Faculty Bibliography

Under current reimbursement models, implementation of IDx-DR may not be financially practical. Adequate reimbursement is necessary to incentivize widespread adoption and realize the potential of automated imaging to increase early detection of diabetic retinopathy.

PURPOSE/OBJECTIVE:To characterize the rates of pan-retinal laser photocoagulation (PRP) and anti-vascular endothelial growth factor (anti-VEGF) medications before and after publication of the DRCR.net Protocol S. DESIGN/METHODS:A retrospective, cross-sectional study from January 1, 2012 to September 30, 2019 using a nationally representative claims-based database, Clinformatics™ Data Mart Database (OptumInsight, Eden Prairie, MN). Subjects, Participants, and/or Controls: Eyes newly diagnosed with proliferative diabetic retinopathy (PDR), continuous enrollment, and no prior treatment with PRP or anti-VEGF. Methods, Intervention, or Testing: Interrupted time series regression analysis was performed to identify the annual change in treatment rates before and after the publication of Protocol S (November 24, 2015). MAIN OUTCOME MEASURES/METHODS:Annual rates of anti-VEGF or PRP treatments per 1,000 treated eyes with PDR. RESULTS:From 2012 to 2019, 10035 PRP or anti-VEGF treatments were given to 3685 PDR eyes. 63.6% (6379) of these were anti-VEGF agents and 36.4% (3656) were PRP treatments. 88.7% of eyes treated with anti-VEGF received the same agent throughout treatment and 7.7% were treated with both PRP and anti-VEGF agents. PRP rates declined from 784/1,000 treated eyes in 2012 to 566/1,000 in 2019 (pre-Protocol S: β = -32 vs. post-Protocol S: β = -77, p=0.005) while anti-VEGF rates increased from 876/1000 in 2012 to 1583/1000 in 2019 (β = -48 vs. β = 161, p=0.001). PRP rates in DME eyes did not significantly change from 474/1000 in 2012 to 363/1000 in 2019 (β = -9 vs. β = -58, p=0.091), but anti-VEGF rates increased significantly from 1533/1000 in 2012 to 2096/1000 in 2019 (β = -57 vs. β = 187, p=0.043). In eyes without DME, PRP use declined from 1017/1000 in 2012 to 707/1000 in 2019 (β = -31 vs. β = -111, p<0.001) and anti-VEGF use increased from 383/1000 in 2012 to 1226/1000 in 2019 (β = -48 vs. β = 140, p<0.001). CONCLUSIONS:Following the publication of Protocol S, PRP rates decreased while anti-VEGF rates increased largely from increases in bevacizumab use. PRP rates significantly declined among eyes without DME. Our findings indicate the impact that randomized controlled trials can have on real-world practice patterns.

PURPOSE/OBJECTIVE:To study the epidemiology of inpatient open globe injuries (OGI) in the United States (US). METHODS:This was a retrospective cohort study of patients with a primary diagnosis of OGI in the National Inpatient Sample (NIS) from 2009 to 2015. Sociodemographic characteristics, including age, gender, race, ethnicity, insurance, and income were stratified for comparison. Annual prevalence rates were calculated using 2010 US Census data. Statistical analysis included Chi-square tests, ANCOVA, and Tukey tests. RESULTS:< .05). CONCLUSIONS:Inpatient OGIs disproportionately affected those over 85, young males, elderly females, patients of African-American descent, on Medicare, and in the lowest income quartile. Additionally, children and young children had lower rates of OGI compared to adolescents. Further studies should delineate causes for socioeconomic differences in OGI rates to guide future public health measures.

PURPOSE/OBJECTIVE:To model Medicare Part B and patient savings associated with increased bevacizumab payment and utilization for intravitreal anti-vascular endothelial growth factor (VEGF) therapy. DESIGN/METHODS:Cost analysis. METHODS:Medicare claims and IRIS® Registry data were used to calculate Medicare Part B expenditures and patient co-pays for anti-VEGF agents with increasing reimbursement and utilization of bevacizumab relative to ranibizumab and aflibercept. MAIN OUTCOME MEASURES/METHODS:Medicare Part B costs and patient co-pays for anti-VEGF agents in the Medicare fee-for-service (FFS) population. RESULTS:Increasing bevacizumab reimbursement to $125.78, equalizing the dollar margin with aflibercept, would result in Medicare Part B savings of $468 million and patient savings of $119 million with a 10% increase in bevacizumab market share. CONCLUSIONS:Increased utilization of bevacizumab achievable with increased reimbursement to eliminate the financial disincentive to its use would result in substantial savings to the Medicare Part B program and to patients receiving anti-VEGF intravitreal injections.

