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Ten years of German benefit assessment: price analysis for drugs with unproven additional benefit. 德国效益评估十年:未证实额外效益的药物价格分析。
IF 3 3区 医学 Q2 HEALTH POLICY & SERVICES Pub Date : 2024-04-01 Epub Date: 2023-08-14 DOI: 10.1017/S1744133123000117
Katrin Kleining, Jan Laufenberg, Philip Thrun, Dorothee Ehlert, Jürgen Wasem, Arne Bartol

Introduction: Since 2011, the prices for all new drugs in Germany are negotiated based on a benefit assessment. The purpose of this study was to analyze the price regulation of drugs with unproven additional benefit.

Methods: Benefit assessment procedures from 2011 to 2020 were reviewed and selected through AMNOG Monitor and Lauer Taxe. Negotiated annual therapy costs, the annual costs of the most cost-efficient appropriate comparative therapy (ACT) and the potential budget impact for 33 included procedures were calculated.

Results: 55% of the included drugs achieved a negotiated price higher than the most cost-efficient ACT, 3% were identified as equal and 42% showed lower negotiated prices. The potential savings exceeded expenditures by around EUR 523.5 m. After price flexibility was adopted by the legislator in 2017, the overall potential savings still outweighed the expenditures by around EUR 62 m.

Conclusions: Our analysis shows that making price negotiations more flexible by law does not undermine the fundamental aim of the AMNOG, which is to avoid additional expenditure without increased patient benefit. The regulation can thus fulfill the objective provided by the legislature of keeping drugs without proven additional benefits in the German healthcare system.

导言:自 2011 年起,德国所有新药的价格均根据效益评估结果进行协商。本研究的目的是分析未经证实具有额外益处的药品的价格监管情况:方法:通过 AMNOG Monitor 和 Lauer Taxe 对 2011 年至 2020 年的效益评估程序进行了审查和筛选。计算了33种纳入程序的谈判年度治疗成本、最具成本效益的适当比较疗法(ACT)的年度成本以及潜在的预算影响:结果:55% 的纳入药物的谈判价格高于最具成本效益的 ACT,3% 的药物被确定为相同价格,42% 的药物的谈判价格较低。在立法者于 2017 年采用价格灵活性后,总体潜在节余仍超过支出约 6 200 万欧元:我们的分析表明,通过法律提高价格谈判的灵活性并不会损害 AMNOG 的基本目标,即在不增加患者利益的情况下避免额外支出。因此,该法规可以实现立法机构规定的目标,即在德国医疗保健系统中保留经证实无额外益处的药品。
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引用次数: 0
New governance of the digital health agency: a way out of the joint decision trap to implement electronic health records in Germany? 数字医疗机构的新管理:德国实施电子病历的联合决策陷阱的出路?
IF 3 3区 医学 Q2 HEALTH POLICY & SERVICES Pub Date : 2024-04-01 Epub Date: 2023-09-11 DOI: 10.1017/S1744133123000142
Tugce Schmitt

Fragmentation in health systems leads to discontinuities in the provision of health services, reduces the effectiveness of interventions, and increases costs. In international comparisons, Germany is notably lagging in the context of healthcare (data) integration. Despite various political efforts spanning decades, intersectoral care and integrated health data remain controversial and are still in an embryonic phase in the country. Even more than 2 years after its launch, electronic health record (elektronische Patientenakte; ePA) users in Germany constitute only 1 per cent of the statutorily insured population, and ongoing political debates suggest that the path to broader coverage is fraught with complexities. By exploring the main stakeholders in the existing (fragmented) health system governance in Germany and their sectoral interests, this paper examines the implementation of ePA through the lens of corporatism, offering insights based on an institutional decision theory. The central point is that endeavours to better integrate health data for clinical care, scientific research and evidence-informed policymaking in Germany will need to address the roles of corporatism and self-governance.

