Current and Future Trends in the HTA of Medical Devices

Abstract

Health Technology Assessment (HTA) has been defined as a ‘multidisciplinary approach studying the clinical, economic, social and ethical implications of development, diffusion and use of health technology’. While the general definition of HTA is widely accepted and its role in policy making is increasingly established in EU countries, the currently adopted methodological framework for HTA does not fully encounter the challenges rising from different types of health technologies, such as medical devices. This paper provides i) an introduction to the HTA methodology, highlight on ii) specific challenges medical devices pose in addition to other health technologies (i.e. short lifecycle and rapid changes, clinical outcomes often depend on training and experience of operator, dynamic pricing), iii) current HTA practices for medical devices and iv) the results of a FP7 funded project, “Methods for Health Technology Assessment of Medical Devices: a European Perspective” (MedTecHTA n. 305694) completed in December 2015. The general objective of MedtecHTA was to enhance HTA methods for medical devices that would acknowledge complexities rising from their integration into clinical practice and to develop recommendations for a wide range of stakeholders in the field. Overall, this paper provides a summary of the current and expected future trends in the assessment of medical devices technology to inform coverage and reimbursement decisions in healthcare within Europe and beyond.