Objective:

Develop guidance on good practices in informing evidence-based, population-based (i.e., payer) decision making for new interventions, with an emphasis on health technology assessment (HTA) approaches.

Background

Over the last few decades, the use of evidence to inform payer decisions for new technologies and health interventions has grown in prominence. In particular, the multidisciplinary activity of health technology assessment (HTA) has seen increased recognition internationally. HTA has become a standard policy tool for reimbursement and pricing – makers who must manage the entry and use of medical devices, drugs, and vaccines within health systems decision. With this growth, there has been an increasing need for good practice standards.

Rationale

Good practice guidance on synthesizing and using evidence in health care decision making is an important step forward in capacity building and education. Despite the ever-increasing activity and attention to HTA and other population-based approaches to decision making (e.g. comparative effectiveness research), there has been no attempt to synthesize good practices in recent years.

Notably, the last comprehensive attempts occurred more than 20 years ago, as the European Union funded a series of projects intended to synthesize and recommend best practices in HTA. The first of these was the EUR-ASSESS Project that explored opportunities for collaboration among EU member states [1]. This was followed by the European Collaboration for Assessment of Health Interventions and Technology (ECHTA/ECAHI) Project with six working groups dedicated to broader aspects of HTA [2]. The latest attempt to broadly synthesize HTA concepts has been through a series of much more narrowly focused reports on medical device regulation issues by the World Health Organization [3]. During 2010-15 EUnetHTA developed guidelines for relative effectiveness assessments and although mainly pointing to existing sources of good practice the HTA Core Model (http://www.eunethta.eu/eunethta-guidelines) also provides some guidance [4]. Given the rapid pace of change in this area, there is clearly a need for a contemporary, comprehensive umbrella review of good practices.

Guideline recommendations will be useful for those developing or involved in HTA processes-stakeholders including decision makers, industry, regulators, health care providers, researchers, academia, as well as patient representatives. A review of good practices can provide a foundation for developing or refining local/regional/national HTA processes and contribute to successful implementation of newly developed HTA processes in countries around the world.

Co-Chairs:

Professor Finn Børlum Kristensen, MD, PhD
Former EUnetHTA Executive Committee Chairman and EUnetHTA Secretariat Director
Professor, Faculty of Health Sciences, University of Southern Denmark
Copenhagen, Denmark

Don Husereau, MSc, BScPharm
Senior Associate, Institute of Health Economics;
Adjunct Professor, School of Epidemiology, Public Health and Preventive Medicine
Ottawa, Canada

Leadership Group:

Federico Augustovski, MD, MS, PhD, Director, Economic Evaluations and HTA Department, Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina

Marc Berger, MD, VP Real World Data and Analytics, Pfizer, Inc., New York, NY, USA

Kenneth Bond, MA, BEd, BA, is Director, Patient Engagement, Ethics and International Affairs, Canadian Agency for Drugs and Technologies in Health (CADTH), Ottawa, Canada

Andrew Booth, PhD, Reader in Evidence Based Information Practice and Director of Information, ScHARR, The University of Sheffield, Sheffield, England, UK

John F. P. Bridges, PhD, Assistant Professor, Department of Health Policy & Management Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

Michael Drummond, DPhil, MCom, BSc, Professor of Health Economics, University of York, York, England, UK

Jeremy Grimshaw, MBCHB, PHD, FRCGP, FCAHS, Director, Cochrane Canada and Professor of Medicine, University of Ottawa, Ottawa, Canada

Mirjana Huić, MD, MSc, Assistant Director, Agency for Quality and Accreditation in Health Care and Social Welfare, Zagreb, Croatia

Maarten J. IJzerman, PhD, Professor of Clinical Epidemiology & Health Technology Assessment (HTA); Head, Department of Health Technology & Services Research, University of Twente, Enschede, The Netherlands

Egon Jonsson, PhD, Executive Director & CEO of the Institute of Health Economics, Edmonton, Canada

Daniel Ollendorf, MPH, PhD, Chief Scientific Officer, Institute for Clinical and Economic Review (ICER), Boston, MA, USA

Alric Rüther, MD, PhD, Head, International Affairs, Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany

Uwe Siebert, MD, MPH, MSc, ScD, Professor of Public Health, Department of Public Health, Medical Decision Making and Health Technology Assessment (HTA), University of Health Sciences, Medical Informatics and Technology (UMIT), Hall in Tirol, Austria

Jitendar Sharma, PhD, Director & CEO, AP MedTech Zone & Advisor (Health), Department of Health & Family Welfare, Andhra Pradesh, India

Allan Wailoo, PhD, MSc, MA, Professor of Health Economics, ScHARR, University of Sheffield and Director, NICE Decision Support Unit, Sheffield, England, UK

Activities:

Where Do We Need Good Research Practice Guidance In Health Technology Assessment?
November 2017 – ISPOR 20th Annual European Congress, Workshop, Glasgow, Scotland, UK

Good Practices For Synthesizing And Using Evidence In Health Care Decision Making?
May 2017 – ISPOR 22nd Annual International Meeting, Workshop, Boston, MA, USA


If you are interested in joining this ISPOR HTA Council Working Group Review Group, please complete the ISPOR Scientific and Health Policy Working Groups Form.


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