OBJECTIVES : Digital therapeutics (DTx), defined as technologies that provide support in the treatment or enhance traditional clinical therapy, have made much progress over the past decade. Within this context, Germany is leading the way by allowing for the reimbursement of DTx. To achieve this, DTx are required to undergo a formal process of evidence assessment in Germany. Other countries in Europe are expected to follow suit, and there is no precedent from such therapies that can be leveraged for the process of health technology assessment (HTA).

METHODS : A search in Medline and Embase databases was conducted to identify systematic literature reviews and meta-analyses on DTx published in the last five years and not restricted by language and geographic scope. Publications were selected for all DTx except for those designed for health promotion or healthy living and all populations apart from healthy individuals.

RESULTS : Over time, the evidence on DTx almost doubled every year since 2015 (mental, behavioral, and neurodevelopmental disorders, cardiovascular disease, diabetes, cancer, and respiratory diseases), however, the use of evidence from RCTs and economic evaluations represented a small proportion of the available published evidence. These findings pose a formidable challenge in meeting HTA requirements established in Germany and the United Kingdom, which set high-quality standards for the assessment of DTx.

CONCLUSIONS : The evaluation of DTx may require innovative approaches that build on existing evidence-generation methodologies which will facilitate the continuous assessment of effectiveness and cost implications in real-world settings. While accounting for therapy-related specificities, there is a need to increase the predictability and clarity of HTA requirements for DTx.