Tale of Two Cities: The Adalimumab Biosimilars Experience for Uveitis and Ocular Inflammatory Diseases at Two Texas...

To assess appeal outcomes and factors influencing those outcomes in insurance-mandated non-medical switching (NMS) from adalimumab (Humira®) to biosimilars in patients with uveitis and ocular inflammatory diseases.

This retrospective observational study reviewed the electronic medical records of patients receiving Humira® for non-infectious uveitis and ocular inflammatory diseases prior to pharmacy benefit manager (PBM) formulary changes effective April 1, 2024, at the University of Texas Southwestern Medical Center (UTSW) and University of Texas Health Austin (UTHA). Data collected included PBM assignment, treatment duration, remission status, incidence of NMS mandates, appeal outcomes, and final treatment status. Appeals at UTSW cited Texas Senate Bill 680, which allows exemptions from new step-therapy protocols. Logistic regression assessed associations between patient characteristics, PBM, and NMS outcomes.

Of the 75 patients, 30 (40%) received NMS mandates. CVS Caremark patients were more likely to receive mandates for NMS (86.4% vs 20.8%; p < 0.01) and had a lower appeal success rate (14.3% vs 90.9%; p < 0.01) compared to non-CVS Caremark patients. Ultimately, 18 (24%) patients (94% CVS Caremark patients, p < 0.01) were forcibly switched. Median appeal time was 11 days (range 1-35), and processing biosimilar transitions added considerable administrative burden, even in the absence of appeals.

PBM-driven formulary changes disrupted treatment continuity for patients with non-infectious ocular inflammation. Enforcement of NMS mandates varied by PBM and often disregarded clinical stability and physician input, underscoring the urgent need for policy reform and uveitis-specific biosimilar outcome data.