医疗系统的分散导致医疗服务的不连续性,降低了干预措施的有效性,并增加了成本。在国际比较中,德国在医疗保健(数据)整合方面明显落后。尽管数十年来在政治上做出了各种努力,但跨部门医疗和整合医疗数据在德国仍存在争议,而且仍处于萌芽阶段。即使在电子病历(elektronische Patientenakte;ePA)推出两年多之后,德国的电子病历用户也仅占法定投保人口的 1%,而持续不断的政治辩论表明,实现更广泛覆盖的道路充满了复杂性。通过探究德国现有(分散的)医疗系统治理中的主要利益相关者及其部门利益,本文从公司主义的视角审视了 ePA 的实施情况,提出了基于制度决策理论的见解。本文的核心观点是,德国要想更好地整合医疗数据,用于临床护理、科学研究和循证决策,就必须处理好公司主义和自治的作用。
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引用次数: 0
We need to talk about values: a proposed framework for the articulation of normative reasoning in health technology assessment. 我们需要讨论价值观:一个在卫生技术评估中阐明规范推理的拟议框架。
IF 3 3区 医学 Q2 HEALTH POLICY & SERVICES Pub Date : 2024-04-01 Epub Date: 2023-09-27 DOI: 10.1017/S1744133123000038
Victoria Charlton, Michael DiStefano, Polly Mitchell, Liz Morrell, Leah Rand, Gabriele Badano, Rachel Baker, Michael Calnan, Kalipso Chalkidou, Anthony Culyer, Daniel Howdon, Dyfrig Hughes, James Lomas, Catherine Max, Christopher McCabe, James F O'Mahony, Mike Paulden, Zack Pemberton-Whiteley, Annette Rid, Paul Scuffham, Mark Sculpher, Koonal Shah, Albert Weale, Gry Wester

It is acknowledged that health technology assessment (HTA) is an inherently value-based activity that makes use of normative reasoning alongside empirical evidence. But the language used to conceptualise and articulate HTA's normative aspects is demonstrably unnuanced, imprecise, and inconsistently employed, undermining transparency and preventing proper scrutiny of the rationales on which decisions are based. This paper - developed through a cross-disciplinary collaboration of 24 researchers with expertise in healthcare priority-setting - seeks to address this problem by offering a clear definition of key terms and distinguishing between the types of normative commitment invoked during HTA, thus providing a novel conceptual framework for the articulation of reasoning. Through application to a hypothetical case, it is illustrated how this framework can operate as a practical tool through which HTA practitioners and policymakers can enhance the transparency and coherence of their decision-making, while enabling others to hold them more easily to account. The framework is offered as a starting point for further discussion amongst those with a desire to enhance the legitimacy and fairness of HTA by facilitating practical public reasoning, in which decisions are made on behalf of the public, in public view, through a chain of reasoning that withstands ethical scrutiny.

人们承认,卫生技术评估是一项固有的基于价值的活动,它利用规范推理和经验证据。但是,用于概念化和阐明HTA规范方面的语言显然是未经授权、不精确和不一致的,破坏了透明度,阻碍了对决策依据的适当审查。这篇论文是由24名在医疗保健优先事项设定方面具有专业知识的研究人员进行的跨学科合作开发的,旨在通过对关键术语进行明确定义并区分HTA期间援引的规范承诺类型来解决这一问题,从而为推理的阐述提供一个新的概念框架。通过对一个假设案例的应用,说明了该框架如何作为一种实用工具运作,通过该工具,HTA从业者和决策者可以提高决策的透明度和一致性,同时使其他人更容易追究他们的责任。该框架是那些希望通过促进实际的公众推理来提高HTA的合法性和公平性的人之间进一步讨论的起点,在公众视野中,通过一系列经得起道德审查的推理来代表公众做出决定。
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引用次数: 0
How reforms hamper priority-setting in health care: an interview study with local decision-makers in London. 改革如何阻碍医疗保健优先事项的确定:对伦敦地方决策者的访谈研究。
IF 3 3区 医学 Q2 HEALTH POLICY & SERVICES Pub Date : 2024-04-01 Epub Date: 2023-09-14 DOI: 10.1017/S174413312300021X
Katharina Kieslich, Clare Coultas, Peter Littlejohns

The fair allocation of scarce resources for health remains a salient topic in health care systems. Approaches for setting priorities in an equitable manner include technical ones based on health economic analyses, and ethical ones based on procedural justice. Knowledge on real-world factors that influence prioritisation at a local level, however, remains sparse. This article contributes to the empirical literature on priority-setting at the meso level by exploring how health care planners make decisions on which services to fund and to prioritise, and to what extent they consider principles of fair priority-setting. It presents the findings of an interview study with commissioners and stakeholders in South London between 2017 and 2018. Interviewees considered principles of fair prioritisation such as transparency and accountability important for offering guidance. However, the data show that in practice the adherence to principles is hampered by the difficulty of conceptualising and operationalising principles on the one hand, and the political realities in relation to reform processes on the other. To address this challenge, we apply insights from the policy and political sciences and propose a set of considerations by which current frameworks of priority-setting might be adapted to better incorporate issues of context and politics.

