디지털치료기기의 경제성 평가: 스코핑리뷰

Economic Evaluation of Digital Therapeutics: a Scoping Review

BACKGROUNDS Digital therapeutics (DTx) are software medical devices that deliver evidence-based interventions to prevent, manage, or treat disease. Their clinical value is recognised, yet economic evidence remains limited and diverse. This study aims to map and appraise the reporting quality of economic evaluations of prescription DTx and identify research gaps. METHODS A scoping review was conducted using Tornvall’s five-stage framework. PubMed/Medline was searched for articles published up to 6 March 2025 by using “digital therap*” or “DTx” combined with economic terms (“economic ev*”, “cost*”, “saving*”). After deduplication, 237 records were screened; 16 studies reporting cost outcomes for DTx interventions were included. Two reviewers independently extracted study characteristics and assessed reporting quality with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 checklist. RESULTS The 16 included studies originated from the United States (81.3 %), Germany (12.5 %), and South Korea (6.2 %). ReSET-O for substance-use disorder was the most frequently evaluated product. DTx interventions usually involved smartphone or tablet applications delivering cognitive-behavioural therapy. Cost-utility analyses and cost analyses predominated; outcomes included quality-adjusted life years (QALYs), incremental cost-effectiveness rations (ICERs), and total savings. Overall, DTx were generally cost-saving or cost-effective, yet development and maintenance costs were rarely disclosed. All of the included studies were of high or moderate reporting quality, but heterogeneity in cost categories, perspectives, and time horizons limited comparability. CONCLUSION Evidence suggests prescription DTx can deliver economic as well as clinical value, but standardized evaluations are needed. Future work should explicitly report all cost components and adopt consistent methodological standards to support reimbursement decisions and sustainable integration of DTx into health systems.