Coverage With Evidence Development as a Potential Solution for the Reimbursement of Digital Therapeutics (DTx)? A Systematic Review of Pathways to Inform Reimbursement Decisions in Major European Healthcare Systems

OBJECTIVES: Digital therapeutics (DTx) are one promising type of innovation, which could lead to a paradigm shift in the delivery of health services. The primary objective of this research was a comparison of pathways for informed reimbursement decisions of DTx solutions across the five major European healthcare systems (EU5). Additionally, a case study for one DTx was conducted to highlight practical insights regarding the analysed differences.

METHODS: For this systematic review all records on the assessment and reimbursement of DTx in the EU5 until 15/02/2024 were considered. Medline, Embase, Scopus and Web of Science were systematically searched.

RESULTS: 35 records were included in the synthesis. Due to the disruptive nature of DTx, authorities in Germany, France, the UK and regions of Spain established separate Health technology assessment (HTA) pathways. Italy is currently designing a designated HTA pathway for DTx. These newly designed pathways incorporate coverage with evidence development mechanisms. Manufacturers of DTx already receive reimbursement while they are still collecting data on the long-term efficacy. The assessment frameworks for national HTA incorporate regulatory, technical and evidence requirements which DTx manufacturers need to comply with to be eligible for reimbursement within the statutory health insurance systems. Regulatory requirements are centrally organized on a European level. Technical requirements are comparable across the EU5 countries. Evidence requirements differ across countries and consider that DTx have the potential to demonstrate medical benefits and additionally improve the organization of care.

CONCLUSIONS: DTx require new pathways to inform reimbursement decisions. The compatibility regarding regulatory and technical requirements across national pathways is high. Guidelines on the transferability of evidence across countries could help to ensure access to DTx across major European countries. Coverage with evidence development approaches help to foster incentives for investments in these new treatment approaches, guarantee evidence-based coverage decisions and ensure access to these innovative therapies for patients.