Subject: Kanuma 2094-A SGM P2024

Drug

KANUMA  (sebelipase alfa)

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and compendial uses are
          considered a covered benefit provided that all the approval criteria are met and the member
          has no exclusions to the prescribed therapy.

          FDA-Approved Indication
          Kanuma is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase
          (LAL) deficiency.

          All other indications are considered experimental/investigational and not medically necessary.


    II.  DOCUMENTATION

          Submission of the following information is necessary to initiate the prior authorization review:
          A.  Initial requests: lysosomal acid lipase enzyme assay or genetic testing results supporting
               diagnosis.
          B.  Continuation requests: lab values or chart notes documenting a positive response to
               therapy.


   IV.  CRITERIA FOR INITIAL APPROVAL

          Lysosomal acid lipase (LAL) deficiency
          Authorization of 12 months may be granted for treatment of LAL deficiency when both of the
          following criteria are met:
          A.  Diagnosis of LAL deficiency was confirmed by enzyme assay demonstrating a deficiency of
               lysosomal acid lipase enzyme activity or by genetic testing; AND
          B.  Member has alanine aminotransferase level (ALT) greater than or equal to 1.5 times the
               upper limit of normal (based on the age- and gender-specific normal ranges) on two
               consecutive ALT measurements obtained at least one week apart.


   IV.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for continued treatment in members requesting
          reauthorization for an indication listed in Section III who are responding to therapy (e.g.,
          improvement, stabilization, or slowing of disease progression for weight-for-age z-score if
          exhibiting growth failure, low-density lipoprotein [LDL], high-density lipoprotein [HDL],
          triglycerides, or alanine aminotransferase [ALT]).

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Kanuma [package insert]. Boston, MA: Alexion Pharmaceuticals, Inc.; November 2021.
2. Burton BK, Balwani, M, Feillet F, et al. A Phase 3 Trial of Sebelipase Alfa in Lysosomal Acid Lipase Deficiency. N Engl J Med 2015; 373:1010-20.

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 18, 2024