Sebelipase Alfa Injections (Kanuma)

Kanuma (sebelipase alfa) is covered only for the FDA‑approved indication of lysosomal acid lipase (LAL) deficiency (not for non‑FDA uses), with authorization for up to 12 months and dosing limited to ≤3 mg/kg IV no more frequently than once weekly. Coverage requires laboratory evidence of deficient LAL activity (in leukocytes, fibroblasts, or liver) or molecular genetic confirmation, prescribing by or consultation with a geneticist, endocrinologist, metabolic disorder subspecialist, or lysosomal storage disorder specialist, and clinical documentation of diagnosis and applicable safety criteria.

"The individual must meet all of the following criteria for approval (i."

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