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Coverage criteria policies

Sebelipase Alfa (Kanuma®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Kanuma requires prior authorization from Pharmacy Administration.


Sebelipase (Kanuma) is generally approved when all the following are met:

  1. Member is diagnosed with one of the following forms of Lysosomal Acid Lipase (LAL) deficiency
    1. Wolman disease or
    2. Cholesteryl ester storage disease (CESD) with elevated alanine aminotransferase levels at least 1.5 times the upper limit of the normal range reported by the laboratory.
  2. Prescribed by a provider specializing in genetics and metabolism.
  3. Prescribed according to the FDA approved regimen of
    1. infants 0-6 months of age – up to 3 mg/kg once weekly
    2. patients 4 years of age and older – 1 mg/kg every other week
  4. The patient and/or guardian has attested that they will adhere to the treatment plan.

Patients previously treated with liver transplantation or severe hepatic dysfunction (Child’s Pugh Class C) will be reviewed on a case by case basis.

Initial authorizations will be provided for six months.

Reauthorizations will be provided with medical chart documentation that the markers of the disease are improved by therapy. These include but may not be limited to survival in Wolman disease and liver enzymes, bilirubin, or reductions in hepatic fat in CESD. Medical chart documentation is required. Subsequent approvals will be provided for 12 months.

Annual reauthorizations will require medical chart documentation that the patient has been seen within the previous 12 months and there is continued documented benefit from the product.


Kanuma is a hydrolytic lysosomal cholesteryl ester and triacylglycerol-specific enzyme indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

HCPCS code




Injection, sebelipase alfa, 1mg

NDC code




Kanuma 20mg/10ml single-use vials

CPT Copyright American Medical Association. All rights reserved.  CPT is a registered trademark of the American Medical Association.


This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

  1. Kanuma Prescribing Information. Alexion Pharmaceuticals Inc., Cheshire, CT, December 2015

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Policy activity

  • 02/16/2016 - Date of origin
  • 11/01/2017 - Effective date
Review date
  • 11/2017
Revision date
  • 08/08/2016

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