Patient-Centered Economic Burden of Diabetic Macular Edema: Retrospective Cohort Study.

BACKGROUND: Diabetic macular edema (DME), a leading cause of blindness, requires treatment with costly drugs, such as anti-vascular endothelial growth factor (VEGF) agents. The prolonged use of these effective but expensive drugs results in an incremental economic burden for patients with DME compared with those with diabetes mellitus (DM) without DME. However, there are no studies on the long-term patient-centered economic burden of DME after reimbursement for anti-VEGFs. OBJECTIVE: This retrospective cohort study aims to estimate the 3-year patient-centered economic burden of DME compared with DM without DME, using the Common Data Model. METHODS: We used medical data from 1,903,603 patients (2003-2020), transformed and validated using the Observational Medical Outcomes Partnership Common Data Model from Seoul National University Bundang Hospital. We defined the group with DME as patients aged >18 years with nonproliferative diabetic retinopathy and intravitreal anti-VEGF or steroid prescriptions. As control, we defined the group with DM without DME as patients aged >18 years with DM or diabetic retinopathy without intravitreal anti-VEGF or steroid prescriptions. Propensity score matching, performed using a regularized logistic regression with a Laplace prior, addressed selection bias. We estimated direct medical costs over 3 years categorized into total costs, reimbursement costs, nonreimbursement costs, out-of-pocket costs, and costs covered by insurance, as well as healthcare resource utilization. An exponential conditional model and a count model estimated unbiased incremental patient-centered economic burden using generalized linear models and a zero-inflation model. RESULTS: In a cohort of 454 patients with DME matched with 1640 patients with DM, the economic burden of DME was significantly higher than that of DM, with total costs over 3 years being 2.09 (95% CI 1.78-2.47) times higher. Reimbursement costs were 1.89 (95% CI 1.57-2.28) times higher in the group with DME than with the group with DM, while nonreimbursement costs were 2.54 (95% CI 2.12-3.06) times higher. Out-of-pocket costs and costs covered by insurance were also higher by a factor of 2.11 (95% CI 1.58-2.59) and a factor of 2.01 (95% CI 1.85-2.42), respectively. Patients with DME had a significantly higher number of outpatient (1.87-fold) and inpatient (1.99-fold) visits compared with those with DM (P<.001 in all cases). CONCLUSIONS: Patients with DME experience a heightened economic burden compared with diabetic patients without DME. The substantial and enduring economic impact observed in real-world settings underscores the need to alleviate patients' burden through preventive measures, effective management, appropriate reimbursement policies, and the development of innovative treatments. Strategies to mitigate the economic impact of DME should include proactive approaches such as expanding anti-VEGF reimbursement criteria, approving and reimbursing cost-effective drugs such as bevacizumab, advocating for proactive eye examinations, and embracing early diagnosis by ophthalmologists facilitated by cutting-edge methodologies such as artificial intelligence for patients with DM.

Patient-Centered Economic Burden of Exudative Age-Related Macular Degeneration: Retrospective Cohort Study.

BACKGROUND: Exudative age-related macular degeneration (AMD), one of the leading causes of blindness, requires expensive drugs such as anti-vascular endothelial growth factor (VEGF) agents. The long-term regular use of effective but expensive drugs causes an economic burden for patients with exudative AMD. However, there are no studies on the long-term patient-centered economic burden of exudative AMD after reimbursement of anti-VEGFs. OBJECTIVE: This study aimed to evaluate the patient-centered economic burden of exudative AMD for 2 years, including nonreimbursement and out-of-pocket costs, compared with nonexudative AMD using the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). METHODS: This retrospective cohort study was conducted using the OMOP CDM, which included 2,006,478 patients who visited Seoul National University Bundang Hospital from June 2003 to July 2019. We defined the exudative AMD group as patients aged >50 years with a diagnosis of exudative AMD and a prescription for anti-VEGFs or verteporfin. The control group was defined as patients aged >50 years without a diagnosis of exudative AMD or a prescription for anti-VEGFs or verteporfin. To adjust for selection bias, controls were matched by propensity scores using regularized logistic regression with a Laplace prior. We measured any medical cost occurring in the hospital as the economic burden of exudative AMD during a 2-year follow-up period using 4 categories: total medical cost, reimbursement cost, nonreimbursement cost, and out-of-pocket cost. To estimate the average cost by adjusting the confounding variable and overcoming the positive skewness of costs, we used an exponential conditional model with a generalized linear model. RESULTS: We identified 931 patients with exudative AMD and matched 783 (84.1%) with 2918 patients with nonexudative AMD. In the exponential conditional model, the total medical, reimbursement, nonreimbursement, and out-of-pocket incremental costs were estimated at US $3426, US $3130, US $366, and US $561, respectively, in the first year and US $1829, US $1461, US $373, and US $507, respectively, in the second year. All incremental costs in the exudative AMD group were 1.89 to 4.25 and 3.50 to 5.09 times higher in the first and second year, respectively, than those in the control group (P<.001 in all cases). CONCLUSIONS: Exudative AMD had a significantly greater economic impact (P<.001) for 2 years on reimbursement, nonreimbursement, and out-of-pocket costs than nonexudative AMD after adjusting for baseline demographic and clinical characteristics using the OMOP CDM. Although economic policies could relieve the economic burden of patients with exudative AMD over time, the out-of-pocket cost of exudative AMD was still higher than that of nonexudative AMD for 2 years. Our findings support the need for expanding reimbursement strategies for patients with exudative AMD given the significant economic burden faced by patients with incurable and fatal diseases both in South Korea and worldwide.

