Health technology assessment of medical devices: a survey of non-European Union agencies

Ciani, O., Wilcher, B., Blankart, C. R., Hatz, M., Rupel, V. P., Erker, R. S., Varabyova, Y. and Taylor, R. S. (2015) Health technology assessment of medical devices: a survey of non-European Union agencies. International Journal of Technology Assessment in Health Care, 31(3), pp. 154-165. (doi: 10.1017/S0266462315000185) (PMID:26044729) (PMCID:PMC4535322)

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Abstract

Objectives: The aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies. Methods: HTA activities for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of existing HTA networks. The data collection was performed in two stages: stage 1–agency Web-site assessment using a standardized questionnaire, followed by review and validation of the collected data by a representative of the agency; and stage 2–semi-structured telephone interviews with key informants of a sub-sample of agencies. Results: In total, thirty-six HTA agencies across twenty non-EU countries assessing medical devices were included. Twenty-seven of thirty-six (75 percent) agencies were judged at stage 1 to have adopted HTA-specific approaches for medical devices (MD-specific agencies) that were largely organizational or procedural. There appeared to be few differences in the organization, process and methods between MD-specific and non–MD-specific agencies. Although the majority (69 percent) of both categories of agency had specific methods guidance or policy for evidence submission, only one MD-specific agency had developed methodological guidelines specific to medical devices. In stage 2, many MD-specific agencies cited insufficient resources (budget, skilled employees), lack of coordination (between regulator and reimbursement bodies), and the inability to generalize findings from evidence synthesis to be key challenges in the HTA of medical devices. Conclusions: The lack of evidence for differentiation in scientific methods for HTA of devices raises the question of whether HTA needs to develop new methods for medical devices but rather adapt existing methodological approaches. In contrast, organizational and/or procedural adaptation of existing HTA agency frameworks to accommodate medical devices appear relatively commonplace.

Item Type:Articles
Additional Information:This study was supported by a research grant from the European Community’s Seventh Framework Program (FP7 - HEALTH Grant Agreement no. 305694).
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Taylor, Professor Rod
Authors: Ciani, O., Wilcher, B., Blankart, C. R., Hatz, M., Rupel, V. P., Erker, R. S., Varabyova, Y., and Taylor, R. S.
College/School:College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU
Journal Name:International Journal of Technology Assessment in Health Care
Publisher:Cambridge University Press
ISSN:0266-4623
ISSN (Online):1471-6348
Published Online:05 June 2015
Copyright Holders:Copyright © Cambridge University Press 2015
First Published:First published in International Journal of Technology Assessment in Health Care 31(3):154-165
Publisher Policy:Reproduced under a Creative Commons license

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