Economic Burden

Economic Burden of Treating Wet Age-Related Macular Degeneration in USA and Europe

United States

The economic burden of treating neovascular age-related macular degeneration (nAMD) in the USA is substantial. Medicare spending on anti-VEGF drugs for neovascular AMD consistently exceeded $4 billion per year between 2015 and 2019. This high expenditure is primarily driven by high prices and varying off-label use of bevacizumab, which is substantially cheaper than other biologics.

A 2022 cost-benefit analysis for 168,400 patients with new-onset NVAMD in 2018 revealed varying treatment costs over an 11-year period: - Bevacizumab monotherapy: $14,772 per patient with a $357,680 societal return (2,421% ROI) - Ranibizumab therapy: $106,582 per patient with a $265,870 societal return (249% ROI) - Aflibercept treatment: $61,811 per patient with a $310,611 societal return (503% ROI)

The overall net societal gain for the 2018 NVAMD treatment cohort was estimated at $28.5 billion over 11 years, with bevacizumab therapy accounting for 84.9% ($24.2 billion). Substituting bevacizumab for the more expensive treatments would save an estimated $1.343 billion over 11 years.

A 2016 study reported the mean annual societal cost for neovascular AMD patients at $39,910 compared to $6,116 for control subjects. Costs increased significantly with vision deterioration: patients with vision 20/30 to 20/50 averaged $20,339, while those with 20/800 to no light perception averaged $82,984. Direct nonmedical costs, primarily caregiver costs, comprised 67.1% of societal costs for AMD patients.

Europe

In Europe, the economic burden varies significantly across countries due to differences in healthcare systems and treatment patterns. A 2022 Spanish study highlighted the significant healthcare burden related to monitoring visits, with patients averaging 16.0 visits and 9.4 intravitreal injections over 24 months.

The off-label use of bevacizumab for wet AMD varies dramatically between European nations, ranging from 0% to 97% according to a 2020 study of 20 European countries.

A 2008 cross-sectional study estimated the average annual societal cost per bilateral NV-AMD patient at: - €7,879 in Canada - €7,349 in France - €12,445 in Germany - €5,732 in Spain - €5,300 in the UK

Direct vision-related medical costs accounted for 23-63% of the total cost. The estimated annual societal costs of bilateral NV-AMD patients ranged from €268 to €1,311 million across these countries, while the estimated annual societal costs of all NV-AMD patients ranged from €671 to €3,278 million.

In the UK (2009 data), treatment costs of verteporfin photodynamic therapy were £3,026 in year 1 and £845 in year 2. A 5-letter decrease in visual acuity was associated with an increase in annual costs of approximately £110.

In Turkey, a 2021 study reported the total direct medical cost for AMD at 9,628 Turkish Lira (TL) per patient for 2 years, with drug costs accounting for the majority (8,371 TL).

Study Design Parameters

Drug used in other indications

DURAVYU™ (Vorolanib Intravitreal Insert) Clinical Trials Beyond Wet AMD

Based on a comprehensive review of available clinical trial data, DURAVYU™ (vorolanib intravitreal insert) is currently being investigated for several ocular indications beyond neovascular (wet) age-related macular degeneration. These additional indications include:

• Diabetic retinopathy (DR)
• Diabetic macular edema (DME)
• Retinal vein occlusion (RVO)
• Myopic choroidal neovascularization (mCNV)

The intervention models employed in these clinical trials utilize various approaches to evaluate the safety and efficacy of DURAVYU™ across these indications:

For diabetic retinopathy and diabetic macular edema, the trials implement a parallel assignment model with multiple arms comparing different dosing regimens. The primary intervention involves the sustained-release intravitreal insert containing vorolanib at doses ranging from 250 μg to 500 μg. These studies evaluate both monotherapy approaches and combination therapy with anti-VEGF agents.

The administration protocol typically involves a single in-office procedure for insert placement, with the device designed to provide continuous drug delivery for up to six months. This represents a significant advancement over current standard treatments that require frequent intravitreal injections.

For retinal vein occlusion, the trials utilize a crossover assignment model where participants receive either DURAVYU™ or standard anti-VEGF therapy initially, followed by the alternative treatment after a washout period. This design allows for within-subject comparisons of treatment efficacy and safety.

The myopic choroidal neovascularization trials employ a single group assignment model with an open-label design. These studies focus primarily on safety outcomes and anatomical changes as measured by optical coherence tomography (OCT).

Across all indications, the trials incorporate comprehensive safety monitoring including assessments of intraocular pressure, visual acuity changes, and device-related adverse events. Efficacy endpoints typically include changes in central retinal thickness, best-corrected visual acuity, and disease progression markers specific to each indication.

The innovative aspect of these intervention models lies in the potential to address the treatment burden associated with current therapies while maintaining or improving visual outcomes. By providing sustained drug delivery, DURAVYU™ aims to reduce the need for frequent clinic visits and injections, potentially improving patient adherence and quality of life for individuals with these chronic retinal conditions.

Early phase results suggest promising pharmacokinetic profiles with consistent drug levels maintained throughout the treatment period, supporting the continued investigation of this novel therapeutic approach across multiple retinal vascular diseases.