OBJECTIVES

: To face rapid growth of digital health technologies are HTA bodies are developing guidelines specifying evidence to be submitted due to digital solutions specificities. The aim of this study was to compare recent guidelines developed by the English (NICE) and French (HAS) HTA agencies.

METHODS

: NICE evidence framework for digital technologies (March 2019) and HAS guide on the assessment of connected medical devices (January 2019) have been compared in terms of eligible solutions, target stakeholders and evidence requirements.

RESULTS

: NICE guidelines are applicable to broad range of digital solutions, as far as they are eligible for commissioning. They may concern not only solutions regulated as medical devices but any digital health technologies intended to be used under the NHS system. The framework classifies solutions to one of four groups based on the risk to users and to one of three groups based on the economic risk to payers. HAS guidelines pertain only to connected medical devices being the subject of the assessment by the CNEDiMTS (HAS committee responsible of clinical assessment of medical devices). HAS guidelines are targeting primarily the solution developers to anticipate clinical requirements for reimbursement. NICE guidelines target broader audience including solution developers, investors and assessors. NICE indicates clinical and economic data expected depending on the risk groups to which the solution was classified. HAS describes clinical requirements pertaining to the all targeted connected medical devices in terms of mortality, morbidity, safety, pertinence and relevance. As HAS guidelines pertains to CNEDiMTS assessment, it does not encompass any economic requirements assessed at the level of the HAS Economic Committee (CEESP).

CONCLUSIONS

: NICE and HAS have developed evidence frameworks to account for elements specific to digital health technologies and to better fit within pathways already existing in the systems – clinical commissioning in England and national funding of medical devices in France.