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.

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.

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

"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.

This is the first book to offer a comprehensive guide to involving patients in health technology assessment (HTA). Defining patient involvement as patient participation in the HTA process and research into patient aspects, this book includes detailed explanations of approaches to participation and research, as well as case studies. Patient Involvement in HTA enables researchers, postgraduate students, HTA professionals and experts in the HTA community to study these complementary ways of taking account of patients’ knowledge, experiences, needs and preferences. Part I includes chapters discussing the ethical rationale, terminology, patient-based evidence, participation and patient input. Part II sets out methodology including: Qualitative Evidence Synthesis, Discrete Choice Experiments, Analytical Hierarchy Processes, Ethnographic Fieldwork, Deliberative Methods, Social Media Analysis, Patient-Reported Outcome Measures, patients as collaborative research partners and evaluation. Part III contains 15 case studies setting out current activities by HTA bodies on five continents, health technology developers and patient organisations. Each part includes discussion chapters from leading experts in patient involvement. A final chapter reflects on the need to clearly define the goals for patient involvement within the context of the HTA to identify the optimal approach. With cohesive contributions from more than 80 authors from a variety of disciplines around the globe, it is hoped this book will serve as a catalyst for collaboration to further develop patient involvement to improve HTA. "If you’re not involving patients, you're not doing HTA!" - Dr. Brian O’Rourke, President and CEO of CADTH, Chair of INAHTA

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.