JMIR Publications

ABSTRACT

Background:

Diabetic macular edema (DME), a leading cause of blindness, necessitates costly treatments like anti-vascular endothelial growth factor (VEGF) agents. The long-term regular use of effective but expensive drugs causes an incremental economic burden for DME patients compared to diabetes mellitus (DM) patients. However, there is no study on the long-term patient-centered economic burden of DME after reimbursement of anti-VEGF.

Objective:

This retrospective cohort study aims to estimate the long-term patient-centered economic burden of DME compared to DM without DME, using the observational medical outcomes partnership-common data model (OMOP-CDM).

Methods:

A retrospective cohort study utilized 1,903,603 patients’ medical data transformed and validated with the Observational Medical Outcome Partnership Common Data Model from Seoul National University Bundang Hospital (2003-2020). We defined the DME group as patients aged >18 years with a non-proliferative diabetic retinopathy (NPDR) diagnosis and intravitreal anti-VEGF or steroids prescriptions. As control group, we defined DM group as patients aged >18 years with a DM or diabetic retinopathy diagnosis without prescription of intravitreal anti-VEGF or steroids. Propensity score matching using a regularized logistic regression with a Laplace prior addressed selection bias. We estimated the direct medical costs categorized into total, reimbursement, non-reimbursement, out-of-pocket costs, and costs covered by insurance for three-years, and health resource utilization. The exponential conditional model and count model with generalized linear model estimated unbiased incremental patient-centered economic burden using generalized linear models.

Results:

In a cohort of 454 patients with DME matched with 1,640 patients with DM, the economic burden of DME was significantly higher than that of DM (P<.001 in all cases), with a 2.09 times higher total cost for three years (95% confidential interval (CI): 1.78–2.47). Reimbursement costs were 1.89 times higher for the DME group compared to the DM group (95% CI: 1.57–2.28), while non-reimbursement costs were 2.54 times higher (95% CI: 2.12–3.06). 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 2.01 (95% CI: 1.85–2.42), respectively. DME patients had a significantly higher number of outpatient (1.87-fold) and inpatient (1.99-fold) visits compared to DM (P<.001 in all cases).

Conclusions:

Patients with DME exhibit a heightened economic burden compared to those with DM. The substantial and enduring economic impact from real-world underscores the imperative to alleviate patients’ burden through preventive measures, effective management, appropriate reimbursement policies, and the advancement of innovative treatments. Strategies to mitigate the economic impact on DME should include proactive approaches such as expanding anti-VEGF reimbursement criteria, approving and reimbursing cost-effective drugs like bevacizumab, advocating for proactive eye examinations, and embracing early diagnosis facilitated by cutting-edge methodologies such as artificial intelligence and machine learning techniques for patients with DM by ophthalmologists.