OBJECTIVES

Digital Therapeutics (DTx) are software programmes increasingly used to diagnose, manage and prevent chronic and behaviour-modifiable diseases. The evidence requirements for the regulatory approval and the reimbursement (including health technology assessments – HTAs) for these technologies present distinct challenges for developers, clinicians and patients alike. We derive a set of frameworks to characterise the pathways and the type of evidence supporting the regulatory approval and reimbursement or HTA of DTx in the United States, EU4 (France, Italy, Spain and Germany) and the UK.

METHODS

A pragmatic literature review was conducted in BIOSIS Previews®, Embase®, MEDLINE®, QUOSA®, using keywords related to DTx, regulatory and reimbursement frameworks (January 2010 - June 2021). Searches were supplemented with gray literature and official guidance documents. Databases (e.g., online FDA) were searched for DTx approved to date, using Python. Evidence was extracted on: the classification of DTx; the expected design of clinical studies; the role of real-world evidence (pre and post license); the required economic evidence.

RESULTS

Across all assessed countries, the evidence required in the regulatory and reimbursement processes of DTx depends on the level of risk associated with them and their claimed degree of innovation. Importantly, clinical and economic evidence is often generated after DTx are licensed and reimbursed, through their own use, leading to a broader role of real-world data and novel studies methodologies. However, the evolution of evidence requirements appears to take place in a fragmented and reactive manner, particularly in the reimbursement assessment of DTx, with several gaps remaining unaddressed.

CONCLUSIONS

DTx are unique technologies, with the potential to reshape the relationship between patients and healthcare providers. Regulators and Payers alike need to ensure that their guidance on evidence requirements maintains the pace of the rapid evolution of these technologies, enabling their adoption whilst ensuring critical risk considerations are adequately addressed.