Ublituximab-xiiy

This policy covers ublituximab‑xiiy (Briumvi) IV infusion for treatment of relapsing forms of multiple sclerosis in adults — including clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS — to reduce relapse rate and MRI disease activity when prescribed consistent with FDA labeling or accepted compendia/off‑label evidence. Coverage requires the specified dosing schedule (150 mg initial, 450 mg at 2 weeks, then 450 mg every 24 weeks), baseline EDSS 0–5.5, baseline and periodic neurologic evaluations and MRIs, negative hepatitis B testing, avoidance of concurrent MS disease‑modifying therapies and live vaccines, pregnancy testing/contraception per policy, and is limited to adults (not indicated for pediatric use).

"Coverage of any FDA-approved drug when prescribed for a use recognized as safe and effective in one or more standard medical reference compendia adopted by the U."