PURPOSE/OBJECTIVE:To investigate whether plasma high sensitivity C-reactive protein (hs-CRP) level is associated with exudative age-related macular degeneration (AMD) as well as variants of ARMS2 A69S and CFH I62V in patients with exudative AMD. METHODS:A case-control study was done comparing CRP among patients with exudative AMD including those with polypoidal choroidal vasculopathy, typical AMD and retinal angiomatous proliferation, and CRP were also compared between cases and controls. Plasma CRP was measured from peripheral blood using latex nepherometry for all participants. Genotyping of ARMS2 A69S and CFH I62V was performed for all patients with exudative AMD using TaqMan technology. RESULTS:) There was not a significant difference in hs-CRP levels among AMD subtypes. Neither variants of ARMS2 nor CFH was associated with hs-CRP level in patients with exudative AMD. A multiple regression analysis revealed that gender male, presence of exudative AMD and presence of cardiovascular diseases were associated with increased plasma hs-CRP. CONCLUSIONS:Plasma hs-CRP was elevated independent of variants of ARMS2 A69S and CFH I62V in patients with exudative AMD.

OBJECTIVE:To estimate temporal trends in total and out-of-pocket (OOP) expenditures for ophthalmic prescription medications among adults in the United States. DESIGN/METHODS:A retrospective longitudinal cohort study. PARTICIPANTS/METHODS:Participants in the 2007-2016 Medical Expenditure Panel Survey (MEPS), age 18 years or older. The MEPS is a nationally representative survey of the noninstitutionalized, civilian US population. METHODS:We estimated trends in national and per capita annual ophthalmic prescription expenditures by pooling data into 2-year cycles and using weighted linear regressions. We also identified characteristics associated with greater total or OOP expenditure with multivariable weighted linear regression. Costs were adjusted to 2016 US dollars using the Gross Domestic Product Price Index. MAIN OUTCOME MEASURES/METHODS:Trends in total and OOP annual expenditures for ophthalmic medications from 2007-2016 as well as factors associated with greater expenditure. RESULTS:From 2007-2016, 9,989 (4.2%) MEPS participants reported ophthalmic medication prescription use. Annual ophthalmic medication utilization increased from 10.0 to 12.2 million individuals from 2007-2008 to 2015-2016. In this same time period, national expenditures for ophthalmic medications increased from $3.39 billion to $6.08 billion and OOP expenditures decreased from $1.34 to $1.18 billion. While the average number of ophthalmic prescriptions filled did not change over the study period (4.2, p=0.10), the average expenditure per prescription increased significantly from $72.30 to $116.42 (p<0.001). Per capita expenditure increased from $338.72 to $499.42 (p<0.001) and per capita OOP expenditure decreased from $133.48 to $96.67 (p<0.001) from 2007-2008 to 2015-2016 respectively. In 2015-2016, dry eye (29.5%) and glaucoma (42.7%) medications accounted for 72.2% of all ophthalmic medication expenditures. Patients who were older than 65 (p<0.001), uninsured (p<0.001), and visually impaired (p<0.001) were significantly more likely to have greater OOP spending on ophthalmic medications. CONCLUSION/CONCLUSIONS:Total ophthalmic medication expenditure in the United States increased significantly over the last decade while OOP expenses decreased. Increases in coverage, copayment assistance and utilization of expensive brand drugs may be contributing to these trends. Policy makers and physicians should be aware that rising overall drug expenditures may ultimately increase indirect costs to the patient and offset a decline in OOP prescription drug spending.

PURPOSE/OBJECTIVE:The purpose of this study was to compare intravitreal ziv-aflibercept (IVZ) monotherapy to intravitreal bevacizumab (IVB) monotherapy in patients with exudative age-related macular degeneration (eAMD). MATERIALS AND METHODS/METHODS:Patients with treatment-naïve eAMD treated with pro re nata (PRN) monotherapy of IVZ (1.25 mg/0.05 ml) or IVB (1.25 mg/0.05 ml) with a minimum follow-up of 12 months were retrospectively analyzed. Study outcomes included change in best-corrected visual acuity (BCVA), central macular thickness, mean number of injections, and total medication cost in both the groups at 12 months. RESULTS:= 0.029). Direct medication cost of IVZ and IVB in our cohort on PRN basis was an average of US$78 (2.6 × US$30) and US$175 (3.5 × US$50), respectively, through 1 year. CONCLUSION/CONCLUSIONS:IVZ-PRN monotherapy resulted in improved visual acuity, reduced treatment burden, and reduced direct medication cost in comparison to IVB-PRN monotherapy through 1 year.