Endothelial Growth Factors ; Female ; Follow-Up Studies ; Ganglion Cysts ; Humans ; Intraocular Pressure ; Intravitreal Injections ; Macular Degeneration ; Male ; Ranibizumab ; Retrospective Studies ; Tomography, Optical Coherence ; Visual Acuity

PURPOSE: This study investigated the optimal strategy to minimize budgetary constraints on National Health Insurance (NHI) services, while maximizing the number of diabetic macular edema (DME) patients who receive anti-vascular endothelial growth factor (anti-VEGF) therapy. METHODS: We estimated the potential budget impact of anti-VEGF treatments in DME patients based on perceived upcoming changes in reimbursement fees over the next 5 years (2018–2022). Four scenarios were evaluated: (1) current anti-VEGF treatment patterns, (2) the hypothetical reimbursement fee, (3) the introduction of a new molecule similar to current anti-VEGF treatments, and (4) the prescription of an off-label drug, bevacizumab. The number of patients, anti-VEGF treatments, and medical costs for each scenario were calculated using claims data from the Korean NHI system and anti-VEGF prescription data from a single hospital. RESULTS: The potential budget impact of anti-VEGF injections in patients with DME over the next 5 years was estimated to be about 97.7 billion and 106.2 billion KRW for scenarios 1 and 2, respectively. In scenario 3, in which a biosimilar product to anti- VEGF is used, the estimated budget of the NHI system would be approximately 98.4 billion KRW. If an off-label drug is reimbursed, roughly 79.5 billion KRW will be required for the NHI system's budget. CONCLUSIONS: If the revised fee structure for AMD patients is similarly applied to anti-VEGF injections for DME patients, the NHI fiscal requirements will increase disproportionately over the next 5 years compared to current reimbursement conditions. Given the growth of DME patients in toda's patient population, the use of a biosimilar or off-label drug is a financially viable alternative to reduce the overall burden on the NHI system.
Bevacizumab ; Budgets ; Endothelial Growth Factors ; Fees and Charges ; Humans ; Macular Edema ; National Health Programs ; Prescriptions ; Ranibizumab ; Vascular Endothelial Growth Factor A

PURPOSE: To evaluate the current use of intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) in patients with diabetic retinopathy. METHODS: We determined the current number of diabetic retinopathy patients and their medical expenditure using National Health Insurance Service claims data (2007-2016). We also analyzed the medical costs of patients with diabetic retinopathy who received anti-VEGF treatment, including ranibizumab and aflibercept. We then evaluated aspects of the use of anti-VEGF injections, such as frequency and intervals, in newly diagnosed diabetic retinopathy patients who received anti-VEGF treatment, along with their medical costs. RESULTS: The number of patients with diabetic retinopathy was 397,956 in 2009 and 721,310 in 2016, a 1.8-fold increase over 8 years. Of these, the number of patients undergoing anti-VEGF therapy was 4,283 in 2015 and 4,270 in 2016. Of the diabetic retinopathy patients in 2016, the total medical cost of those treated with anti-VEGF was 1.5 billion won, and the average medical cost per person was 3,531,064 won. CONCLUSIONS: Based on the National Health Insurance claims data, the use of ranibizumab and aflibercept is increasing. The results of this study suggest that diabetic retinopathy will become an important public health issue.
Diabetic Retinopathy ; Endothelial Growth Factors ; Health Expenditures ; Humans ; Intravitreal Injections ; National Health Programs ; Public Health ; Ranibizumab

PURPOSE: To evaluate the current use of intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) in patients with age-related macular degeneration (AMD). METHODS: We analyzed the number and medical costs of patients with AMD diagnosed by the National Health Insurance Corporation (2007–2016). We also analyzed the number and medical costs of such patients who received anti-VEGF treatment, and analyzed the frequency, period of use, and average medical cost of anti-VEGF use in AMD patients. Finally, we evaluated the use of anti-VEGF injections for new AMD patients. RESULTS: The number of patients with AMD was 236,158 in 2009 and 537,528 in 2016, which represented a 2.3-fold increase over 8 years. Of these, the number of patients undergoing anti-VEGF therapy increased steadily from 9,961 in 2009 to 35,762 in 2016. The mean number of cycles of ranibizumab or aflibercept per patient was 4.87 ± 3.37, and the mean interval between treatments was 2.89 months. On average, 6.2 injections were performed in the first year of diagnosis, and the frequency of use decreased with time, with an average of 1.2 cycles after 4 years of diagnosis. Among all AMD patients in 2016, the total medical cost of those treated with anti-VEGF was 76.9 billion won, and the average medical cost per person was 2,162,145 won. CONCLUSIONS: The use of two drugs, ranibizumab and aflibercept, as reflected in public health insurance claims, steadily increased over the study period. Notably, there was a tendency to substitute aflibercept for ranibizumab.
Diagnosis ; Endothelial Growth Factors ; Humans ; Insurance ; Intravitreal Injections ; Macular Degeneration ; National Health Programs ; Public Health ; Ranibizumab

