瑞典药品补偿政策改革对药品费用支出的影响

目的:了解1986-2002年瑞典药品补偿政策改革引起的药品费用与数量的变化趋势.方法:利用瑞典所有已经注册的药品和5个指标药来评价1986-2002年补偿政策改革的结果,并由瑞典国家药品公司提供全国所有药房的药品交易数据.这期间有五次补偿政策改革,其中有三次提高共付比例,一次启用参考价格机制和提高累积个人支付费用和一次补偿政策的结构调整.结果:分阶段线性回归分析,增加累计个人支付费用,药品的费用和数量变化没有相关关系;新的补偿政策导致总药品和某些指标药的费用和数量的水平下降;启用参考定价政策减少了总药品和5个指标药的限定日剂量的价格水平.结论:补偿制度的大调整对药品的费用,数量和价格有明显影响,即新的补偿政策(新的结构调整)使药品费用和数量有所减少,启用参考定价政策会导致药品单价降低.     

从国际视角看我国的药品定价、补偿和可及性问题

随着药品费用的快速增长,药品政策在我国显得愈发重要。药品政策出台的目的是有效控制药品费用,而截至目前为止,这些政策的实施效果仍不尽如人意。通过比较研究的方法,对我国药品定价、补偿和可及性等问题提出一些政策建议。这些建议不仅是针对药品费用问题,更多的是针对正在不断增长的卫生费用问题。     

中国药品定价和补偿政策及其效果

背景:近年来,中国药物政策存在着药品费用快速增长,以及质量、定价和提供能力等方面的问题,其解决的关键在于理清其中的定价和补偿问题。方法:本文较为系统收集了药物领域的学术文献和灰色文献,以及中国政府的官方统计数据,并结合中国国务院发展研究中心举办的研讨会信息,概述了中国的药品定价和补偿情况。结果:通过一个融合了供应方、代理方和需求方多方政策的框架,分析了定价与补偿政策。在目前药品政策的相互影响下,出现了药品价格高、质量低、不合理开药等问题。分立的监管环境也不利于药品政策的改革。结论:提高药品质量标准、市场集中度、政府补贴,以质量为导向的招标、扩大零差率政策的实施范围、建立补偿与合理开药的联动机制以及促进卫生技术评估与比较效能研究来改善定价和补偿政策。另外,整合广泛的监管分立体制、改善透明度和打击腐败等问题将有助于确保制定出具有一致性的、循证的政策。     

我国医保药品支付标准建设的理论与现实分析

建立针对药品的医疗保险支付标准(参考价)是多国控制药品费用不合理增长的重要措施。医保药品支付标准通过药品价格竞争刺激患者需求和增强患者选择的权利来影响医生行为和药品企业定价。我国放开药品政府定价后也亟需建立适应药品市场发展的价格形成机制,建立医保药品支付标准需要从我国药品管理政策转变和现状出发,厘清控费的具体机制,根据当前我国实践中存在的问题,从药物经济学评价、药品分级分类管理、完善医保药品支付方式和补偿机制、合理分配补偿结余等方面入手,提升药品的可及性、费用的可控性和政策的激励性。     

部分发达国家药品价格管制政策比较及启示

目的：分析比较主要发达国家的国家药品价格政策或措施，为我国药品定价政策改革提供建议。方法：文献综述和比较法。内容：法国、德国、英国等国家药品价格政策的实施、优缺点等。结果：国家药品价格政策实施具有综合性；政策的因地制宜；影响药品费用的多因素性；政策实施效果的有限性；直接控制的国家比间接控制的国家药品价格水平低。建议：药品价格改革必须与医疗保险等改革配套；采取多种费用控制措施；药品价格改革不应损害本国医药产业的健康发展；充分考虑政策对卫生服务供方的影响，尤其是对医生既得利益的影响。     

药物经济学的研究进展

2003年6月,第四届国际卫生经济学会重点讨论了药品增长对健康和医疗成本的影响。在本次大会上有1个专题:“在亚洲经济中的药品定价”,日本、中国、韩国和台湾地区分别介绍了在药品定价和药品降价政策的效果。了解亚洲不同国家对药物定价的情况对药品合理定价很有帮助。1有关新药问题的讨论估计发展1种新药的成本对认识药品费用的增长是有帮助的。过去都建立在单个药物的调查基础上,目前,采用Du-Masi(1991年)成本模拟模型的方法,将所有的投入参数按随机变数来处理,由临床研究各期的成本参数来决定。发现估计成本的可信限范围很大,要达到平均…     

药品降价政策对医院经营的影响分析

药品降价政策是遏制药品虚高定价及药品费用过快上涨的调控对策之一,其实施对医院经营具有直接的影响。通过对样本医院3年运行状况的调查,探讨医院经营模式的变化趋势与现行政策的效果,分析存在的问题,并提出相应的对策和建议。     

