Subject: Koselugo 3770-A SGM P2024
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.
A. FDA-Approved Indication
Koselugo is indicated for the treatment of pediatric patients 2 years of age and older with
neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas
(PN).
B. Compendial Uses
1. Circumscribed glioma
2. Langerhans cell histiocytosis
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:
Documentation of BRAF mutation status, where applicable.
III. CRITERIA FOR INITIAL APPROVAL
A. Neurofibromatosis type 1
Authorization of 12 months may be granted for treatment of neurofibromatosis type 1 (NF1)
when either of the following criteria are met:
1. Member is 2 years of age or older with symptomatic, inoperable plexiform neurofibromas
(PN), or
2. The requested medication will be used as a single agent in members with recurrent or
progressive NF-1 mutated glioma
B. Circumscribed Glioma
Authorization of 12 months may be granted as a single agent for treatment of recurrent or
progressive circumscribed glioma with a BRAF fusion or BRAF V600E activating mutation.
C. Langerhans Cell Histiocytosis
Authorization of 12 months may be granted as a single agent for treatment of Langerhans
cell histiocytosis.
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 when there is no evidence of unacceptable
toxicity or disease progression while on the current regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Koselugo [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; January 2024.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed February 28, 2024.
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
