Is therapeutic germline editing value-based healthcare? an early health technology assessment

Abstract

Innovative healthcare technologies may raise ethical concerns which prevent their implementation for fear of unexpected or undesirable outcomes, even before they are introduced into usual clinical practice. Essential to innovation is therefore to analyze benefits and drawbacks from a multidisciplinary point of view (i.e., biomedical, social, financial). Value-based healthcare is currently the most comprehensive theoretical framework to evaluate the benefits of healthcare technologies on patients and society in the longer term. Technically, "the systematic evaluation of properties, effects and/or impacts of health technologies"must be performed by validated procedures of Health Technology Assessment (HTA), supported by early HTA procedures to retrieve preliminary evidence and expert opinions. The aim of this study is to perform an early HTA of germline editing technologies in order to estimate their impact on patients and society, in light of the recent, controversial debate which followed the germline gene editing of human embryos.