EU HTA 101

EU HTA 101 PDF

Author: Thomas Ecker

Publisher: tredition

Published: 2023-09-29

Total Pages: 261

ISBN-13: 338403094X

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The regulation on European Health Technology Assessment (EU HTA) entered into force on 11 January 2022 and will apply from 12 January 2025. It introduces joint clinical assessments and joint scientific consultations at the European level for new health technologies, including pharmaceuticals and medical devices. While market access, pricing and reimbursement will continue to be the responsibility of EU member states, EU HTA will nevertheless have an immense impact on these national market access activities. This book serves as a practical guide designed to help developers of pharmaceuticals prepare for the upcoming EU HTA process.

Hospital-Based Health Technology Assessment

Hospital-Based Health Technology Assessment PDF

Author: Laura Sampietro-Colom

Publisher: Springer

Published: 2017-01-23

Total Pages: 397

ISBN-13: 3319392050

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A timely work describing how localized hospital-based health technology assessment (HB-HTA) complements general, ‘arms-length’ HTA agency efforts, and what has been the collective global impact of HB-HTA across the globe. While HB-HTA has gained significant momentum over the past few years, expertise in the field, and information on the operation and organization of HB-HTA, has been scattered. This book serves to bring this information together to inform those who are currently working in the field of HTA at the hospital, regional, national or global level. In addition, this book is intended for decision-makers and policy-makers with a stake in determining the uptake and decommissioning of new and established technologies in the hospital setting. HTA has traditionally been performed at the National/Regional level by HTA Agencies, typically linked to governments. Yet hospitals are the main entry door for most health technologies (HTs). Hospital decision-makers must undertake multiple high stakes investment and disinvestment decisions annually for innovative HTs, usually without adequate information. Despite the existence of arms-length HTA Agencies, inadequate information is available to hospital decision-makers either because relevant HTA reports are not yet released at the time of entry of new technologies to the field, or because even when the report exists, the information contained is insufficient to clarify the contextualized informational needs of hospital decision makers. Therefore, there has recently been a rising trend toward hospital-based HTA units and programs. These units/programs complement the work of National/Regional HTA Agencies by providing the key and relevant evidence needed by hospital decision makers in their specific hospital context, and within required decision-making timelines. The emergence of HB-HTA is creating a comprehensive HTA ecosystem across health care levels, which creates better bridges for knowledge translation through relevance and timeliness.

Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies

Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies PDF

Author: OECD

Publisher: OECD Publishing

Published: 2019-10-17

Total Pages: 447

ISBN-13: 9264805907

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This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Assuring the Quality of Health Care in the European Union

Assuring the Quality of Health Care in the European Union PDF

Author: Helena Legido-Quigley

Publisher: World Health Organization

Published: 2008

Total Pages: 242

ISBN-13: 9289071931

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People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.

Health Technology Assessment and Health Policy-making in Europe

Health Technology Assessment and Health Policy-making in Europe PDF

Author: Marcial Velasco Garrido

Publisher: WHO Regional Office Europe

Published: 2008

Total Pages: 198

ISBN-13: 9289042931

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New technologies with the potential to improve the health of populations are continuously being introduced. But not every technological development results in clear health gains. Health technology assessment provides evidence-based information on the coverage and usage of health technologies, enabling them to be evaluated properly and applied to health care efficaciously, promoting the most effective ones while also taking into account organizational, societal and ethical issues. This book reviews the relationship between health technology assessment and policy-making, and examines how to increase the contribution such research makes to policy- and decision-making processes. By communicating the value and potential of health technology assessment to a wider audience, both within and beyond decision-making and health care management, it aims ultimately to contribute to improve the health status of the population through the delivery of optimum health services.

Regulating Pharmaceuticals In Europe: Striving For Efficiency, Equity And Quality

Regulating Pharmaceuticals In Europe: Striving For Efficiency, Equity And Quality PDF

Author: Mossialos, Elias

Publisher: McGraw-Hill Education (UK)

