REAL-WORLD UTILIZATION AND TREATMENT ADHERENCE OF BRAND AND GENERIC CYCLOSPORINE OPHTHALMIC EMULSION IN DRY EYE DISEASE
Author(s)
Sourab Ganna, PharmD1, Rajender Aparasu, PhD2, Jieni Li, MPH, PhD2;
1University of Houston, Student, Houston, TX, USA, 2University of Houston, Houston, TX, USA
1University of Houston, Student, Houston, TX, USA, 2University of Houston, Houston, TX, USA
OBJECTIVES: Dry eye disease (DED) is a prevalent chronic ocular condition that significantly impairs quality of life. While cyclosporine ophthalmic emulsion (Restasis®) has been a mainstay of DED treatment, high costs have raised concerns about long-term affordability and adherence. In February 2022, the first FDA-approved generic cyclosporine formulation entered the U.S. market, offering a lower-cost alternative. This study compared the utilization and treatment adherence of brand and generic cyclosporine in patients with DED.
METHODS: A retrospective cohort study was conducted using 2022-2024 MarketScan Commercial Claims data. Adults (≥18) with DED (ICD-10: H04.12x, 375.15) and an incident cyclosporine fill between February 2022 and December 2023 were included. Continuous enrollment for 12 months pre- and post-initiation was required. Outcomes included the proportion of days covered (PDC), switching, and discontinuation (≥60-day gap). Kaplan-Meier curves were used to describe time to switching and discontinuation, while Cox proportional hazards models estimated adjusted risks controlling for demographic, clinical, healthcare utilization, and medication-related covariates.
RESULTS: Among 16,839 incident cyclosporine users, 87.1% used Restasis® and 12.9% used generic cyclosporine. Overall adherence was 11% (PDC≥80%), with an overall mean PDC of 0.38±0.27 (Brand:0.39±0.27;Generic:0.32±0.25). Medication switching was uncommon, occurring in 1,132 patients (6.5%). However, generic initiators were substantially more likely to switch treatments, primarily from generic to brand (hazard ratio [HR]=12.46;95%CI:7.35-21.10). Generic users also demonstrated significantly higher risk of treatment discontinuation compared to Restasis® (HR=1.72;95%CI:1.65-1.78). Survival curves showed early drop-offs in persistence around 30 and 90 days.
CONCLUSIONS: Adherence to cyclosporine therapy for DED was very low. Generic users were more likely to switch and discontinue than brand users, and this may be due to complex ophthalmic formulations. More work is needed to understand the role of clinical tolerability, effectiveness, and costs in treatment adherence in DED.
METHODS: A retrospective cohort study was conducted using 2022-2024 MarketScan Commercial Claims data. Adults (≥18) with DED (ICD-10: H04.12x, 375.15) and an incident cyclosporine fill between February 2022 and December 2023 were included. Continuous enrollment for 12 months pre- and post-initiation was required. Outcomes included the proportion of days covered (PDC), switching, and discontinuation (≥60-day gap). Kaplan-Meier curves were used to describe time to switching and discontinuation, while Cox proportional hazards models estimated adjusted risks controlling for demographic, clinical, healthcare utilization, and medication-related covariates.
RESULTS: Among 16,839 incident cyclosporine users, 87.1% used Restasis® and 12.9% used generic cyclosporine. Overall adherence was 11% (PDC≥80%), with an overall mean PDC of 0.38±0.27 (Brand:0.39±0.27;Generic:0.32±0.25). Medication switching was uncommon, occurring in 1,132 patients (6.5%). However, generic initiators were substantially more likely to switch treatments, primarily from generic to brand (hazard ratio [HR]=12.46;95%CI:7.35-21.10). Generic users also demonstrated significantly higher risk of treatment discontinuation compared to Restasis® (HR=1.72;95%CI:1.65-1.78). Survival curves showed early drop-offs in persistence around 30 and 90 days.
CONCLUSIONS: Adherence to cyclosporine therapy for DED was very low. Generic users were more likely to switch and discontinue than brand users, and this may be due to complex ophthalmic formulations. More work is needed to understand the role of clinical tolerability, effectiveness, and costs in treatment adherence in DED.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR150
Topic
Patient-Centered Research
Topic Subcategory
Adherence, Persistence, & Compliance
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Sensory System Disorders (Ear, Eye, Dental, Skin)