PURPOSE: To compare the efficacy and safety of intravitreal injections of bevacizumab, ranibizumab, and aflibercept for the treatment of new patients with age-related macular degeneration (AMD). METHODS: We conducted an update of the most recent and high quality systematic reviews (Canadian Agency for Drug Technology in Health [CADTH] 2016). Three randomized clinical trials were added to 13 trials identified from the CADTH report. The efficacy outcomes were 1) average improvement in visual acuity, 2) proportion of patients who experienced an improvement in vision (an increase in best-corrected visual acuity (BCVA) of ≥ 15 on Early Treatment Diabetic Retinopathy Study [ETDRS] letters), and 3) proportion of patients who experienced worsening of vision (decrease in BCVA of ≥ 15 ETDRS letters). In addition, safety outcomes included systemic adverse events and ocular-related adverse events. To analyze the outcomes of 16 randomized controlled trials, we conducted meta-analyses on the outcome measures. RESULTS: There was no significant difference in efficacy outcomes among anti-vascular endothelial growth factor (anti-VEGF) drugs. The mean difference in BCVA between ranibizumab and bevacizumab was 0.33 (95% confidence interval [CI]: −1.29, 1.95), and the odds ratio (OR) for a vision gain in the BCVA of ≥ 15 ETDRS letters for the ranibizumab versus aflibercept treatment was 1.02 (95% CI: 0.80, 1.30). There was also no significant difference in safety outcomes, except in terms of arterial thromboembolic events (ranibizumab vs. bevacizumab; OR: 2.15; 95% CI: 1.04, 4.41). CONCLUSIONS: The efficacy of anti-VEGF drugs for AMD patients was not significantly different. The safety of the drugs was also not significantly different, except in terms of arterial thromboembolic events.
Bevacizumab ; Diabetic Retinopathy ; Endothelial Growth Factors ; Humans ; Intravitreal Injections ; Macular Degeneration ; Odds Ratio ; Outcome Assessment (Health Care) ; Ranibizumab ; Visual Acuity

PURPOSE: To investigate the short-term efficacy and safety of ranibizumab in the routine clinical setting in patients with neovascular age-related macular degeneration and to analyze the associated factors for visual outcome. METHODS: This was a post-hoc analysis of a ranibizumab regulatory post-marketing surveillance study in which 4,136 patients were enrolled and followed for 12 weeks. Change in best-corrected visual acuity (BCVA), size of choroidal neovascularization, and the presence of hemorrhage and exudate were analyzed and the association between BCVA change and baseline characteristics were investigated. Data on ocular and systemic adverse events were collected. RESULTS: Mean BCVA improved significantly and mean BCVA change was the logarithm of the minimal angle of resolution 0.13 ± 0.01 (p < 0.001). A lower baseline BCVA and younger age were significant predictive factors for visual improvement or maintenance (≥0 lines). For greater visual acuity gain (≥3 lines), no treatment history, lower baseline BCVA, younger age, and classic-type choroidal neovascularization were significant predictive factors. No new safety signals were found. CONCLUSIONS: In this study, conducted in real-world clinical practice with a large number of neovascular age-related macular degeneration patients, visual and anatomical outcomes improved significantly after three monthly ranibizumab treatments. Treatment-naive patients had a higher chance of greater visual gain (≥3 lines) than non-naive patients.
Choroidal Neovascularization ; Exudates and Transudates ; Hemorrhage ; Humans ; Macular Degeneration ; Ranibizumab ; Visual Acuity

PURPOSE: To evaluate the influence of axial length on the recurrence of wet age-related macular degeneration (AMD) after anti-vascular endothelial growth factor therapy. METHODS: A retrospective review of the medical records for 45 eyes of 45 patients, who were diagnosed with neovascular AMD and treated with three ranibizumab injections per month, was performed. Axial length was compared between eyes with (recurrence group) and without (no recurrence group) recurrence of fluid during a 12-month follow-up period. In eyes with recurrence, the association between axial length and the time between the third injection and the first recurrence was also evaluated. RESULTS: The axial length was measured at a mean of 20.6 ± 10.1 months after the diagnosis of neovascular AMD. The mean axial length at that time was 23.33 ± 0.90 mm. The mean axial length was 23.29 ± 0.96 mm in the recurrence group (n = 30) and 23.40 ± 0.79 mm in the no-recurrence group (n = 15). There was no difference in the axial length between the two groups (p = 0.709). In the recurrence group, the period between the third injection and the first recurrence was not associated with axial length (p =0.582). CONCLUSIONS: There was no significant difference in axial length between eyes with and without recurrence after initial treatment for wet AMD. In addition, the time to first recurrence was not significantly associated with axial length. Because the present study was retrospective and the sample size was small, further prospective studies with a better design are needed to more accurately assess the influence of axial length.
Choroidal Neovascularization ; Diagnosis ; Endothelial Growth Factors ; Follow-Up Studies ; Humans ; Macular Degeneration ; Medical Records ; Prospective Studies ; Ranibizumab ; Recurrence ; Retrospective Studies ; Sample Size