Published: 2004-06-01

Total Pages: 390

ISBN-13: 0335214657

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"This thoughtful and comprehensive book represents the best work I have seen on the current situation concerning medication policies in the EU. It is not just that this is a very up-to-date compendium of facts and data across a wide variety of domains that impact on pharmaceutical regulation. The book is also strong on analysis of those facts as well." Jerry Avorn, Harvard Medical School. "This book offers a comprehensive examination of approaches to manage pharmaceutical expenditures in Europe. It is a must-read for those who seek to understand and navigate the changing regulatory environment for medicines in the European Union." Bernie O'Brien, McMaster University, Canada. The rising cost of pharmaceutical expenditures in many European countries is of concern to governments required to make effective use of health care budgets. Taking a broad perspective that encompasses institutional, political and supranational aspects of pharmaceutical regulation, this book examines approaches used to manage pharmaceutical expenditure across Europe and what impact these strategies have had on efficiency, quality, equity and cost of pharmaceutical care.Regulating Pharmaceuticals in Europe is an important book for students of health policy, regulation and management, and for health managers and policy makers. The editors: Elias Mossialos is Brian Abel-Smith Professor of Health Policy at the London School of Economics and Political Science and a Research Director of the European Observatory on Health Systems and Policies. Monique Mrazek is a Health Economist (Europe and Central Asia region) for the World Bank and formerly a Research Officer in Health Economics for the European Observatory on Health Systems and Policies. Tom Walley is Professor of Clinical Pharmacology at the University of Liverpool and Director of the UK National Health Technology Assessment Programme. Contributors:Julia Abelson, Christa Altenstetter, Vittorio Bertele’, Christine Bond, Marcel L. Bouvy, Colin Bradley, Steve Chapman, Anna Dixon, Michael Drummond, Pierre Durieux, Edzard Ernst, Armin Fidler, Eric Fortess, Richard Frank, Silvio Garattini, Leigh Hancher, Ebba Holme Hansen, Steve Hudson, Kees de Jonchere, Panos Kanavos, Sjoerd Kooiker, Jean-Marc Leder, Graham Lewis, Donald W. Light, Alistair McGuire, Elias Mossialos, Monique Mrazek, Maria Pia Orru', Govin Permanand, Guenka Petrova, Munir Pirmohamed, Dennis Ross-Degnan, Frans Rutten, Steven Soummerai, David Taylor, Sarah Thomson, Tom Walley.

Health Technology Assessment of Medical Devices

Health Technology Assessment of Medical Devices PDF

Author: World Health Organization

Publisher: Who Medical Device Technical

Published: 2012-10-25

Total Pages: 39

ISBN-13: 9789241501361

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WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. HTA is the systematic evaluation of properties, effects, and/or impacts of health technology. Its main purpose is to inform technology-related policy-making in health care, and thus improve the uptake of cost-effective new technologies and prevent the uptake of technologies that are of doubtful value for the health system. It is one of three complementary functions to ensure the appropriate introduction and use of health technology. The other two components are regulation, which is concerned with safety and efficacy, and assessment of all significant intended as well as unintended consequences of technology use; and management, which is concerned with the procurement and maintenance of the technology during its life-cycle. The performance of health systems is strengthened when the linkages and exchange among these elements are clearly differentiated but mutually supportive. This document integrates health technology assessment into the WHO framework for evidence-informed policy-making. Health systems are strengthened when HTA is integrated into the human and material resources, data, transparent decision- and policy-making, and linked to the overall vision of equity and accountability. Good governance can rely on health technology assessment to provide a policy approach that is accountable for its decisions to the population.

Ensuring Value for Money in Health Care

Ensuring Value for Money in Health Care PDF

Author: Corinna Sorenson

Publisher: WHO Regional Office Europe

Published: 2008

Total Pages: 174

ISBN-13: 9289071834

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This report addresses the concepts and controversy surrounding health technology assessment in Europe, with a particular focus on selected Member States including Sweden, the Netherlands, Finland, France, Germany and the United Kingdom. It is intended to identify and address current considerations regarding HTA methodological and process issues related to the prioritization and financing of modern health care. In particular, it describes the processes and challenges for identifying and prioritizing assessments; assesses and compares current assessment methods and procedures; and highlights the barriers to effective implementation. The report also ascertains the roles and terms of engagement of key stakeholders, and captures the opportunities and challenges for the use of HTA guidance in general priority-setting, decision-making and health-care provision.

Assessing Medical Technologies

Assessing Medical Technologies PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1985-02-01

Total Pages: 592

ISBN-13: 030903583X

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New drugs, new devices, improved surgical techniques, and innovative diagnostic procedures and equipment emerge rapidly. But development of these technologies has outpaced evaluation of their safety, efficacy, cost-effectiveness, and ethical and social consequences. This volume, which is "strongly recommended" by The New England Journal of Medicine "to all those interested in the future of the practice of medicine," examines how new discoveries can be translated into better care, and how the current system's inefficiencies prevent effective health care delivery. In addition, the book offers detailed profiles of 20 organizations currently involved in medical technology assessment, and proposes ways to organize U.S. efforts and create a coordinated national system for evaluating new medical treatments and technology.