药物经济学评估与药品定价和支付机制的关系及其对中国的启示

世界各国医疗服务费用都在不断增加,给各国政府带来了极大的经济负担。导致医疗服务费用增长的主要原因之一是由于药品市场在定价与支付,以及在价格调整过程中未尽完善。随着药物经济学评估的发展,越来越多的国家注意到药物经济学评估在上述过程中可发挥的作用。自1993年澳大利亚政府首先将药物经济学评估用于定价和支付机制开始,各国纷纷建立了类似的评估指南作为规范药品的定价和支付的指导。同时也使药物经济学评估成为政府与制药行业之间沟通的桥梁。     

日本与澳大利亚的医用耗材定价和补偿机制分析及启示

随着我国医药卫生体制改革的不断深入,对医用耗材的价格管理也提出新的要求。文章结合我国当前医用耗材价格管理的现状,对日本、澳大利亚的医用耗材定价和补偿机制进行了研究。提出了优化我国医疗服务项目打包收费、发挥循证评价和经济学评价在医用耗材价格形成中的作用、构建医用耗材价格监测体系来完善我国医用耗材价格管理模式。     

台湾地区医保药品的采购模式和支付价格

目的:分析台湾地区医保药品在采购和支付方面的做法和经验,为大陆地区推进药品采购模式和支付价格改革提供参考。方法:系统梳理台湾地区在医保药品采购和支付方面的政策文件和相关文献,并与大陆地区药品采购和支付政策进行对比分析。结果:台湾地区医疗机构根据自身用药需求,自主采购药品,采购价格由供需双方直接谈判形成。政府仅对医保药品的价格进行管理,对新药采用国际参考定价办法;原厂药、BA/BE学名药、一般学名药的支付价以国际参考价格为上限,依次降低。药品质量也在医保支付标准考虑之列。此外,药品的支付价格依据采购价格实行动态调整,当二者差值大于30%时,健保署便会调整支付价格以减小二者的差价。结论:台湾地区通过制度设计和调整,较好地统筹了药品采购和补偿两个环节,形成了合理的药品采购价格和支付价格,这些经验可为中国大陆地区完善药品采购和支付政策提供参考。     

Evidence-Based Decision-Making in Asia-Pacific with Rapidly Changing Health-Care Systems: Thailand, South Korea, and Taiwan

Objective:  To review the use of evidence in the market approval process, reimbursement, and price control mechanisms for medicines and medical devices in Thailand, South Korea, and Taiwan.
Methods:  Documentary reviews supplemented by interviews with senior policymakers of relevant public health authorities.
Results:  Drug regulatory authorities play a vital role in the market authorization process by considering evidence on safety, efficacy and quality for new medicines, and bio-equivalence for new generic products of previously patented medicines. For the formulation of the reimbursement list, all three cases applied evidence on cost-effectiveness, to various degrees, with clear institutional structure, capacity, and functions. Only Thailand has specified an explicit benchmark on cost-effectiveness for inclusion in the reimbursement list. For price control, all have established mechanisms and processes for price negotiation. These mechanisms apply evidence on cost structure and relative prices in other countries to ensure affordable prices, especially with the patented drug industry. Thailand's universal insurance schemes use a capitation payment model which proves effective in implicit price control. To increase access to essential medicines that have patents on and high price, Thailand applied Trade-Related Aspects of Intellectual Property flexibilities; "government use of patent," for public noncommercial purposes to seven essential drugs in 2006 to 2008.
Conclusion:  Rapidly increasing health expenditure and universal health insurance systems have created greater requirement for proof of "value for money" in the approval and funding of new medical technologies. All settings have established clear mechanisms to apply appropriate evidence in the processes of market approval, reimbursement, and pricing control.     