公平分配稀缺的卫生资源仍然是医疗系统的一个突出问题。以公平的方式确定优先事项的方法包括基于卫生经济分析的技术方法和基于程序正义的伦理方法。然而,在现实世界中,影响地方一级确定优先次序的因素仍然很少。本文通过探讨医疗保健规划者如何决定为哪些服务提供资金和确定优先次序,以及他们在多大程度上考虑了公平确定优先次序的原则,为有关中观层面优先次序确定的实证文献做出了贡献。报告介绍了 2017 年至 2018 年间对伦敦南部地区的专员和利益相关者进行访谈研究的结果。受访者认为,透明度和问责制等公平确定优先次序的原则对于提供指导非常重要。然而,数据显示,在实践中,原则的遵守受到了阻碍,一方面是难以概念化和操作化原则,另一方面是与改革进程相关的政治现实。为了应对这一挑战,我们运用了政策和政治科学的见解,并提出了一系列考虑因素,通过这些考虑因素,可以调整当前的优先事项制定框架,以更好地纳入背景和政治问题。
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引用次数: 0
Pricing of hospital services: evidence from a thematic review. 医院服务定价:专题审查的证据。
IF 3 3区 医学 Q2 HEALTH POLICY & SERVICES Pub Date : 2024-04-01 Epub Date: 2024-02-05 DOI: 10.1017/S1744133123000397
Andria J N Sirur, Rajasekharan Pillai K

The management implications of pricing healthcare services, especially hospitals, have received insufficient scholarly attention. Additionally, disciplinary overlaps have led to scattered academic efforts in this domain. This study performs a thematic synthesis of the literature and applies retrospective analysis to hospital service pricing articles to address these issues. The study's inputs were sourced from well-known online repositories, using a structured search string and PRISMA flow chart to select the pertinent documents. Our thematic analysis of pricing literature encompasses: (a) comprehension of hospital service pricing nature; (b) pricing objectives, strategies and practices differentiation; (c) presentation of factors impacting hospital service pricing. We observe that hospital pricing is an intricate and unclear matter. The terms 'pricing strategies' and 'pricing practices' are often used interchangeably in academic literature. Hospital service pricing is influenced by costs, demand and supply factors, market structure, pricing regulation and third-party reimbursements. The study's findings provide policy implications for service pricing in hospitals, in addition to suggesting avenues for future research on hospital pricing.

医疗保健服务(尤其是医院)定价对管理的影响尚未得到学术界的充分关注。此外,学科重叠也导致该领域的学术研究分散。本研究对文献进行了专题综述,并对医院服务定价文章进行了回顾性分析,以解决这些问题。本研究的资料来源于著名的在线资料库,使用结构化搜索字符串和 PRISMA 流程图来选择相关文献。我们对定价文献的专题分析包括:(a)对医院服务定价性质的理解;(b)定价目标、策略和做法的差异化;(c)对影响医院服务定价因素的介绍。我们发现,医院定价是一个复杂而不明确的问题。在学术文献中,"定价策略 "和 "定价实践 "这两个术语经常交替使用。医院服务定价受成本、供求因素、市场结构、定价监管和第三方补偿的影响。研究结果为医院服务定价提供了政策启示,同时也为医院定价的未来研究提出了建议。
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引用次数: 0
Value assessment and decision-making: how to move health systems forward? 价值评估和决策:如何推动卫生系统向前发展?
IF 3 3区 医学 Q2 HEALTH POLICY & SERVICES Pub Date : 2024-04-01 Epub Date: 2024-07-10 DOI: 10.1017/S1744133124000082
Iris Wallenburg, Rocco Friebel
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引用次数: 0
Managed competition in Aotearoa New Zealand: past experiences and future prospects. 新西兰奥特亚罗瓦的管理竞争:过去的经验和未来的前景。
IF 1.7 3区 医学 Q2 HEALTH POLICY & SERVICES Pub Date : 2024-02-14 DOI: 10.1017/S1744133123000403
Jacqueline Cumming

