Alemtuzumab

Alemtuzumab (Lemtrada) is covered as a disease‑modifying therapy for relapsing forms of multiple sclerosis (relapsing‑remitting or active secondary progressive) in patients ≥17 years who have had an inadequate response to at least two FDA‑approved MS therapies, administered per the FDA‑approved dosing regimen. Coverage requires REMS enrollment and documentation of HIV‑negative status and no active infection, completion of required immunizations (including VZV) at least 6 weeks prior, baseline and periodic laboratory monitoring for adverse events through 48 months after the last course, corticosteroid premedication and antiviral prophylaxis, and is limited to FDA‑labeled indications (not covered for non‑FDA or pediatric uses).

"Coverage of an 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."