Assessing the impact of the Australia-United States Free Trade Agreement on Australian and global medicines policy

On 1 January 2005, a controversial trade agreement entered into force between Australia and the United States. Though heralded by the parties as facilitating the removal of barriers to free trade (in ways not achievable in multilateral fora), it also contained many trade-restricting intellectual property provisions and others uniquely related to altering pharmaceutical regulation and public health policy in Australia. The latter appear to have particularly focused on the world-respected process of federal government reimbursement after expert cost-effectiveness evaluation, popularly known as the Pharmaceutical Benefits Scheme ('PBS'). It remains uncertain what sort of impacts – if any – the Australia-United States Free Trade Agreement ('AUSFTA') will have on PBS processes such as reference pricing and their important role in facilitating equitable and affordable access to essential medicines.     

Analysis of Medicine Prices in New Zealand and 16 European Countries

ObjectiveTo compare prices of medicines, both originators and generics, in New Zealand and 16 European countries.MethodsEx-factory price data as of December 2012 from New Zealand and 16 European countries were compared for a basket of 14 medicines, most of which were at least partially funded by the state in the 17 countries. Five medicines had, at least in some countries, generic versions on the market whose prices were also analyzed. Medicine price data for the 16 European countries were provided by the Pharma Price Information service. New Zealand medicine prices were retrieved from the New Zealand Pharmaceutical Schedule. Unit prices converted into euro were compared at the ex-factory price level.ResultsFor the 14 medicines surveyed, considerable price differences at the ex-factory price level were identified. Within the European countries, prices in Greece, Portugal, the United Kingdom, and Spain ranked at the lower end, whereas prices in Switzerland, Germany, Denmark, and Sweden were at the upper end. The results for New Zealand compared with Europe were variable. New Zealand prices were found in the lowest quartile for five medicines and in the highest quartile for seven other products. Price differences between the originator products and generic versions ranged from 0% to 90% depending on the medicine and the country.ConclusionsMedicine prices varied considerably between European countries and New Zealand as well as among the European countries. These differences are likely to result from national pricing and reimbursement policies.     

Managed entry agreements for pharmaceuticals in Australia

In Australia, a number of managed entry agreements have been developed to enable national coverage of new medicines. Non-outcome based agreements are usually pricing arrangements that involve price or volume rebate agreements. In February 2013, there were at least 71 special pricing arrangements in place, including 26 for medicines restricted to use in hospitals. Health outcome based agreements can be made at the individual or population level. At the individual level, there were 28 medicines funded subject to continuation rules involving documentation of adequate benefit within the individual; some of these medicines also had price agreements in place. At the population level, only one outcome-based agreement has been implemented so far, for bosentan, a medicine marketed for pulmonary hypertension. In May 2010, a memorandum of understanding signed between the Australian Government and Medicines Australia, the peak pharmaceutical industry organisation, included the possibility for industry to request consideration of a ‘Managed Entry Scheme’ as part of the funding submission process for medicines with high clinical needs. It includes the possibility of a randomised controlled trial (RCT)-based entry scheme. Although this form of managed entry has yet not been trialed in Australia, several 2012/2013 funding recommendations included requests by the decision making committee for further evidence development.     

Impact of Cross-Reference Pricing on Pharmaceutical Prices

Objective

Several EU countries are determining reimbursement prices of pharmaceuticals by cross-referencing prices of foreign countries. Our objective is to quantify the theoretical cross-border spill-over effects of cross-reference pricing schemes on pharmaceutical prices in the former EU-15 countries.

Methods

An analytical model was developed estimating the impact of pharmaceutical price changes in Germany on pharmaceutical prices in other countries in the former EU-15 using cross-reference pricing. We differentiated between the direct impact (from referencing to Germany directly) and the indirect impact (from referencing to other countries that conduct their own cross-reference pricing schemes).

Results

The relationship between the direct and indirect impact of a price change depends mainly on the method applied to set reimbursement prices. When applying cross-reference pricing, the reimbursement price is either determined by the lowest of foreign prices (e.g. Portugal), the average of foreign prices (e.g. Ireland) or a weighted average of foreign prices (e.g. Italy). If the respective drug is marketed in all referenced countries and prices are regularly updated, a price reduction of € 1.00 in Germany will reduce maximum reimbursement prices in the former EU-15 countries from €0.15 in Austria to €0.36 in Italy.

