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 the following criteria are met:
- Deficiency of LAL in peripheral blood leukocytes, fibroblasts, or dried blood spots; or
- Documented molecular genetic test revealing biallelic pathogenic variants (2) mutations in the LIPA gene; and
- Individual does not have severe liver cirrhosis (e.g., Child-Pugh class C); and
- Documentation of baseline weight for age Z-score for LDL, HDL, AST, ALT and/or triglycerides.
Continuation of therapy with sebelipase alfa (Kanuma) may be considered medically necessary for a reauthorization period of 12 months when ALL of the following are met:
- The individual has previously been approved for Sebelipase alfa (Kanuma) through Blue Cross Blue Shield of North Dakota's precertification process; and
- The individual has not experienced any unacceptable adverse effect (e.g., anaphylaxis); and
- Treatment has resulted in a clinical benefit such as an improvement in weight for age Z-scores for individuals with growth failure, improved LDL, HDL, AST, ALT and/or triglycerides compared to previously submitted documentation.
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.