我国低价药品目录的品种及价格分析

目的:分析低价药品政策可能产生的影响及实施过程中存在的问题。方法:检索国家食品药品监督管理总局等相关网站,收集低价药品清单中相关药品说明书;计算全国各省2009年1月—2014年8月不同企业品种中标价格对应的最高日均药品费用、最低日均药品费用等指标。结果:(1)低价药品清单中包含533种通用名药品,和基本药物品种的重合率为51.59%;97.56%的低价药品种纳入国家医保目录。(2)不同企业生产的同种药品中标价格对应的最高日均药品费用和最低日均药品费用的差值为0.01元~30.96元;89.1%的西药品种剂型低于限价标准。(3)不同低价药品生产企业中标价的日均药品费用差为0.01元~19.35元;92.13%的中成药品种低于限价标准。讨论:低价药品清单纳入品种缺乏严谨论证;低价药品定价的合理性和效果尚需验证;低价药品价格管理政策与其他政策的衔接仍需明确。     

中低收入国家药品定价和采购的政策选择

药品支出上涨是全球问题。为应对这一压力,多数高收入国家制定并实施了一系列的药品定价和采购政策。然而,尽管中低收入国家希望能够有效控制药品支出预算,但其药品市场不规范,并缺乏可行的药品定价或采购政策。高收入国家药品支出通常由国家或社会医疗保险机构支付,而中低收入国家大多是个人自付,这会给政策执行造成阻力。由于对药品定价和采购政策是否高效缺乏严谨的调查研究,因而一定程度上阻碍了中低收入国家政策方案的实施。本文对已发表的有关药品定价和采购政策的文章进行综述发现,许多有效的政策也伴随着各种风险。全球尚没有一种最佳的政策选择,各国应根据具体国情,多种政策结合使用。中低收入国家的实证研究尚不足,由于缺乏完善的法律体系以及未建立专门的药品采购机构,任何一种政策选择所伴随的风险在这些国家都会引起更大的争议,然而这或许是帮助其改善药品定价和采购体系的关键因素。     

关于药品费用问题的探讨

该文从药品的生产、流通、消费、价格管理等各个环节分析了药品费用过快增长的原因,对现行的药品价格管理办法进行了讨论,介绍了国外药品费用控制政策,提出了综合治理药费问题的若干政策建议。     

Pharmaceutical reference pricing in Germany: definition of therapeutic groups, price setting through regression procedure and effects

The German reference pricing system defines a reimbursement threshold for groups of pharmaceuticals. Pharmaceuticals are grouped according to certain criteria by the Federal Joint Committee. To make different active ingredients comparable, so called reference values are defined. Subsequently, the federal association of sickness funds sets reference prices using a regression procedure. However, the impact of the reference price system is limited. On the one hand there is a strong incentive for pharmaceutical companies to decrease prices to the reference price. On the other hand there is no incentive for further price reductions. Additionally, only one part of the pharmaceutical market is affected by reference pricing. Therefore the instrument has only managed to lower pharmaceutical expenditure in the short run. For sustainable long-term cost containment the use of other regulatory instruments is necessary. Nevertheless, compared to other instruments of price-regulation, reference pricing seems to be a good alternative to control pharmaceutical prices, since rationing is kept as little as possible.     

Regulation of pharmaceutical markets in Germany: improving efficiency and controlling expenditures?

Rising pharmaceutical expenditure has become a major concern for policy makers in Germany over recent years. Therefore, the pharmaceutical market has been increasingly targeted by different kinds of regulation, focussing on both the supply and the demand side, using price, volume and spending controls. Specific regulations include price reductions, reference pricing, pharmacy rebates for sickness funds, increasing co-payments, an 'autidem' substitution, parallel imports, a negative list, directives, and finally, spending caps for pharmaceutical expenditure per physicians' association. Although it is difficult to attribute certain effects to single measures, some measures like reference pricing and physician spending caps are more effective and long-lasting than others. In spite of being opposed by physicians, the spending caps applied between 1993 and 2001 have limited pharmaceutical expenditure for an entire decade. However, while some measures do effectively control expenditures, their effect on allocative efficiency may be detrimental.     

Australian pharmaceutical policy: price control, equity, and drug innovation in Australia

This paper outlines the increasing salience of drug "innovation" in the debate for reform of Australia's pharmaceutical policy, particularly change to Australia's price control mechanisms. The pharmaceutical industry has consistently criticised the central role of price control in Australia's pharmaceutical regulatory regime as an impediment to drug innovation and industry growth. Despite ambivalent or contrary evidence on the impact of price control on drug innovation, this criticism, and the appeals for reform it supports, appear to be increasingly influential in directing pharmaceutical policy. This is particularly evident in the implementation of the Australia/United States Free Trade Agreement, which has led to a weakening of the historical process of evidence-based reference pricing in Australia. Should drug innovation come to dominate Australian pharmaceutical policy, there is the potential to precipitate a devaluing of the current public orientation of regulation and diminish equitable access to affordable pharmaceuticals. The manner in which trade policy has effectively undermined a publicly funded pharmaceutical benefits scheme has clear implications for many countries that maintain such programmes.     

