Sebelipase Alfa Injections (Kanuma)

Kanuma (sebelipase alfa) is covered only for the FDA‑approved indication of lysosomal acid lipase (LAL) deficiency and is not covered for non‑FDA indications. Approval (up to 12 months) requires documented diagnostic confirmation by deficient LAL enzyme activity in leukocytes, fibroblasts, or liver tissue OR by molecular genetic testing showing an LAL gene mutation, prescription by or consultation with a geneticist, endocrinologist, metabolic disorder subspecialist, or lysosomal storage disorder specialist, and dosing limited to IV 3 mg/kg no more frequently than once weekly.

"Treatment of individuals with lysosomal acid lipase (LAL) deficiency (FDA-approved indication)."

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