Stakeholders' Perceptions Regarding Digital Therapeutics Reimbursement in South Korea: Qualitative Study.

Background: Digital therapeutics (DTx) are therapeutic interventions driven by software and directly provided to patients, allowing them to manage their health with ease in any setting. A growing interest in DTx has spurred a discussion concerning their reimbursement pathways. However, DTx are still at a premature stage, with insufficient evidence on effectiveness, efficiency, and safety. Currently, although industries desire to quickly enter the market, especially by getting their products reimbursed by the National Health Insurance (NHI) fund, the NHI is cautious about DTx due to their uncertainties. Thus, public discussion and social consensus are crucial in deciding whether to reimburse DTx by the NHI fund. Objective: This study examined multiple stakeholders' awareness and attitudes toward DTx and perceptions of regulatory pathways for adopting DTx. Methods: In-depth interviews were conducted with 11 stakeholders in South Korea (industry: n=4, health care: n=3, academia: n=2, and consumer: n=2) using semistructured guidelines. They were purposively sampled to identify individuals with expertise in DTx and NHI policies. The interviews were conducted either in person or via a videoconference for 45-70 minutes. Qualitative data were analyzed using directed content analysis, which uses interview guidelines as an analytical framework. Results: Findings were divided into three categories: (1) awareness and attitude toward DTx, (2) perception of whether DTx are worth entering the market and being reimbursed by the NHI fund, and (3) perception of how to enter the market and how to reimburse DTx by the NHI fund if they are worth it. Although consumer stakeholders were not familiar with the basic concept of DTx, the other stakeholders understood it thoroughly. However, all participants showed positive attitudes and acceptance of DTx. Most of them responded that DTx are worth entering the market, but they could not reach an agreement on the pathways for DTx to enter the market. Although participants were in favor of the reimbursement of DTx in principle, they responded that a conservative approach is required due to insufficient clinical evidence for DTx. Conclusions: We found that stakeholders in South Korea had positive attitudes toward DTx, perceived them as worth using, and agreed to allow them to enter the market. The main issue was not the problem of the technology itself but the difference in opinion as to the pathways for reimbursement. Therefore, this study concluded that the NHI fund, which is operated very conservatively, is insufficient to quickly adopt and implement DTx. Various reimbursement methods, including tax-based financing, raising innovation funds for new technologies, and pilot studies using the NHI fund, should be used to rapidly generate clinical evidence and reduce the uncertainties of DTx to secure a stable market.

Analysis of the prescription trends of potentially inappropriate medications in Korean older outpatients by sex: A retrospective study using data from the health insurance review and assessment service.

This study aimed to determine the policy implications for drug management by identifying the prescription trends of potentially inappropriate medications (PIMs) in older outpatients. Considering the Drug Utilization Review and Korean version of the standards for PIMs based on the Beers Criteria, 141 ingredients were selected that spanned over 7 years of health insurance claims data analysis. During the study period, the number of patients and claims related to PIMs increased. Although the number of health insurance claims decreased in 2020 owing to coronavirus disease (COVID-19), it increased again in 2021. Tamsulosin was the most frequently prescribed drug for male patients, followed by alprazolam and zolpidem. For female patients, eperisone was the most frequently prescribed drug, followed by alprazolam, zolpidem, and etizolam. In Korea, health insurance claims for PIMs decreased in 2020 owing to the COVID-19 pandemic. However, an overall increasing trend was observed from 2015 to 2021. Moreover, during this period, the prescription trend of benzodiazepine-type drugs and zolpidem increased in both male and female patients. Therefore, management policies regarding PIMs and drug ingredients, such as benzodiazepines and zolpidem, are required.

Reimbursement of Digital Therapeutics: Future Perspectives in Korea.

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.