Sebelipase Alfa Injections (Kanuma)

Kanuma (sebelipase alfa) is covered only for FDA‑approved treatment of lysosomal acid lipase (LAL) deficiency and no off‑label compendial uses are covered. Coverage requires diagnostic confirmation by LAL enzyme assay or genetic testing, adherence to dosing (typical 1 mg/kg IV every other week; for rapidly progressive infants start 1 mg/kg weekly with possible escalation to 3 mg/kg weekly), documentation of FDA indication and safety criteria, and approvals are issued for 12 months.

"Kanuma is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency."

Sign up to see full coverage criteria, indications, and limitations.