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Sebelipase alfa (Kanuma)

Section: Injections
Effective Date: August 01, 2019
Revised Date: July 31, 2019

Description

Sebelipase alfa (Kanuma) is a recombinant human lysosomal acid lipase (rhLAL). Lysosomal acid lipase is a lysosomal glycoprotein enzyme that catalyzes the hydrolysis of cholesteryl esters to free cholesterol and fatty acids and the hydrolysis of triglycerides to glycerol and free fatty acids.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Sebelipase alfa (Kanuma) ) may be considered medically necessary for the treatment of lysosomal acid lipase (LAL) [Wolman's disease, cholesteryl ester storage disease (CESD)] deficiency when EITHER of the following indications is met:

  • Deficiency of LAL in peripheral blood leukocytes, fibroblasts, or dried blood spots; or
  • Documented molecular genetic test revealing mutations in the LIPA gene.

Sebelipase Alfa (Kanuma) is considered experimental/investigational for any other indication and therefore non-covered. Scientific evidence does not support its use for any other indications.

Procedure Codes

J2840

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

E75.5

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