International Profiles of Health Care Systems

Compares the healthcare systems of Australia, Canada, Denmark, England, France, Germany, Italy, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the United States, including spending, use of health information technology, and coverage

International Profiles of Health Care Systems, 2012

This publication presents overviews of the health care systems of Australia, Canada, Denmark, England, France, Germany, Japan, Iceland, Italy, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the United States. Each overview covers health insurance, public and private financing, health system organization, quality of care, health disparities, efficiency and integration, care coordination, use of health information technology, use of evidence-based practice, cost containment, and recent reforms and innovations. In addition, summary tables provide data on a number of key health system characteristics and performance indicators, including overall health care spending, hospital spending and utilization, health care access, patient safety, care coordination, chronic care management, disease prevention, capacity for quality improvement, and public views

International Profiles of Health Care Systems, 2011

This publication presents overviews of the health care systems of Australia, Canada, Denmark, England, France, Germany, Japan, Italy, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the United States. Each overview covers health insurance, public and private financing, health system organization, quality of care, health disparities, efficiency and integration, use of health information technology, use of evidence-based practice, cost containment, and recent reforms and innovations. In addition, summary tables provide data on a number of key health system characteristics and performance indicators, including overall health care spending, hospital spending and utilization, health care access, patient safety, care coordination, chronic care management, disease prevention, capacity for quality improvement, and public views

Paying for "End-of-Life" Drugs in Australia, Germany, and the United Kingdom: Balancing Policy, Pragmatism, and Societal Values

Analyzes British, Australian, and German health systems' policies on covering expensive end-of-life drugs while maintaining equity and efficiency, such as requiring evidence of comparative clinical and cost-effectiveness. Outlines challenges for the U.S

Coverage with evidence development: applications and issues

Copyright © Cambridge University Press, 2010OBJECTIVES: The aim of this study was to describe the current issues surrounding Coverage with Evidence Development (CED). CED is characterized by restricted coverage for a new technology in parallel with targeted research when the stated goal of the research or data collection is to provide definitive evidence for the clinical or cost-effectiveness impact of the new technology. METHODS: Presented here is information summarized and interpreted from presentations and discussions at the 2008 Health Technology Assessment International (HTAi) meeting and additional information from the medical literature. This study describes the differences between CED and other conditional coverage agreements, provides a brief history of CED, describes real-world examples of CED, describes the areas of consensus between the stakeholders, discusses the areas for future negotiation between stakeholders, and proposes criteria to assist stakeholders in determining when CED could be appropriate. RESULTS: Payers could interpret the evidence obtained from a CED program either positively or negatively, and a range of possible changes to the reimbursement status of the new technology may result. Striking an appropriate balance between the demands for prompt access to new technology and acknowledging that some degree of uncertainty will always exist is a critical challenge to the uptake of this innovative form of conditional coverage. CONCLUSIONS: When used selectively for innovative procedures, pharmaceuticals, or devices in the appropriate disease areas, CED may provide patients access to promising medicines or technologies while data to minimize uncertainty are collected.The development of the manuscript was funded by Medicines Australi

Outcome-based pricing for new pharmaceuticals via rebates

The price of new brand-name prescription drugs has been rising fast in the United States. For example, the Amgen cholesterol drug Repatha had an initial list price of $14,523 per year. Patients, even with insurance coverage, must pay out of pocket a significant portion of this price. The treatment might not be successful, and this possibility reduces risk-sensitive patients’ incentives to purchase the drug. The high price together with the chance of negative treatment outcomes may lead payers to deny coverage for the drug. Outcome-based pricing has been proposed as a way to reallocate the risks and improve both payer resource allocation and patient access to drugs. According to an outcome-based rebate contract between Amgen and Harvard Pilgrim Healthcare, if a patient on Repatha suffers a heart attack or a stroke, both patient and insurer are refunded the cost of the drug. We use a stylized model to analyze the effect of outcome-based pricing via rebates. Our model captures the interaction between heterogenous, price-sensitive, risk-sensitive patients who decide whether to purchase the drug; a payer deciding whether to provide coverage for the drug; and a price-setting pharmaceutical firm seeking to maximize expected profits. We find that, in many cases, a pharmaceutical firm and payer cannot simultaneously benefit from outcome-based pricing, and who will benefit is determined by the probability of treatment success. Outcome-based pricing thus appears unlikely to solve the issues of high drug prices and high payer expenditures. However, supplementing outcome-based pricing with a transfer payment from firm to payer can make payer and firm (but not necessarily the patients) better off than under uniform pricing when the drug has a low chance of success

