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.

Vaccine effectiveness of COVID-19 and rebound in the real world.

We intend to evaluate the relationship between the rates of global SARS-CoV-2 vaccination and the number of COVID-19 confirmed cases, as well as the mortality rate after the declaration of a pandemic. Of the data from 191 countries at the time of data retraction, we selected 111 countries that have SARS-CoV-2 vaccination reports. We stratified countries into high-income and non-high-income countries (HIC and non-HIC) based on World Bank income-group. We used a fixed-effects model (FEM) and performed a longitudinal analysis. The number of confirmed cases decreased as the vaccination rates increased in both non-HICs (B = - 0.027, T = - 2.0) and HICs (B = - 0.207, T = - 17.5). The number of deaths decreased as the vaccination rates increased in both non-HICs (B = - 0.151, T = - 2.3) and HICs (B = - 0.230, T = - 40.9). For full vaccination, this measure had a negative association with daily confirmed cases and daily deaths in both non-HICs and HICs. In non-HICs, daily cases and daily deaths decreased as the first vaccination and full vaccination coverages increased. However in HICs, daily cases and daily deaths decreased as the first vaccination and full vaccination coverages increased in the early phase, but after a certain period, they tended to increase again. We observed a significant association between the increase in vaccination coverage in the real world and reduced daily confirmed cases and deaths. However, as the confirmed cases and deaths have rebounded in HICs, our findings indicate that COVID-19 is not completely prevented through vaccine distribution.

Evaluating the effect of the COVID-19 pandemic on hypertension and diabetes care in South Korea: an interrupted time series analysis.

BACKGROUND: Access to healthcare services is important, especially for patients with chronic diseases. We evaluated the effect of the COVID-19 pandemic on outpatient visits and medication for patients with hypertension and diabetes in South Korea. METHODS: Nationwide claims data were extracted for patients with hypertension and diabetes from January 2019 to July 2020. We used an interrupted time series (ITS) analysis to evaluate the pandemic's impact on outpatient care using the number of outpatient visits and days of medication supplied per visit. We identified the change in the continuity of care in medication, a consequence of the change in outpatient care, using the Medication Possession Ratio (MPR). RESULTS: The number of outpatient visits for diabetes significantly declined in February 2020, when community transmission began. However, when high-intensity social distancing was relaxed in April 2020, outpatient visits for hypertension and diabetes rebounded significantly. Moreover, when the outpatient visits declined, the number of days of medication supplied per visit increased. Consequently, the average MPRs significantly increased compared to 2019, increasing the ratio of patients with appropriate medication supply (MPR ≥ 0.8). CONCLUSIONS: Outpatient visits decreased immediately when COVID-19 spread to local communities. However, the number of days of medication supplied per visit increased to compensate for the longer intervals between visits. Rather, the change in the continuity of care in medication improved; thus, the temporary decrease in outpatient visits might have had a limited negative impact on health outcomes.

Trends in patient suicide rate after psychiatric discharge in Korea from 2010 to 2018: A nationwide population-based study.

BACKGROUND: There is limited quantitative evidence to investigate short-term suicide rates although the risk of suicide in psychiatric patients is exceptionally high in the early post-discharge period. This study aimed to explore the trends of the 30 days suicide rate after discharge using population-based data from Korea. METHODS: This study was conducted on psychiatric patients aged 15 years or older discharged between 2010 and 2018. Patients were extracted from the National Health Insurance Claim Database (NHICD) and information on suicide was obtained from the National Statistical Office. Age-standardized suicide rate (ASR) and Standardized Mortality Ratio (SMR) within 30 days after discharge was estimated and tested using joinpoint regression. RESULTS: Of the 1,576,028 patients discharged from hospitals from 2010 to 2018, 53.9 % were male and 47.9 % were aged between 40 and 59 years. The 30 days ASRs for psychiatric patients after discharge varied from 174.9 to 218.0 per 100,000 patients with no clear trend excluding patients with schizophrenia and anxiety disorder. The SMR for suicide within 30 days after discharge was 66.8 in 2016-2018, and patients aged 20 to 39, female, and patients with depression had high SMRs compared to other groups. LIMITATIONS: Factors that may impact the suicide were not considered in this study. Since the NHICD data is collected for payment of medical expenses, there may be scope for inaccuracies. CONCLUSIONS: The 30 days suicide rate after psychiatric discharge has failed to decrease between 2010 and 2018. This study recommends early interventions after discharge and intensive interventions for patient groups who may be vulnerable to suicide.

Evaluation of Thirdhand Smoke Exposure after Short Visits to Public Facilities (Noraebang and Internet Cafés): A Prospective Cohort Study.

