Subject: Kanuma 2094-A SGM P2021

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.   REQUIRED DOCUMENTATION 

      Submission of the following information is necessary to initiate the prior authorization review: lysosomal acid lipase enzyme assay or genetic testing results supporting diagnosis.

 
III. 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) ≥ 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 lysosomal acid lipase (LAL) deficiency 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]. Cheshire, CT: Alexion Pharmaceuticals Inc.; December 2015.
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.

December 30, 2021