Digital therapeutics in Japan: Present and future directions

Abstract

Digital therapeutics (DTx) represent an innovative approach to healthcare, leveraging software applications (apps) delivered through digital devices to treat medical conditions. This review focuses on three DTx apps approved in Japan, targeting nicotine dependence, hypertension, and insomnia. CureApp SC, the DTx system for nicotine dependence, comprises a patient smartphone app, an Internet of Things device for exhaled carbon monoxide measurement, and a Web-based physician app. A clinical trial demonstrated significantly higher rates of continuous abstinence in the intervention group than in the controls (63.9 % vs. 50.5 %, p = 0.001) at 24 weeks, with effects persisting through 52 weeks. For hypertension management, CureApp HT focuses on lifestyle modifications with daily home blood pressure monitoring. The HERB-DH1 trial showed a significant reduction in 24-h systolic blood pressure (between-group difference, -2.4 mmHg; p = 0.024) and morning home blood pressure (between-group difference, -4.3 mmHg; p < 0.001) in the intervention group compared with those in the controls. This hypertension DTx app also exhibits potential lifetime cost-effectiveness. Regarding insomnia management, SUSMED MedCBT-i supports physician-delivered cognitive behavioral therapy for insomnia. In a randomized controlled trial, Athens Insomnia Scale scores significantly improved in the intervention group compared with those in the controls (between-group difference, -3.4 point; p < 0.001) at 8 weeks. These DTx apps represent a significant advancement in managing chronic conditions, offering scalable and accessible methods for delivering evidence-based interventions. They also address the challenges in implementing lifestyle modifications and behavioral therapies in traditional healthcare settings. As DTx become more integrated into routine clinical practice, ongoing research is crucial to evaluate their long-term efficacy, safety, and cost-effectiveness. The success of these initial DTx apps in Japan paves the way for more comprehensive digital health solutions, potentially improving individual patient outcomes and contributing to larger-scale public health improvements in managing chronic conditions.

Keywords: Digital medicine; Digital therapeutics; SaMD; mHealth.