Discussion

On one side, the cross-border spill-over effects of price reductions are undoubtedly welcomed by decision makers and may be favourable to the healthcare system in general. On the other side, these cross-border spill-over effects also provide strong incentives for strategic product launches, launch delays and lobbying activities, and can affect the effectiveness of regulation.

Conclusions

To avoid the negative effects of cross-reference pricing, a weighted index of prices from as many countries as possible should be used to determine reimbursement prices in order to reduce the direct and indirect impact of individual countries.     

Balancing health and industrial policy objectives in the pharmaceutical sector: lessons from Australia

INTRODUCTION: Policy-makers worldwide struggle to balance health with industrial policy objectives in the pharmaceutical sector. Tensions arise over pricing and reimbursement in particular. What health plans view as necessary to maintain equitable access to medicines, industry views as inimical to R&D and innovation. Australia has grappled with this issue for years, even incorporating the goal of "maintaining a responsible and viable medicines industry" into its National Medicines Policy. METHODS: This case study was conducted via a narrative review that examined Australia's experiences balancing health and industrial policy objectives in the pharmaceutical sector. The review included electronic databases, grey literature and government publications for reports on relevant Australian policy published over the period 1985-2007. RESULTS: While pharmaceutical companies claim that Australia's pricing and reimbursement policies suppress drug prices and reduce profits, national policy audits indicate these claims are misguided. Australia appears to have secured relatively low prices for generics and "me-too drugs" while paying internationally competitive prices for "breakthrough" medicines. Simultaneously, Australia has focused efforts on local pharmaceutical investment through a variety of industry-targeted R&D incentive policies. DISCUSSION: Despite the fact that policy reviews suggest that Australia has achieved balance between health and industrial policy objectives, the country continues to face criticism from industry that its health goals harm innovation and R&D. Recent reforms raise the question whether Australia can sustain the apparent balance.     

The End of the International Reference Pricing System?

All 28 EU member states except Sweden and the UK apply international reference pricing (IRP), international price comparison, external reference pricing or cross-reference pricing. The attractiveness of using prices of other countries as a benchmark for decisions within a national price control is obvious. Alternative models for price and reimbursement decision making such as value-based pricing (VBP), i.e. cost-effectiveness analyses, are more complicated. However, IRP provides incentives for stakeholders to take action not in line with optimal (welfare-maximizing) pricing. IRP is costly for two reasons. First, manufacturers are incentivised to limit or delay access to new innovative treatments in countries with small markets and/or a low income, which can be costly in terms of loss of health. Second, all countries also experience a loss of welfare (health) because IRP reduces the opportunities for differential pricing (Ramsey pricing), i.e. using the fact that the ability and willingness to pay differs between countries. Thus, IRP results in less sales revenue to finance research and development of new innovative drugs. We can now observe that payers and manufacturers are engaged in different types of risk-sharing schemes, price–volume negotiations, payback arrangements, confidential discounts, coverage with evidence developments, etc., all with the purpose of returning to the old model of price discrimination and Ramsey pricing. Shortly, real prices for use in IRP systems will cease to exist and, thus, we expect to soon see the end of IRP, a new system for price discrimination and an increasing demand for VBP.     

Competition in the off-patent medicine market in Spain: The national reference pricing system versus the regional system of tendering for outpatient prescription medicines in Andalusia

Spain has a reference price system (RPS) for off-patent medicines since 1997. In addition, from 2012, Andalusia is running a series of tenders for procuring off-patent medicines dispensed by community pharmacies, for those medicines included in the system of homogenous clusters within the national reference price system. Such tenders offer additional savings to the regional payer – in the form of rebates (“economic improvements”) from companies winning the tender. This paper estimates that the regional savings were between €43 M to €54 M over the period of study (April – September 2015). The paper also estimates that Spain could have made between 14 and 17 times higher savings than the national reference pricing system savings, had the Andalusian-type tender been implemented at national level over the same period of study. Based on our analysis, we have four remarks. First, the national RPS in Spain is not generating enough price competition for off-patent products dispensed in primary care pharmacies. Second, tenders can be a useful way to generate competition and financial savings in the off-patent market. Third, tenders can lead to discounts offered by medicine providers being redistributed from pharmacies to payers. And fourth, before implementing a national tender in Spain, several key issues need to be addressed to ensure it provides the right incentives both in the short and long run.     