我国药品价格管制的政策选择

我国已建立起一整套药品价格管制政策，但是，以成本加成为基础的价格管制与其他体制与机制性因素互动作用后，促成并强化了我国特定背景下医药不正当利益纽带关系。现行的成本加成定价管理是对企业创新产生的成本的补偿，而不是对企业创新产生的价值的回报。在成本加成的定价管理基础上，综合考虑药品的创新程度及其对医疗费用的影响，同时参考周边国家和地区同一药品品种的市场销售价格，可以作为我国药品价格管制变革的替代性方案。更长远地，我国应该构建以价值为基础的药品价格管制方式，以药品的成本效果为导向合理确定其相对价格水平。对仿制药可借鉴国际经验采用参考定价方法。     

How the Trans Pacific Partnership Agreement could undermine PHARMAC and threaten access to affordable medicines and health equity in New Zealand

New Zealand's Pharmaceutical Management Agency (PHARMAC) has been highly successful in facilitating affordable access to medicines through a combination of aggressive price negotiations, innovative procurement mechanisms, and careful evaluation of value for money. Recently the US government, through the establishment of a series of bilateral and plurilateral “free” trade agreements, has attempted to constrain the pharmaceutical access programs of other countries in order to promote the interests of the pharmaceutical industry. The Trans Pacific Partnership Agreement (TPPA) represents the latest example; through the TPPA the US is seeking to eliminate therapeutic reference pricing, introduce appeals processes for pharmaceutical companies to challenge formulary listing and pricing decisions, and introduce onerous disclosure and “transparency” provisions that facilitate industry involvement in decision-making around coverage and pricing of medicines (and medical devices). This paper argues that the US agenda, if successfully prosecuted, would be likely to increase costs and reduce access to affordable medicines for New Zealanders. This would in turn be likely to exacerbate known inequities in access to medicines and thus disproportionately affect disadvantaged population groups, including Māori and Pacific peoples.     

Restoring a reputation: invoking the UNESCO Universal Declaration on Bioethics and Human Rights to bear on pharmaceutical pricing

In public health, the issue of pharmaceutical pricing is a perennial problem. Recent high-profile examples, such as the September 2015 debacle involving Martin Shkreli and Turing Pharmaceuticals, are indicative of larger, systemic difficulties that plague the pharmaceutical industry in regards to drug pricing and the impact it yields on their reputation in the eyes of the public. For public health ethics, the issue of pharmaceutical pricing is rather crucial. Simply, individuals within a population require pharmaceuticals for disease prevention and management. In order to be effective, these pharmaceuticals must be accessibly priced. This analysis will explore the notion of corporate social responsibility in regards to pharmaceutical pricing with an aim of restoring a positive reputation upon the pharmaceutical industry in the public eye. The analysis will utilize the 2005 United Nations Educational, Scientific, and Cultural Organization’s Universal Declaration on Bioethics and Human Rights (UDBHR) to establish implications regarding the societal responsibilities of pharmaceutical companies in a global context. To accomplish this, Article 14 of the UDBHR—social responsibility and health—will be articulated in order to advocate a viewpoint of socially responsible capitalism in which pharmaceutical companies continue as profit-making ventures, yet establish moral concern for the welfare of all their stakeholders, including the healthcare consumer.     

Pharmaceutical policy in China

Contradictory goals plague China's pharmaceutical policy. The government wants to develop the domestic pharmaceutical industry and has used drug pricing to cross-subsidize public hospitals. Yet the government also aims to control drug spending through price caps and profit-margin regulations to guarantee access even for poor patients. The resulting system has distorted market incentives, increased consumers' costs, and financially rewarded inappropriate prescribing, thus undermining public health. Pharmaceuticals account for about half of total health spending in China, representing 43 percent of spending per inpatient episode and 51 percent of spending per outpatient visit. Yet some essential medicines are unavailable or of questionable quality.     

Pharmaceutical regulation in Greece at the crossroad of change: economic, political and constitutional considerations for a new regulatory paradigm

This paper examines the economic, political and legal characteristics of the Greek pharmaceutical market, which is largely affected by the paradox of state intervention: while pharmaceutical regulation is mainly directed towards a rationalisation of total pharmaceutical expenditure, all measures taken to date aim at exhaustive pricing controls, i.e. interventions on the supply side alone, disregarding the "balloon" effect of shrinking prices on the expanding volume of consumption. As a result, pharmaceutical expenditure has been steadily rising, adding a disproportional burden on both social insurance and private income. The "unconstitutionality" of current pricing regulations exerted further pressure for a comprehensive reform. The paper proposes an alternative regulatory paradigm, which is loosely founded on European experience with regulating pharmaceutical markets. The conclusions of the economic, political and constitutional analysis help formulate a proposal for a comprehensive pharmaceutical policy that could assure the financial viability of the system as well as adhere to the principle of "legality", as the latter is constitutionally defined.