Health Technology Assessment

Bayesian methods have  increasingly become the standard statistical approach in medical research. Their use is encouraged by regulatory bodies, such as the FDA, due to the versatility of the methodology. This new edition of the leading text on Bayesian approaches to clinical trials has been extensively revised and updated to reflect recent developments in the field, and places greater emphasis on health technology assessment. New material on missing data and longitudinal analysis issues is also included. The book is introductory in nature and covers a broad array of essential topics.

The first edition received universal praise.  This update is designed to meet the developing needs of statisticians in the pharmaceutical industry, and anyone involved in conducting clinical trials and HTA work.

420 pages
Publisher: Wiley
ISBN13: 9781118932674

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.

234 pages
Publisher: Tredition
ISBN13: 9783384030931

Both developing and developed countries face an increasing mismatch between what patients expect to receive from healthcare and what the public healthcare systems can afford to provide. Where there has been a growing recognition of the entitlement to receive healthcare, the frustrated expectations with regards to the level of provision has led to lawsuits challenging the denial of funding for health treatments by public health systems.

This book analyses the impact of courts and litigation on the way health systems set priorities and make rationing decisions. In particular, it focuses on how the judicial protection of the right to healthcare can impact the institutionalization, functioning and centrality of Health Technology Assessment (HTA) for decisions about the funding of treatment. Based on the case study of three jurisdictions – Brazil, Colombia, and England – it shows that courts can be a key driver for the institutionalization of HTA. These case studies show the paradoxes of judicial control, which can promote accountability and impair it, demand administrative competence and undermine bureaucratic capacities. The case studies offer a nuanced and evidence-informed understanding of these paradoxes in the context of health care by showing how the judicial control of priority-setting decisions in health care can be used to require and control an explicit scheme for health technology assessment, but can also limit and circumvent it. 

It will be essential for those researching Medical Law and Healthcare Policy, Human Rights Law, and Social Rights.

214 pages
Publisher: Routledge
ISBN13: 9781032184913

This book analyses the factors that influence the development and implementation of Health Technology Assessment (HTA) from multiple perspectives. It investigates the development of HTA activities in decentralized countries with a specific focus on the analysis of healthcare professionals' perceptions. Although these perceptions are highly relevant in terms of implementing HTA processes, especially at the local level, they are rarely captured, and require further investigation, which this book provides. 
In particular, HTA has been introduced as a support tool for reviewing and assessing the introduction and dissemination of healthcare technologies. The book discusses how individual and organisational factors affect knowledge production and translation, and their relevance in the context of HTA. Furthermore, it explores how HTA could be more successfully implemented in decentralized healthcare systems.

724 pages
Publisher: Springer Nature
ISBN13: 9783030703080

The term health technology refers to drugs, devices, and programs that can improve and extend quality of life. As decision-makers struggle to find ways to reduce costs while improving health care delivery, health technology assessments (HTA) provide the evidence required to make better-informed decisions.

This is the first book that focuses on the statistical options of HTAs, to fully capture the value of health improvements along with their associated economic consequences. After reading the book, readers will better understand why some health technologies receive regulatory or reimbursement approval while others do not, what can be done to improve the chances of approval, as well as common shortcomings of submissions for drug and device reimbursement.

The book begins by contrasting the differences between regulatory approval and reimbursement approval. Next, it reviews the principles and steps for conducting an HTA, including the reasons why different agencies will have a different focus for their scope in the HTA.

Supplying an accessible introduction to the various statistical options for different methods in an HTA, the book identifies the links to regulatory and reimbursement decisions for each option. It highlights many of the methodological advances that have occurred since HTA research began, to provide researchers and decision-makers with a cutting-edge framework. It also details the logical basis for the methods along with simple instructions on how to conduct the various techniques.

Both authors have considerable experience in generating evidence for submissions and reviewing submissions to decision-makers for funding. One of the authors has also received a nationally recognized lifetime achievement award in this area.