This paper considers whether and how managed competition arrangements could be introduced into the Aotearoa health and disability system. The paper describes the key features of the system, including new organisational arrangements established from 1 July 2022. It discusses major reforms and managed competition plans that were developed in the 1990s, with the managed competition plans abandoned fairly early on, as a result of major issues with the reforms that had been implemented and with problems in designing a fair payment system for competing health plans. The paper goes on to argue that the development of capitated, risk-bearing and competing Primary Health Organisations set up in the 2000s should be considered in terms of managed competition, and the paper points to the issues that have arisen in Aotearoa due to a lack of regulations that would have better supported the better achievement of effectiveness, efficiency, and equity goals over the past 20 years. Finally, the paper also looks ahead to whether and how managed competition might again be considered in Aotearoa and the extent to which the system currently includes key pre-conditions to support such arrangements.

本文件探讨了是否以及如何将管理下的竞争安排引入奥特亚罗瓦医疗与残疾系统。本文介绍了该系统的主要特点,包括自 2022 年 7 月 1 日起建立的新组织安排。它讨论了 20 世纪 90 年代制定的重大改革和管理下竞争计划,由于已实施的改革存在重大问题,以及在为相互竞争的医疗计划设计公平的支付系统方面存在问题,管理下竞争计划很早就被放弃了。本文接着指出,2000 年代建立的按人头付费、风险自担和相互竞争的初级保健组织的发展应从管理下竞争的角度加以考虑,本文还指出了奥特亚罗亚由于缺乏规章制度而出现的问题,这些规章制度本可以更好地支持在过去 20 年中更好地实现有效性、效率和公平目标。最后,本文还展望了是否以及如何在奥特亚罗瓦再次考虑有管理的竞争,以及目前的制度在多大程度上包含了支持这种安排的关键先决条件。
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引用次数: 0
Healthcare reform in the Netherlands: after 15 years of regulated competition. 荷兰的医疗改革:经过 15 年的规范竞争。
IF 1.7 3区 医学 Q2 HEALTH POLICY & SERVICES Pub Date : 2024-02-01 DOI: 10.1017/S1744133123000385
Hans Maarse, Patrick Jeurissen

This article discusses the results and prospects of the market reform in Dutch health care which came into force in 2006. Attention is paid to the results of the health insurance reform, the experience with the shift from passive to active purchasing and the impact of the reform on healthcare provision and cost control respectively. Other topics discussed are the consequences of the reform for administrative costs, institutional trust in health insurance, and the power balance in health care after reform. The central message is that the high expectations of the market reform have not come true. Dutch health care features a high degree of hybridity and there are indications that the system is becoming ever more hybrid: the system operates much less market-like than the market frame suggests. Currently, the policy narrative on the reform is changing. Policymakers and policy documents underscore the need for cooperation in provider networks and more state direction. The Dutch experience with health care reform illustrates the pendulum theory. After a period of a belief in competition and less state direction the pendulum in policymaking swings back to a belief in cooperation and a pro-active role of the state.

本文讨论了 2006 年生效的荷兰医疗市场改革的成果和前景。文章关注了医疗保险改革的结果、从被动购买向主动购买转变的经验,以及改革分别对医疗服务提供和成本控制的影响。还讨论了改革对行政成本的影响、机构对医疗保险的信任以及改革后医疗保健领域的权力平衡。核心信息是市场改革的高期望值并未实现。荷兰的医疗保健系统具有高度的混合性,而且有迹象表明,该系统正变得越来越混合:该系统的运作远没有市场框架所显示的那么市场化。目前,有关改革的政策论述正在发生变化。政策制定者和政策文件都强调了医疗服务提供者网络合作的必要性,以及更多的国家指导。荷兰的医疗改革经验说明了钟摆理论。经过一段相信竞争和减少国家指导的时期后,决策钟摆又摆回到相信合作和国家发挥积极作用的时期。
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引用次数: 0
Preconditions for efficiency and affordability in mixed health systems: are they fulfilled in the Australian public-private mix? 混合医疗系统的效率和可负担性的先决条件:澳大利亚的公私混合医疗系统是否满足了这些先决条件?
IF 1.7 3区 医学 Q2 HEALTH POLICY & SERVICES Pub Date : 2024-01-24 DOI: 10.1017/S1744133123000336
Chiara Berardi, Pablo Arija Prieto, Josefa Henríquez, Francesco Paolucci

