European Collaboration in Health Technology Assessment (HTA): goals, methods and outcomes with specific focus on medical devices.

Judit Erdös,Julia Mayer-Ferbas,Cecilia De Villiers,Claudia Wild,Sabine Ettinger

doi:10.1007/s10354-019-0684-0

Abstract

SummaryThe European Network for Health Technology Assessment (EUnetHTA) was founded to support efficient production and use of health technology assessments (HTAs) across Europe by reducing redundancies through collaboration. To facilitate collaboration, a range of practical tools, methods and process definitions were developed. The article describes when and how these tools and methods are used along the HTA process with specific focus on “other technologies”, that is medical devices and non-pharmaceutical procedures. EUnetHTA was able to deliver tangible achievements complying with its goals. The practical tools and the developed methods formed a basis for close collaboration among over 70 agencies at a European level. The activities of EUnetHTA laid a strong foundation for sustainable cooperation. In the long run, jointly produced assessments could realise economies of scale with improved quality, consistency and transparency for the health systems in Europe.

Highlights

All healthcare systems in Europe and worldwide have to make decisions on investments in new medical interventions such as screening programs, large technical equipment, drugs or medical devices
The Cross Border Directive (2011) provided the political and regulatory framework for Joint Action 1 (JA1) and the succeeding JA2 and JA3, stating in article 15 that “The Union shall support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for health technology assessment designated by the Member States” [2]
Selection and prioritization process Planned and Ongoing Projects (POP) Database Internal procedure manual describing the process of project management of EUnetHTA assessments and European Activity Centres for managing collaborative assessments Procedure manual for rapid relative effectiveness assessment (REA) Templates: project plan template, assessment template, evidence submission template Standardized reporting structure: the CoreModel® EUnetHTA methodological guidelines Processes of stakeholder involvement Evidence database on new technologies (EVIDENT database) Companion Guide comprising all templates, guidelines and process descriptions in the format of standard operating procedures EUnetHTA website

Summary

Introduction

All healthcare systems in Europe and worldwide have to make decisions on investments in new medical interventions such as screening programs, large technical equipment, drugs or medical devices. The work programmes of European health technology assessment (HTA) agencies comprise similar topics, as decision support for such investments is often given at the same point in time. This insight is not novel and is mainly based on an overview of the. The Cross Border Directive (2011) provided the political and regulatory framework for Joint Action 1 (JA1) and the succeeding JA2 and JA3, stating in article 15 that “The Union shall support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for health technology assessment designated by the Member States” [2]

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Conclusion