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HealthPartners

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

Sebelipase Alfa (Kanuma) requires prior authorization from HealthPartners Pharmacy Administration. The setting of drug administration will be reviewed as part of the prior authorization.

Note:

For all inquiries, transfer to the Medical Injectable Line (ext 26135).

Coverage

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; and,
  2. Prescribed by a provider specializing in genetics and metabolism; and,
  3. Prescribed according to the FDA approved dosing regimen; and,
  4. The patient and/or guardian has attested that they will adhere to the treatment plan; and,
  5. Documentation of patient’s weight and diagnosis are provided to HealthPartners; and,
  6. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

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.

Definitions

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.

Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.

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

Codes

Description

J2840

Injection, sebelipase alfa, 1mg

NDC code

Code

Description

25682000701

Kanuma 20 MG/10ML SOLN

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

Products

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.

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

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Policy activity

  • 02/16/2016 - Date of origin
  • 01/01/2019 - Effective date
Review date
  • 11/2018
Revision date
  • 11/05/2018

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