The Australian health system is characterised by high quality care by international standards, produced by a mix of public and private provision and funding of healthcare services. Despite good overall results, three issues are of concern. The first issue relates to the public procurement of healthcare, whose flaws have impacted individuals' access to care, and the high out-of-pocket spending. The second issue concerns the sustainability of the private health insurance market, given the government's goal of relieving cost and capacity from the public scheme, incentivising participation. Third, there are existing inefficiencies and inequities related to the duplication resulting from the interaction between public and private schemes. To ensure a sustainable, efficient and equitable health system, structural reforms are necessary to achieve long-term performance improvements. Using a framework for mixed public-private health systems, we assess the extent to which the Australian healthcare system achieves preconditions for efficiency and affordability in competitive healthcare markets.

按照国际标准,澳大利亚医疗系统的特点是提供高质量的医疗服务,其医疗服务由公共和私人部门共同提供和资助。尽管总体结果良好,但有三个问题值得关注。第一个问题与医疗保健的公共采购有关,其缺陷影响了个人获得医疗保健的机会以及高额的自付支出。第二个问题涉及私营医疗保险市场的可持续性,因为政府的目标是减轻公共计划的成本和能力,激励人们参与。第三,由于公共计划和私人计划之间的相互作用,目前存在着重复劳动造成的低效和不公平现象。为确保医疗系统的可持续发展、高效和公平,有必要进行结构改革,以实现长期的绩效改善。利用公私混合医疗体系框架,我们评估了澳大利亚医疗体系在多大程度上实现了竞争性医疗市场的效率和可负担性的前提条件。
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引用次数: 0
Managed competition in Colombia: convergence of public and private insurance and delivery. 哥伦比亚的有管理竞争:公共和私营保险与交付的融合。
IF 1.7 3区 医学 Q2 HEALTH POLICY & SERVICES Pub Date : 2024-01-22 DOI: 10.1017/S1744133123000348
Ramon Castano, Sergio I Prada, Norman Maldonado, Victoria Soto

The Colombian health system has made a deep transition into managed competition since a major reform in 1993. A market for insurers was created, the consumer has free choice of insurer and a national-level equalisation fund distributes revenues via a per-capita payment. Fully subsidised insurance for the poor and informal, and a comprehensive standardised benefit package for subsidised and contributory schemes (both schemes covering 98 per cent of the population), has led to a low level of out-of-pocket expenses and high financial protection, as well as to reduced gaps in equity in access. The preconditions for managed competition are largely met, but improving health care providers' organisation towards integrated care, to enable them to deliver more value, is a necessary step to achieve the expected results of managed competition in terms of efficiency and quality. Although the current system is likely to be reformed in the coming months, the nature and extent of those reforms are not defined yet, so our analysis is based on the current system.

自 1993 年进行重大改革以来,哥伦比亚的医疗系统已深入过渡到有管理的竞争。保险公司的市场得以建立,消费者可以自由选择保险公司,国家级的均衡基金通过按人头付费的方式分配收入。为穷人和非正规保险提供全额补贴,为补贴计划和缴费计划提供全面的标准化福利包(这两种计划均覆盖 98% 的人口),从而降低了自付费用,提供了较高的经济保障,并缩小了公平获得保险服务方面的差距。管理式竞争的先决条件已基本满足,但要实现管理式竞争在效率和质量方面的预期成果,还必须改善医疗服务提供者的组织结构,使其能够提供更多的价值,从而实现综合医疗服务。尽管现行制度很可能在未来几个月内进行改革,但改革的性质和程度尚未确定,因此我们的分析是基于现行制度的。
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引用次数: 0
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