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E-Bulletin No. 9 - November 2022 | Digital Therapeutics

Published on: 17 Nov 2022 Viewed: 303

This week, Connected Health (CH) journal continues to share several latest articles related to digital therapeutics.

1. Title: Reimbursement of Digital Therapeutics: Future Perspectives in Korea

Authors: Jin Han Ju, Boram Sim, Jeongeun Lee, Jin Yong Lee

Type: State of the Art Review

Digital health is rapidly growing worldwide and its area is expanding from wellness to treatment due to digital therapeutics (DTx). This study compared DTx in the Korean context with other countries to better understand its political and practical implications. DTx is generally the same internationally, often categorized as software as a medical device. It provides evidence-based therapeutic interventions for medical disabilities and diseases. Abroad, DTx support entailed state subsidies and fundraising and national health insurance coverage. In the case of national health insurance coverage, most cases were applied to mental diseases. Moreover, in Japan, DTx related to hypertension will possibly be under discussion for national health insurance coverage in 2022. In overseas countries, coverage was decided only when the clinical effects were equivalent to those provided by existing technology, and in the UK, real usage data for DTx and associated evaluations were reflected by national health coverage determination. Prices were either determined through closed negotiations with health insurance operating agencies and manufacturers or established based on existing technology. Concerning the current situation, DTx dealing with various diseases including hypertension are expected to be developed near in the future, and the demand for use and compensation will likely increase. Therefore, it is urgent to define and prepare for DTx, relevant support systems, and health insurance coverage listings. Several support systems must be considered, including government subsidies, science/technology funds, and health insurance.

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2. Title: The first software as medical device of evidence-based hypertension digital therapeutics for clinical practice

Authors: Kazuomi Kario, Noriko Harada and Ayako Okura

Type: Mini Review

In 2021, the open-label randomized HERB-Digital Hypertension 1 (HERB-DH1) trial showed for the first time that hypertension digital therapeutics (a hypertension treatment app) successfully reduced blood pressure (BP) in patients with hypertension. Patients in the digital therapeutics group who used the app and home BP monitoring (HBPM) showed significant and persistent decreases in office, home and ambulatory BP values compared with the control group (who were under physician management using HBPM and lifestyle modifications). The results of the pivotal study led to the first global approval of this app for the treatment of hypertension in Japan in 2022, including medical insurance reimbursement. As a result, this hypertension app is expected to become widely used in the clinical management of all stages of hypertension. The most important remaining research issues include the identification of patients likely to respond to this therapeutic approach and the development of clinical efficacy indices. In addition, guidelines for the appropriate use of hypertension apps in the treatment of hypertension are needed. Next steps include the development and research of digital tools to facilitate the behavioral modifications required to prevent hypertension.

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3. Title: Efficacy and safety of digital therapeutics-based cardiac rehabilitation in heart failure patients: a systematic review

Authors: Xiu Zhang, Zeruxin Luo, Mengxuan Yang, Wei Huang, Pengming Yu

Type: Review

During the coronavirus disease 2019 (COVID-19) pandemic, it has become difficult to provide centre-based cardiac rehabilitation for heart failure patients. Digital therapeutics is a novel concept proposed in recent years that refers to the use of evidence-based therapeutic interventions driven by high-quality software programs to treat, manage, or prevent a medical condition. However, little is known about the use of this technology in heart failure patients. This study aims to explore the safety and efficacy of digital therapeutics-based cardiac rehabilitation in heart failure patients and to provide new insights into a new cardiac rehabilitation model during the COVID-19 era. To identify technologies related to digital therapeutics, such as the use of medical applications, wearable devices, and the Internet, all relevant studies published on PubMed, EMBASE, Cochrane database, and China National Knowledge Internet were searched from the time the database was established until October 2021. The PEDro was used to assess the quality of included studies. We ultimately identified five studies, which included 1119 patients. The mean age was 66.37, the mean BMI was 25.9, and the NYHA classification ranged from I to III (I = 232, II = 157, III = 209). The mean 6-min walk distance was 397.7 m. The PEDro scores included in the study ranged from 4 to 8, with a mean of 5.8. Exercise training was performed in four studies, and psychological interventions were conducted in three studies. No death or serious adverse events were observed. Adherence was reported in three studies, and all exceeded 85%. The results of most studies showed that digital therapeutics-based cardiac rehabilitation significantly increases exercise capacity and quality of life in heart failure patients. Overall, although this study suggests that digital therapeutics-based cardiac rehabilitation may be a viable intervention for heart failure patients during the COVID-19 era, the efficacy of this new model in routine clinical practice needs to be further validated in a large clinical trial.

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4. Title: Appropriate controls for digital therapeutic clinical trials: A narrative review of control conditions in clinical trials of digital therapeutics (DTx) deploying psychosocial, cognitive, or behavioral content

Authors: Jacqueline Lutz, Emanuela Offidani, Laura Taraboanta, Shaheen E. Lakhan and Timothy R. Campellone

Type: Review

Digital therapeutics (DTx) are software programs that treat a disease or condition. Increasingly, DTx are part of medical care, and in the US healthcare system they are regulated by the FDA as Software as a Medical Device (SaMD). Randomized controlled trials (RCT) remain a key evidence generation step for most DTx. However, developing a unified approach to the design of appropriate control conditions has been a challenge for two main reasons: (1) inheriting control condition definitions from pharmacotherapy and medical device RCT that may not directly apply, and (2) challenges in establishing control conditions for psychosocial interventions that build the core of many DTx. In our critical review we summarize different approaches to control conditions and patient blinding in RCT evaluating DTx with psychosocial, cognitive or behavioral content. We identify control condition choices, ranging from very minimal digital controls to more complex and stringent digital applications that contain aspects of “fake” therapy, general wellness content or games. Our review of RCTs reveals room for improvement in describing and naming control conditions more consistently. We further discuss challenges in defining placebo controls for DTx and ways in which control choices may have a therapeutic effect. While no one-size-fits-all control conditions and study designs will apply to all DTx, we propose points to consider for defining appropriate digital control conditions. At the same time, given the rapid iterative development and optimization of DTx, treatments with low risk profile may be evaluated with minimal digital controls followed by extensive real-world effectiveness trials.

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We hope this sharing will inspire you. Looking forward to meeting you next time in CH Bulletin.

Respectfully submitted by the Editorial Office of Connected Health

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