Reimbursement of Digital Therapeutics: Future Perspectives in Korea

Ju, Jin Han; Sim, Boram; Lee, Jeongeun; Lee, Jin Yong

doi:10.4070/kcj.2022.0014

Cited by 17 publications

(19 citation statements)

References 7 publications

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“…Future perspectives of reimbursement in other countries, such as South Korea, have also been published. 82 We also chose to not discuss in detail the topic of engagement as it is recognized as a major barrier for the field. As said, this topic is currently the focus of significant research activities.…”

Section: Limitations and Other Important Uncovered Areasmentioning

confidence: 99%

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Digital Therapeutics as a New Therapeutic Modality: A Review from the Perspective of Clinical Pharmacology

Ribba,

Peck,

Hutchinson

et al. 2023

Clin Pharma and Therapeutics

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The promise of transforming digital technologies into treatments is what drives the development of digital therapeutics (DTx), generally known as software applications embedded within accessible technologies—such as smartphones—to treat, manage, or prevent a pathological condition. Whereas DTx solutions that successfully demonstrate effectiveness and safety could drastically improve the life of patients in multiple therapeutic areas, there is a general consensus that generating therapeutic evidence for DTx presents challenges and open questions. We believe there are three main areas where the application of clinical pharmacology principles from the drug development field could benefit DTx development: the characterization of the mechanism of action, the optimization of the intervention, and, finally, its dosing. We reviewed DTx studies to explore how the field is approaching these topics and to better characterize the challenges associated with them. This leads us to emphasize the role that the application of clinical pharmacology principles could play in the development of DTx and to advocate for a development approach that merges such principles from development of traditional therapeutics with important considerations from the highly attractive and fast‐paced world of digital solutions.

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Section: Limitations and Other Important Uncovered Areasmentioning

confidence: 99%

“…Health technology assessment frameworks include the establishment of the cost‐effectiveness profile, the therapeutic value as well as the impact on a patient's health and budget. Future perspectives of reimbursement in other countries, such as South Korea, have also been published 82 …”

Section: Limitations and Other Important Uncovered Areasmentioning

confidence: 99%

Digital Therapeutics as a New Therapeutic Modality: A Review from the Perspective of Clinical Pharmacology

Ribba,

Peck,

Hutchinson

et al. 2023

Clin Pharma and Therapeutics

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show abstract

“…Mobile health (mHealth) is defined by the World Health Organization as "medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices" [33]. The capability of mHealth to digitally perform therapeutic activities has raised the interest of clinicians and providers due to its potential use in disease prevention, diagnosis, and treatment through commonplace smart devices [32,[34][35][36][37][38][39]. Previous studies concerning the validity and reliability of smartphone-based administration of MBI examinations and OSDI questionnaires yielded a satisfactory result [3,32,40].…”

Section: Introductionmentioning

confidence: 99%

Diagnostic Ability of a Smartphone App for Dry Eye Disease: Protocol for a Multicenter, Open-Label, Prospective, and Cross-sectional Study (Preprint)

Nagino¹,

Okumura²,

Yamaguchi³

et al. 2022

Preprint

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BACKGROUND Dry eye disease (DED) is one of the most common ocular surface diseases. Numerous patients with DED remain undiagnosed and inadequately treated, experiencing various subjective symptoms and a decrease in quality of life and work productivity. A mobile health smartphone app, namely, the DEA01, has been developed as a noninvasive, noncontact, and remote screening device, in the context of an ongoing paradigm shift in the health care system, to facilitate a diagnosis of DED. OBJECTIVE This study aimed to evaluate the capabilities of the DEA01 smartphone app to facilitate a DED diagnosis. METHODS In this multicenter, open-label, prospective, and cross-sectional study, the test method will involve using the DEA01 smartphone app to collect and evaluate DED symptoms, based on the Japanese version of the Ocular Surface Disease Index (J-OSDI), and to measure the maximum blink interval (MBI). The standard method will then involve a paper-based J-OSDI evaluation of subjective symptoms of DED and tear film breakup time (TFBUT) measurement in an in-person encounter. We will allocate 220 patients to DED and non-DED groups, based on the standard method. The primary outcome will be the sensitivity and specificity of the DED diagnosis according to the test method. Secondary outcomes will be the validity and reliability of the test method. The concordance rate, positive and negative predictive values, and the likelihood ratio between the test and standard methods will be assessed. The area under the curve of the test method will be evaluated using a receiver operating characteristic curve. The internal consistency of the app-based J-OSDI and the correlation between the app-based J-OSDI and paper-based J-OSDI will be assessed. A DED diagnosis cutoff value for the app-based MBI will be determined using a receiver operating characteristic curve. The app-based MBI will be assessed to determine a correlation between a slit lamp–based MBI and TFBUT. Adverse events and DEA01 failure data will be collected. Operability and usability will be assessed using a 5-point Likert scale questionnaire. RESULTS Patient enrollment will start in February 2023 and end in July 2023. The findings will be analyzed in August 2023, and the results will be reported from March 2024 onward. CONCLUSIONS This study may have implications in identifying a noninvasive, noncontact route to facilitate a diagnosis of DED. The DEA01 may enable a comprehensive diagnostic evaluation within a telemedicine setting and facilitate early intervention for undiagnosed patients with DED confronting health care access barriers. CLINICALTRIAL Japan Registry of Clinical Trials jRCTs032220524; https://jrct.niph.go.jp/latest-detail/jRCTs032220524 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/45218

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“…After the use period, health insurance coverage may be determined through the health insurance enrollment process based on accumulated clinical evidence. 5 Given limited insurance financing and equity, it may be difficult to build a social consensus to require special benefits in health insurance reimbursement for reasons of global competitiveness or industry specificity.…”

mentioning

confidence: 99%

The Beginning of the Era of Digital Therapeutics in Korea: Challenges and Opportunities

Cho

2023

J Korean Med Sci

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Reimbursement of Digital Therapeutics: Future Perspectives in Korea

Cited by 17 publications

References 7 publications

Digital Therapeutics as a New Therapeutic Modality: A Review from the Perspective of Clinical Pharmacology

Digital Therapeutics as a New Therapeutic Modality: A Review from the Perspective of Clinical Pharmacology

Diagnostic Ability of a Smartphone App for Dry Eye Disease: Protocol for a Multicenter, Open-Label, Prospective, and Cross-sectional Study (Preprint)

The Beginning of the Era of Digital Therapeutics in Korea: Challenges and Opportunities

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