Subject: Kanuma 2094-A SGM P2023
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 (e.g.,
improvement, stabilization, or slowing of disease progression
for weight-for-age z-score if exhibiting growth failure, LDL,
HDL, triglycerides, or ALT).
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 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:
- Kanuma [package insert]. Boston, MA: Alexion Pharmaceuticals Inc.; November, 2021.
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, 2023