Promoting Academic Entrepreneurship in Europe and the United States: Creating an Intellectual Property Regime to Facilitate the Efficient Transfer of Knowledge from the Lab to the Patient

In 2014, the European Commission announced the launch of a study of knowledge transfer by public research organizations and other institutes of higher learning “to determine which additional measures might be needed to ensure an optimal flow of knowledge between the public research organisations and business thereby contributing to the development of the knowledge based economy.” As the European Commission has recognized, the European Union (“EU”) needs to take action to “unlock the potential of IPRs [intellectual property rights] that lie dormant in universities, research institutes and companies.” This article builds on our earlier work on structuring efficient pharmaceutical public-private partnerships (“PPPPs”), but focuses on the regulatory infrastructure necessary to support the efficient commercialization of publicly funded university medical research in both the European Union and the United States (“U.S.”). Our comparative analysis of the EU and U.S. approaches to translational medicine shows that there are lessons to be shared. The EU can apply the experiences from the U.S. Bayh-Dole Act and PPPPs in the United States, and the United States can emulate certain of the open innovation aspects of the European Innovative Medicines Initiative and the tighter patenting standards imposed by the European Patent Office. Thus, a secondary purpose of this article is suggesting amendments to the U.S. laws governing the patenting and licensing of government-funded technology to prevent undue burdens on the sharing of certain upstream medical discoveries and research tools

Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers

<p>Abstract</p> <p>Background</p> <p>There has been an increase in 'risk sharing' schemes for pharmaceuticals between healthcare institutions and pharmaceutical companies in Europe in recent years as an additional approach to provide continued comprehensive and equitable healthcare. There is though confusion surrounding the terminology as well as concerns with existing schemes.</p> <p>Methods</p> <p>Aliterature review was undertaken to identify existing schemes supplemented with additional internal documents or web-based references known to the authors. This was combined with the extensive knowledge of health authority personnel from 14 different countries and locations involved with these schemes.</p> <p>Results and discussion</p> <p>A large number of 'risk sharing' schemes with pharmaceuticals are in existence incorporating both financial-based models and performance-based/outcomes-based models. In view of this, a new logical definition is proposed. This is "<it>risk sharing' schemes should be considered as agreements concluded by payers and pharmaceutical companies to diminish the impact on payers' budgets for new and existing schemes brought about by uncertainty and/or the need to work within finite budgets</it>". There are a number of concerns with existing schemes. These include potentially high administration costs, lack of transparency, conflicts of interest, and whether health authorities will end up funding an appreciable proportion of a new drug's development costs. In addition, there is a paucity of published evaluations of existing schemes with pharmaceuticals.</p> <p>Conclusion</p> <p>We believe there are only a limited number of situations where 'risk sharing' schemes should be considered as well as factors that should be considered by payers in advance of implementation. This includes their objective, appropriateness, the availability of competent staff to fully evaluate proposed schemes as well as access to IT support. This also includes whether systematic evaluations have been built into proposed schemes.</p

Modeling Pharmaceutical Risk-Sharing Agreements

Many new and expensive drugs have been introduced in the past 10 years. However, at the time of introduction, the effectiveness of these drugs outside of clinical trials is often unknown. This creates a risk to third-party payers, as the outcome of these drugs in real-world practice is uncertain at the time of introduction. A pay-for-performance risk-sharing agreement is a type of contract that shares part of this risk with the manufacturer by linking the performance of a drug to the manufacturer’s revenue. This dissertation consists of three essays to examine the performance of two types of pharmaceutical pay-for-performance risk-sharing agreements. In my first essay I examine the performance of a pay-for-performance risk-sharing agreement in which patients are assessed at some evaluation time to determine their response to the drug. The manufacturer rebates to the payer a proportion of the sales from all patients excluding the sales from those responding at the evaluation time. I model disease progression using a continuous time Markov chain with uncertain transition rates. I address the following questions regarding the performance of this agreement: What is the optimum evaluation time and under what conditions will the manufacturer make a profit? What is the distribution of the manufacturer’s profit resulting from different sources of uncertainty? In the second essay I extend the model developed in the first essay to calculate the net monetary benefits of the payer and identify the conditions under which both parties have incentives to introduce the new drug. The third essay focuses on the analysis of a risk-sharing agreement in which patients are prescribed a drug only if their probability of response lies within a range of success probabilities. The payer determines this range such that the use of the drug is cost-effective. I generalize from the existing literature by allowing the rebate to be different from the price of the drug and incorporating two types of administrative costs. I seek to answer two important policy questions: First, under what conditions does the payer benefit from the agreement? Second, under what conditions does the agreement become welfare-improving

