Early medical technology assessments of medical devices and tests

Abstract

Background: Classic medical technology assessment (MTA) is typically conducted at the end of the development process to assess the overall value of a drug, medical device or diagnostic test. Recently, researchers and manufacturers have recognized that MTA in the early phases could help to make better decisions about further development, the regulatory and reimbursement strategy, and allocating public support for new technologies. The aim of this study is to introduce the most commonly used methods in early MTAs of emerging technologies and examine which methods have been used in the early MTAs of medical devices and tests. Methods: An explorative literature review. Results: Classic MTA supports particularly regulators and payers in market and reimbursement decisions, while early MTA primarily supports decisions of manufacturers about investments and strategies regarding further development as well as decisions by policymakers about public support. Important methods that can be used in early MTAs of medical devices include early health economic modelling, the headroom method, the Bayesian analytical framework, clinical trial simulation, multi-criteria decision analysis and value of information analysis. Only a few articles have been described early HTAs of devices and tests and most of these have used economic modelling, sometimes in combination with other methods. Conclusions: Various methods can be applied in performing early MTA. While early MTA follows the same steps as classic MTA, repeated assessments and sensitivity analysis play a more significant role.