We aimed to evaluate the degree of thirdhand smoke (THS) caused by short-term exposure to smoking-related substances. To this end, we evaluated the change in concentration of a smoking-related urine biomarker in volunteers before and after visiting public spaces where there is likely THS exposure. We hypothesized that a visit to such public spaces would result in an increase in such biomarkers. Participants visited one of the predetermined facilities (noraebang, PC café) and revisited the same facility after 24 h, spending around 2 h per visit. We selected creatinine-corrected urine cotinine (CUC) as a biomarker to evaluate THS. In addition, we collected nicotine-derived nitrosamine ketone (NNK) from surface dust at each site with cotton swabs (diameter of 2.5 cm). We examined whether CUC concentration significantly changed across three time points (baseline, first visit, and second visit) via repeated-measures analysis of variance (RM-ANOVA). Moreover, we analyzed the interaction to determine whether cigarette smell affects the CUC concentration. Finally, CUC and dust NNK were analyzed with Pearson's correlation. The CUC concentration did not increase from baseline to the first visit, but increased from the baseline to the second visit (Diff = Ln [0.565] ng/mg, P < 0.01). Further, the CUC concentration increased from the first to the second visit (Diff = Ln [0.393] ng/mg, p < 0.01). In the case of the interaction effect, there were statistically significant differences in CUC concentration depending on the smell of smoke in the facility (Diff = Ln [0.325], F value = 4.438, p value = 0.041). The change in CUC concentration from baseline to the second visit (r = 0.562, p < 0.001) and from the first to the second visit (r = 0.544, p < 0.001) were correlated with NNK concentration. We evaluated whether a short stay in a facility with smoke-related substances that adhere to the surrounding environment would expose individuals to THS even if they do not smell or are directly exposed to cigarette smoke. We confirmed that even two relatively short stays (approximately 2 h each) in a facility in which people had previously smoked can lead to THS exposure.

The Impact of COVID-19 Pandemic on Outpatient Visits for All-Cause and Chronic Diseases in Korea: A Nationwide Population-Based Study.

This study explores the impact of the coronavirus disease 2019 (COVID-19) pandemic on outpatient visits for all-cause and chronic diseases in 2020. We extracted the data of patients who visited medical institutions over the past five years (2016-2020) from nationwide claims data and measured the number of monthly outpatient visits. A negative binomial regression model was fitted to monthly outpatient visits from 2016 to 2019 to estimate the numbers of 2020. The number of all-cause outpatient visits in 2020 was 12% lower than expected. However, this change was relatively stable in outpatient visits for chronic diseases, which was 2% lower than expected. Deficits in all-cause outpatient visits were observed in all months except January; however, deficits in outpatient visits for chronic diseases have rebounded since April 2020. The levels of change in healthcare utilization were observed differently among disease groups, which indicates that the impacts of the pandemic were disproportionate. This study calls for a policy response to emerging and reemerging infectious diseases, as the findings confirm that a health crisis, such as the COVID-19 pandemic, could disrupt the healthcare system. Assessing the mid-to long-term impacts of COVID-19 on healthcare utilization and health consequences will require further research.

Public Health Financing and Responses to COVID-19: Lessons from South Korea.

Health financing strategies contribute significantly to containing the outbreak of the Coronavirus disease 2019 (COVID-19). This study aims to reassess Korea's financing strategies in response to COVID-19 in 2020, to ascertain its effects and sustainability. The Joint External Evaluation tool was adopted to analyze the data collected from government reports, official statistics, and other sources. Findings show that Korea could maintain a low incidence and fatality rate compared with other countries, at low costs. It was a result of rapidly procured healthcare resources based on laws and policies established after the 2015 epidemic, and the National Health Insurance. However, to achieve long-term sustainability, it is important to enhance the financial stability of the national health insurance and increase the proportion of the public sector in healthcare resources.

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.

Estimation of Excess All-cause Mortality during COVID-19 Pandemic in Korea.