276 pages
Publisher: CRC Press
ISBN13: 9781032098715

Representing the first book on the topic, this work offers the reader an introduction to the Japanese systems for health technology assessment (HTA) officially introduced by the Ministry of Health, Labour and Welfare (MHLW) in 2016. Policy and guidelines are discussed, with the relevant methods and conditions of cost-effectiveness analysis explained alongside. Numerous instructive examples and exercises, ranging from basic to advanced, impart valuable knowledge and insight on the quantitative methods for economic evaluation, which will appeal to both beginners and experts. This guidebook is authored by Japan's foremost expert in HTA and pharmacoeconomics, with a view to strengthening the reader's expertise in value-based healthcare and decision-making. The methods presented are essential to informing regulatory, local and patient decisions; as such, the book is equally recommended to industry and government, as well as academia, and anyone with an interest in Japanese HTA.

196 pages
Publisher: Springer Nature
ISBN13: 9789811357930

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 translationthrough relevance and timeliness.

409 pages
Publisher: Adis
ISBN13: 9783319818429

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

460 pages
Publisher: Adis
ISBN13: 9789811350399

Das Buch befasst sich mit den weltweit laufenden Bemühungen, Health Technology Assessment (HTA) im Gesundheitswesen zu etablieren. Der Autor stellt die historische Entwicklung von HTA dar und präsentiert eine sorgfältige Definition des Begriffes. Dazu gehört eine kritische Auseinandersetzung mit den Grundprinzipien von HTA sowie der damit verknüpften rechtlichen Aspekte. Neben Aufbau und Unterarten von HTAs wird zudem ein Lösungsansatz vorgestellt, um HTA-Arten klar voneinander abzugrenzen. Ein Grossteil der Arbeit umfasst eine zugängliche Einführung in die an HTA beteiligten Disziplinen. Zudem werden ausgewählte nationale und internationale HTA-Agenturen porträtiert. Überlegungen zur „Best-Practice“ und ein dreistufiger Lösungsansatz zur Implementation von HTA runden das Werk ab. Es ist das erste Werk, dass sich in so ganzheitlicher Weise mit der Thematik auseinandersetzt.

The book deals with the ongoing efforts worldwide to establish Health Technology Assessment (HTA) in the healthcare system. The author describes the historical development of HTA and presents a careful definition of the term. This includes a critical examination of the basic principles of HTA and the associated legal aspects. In addition to the structure and subtypes of HTAs, an approach is also presented to clearly differentiate between HTA types. A large part of the work includes an accessible introduction to the disciplines involved in HTA. In addition, selected national and international HTA agencies are portrayed. Considerations on "best practice" and a three-stage approach to implementing HTA round off the work. It is the first work to deal with the topic in such a holistic way.

506 pages
Publisher: Springer
ISBN13: 9783662464311

This book disentangles the issues in connection with the advancement of Health Technology Assessment (HTA) and its interface with health policy. It highlights the factors that should shape its progress in the near future. Interdisciplinary and critical views from a number of professionals are put together in a prescient order to cast some light and make recommendations as to the next steps HTA should take to be fit for purpose. A wealth of documents dealing with HTA have been published over the last three decades. HTA allegedly is one of the bedrocks of regulation and medical decision making. However, counter vailing visions contend that geographical variations in the role that HTA is actually playing within countries pinpoints specific room for improvement. Given our social preferences, cherry-picking HTA’s features and successes over the last decades moves it away from its possibility frontier. Some of the most noteworthy hindrances that HTA faces, in several countries, to making headway towards its consolidation as an efficient tool for regulation and decision making are as follows: insufficient resources, delays in assessment, inadequate priority setting, regulatory capture, public distrust, actual influence on regulatory decisions, the need for strengthening international cooperation and harmony, the lack of sound and consistent assessments of diagnostic tests, medical devices and surgical innovations and limited dissemination. Time has come for HTA to take a renewed stand. There is a pressing need to submit HTA to in-depth critical scrutiny.

172 pages
Publisher: Adis
ISBN13: 9783319150048