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This study compares the costs and outcomes of using aflibercept, laser, or observation in managing eyes with CI-DME and good VA over a 10-year period. The analysis focuses on per-person costs and extrapolated costs for the entire US population, highlighting the implications for healthcare planning. Methods for calculating costs and the rationale for conducting such analyses are discussed, providing valuable insights for clinicians and policymakers.
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DRCR Retina Network Comparison of 10-Year U.S. Population Costs When Initially Managing Eyes with CI-DME and Good VA with Aflibercept, Laser, or Observation (Protocol V) 1
Protocol V (CI-DME and Good VA) There was no difference in VA loss with initial management strategies of aflibercept, focal/grid laser, or observation at 2 years (16 19%) Aflibercept was given in the laser and observation groups if VA decreased from baseline All three management strategies resulted in mean VA at 2 years of 20/20 Based on these results, many clinicians and patients might choose initial observation for eyes with CI-DME and good VA and withhold anti-VEGF treatment unless vision worsens 2
Objective 1. Estimate per-personcosts with the DRCR Retina Network Protocol V strategy of initial aflibercept, laser, or observation for eyes with CI-DME and good VA 2. Estimate 10-year US population costs of initial aflibercept, laser, or observation management 3
Why Conduct Cost Analyses? 1. Understanding estimated costs of employing each of these strategies to the entire US population are relevant for health care planning 2. If DRCR Retina Network does not perform analyses, someone else will 4
Methods Calculating Per-Person Costs Costs of clinic visits, diagnostic tests, study interventions (aflibercept and laser), additional interventions, and complications over 2 years as captured in Protocol V 5
Methods Calculating Total Cost Over 10 Years Costs: Protocol V data from years 0 2 plus extrapolated data from years 3 10 assuming 3 clinic visits, 3 OCTs, and 0.5 injections per year in all groups Number of Patients with Diabetes: Estimated based on published prevalence and incidence data (reduced for mortality) Number of Patients with CI-DME and Good VA: CSME estimated based on data from LALES, WESDR and ETDRS. 6
Per-Person Cost Over 2-Years (2019 US$) $20,000 $17,330 $15,000 $10,000 $6,917 $5,885 $5,000 $0 Aflibercept Laser Observation Injections Laser Other Visits Other 7
US Population Total Cumulative Costs Over 10 Years Treatment Group Comparisons 60 Differences (Billions) 14.39 Billion Aflibercept vs. Laser 40 Billions 28.80 Observation vs. Laser 1.29 Billion 15.70 14.42 20 13.10 Billion Aflibercept vs. Observation 0 Aflibercept Laser Observation 8
US Population Cumulative Costs Over 10-Years $6 Total Annual Costs (billions) $5 $4 $3 $2 $1 $- 2020 2022 2024 2026 2028 2030 Aflibercept Laser Observation 9
Sensitivity Analyses Varying Cost of Aflibercept Injections $30 Discounted Costs (billions) $25 10-year cumulative $20 $15 $10 $5 $- $0 $500 $1,000 $1,500 $2,000 Drug Cost/Injection Aflibercept Laser Observation 10
Sensitivity Analyses Varying Number of Aflibercept Injections $50 10-year cumulative Discounted Costs $40 $30 $20 $10 $- - 0.5 1.0 1.5 2.0 Number of annual aflibercept injections in years 3+ Aflibercept Laser Observation 11
Discussion Limitations Cost across countries can vary and estimates using the models to achieve these numbers should be interpreted carefully. The modeling for years 3 10 involves making longer- term assumptions about 1. prevalence and incidence of diabetes and CI-DME and 2. patters of resource utilization. This was not a cost-effectiveness analysis and does not examine potential improvements in VA that might be worth paying for. 12
Summary Assuming aflibercept is added if VA worsens following laser or observation, the 10-year projected costs for all patients with DME and good VA managed with 1. Aflibercept = $28.80 billion 2. Laser = $14.42 billion 3. Observation = $15.70 billion Although individual patient factors should be used to make initial management decisions for each patient, by managing DME with good VA laser or observation initially, substantial cost savings will be achieved. 13