PURPOSE: This study was performed to investigate the changes in clinical findings after switching from ranibizumab or aflibercept to bevacizumab due to the limited number of insured injections in patients with exudative age-related macular degeneration (ARMD). METHODS: The study population consisted of patients who had undergone intravitreal injection of ranibizumab or aflibercept for ≥ 6 months and were then treated with bevacizumab for ≥ 6 consecutive months for exudative ARMD. We evaluated best-corrected visual acuity, central subfield macular thickness, disease activity, and the number of injections for one year at the time of switching the drugs. RESULTS: Forty patients (26 men and 14 women) were included in the analysis. The mean age was 71.9 (56-89) years old, with typical ARMD in 23 eyes, polypoidal choroidal vasculopathy in 15 eyes, and retinal angiomatous proliferation in two eyes. The number of injections for 6 months increased from 2.3 to 2.9 after switching the drugs (p < 0.001). Visual acuity was not significantly different between 6 months before and at the time of switching (LogMAR 0.55 ± 0.34 and 0.52 ± 0.27, respectively) (p = 0.300), but decreased significantly to 0.57 ± 0.34 at 6 months after switching (p = 0.018). There were no significant differences in central subfield macular thickness or disease activity. CONCLUSIONS: Bevacizumab required more injections to achieve similar anatomical outcomes in patients with exudative ARMD treated with ranibizumab or aflibercept, and visual acuity decreased despite anatomical stability.
Bevacizumab ; Choroid ; Humans ; Intravitreal Injections ; Macular Degeneration ; Male ; Ranibizumab ; Retinaldehyde ; Visual Acuity

PURPOSE: Intravitreal aflibercept, ranibizumab, bevacizumab, and dexamethasone are the most widely used drugs in the treatment of diabetic macular edema (DME). The aim of this study was to compare the efficacy and safety of anti-vascular endothelial growth factors and dexamethasone for the treatment of DME. METHODS: There were nine previous systematic reviews on this topic; we updated these high-quality reviews. Seven studies were added to two studies following a literature search. Efficacy outcomes were 1) average improvement in visual acuity, 2) proportion of patients who experienced an improvement in vision (an increase in best-corrected visual acuity (BCVA) of ≥ 15 in the Early Treatment Diabetic Retinopathy Study [ETDRS]), and 3) proportion of patients who experienced worsening vision (a decrease in BCVA of ≥ 15 in the ETDRS). Safety outcomes included systemic adverse events and ocular-related adverse events. RESULTS: The mean difference in the BCVA for ranibizumab versus bevacizumab treatment was 0.16 (95% confidence interval [CI]: −0.02, 0.34), and that for ranibizumab versus aflibercept was −0.08 (95% CI: −0.26, 0.10). The mean difference in the change of BCVA for aflibercept versus ranibizumab was −0.20 (95% CI: −0.40, −0.01), and that for aflibercept versus bevacizumab was −0.34 (95% CI: −0.53, −0.14). Other efficacy outcomes showed similar trends, and there was no significant difference between treatments. There was also no significant difference in both systemic and ocular adverse events rates between the treatments. CONCLUSIONS: In DME patients, the efficacy of aflibercept was found to be higher with respect to BCVA changes compared with ranibizumab or bevacizumab. However, there were no significant difference in terms of visual acuity improvement or visual acuity of more than 15 letters, nor in terms of anti-vascular endothelial growth factors (as a safety outcome).
Bevacizumab ; Dexamethasone ; Diabetic Retinopathy ; Endothelial Growth Factors ; Humans ; Intravitreal Injections ; Macular Edema ; Ranibizumab ; Visual Acuity

PURPOSE: To analyze the incidence and prevalence of exudative age-related macular degeneration (AMD) and to predict the future AMD populations and health expenditures of intravitreal ranibizumab injection. METHODS: From 2010 to 2014, the National Health Insurance claims data were used to estimate the incidence and prevalence change of exudative AMD, according to demographic characteristics (year, sex, residence, and age). Based on the above results and changes in future population distribution, we estimated the AMD population by 2030. Considering the cost of Intravitreal ranibizumab injection from 2010 to 2014, we predicted the future health expenditure for AMD. RESULTS: The incidence and prevalence of exudative AMD increased from 14.04 and 295.11 per 100,000 populations in 2010 to 14.25 and 580.71 in 2014, respectively. The prevalence rate was higher in men and showed a large increase over 70 years of age. The ranibizumab was prescribed 13 times per person in average, and the amount consumed increased as the number of insurance coverage increased from 2013. Future AMD populations are predicted to reach 557,007 in 2030 from 146,871 in 2014. As a result, the cost of intravitreal ranibizumab injection is expected to increase from 83.6 billion won in 2014 to 171.7 billion won in 2030. CONCLUSIONS: The increase in medical expenses for AMD is expected due to social aging. Therefore, we need policies to secure medical resources and expand insurance indications.
Aging ; Demography ; Health Expenditures ; Humans ; Incidence ; Insurance ; Insurance Coverage ; Korea ; Macular Degeneration ; Male ; National Health Programs ; Prevalence ; Ranibizumab