Project of Polish guidelines for conducting pharmacoeconomic evaluations in comparison to international health economic guidelines

We present the project of Polish guidelines for conducting economic evaluation and compare them with international health economic guidelines, highlighting areas of agreement and dissent. The Polish guidelines are very similar to those in Australia, Canada, and some European Union countries. Nevertheless a number of implementation and attitude problems seem to have delayed the introduction of pharmacoeconomic evaluation as a prerequisite for reimbursement of new pharmaceutical products. A transitional phase is required for collecting reliable cost data and familiarizing and training personnel both in public authorities and private industry.     

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。     

我国药品价格政策分析和改革思路探讨

我国政府一直通过不同措施控制药品价格。目前政府对药品实行按社会平均成本,直接制定每一种药品的价格。这种定价机制的困难在于如何获得真实的企业生产成本信息。单纯通过降低药品价格控制药品费用增长,其作用是非常有限的。药品价格改革必须与医院补偿机制改革、社会医疗保险制度改革相协调。在改革药品定价机制时,可以考虑使用参考定价的方法,引入药物经济学的评价;加强对药品价格改革的研究和监督,评价药品价格改革对基本药物可及性的影响。     

医保支付价背景下药物经济学评价的应用探索

针对我国医保支付价存在的"劣药驱逐良药"与评价流程不规范的问题,通过借鉴国外经验,为我国医保支付价制定及经济学评价流程的规范提出合理建议。     

日本药品价格制度研究及对我国药品价格管理的启示

目的:分析和研究日本药品价格管理机制,为中国药品价格政策制定提供借鉴与参考。方法:文献比较研究和描述性分析。结果:日本药品费用控制合理,很大程度上得益于日本统一、有效的药品价格管理制度,其市场已经建立起价格制定的完整体系,尤其在创新药品定价、国际价格比较、仿制药一致性评价以及仿制药定价等诸方面有较为科学的流程与依据。结论:日本药品价格管理的实质是实施医保支付价管理,这为中国未来医保支付价制定和建立科学价格管理机制提供了参考。     

A re-examination of the impact of reference pricing on anti-hypertensive drug plan expenditures in British Columbia

Reference pricing (RP) limits drug plan reimbursement of interchangeable medicines to a reference price, which is typically equal to the price of the lowest-cost interchangeable drug; any cost above that is borne by the patient. Much of the evidence of the effects of RP comes from 'before and after' studies of the RP scheme adopted by Pharmacare, the publicly funded drug plan for seniors and others in British Columbia, Canada. We critically assess the identifying assumption inherent in the before and after design - namely, that pre-RP trends accurately predict counterfactual outcomes - in the context of estimating the impact of RP on Pharmacare's expenditure on anti-hypertensive drugs for its senior beneficiaries. We use similar data from a public plan that has not introduced RP to estimate the effects on drug expenditures of patent expiration, secular changes in prescribing patterns and various other factors common to all Canadian public drug plans that could potentially confound the before and after estimates of the effect of RP on drug plan expenditures. We find that controlling for such factors reduces estimates of drug plan savings attributable to RP of the Calcium Channel Blockers by about half.     

上海市中医医院收入与支出分析

目标:测算上海市中医医院2002—2007年财务收支情况。资料与方法:采用上海市4家三级中医院、16家二级中医院的财务数据,以及来自关键知情人的访谈资料,进行描述性分析。结果:上海市中医医院相比于综合医院更易受到政策药品差价控制的影响。因人员支出的上升和药品加成率的下降,上海市中医医院2007年亏损1.88亿,占全市公立医院亏损的大部分。建议:在成本核算的基础上推进中医医疗服务的合理定价和优化补偿结构,完善中医医院的补偿机制,保证药品质量的基础上鼓励中药的使用。