The Trans Pacific Partnership Agreement negotiations and the health of Australians

The Trans Pacific Partnership Agreement has the potential to negatively impact the health of Australians by raising the cost of medicine and limiting the government\u27s ability to regulate tobacco and alcohol, argues this policy brief based on publicly available and recently leaked negotiating documents. Executive summary The purpose of this policy brief is to inform the debate from a health perspective in the final stages of the negotiations on the Trans Pacific Partnership Agreement (TPPA), particularly during meetings of chief negotiators and ministers in February 2014. This policy brief outlines the evidence about the potential health effects on the Australian community of actions related to the TPPA, based on publicly available and recently leaked negotiating documents. The purpose of the TPPA is to enhance each of the countries’ economic development and that this may lead to improved social and health development. However, although there may be positive impacts on the health and wellbeing of Australians resulting from economic growth, there are also many ways in which the TPPA has the potential to have negative impacts on the health of Australians. This policy brief examines the potential impact of provisions proposed for the TPPA on the health of Australians, focusing on two specific issues: the cost of medicines, and the ability of government to take major steps to improve the health of Australians by regulating the areas of tobacco and alcohol policy. In each of these areas we trace some of the pathways through which provisions that have been proposed for the TPPA may impact on the health of the Australian population, and the health of specific groups within the population. We highlight the ways in which some of the expected economic gains from the TPPA may be undermined by health and economic costs. Concerning the cost of medicine we focus on how proposed provisions in the TPPA could impact the affordability of medicines through several different routes: by delaying the availability of cheaper generic medicines, by altering the operation of the Pharmaceutical Benefits Scheme (PBS) making it more difficult to keep costs down, and by enabling pharmaceutical companies to sue the government over its pharmaceutical policies. These changes would increase the cost of the PBS for the government and taxpayers. Strategies to compensate for an increase in medication costs include increased cost-sharing, with patients assuming higher co-payments, or funding reallocation from other parts of the healthcare system. Provisions in the TPPA may impact the ability of Government to enforce existing policies and implement new policies that support public health. Australia is internationally recognised for the success of comprehensive strategies to reduce tobacco smoking. And more recently, there are multiple initiatives being proposed to achieve similar success to reduce harmful use of alcohol. We outline several of the many provisions in the TPPA that could affect tobacco and alcohol policies in Australia. Concerning tobacco these include an investor-state dispute settlement mechanism clause in the TPPA would provide more opportunities for tobacco companies to sue the Australian government over strong tobacco control measures. Rules about ‘indirect expropriation’ (i.e. depriving an investor of property, which, if broadly defined, can include intellectual property such as trademarks) and ‘fair and equitable treatment’ provide additional grounds for corporations to argue that their assets are being unfairly affected by government policies and laws. Provisions in the TPPA may impact the Government’s ability to implement effective alcohol control policies such as restrictions on liquor licences, bans or limits on alcohol advertising, and alcohol health warning labels. Concerning alcohol these include provisions in the Technical Barriers to Trade (TBT) Chapter of the TPPA which could limit possibilities for introducing innovative alcohol policies, such as requiring health warning labels. Provisions in the wine and spirits annex to the TBT Chapter may limit the options available to create a fully effective alcohol warnings scheme for wine and spirits. If Australia agrees to an investor-state dispute settlement (ISDS) mechanism applying to Australia, the alcohol industry will have access to a new legal channel to sue the Australian Government over alcohol policy decisions that adversely impact their investments. We conclude that while there is some potential for the TPPA to contribute to economic development, there is also significant risk that the economic gains which the TPPA may represent, as well as the health of the Australian community, will be threatened if certain proposed provisions are adopted for the TPPA. These include increased direct costs in terms of providing health care and increased use of hospitals, higher costs of obtaining pharmaceuticals, indirect costs associated with lost productivity across society, continuing or exacerbating inequalities in society, and worsening the health of Australia’s already vulnerable communities. Authored by: Katie Hirono, Centre for Health Equity Training, Research and Evaluation, University of New South Wales Deborah Gleeson, School of Public Health and Biosciences, La Trobe University Fiona Haigh, Centre for Health Equity Training, Research and Evaluation, University of New South Wales Patrick Harris, Centre for Health Equity Training, Research and Evaluation, University of New South Wale