Clinical and economic impact of changing reimbursement criteria for statin treatment among patients with type 2 diabetes mellitus in South Korea.

Aim: Patients with type 2 diabetes mellitus (T2DM) in South Korea can be reimbursed for statins if they have a low-density lipoprotein cholesterol (LDL-C) level of ≥100 mg/dL. We aimed to explore the clinical and economic benefit received by T2DM patients when easing the current criteria for statin treatment by lowering the LDL-C threshold from 100 mg/dL to 70 mg/dL. Methods: We used a static course model with a 5-year period to compare the following two scenarios in T2DM patients with no history of cardiovascular (CV) events: the current criteria covering LDL-C ≥100 mg/dL and the revised criteria covering LDL-C ≥70 mg/dL. The number of target patients was estimated based on previous Korean studies on patients with T2DM. The current mix of treatments used for T2DM and costs involving CV events were estimated using the National Health Insurance Service-National Health Screening Cohort database. The baseline CV event rates and case fatality were estimated using NHIS Customized database, including 50% patients who were prescribed atorvastatin and 100% who were not prescribed statins between 2009 and 2012 among patients with T2DM in the entire Korean population. After propensity score matching, patients with T2DM not prescribed statins were followed up until 2018 to estimate the incidence rates of coronary heart disease (CHD) and stroke. The efficacy of atorvastatin for the primary prevention of CV events in patients with T2DM was derived from a pivotal clinical trial. The outcome measures were the number of CV events prevented after the change in criteria and the consequent cost savings. Results: In South Korea, the current and revised criteria covered 2,434,379 and 3,446,149 patients with T2DM, respectively. The change in criteria resulted in the prevention of 726 CV events and cost savings of US dollars (USD) 5.5 million at the national level and USD 0.0089 per member per month in the fifth year. Conclusion: Easing the reimbursement criteria for statin treatment among patients with T2DM was associated with a reduction in CV events and their related costs; therefore, changing the reimbursement criteria is worth further consideration to mitigate the burden of CV disease.

Efficacy of melatonin for chronic insomnia: Systematic reviews and meta-analyses.

We conducted systematic reviews and meta-analyses to evaluate the efficacy of melatonin versus placebo or other hypnotic agents in improving sleep quality and quantity in patients with chronic insomnia. A literature search on Ovid-MEDLINE, EMBASE, and the Cochrane Library was performed up to November 2020. Sleep onset latency, total sleep time, sleep efficiency, sleep quality and quality of life were examined as outcomes. We identified 24 randomized controlled trials of chronic insomnia including four studies of patients with comorbid insomnia. All studies were compared with placebo. Due to heterogeneity, we conducted subgroup analyses by age group. In non-comorbid insomnia, melatonin was only significantly effective in sleep onset latency and total sleep time in children and adolescents. In adults group, melatonin was not significantly effective in improving sleep onset latency, total sleep time, and sleep efficiency. In comorbid insomnia, melatonin significantly improved sleep onset latency in all age groups, but there was only one study in adults group. In conclusion, melatonin did not appear to be effective in adults but might be effective in children and adolescents with chronic insomnia for both comorbid insomnia and non-comorbid insomnia. Further studies are needed to establish the efficacy and safety of melatonin by age groups.

Emergency department visits and hospitalisations for emergent asthmatic symptoms from 2014 to 2016: cross-sectional study in Korea.

OBJECTIVE: To evaluate the characteristics of emergent patients with asthma who visited emergency departments (EDs) in Korea, and the consequences of these visits. DESIGN: Retrospective cross-sectional study. SETTING: We used data from the National Emergency Department Information System database from 2014 to 2016. The data included reports collected from 408 EDs in Korea. PARTICIPANTS: We analysed the ED cases for asthma-related emergent symptoms that met the following inclusion criteria: (1) had a main diagnosis code of asthma (International Classification of Diseases 10th Revision code: J45/J46), and (2) recorded as an emergent symptom in the EDs. RESULTS: During 2014-2016, there were 58 713 ED visits related to an asthma diagnosis with emergent symptoms. Following an ED visit, 31.69% were hospitalised, of which 89.88% were admitted to the general wards, and 10.12% to the intensive care units (ICUs). More than 50% of the hospitalised cases included in the group ≥70 years of age. The incidence of death during hospitalisation generally increased with age and the proportion of death in ICU exceeded 10% among the group ≥70 years. The ratio of ICU/general ward admission at the arrival time of 0-03:00, in the ≥60 years age group was the highest compared with other times of the day and age groups. CONCLUSIONS: We found that among all age groups, ED visits by older patients resulted in more ICU admissions. Our results can help in providing a better understanding of medical resource utilisation by emergent patients with asthma.