BACKGROUND: Excess all-cause mortality is helpful to assess the full extent of the health impact, including direct and indirect deaths of coronavirus disease 2019 (COVID-19). The study aimed to estimate overall and regional excess all-cause mortality during the pandemic in Korea. METHODS: We obtained all-cause death data and population statistics from January 2010 to December 2020. The expected mortality in 2020 was estimated using a quasi-Poisson regression model. The model included death year, seasonal variation, cold wave (January), average death counts in the previous month, and population. Excess mortality was defined as the difference between the observed mortality and the expected mortality. Regions were classified into three areas according to the numbers of COVID-19 cases. RESULTS: There was no annual excess all-cause mortality in 2020 at the national and regional level compared to the average death for the previous ten years. The observed mortality in 2020 was 582.9 per 100,000 people, and the expected mortality was 582.3 per 100,000 people (95% confidence interval, 568.3-596.7). However, we found monthly and regional variations depending on the waves of the COVID-19 pandemic in Korea. While the mortality in August, October, and November exceeded the expected range, the mortality in September was lower than the expected range. The months in which excess deaths were identified differed by region. CONCLUSION: Our results show that the mortality in 2020 was similar to the historical trend. However, in the era of the COVID-19 pandemic, it would be necessary to regularly investigate COVID-19-related mortality and determine its direct and indirect causes.

Exposure to Secondhand Smoke: Inconsistency between Self-Response and Urine Cotinine Biomarker Based on Korean National Data during 2009-2018.

This study aimed to estimate the secondhand smoke (SHS) exposure using urinary cotinine (UCo) to prove that the SHS exposure could not be properly assessed by self-reporting (SR). In total, 28,574 nonsmokers aged >19 years were selected from the Korean National Health and Nutrition Examination Survey data (2009-2018). First, changes in the annual concentration of UCo were analyzed, and the annual SHS exposure rates were measured based on SR and UCo from 2009 to 2018. Then, the average UCo concentration and UCo-measured SHS exposure rate were confirmed according to the subjects' characteristics. Finally, factors associated with the UCo-measured SHS exposure rate were identified based on multiple regression analysis. The findings showed that the annual UCo concentrations and self-reported SHS exposure rates dropped significantly over the past decade. In contrast, the UCo-measured SHS exposure rate indicated that >80% of nonsmokers are still exposed to SHS. Moreover, we found vulnerable groups using UCo-measured SHS exposure rate. In particular, the self-reported SHS exposure at home and in workplaces and house type was highly associated with SHS exposure. Thus, these findings indicate that the actual SHS exposure could not be properly assessed by SR and should be verified using a biomarker, such as UCo. Considering that even a short-term exposure can be harmful to health, the goal of the policy should be to keep cotinine concentration as low as possible.

Association between urine cotinine and depressive symptoms in non-smokers: National representative sample in Korea.

BACKGROUND: Secondhand smoke (SHS) exposure is known to have negative effects on mental as well as physical health. However, the association between SHS and mental health problems has not been assessed in non-smokers. To evaluate the association of exposure to tobacco smoke and depressive symptoms, and that of the prevalence of having depressive symptoms and urinary cotinine (UCo) concentrations in non-exposed subjects. METHODS: Data was extracted from the Korea National Health and Nutrition Examination Survey (KNHANES). Depressive symptoms were determined based on a patient's overall score on the Patient Health Questionnaire (PHQ)-9, and SHS exposure was evaluated using self-reported data and UCo concentration. Overall, 13,219 non-smokers, ≥ 19 years were included in the study. Multinomial logistic regression analysis was conducted to identify factors related to depressive symptoms; independent t-test was conducted to confirm the differences in UCo concentration according to the prevalence of depression. RESULTS: Among the non-exposure groups, 2.0% of the males and 5.6% of the females showed depressive symptoms. Lower social-economic status, higher UCo concentration, and SHS exposure increased the prevalence of depressive symptoms. The UCo concentration of females with depressive symptoms was significantly higher than those of females without depressive symptoms. LIMITATIONS: This study only demonstrated an association between SHS exposure and depression, not the causal effects, because of the cross-sectional study design. CONCLUSION: SHS exposure and depressive symptoms are correlated. The association was also confirmed by evaluating the UCo concentration of those who were not exposed to SHS based on self-reported data.

Influence of intensive net cage farming on hydrodynamic and geochemical environmental conditions and the mass mortality of abalone in South Korea.

The abalone aquaculture industry in South Korea has grown rapidly since the 2000s. In this study, we investigated the sedimentary pollution at four major abalone farms responsible for ~60% of all South Korean abalone produced. We also surveyed the current statuses of cage facilities, abalone mass mortality, and current velocities within and outside farm cages. The concentrations of total organic carbon in the study area were 7.92 ± 2.09 mg g-1, indicating a mild level of sedimentary pollution. We observed higher mortality rates in rectangular-shaped shelter cages than in triangular shelters. With increases in the number and size of abalone farming facilities, current velocities inside the cages declined by an average of 45% relative to those outside the cages, leading to poor habitat conditions for farmed abalone. Our results provide insights into the current status of the benthic environments and major causes of mass mortality in the abalone farms of South Korea.