DIGITAL THERAPEUTICS WORLDWIDE: A SCOPING REVIEW OF ADOPTION, REGULATION, REIMBURSEMENT/HTA, AND PATIENT OUTCOMES
Author(s)
Pradeep Manohar Muragundi, PhD, Mohammed Rahil T R, M.Pharm, Harshada Bhimrao Pawar, M.S. Pharm.
Pharmaceutical Regulatory Affairs and Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India.
Pharmaceutical Regulatory Affairs and Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India.
OBJECTIVES: Digital therapeutics (DTx) are evidence-based software interventions delivering medical therapies. While regulatory approval and health system adoption are evolving, real-world uptake remains limited. This scoping review maps the extent and nature of evidence on DTx adoption, regulation, reimbursement/health technology assessment (HTA), and patient outcomes worldwide.
METHODS: Following JBI guidance and PRISMA-ScR, we searched PubMed, Embase, Web of Science, Scopus, and Cochrane Library (Jan 2020- May 2026). Eligibility used a PCC framework: Population (patients, providers, policymakers), Concept (DTx adoption, regulation, reimbursement/HTA, outcomes), Context (all countries). Two reviewers independently screened records. Total 47 studies were included for the review after full text screening. Data were charted and synthesized narratively by theme and region.
RESULTS: Regulatory pathways vary: the FDA (US) approved 192 DTx products, China's NMPA approved 235, Germany's DiGA listed 55 (35 permanent, 20 provisional), and Belgium approved 25. France (PECAN), Korea (Integrated Review), and the UK (DTAC/EVA) operate dedicated pathways. Reimbursement models differ: Germany combines regulatory approval with statutory insurance coverage (374,000+ prescriptions); France uses HTA-informed pricing; UK NICE guidance is advisory; Spain published a digital HTA framework in 2023. Adoption barriers include provider knowledge gaps, lack of interoperability, reimbursement uncertainty, and digital literacy deficits. Clinical outcomes show improved adherence in diabetes, hypertension, and mental health.
CONCLUSIONS: DTx regulatory and reimbursement landscapes remain fragmented globally. While high-income countries have established pathways, LMICs lack regulatory clarity and reimbursement structures. Evidence supports clinical effectiveness, but significant equity gaps exist in trial representation and access. Standardized global frameworks, expanded LMIC evidence generation, and equitable reimbursement policies are needed to realize DTx potential.
METHODS: Following JBI guidance and PRISMA-ScR, we searched PubMed, Embase, Web of Science, Scopus, and Cochrane Library (Jan 2020- May 2026). Eligibility used a PCC framework: Population (patients, providers, policymakers), Concept (DTx adoption, regulation, reimbursement/HTA, outcomes), Context (all countries). Two reviewers independently screened records. Total 47 studies were included for the review after full text screening. Data were charted and synthesized narratively by theme and region.
RESULTS: Regulatory pathways vary: the FDA (US) approved 192 DTx products, China's NMPA approved 235, Germany's DiGA listed 55 (35 permanent, 20 provisional), and Belgium approved 25. France (PECAN), Korea (Integrated Review), and the UK (DTAC/EVA) operate dedicated pathways. Reimbursement models differ: Germany combines regulatory approval with statutory insurance coverage (374,000+ prescriptions); France uses HTA-informed pricing; UK NICE guidance is advisory; Spain published a digital HTA framework in 2023. Adoption barriers include provider knowledge gaps, lack of interoperability, reimbursement uncertainty, and digital literacy deficits. Clinical outcomes show improved adherence in diabetes, hypertension, and mental health.
CONCLUSIONS: DTx regulatory and reimbursement landscapes remain fragmented globally. While high-income countries have established pathways, LMICs lack regulatory clarity and reimbursement structures. Evidence supports clinical effectiveness, but significant equity gaps exist in trial representation and access. Standardized global frameworks, expanded LMIC evidence generation, and equitable reimbursement policies are needed to realize DTx potential.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR232
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas