取到取得了显著的效果。     

国际合作是加速我国创新药研发的助推器——南京先声药业集团国际合作成果调研

中国是世界第三大药品市场,但新药研发能力低下,70％是仿制药,具有完全自主知识产权的创新药风毛麟角。南京先声药业集团积极开辰国际合作,吸引了大批海外高端人才,极大提升了研发能力,并成功开拓多种渠道获职新药,对促进我国新药研发模式进行了有益的探索。对先声药业集团国际合作＋持续投入研发＋顶尖开发团队的发展战略和实践经验进行介绍,其典型意义在于：世界医药行业正处在一种求变的局势中,各个方面都有着可待开发的机遇;中国药企应大力开展国际合作,主动逐步融入全球健康产业链,成为其中不可缺少的中坚力量;抓住中国的国际机会,在国际合作中获得国内定价权。     

加拿大专利药品政府管制定价政策介绍

目的 分析加拿大对专利药品价格的管制制度,包括价格审查部门职责、管制的过程和管制政策;方法 文献研究和比较分析方法 对加拿大专利药品政府管制定价政策进行详细介绍;结果 与结论加拿大政府对专利药品的价格管制职能部门PMPRB 的建立,价格管制审评过程以及对过高药品控价的政策都值得我国借鉴.     

Pricing dynamics and product quality: the case of antidepressant drugs

The rising prices of pharmaceuticals have generated considerable, and often acrimonious, debate. Yet, there is little conceptual work or empirical evidence on pharmaceutical pricing strategies or on the time paths of these prices. This study provides a conceptual framework describing the interplay between quality and product differentiation in determining the preferred pricing strategy. We hypothesize that higher quality products will engage in price skimming strategies in markets where products are sufficiently differentiated, but will choose a market penetration strategy in markets that are less differentiated. We apply an empirical analysis to brand name antidepressants during the years 1999–2002, a market where differences in quality are modest. A nationally representative data set on drug utilization and expenditures is combined with a physician survey on the quality attributes of drugs to examine the effect of drug quality on pharmaceutical pricing strategies. Results indicate that higher quality antidepressants engage in a market penetration strategy, charging initially lower prices that rise over time. At approximately 6–7 years post-entry, prices of the antidepressant drugs examined converge. Prices of higher quality antidepressants continue to increase thereafter, eventually becoming the highest priced drugs in the therapeutic class. These findings are consistent with a market in which product differentiation is modest and consumers learn which drug works best for them through experience.     

Third-Degree Price Discrimination in the Presence of Subsidies

Abstract. According to a classical result, a move from uniform pricing to third-degree price discrimination only improves welfare if total output increases. In this paper I show that the classical result fails in the presence of subsidies. This finding appears to be relevant for the pharmaceutical sector where a consumer pays a fraction of the actual drug price due to health insurance coverage.     

Pricing and patents of HIV/AIDS drugs in developing countries

This article provides empirical evidence on the impact of patents on drug prices across developing countries. It uses sales data on human immunodeficiency virus (HIV)/acquired immuno deficiency syndrome (AIDS) drugs in a sample of 34 low- and middle-income countries between 1995 and mid-2000. The main findings are that patents do shift drug prices up, drug prices are correlated to per capita income levels and drug firms follow a skimming strategy when pricing new HIV/AIDS drugs. That is, there is across country and intertemporal price discrimination in the global drug markets.     

IMPORTATION AND INNOVATION

Importation of drugs into the US may soon become legal. Since prices of drugs are lower in most other countries than they are in the US, importation would result in a decline in US drug prices. The purpose of this paper is to assess the consequences of importation for new drug development. First, the author presents a simple theoretical model of drug development which suggests that the elasticity of innovation with respect to the expected price of drugs should be at least as great as the elasticity of innovation with respect to expected market size (disease incidence). Then, the cross-sectional relationship between pharmaceutical innovation and market size among a set of diseases (different types of cancer) exhibiting substantial exogenous variation in expected market size is examined. Two different measures of pharmaceutical innovation are analysed: the number of distinct chemotherapy regimens for treating a cancer site and the number of articles published in scientific journals pertaining to drug therapy for that cancer site. Both analyses indicate that the amount of pharmaceutical innovation increases with disease incidence. The elasticity of the number of chemotherapy regimens with respect to the number of cases is 0.53. The elasticity of MEDLINE drug cites with respect to cancer incidence throughout the world is 0.60. In the long run, a 10% decline in drug prices would therefore be likely to cause at least a 5–6% decline in pharmaceutical innovation. Evidence suggests that pharmaceutical industry employment would also decline (by at least 3.5–4%) in response to an exogenous 10% decline in drug prices.     

Regulation and pricing of pharmaceuticals: Reference pricing or price cap regulation?

We study the relationship between regulatory regimes and pharmaceutical firms’ pricing strategies using a unique policy experiment in Norway, which in 2003 introduced a reference price (RP) system called “index pricing” for a sub-sample of off-patent pharmaceuticals, replacing the existing price cap (PC) regulation. We estimate the effect of the reform using a product level panel dataset, covering the drugs exposed to RP and a large number of drugs still under PC regulation in the time before and after the policy change. Our results show that RP significantly reduces both brand-name and generic prices within the reference group, with the effect being stronger for brand-names. We also identify a negative cross-price effect on therapeutic substitutes not included in the RP system. In terms of policy implications, the results suggest that RP is more effective than PC regulation in lowering drug prices, while the cross-price effect raises a concern about patent protection.     

Price regulation of drugs: Lessons from Germany

This paper purports to explain the pricing policy of pharmaceutical companies in Germany prior and after the introduction of reference prices (RP) in 1989. First, the threat of such regulation may have kept prices finite despite a completely insured market. Next, the pricing policies of both the producer of an innovative drug and of a competing generic under RP are predicted. These predictions are then confronted with actual pricing policy for three products in the guise of case studies. Finally, the impact of modified copayment rules on pricing decisions is analyzed.The authors would like to thank Dr Michael Wiegand (Bonn) for valuable information and two anonymous referees for helpful criticisms.     

价格上限规制在药品定价领域的应用

本文从价格上限规制的产生原因、基本理论和规制效果出发,详细介绍了这一价格规制形式的要点。随后,研究了其在药品价格领域的应用,例如价格上限规制和国际价格比较以及参考定价等制度的结合与对比。最后,以我国药品价格管理的现实问题为基础,重点讨论了价格上限规制在我国的应用前景和实施方法。