Practical Use of Early Stage Health Technology Assessment of Medical Devices: Systematic Literature Review

摘要

The early stage HTA (eHTA) is a commonly used tool for identifying economic indicators of health technology in early phases of research and development. It provides powerful influence instruments to manage the manufacturer's investment risks and to improve the device design. There is no uniform generally accepted standard of eHTA implementation, but an analysis of several large-scale theoretical studies showed that, in general, the eHTA process for medical devices consists of three stages: conceptual modelling of the new medical technology, determination of new technology parameters by expert elicitation methods, and simulation allowing for an analysis of commercial options. The aim of this study is a systematic review of studies published from 2014 till 2019 and an analysis of selected articles in terms of the methods used in each step of the early stage health technology assessment. Most of the analyzed case studies deal only with a part of the early stage medical device assessment, probably because of its confidential character. But we have found the popularity of decision-making models, the applicability of AHP (the analytic hierarchy process) methods to the elicitation process, and information on the use of CEA (cost-effectiveness analysis) methods and headroom methods as economic analysis tools.