Subject: Koselugo 3770-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.
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. Pilocytic astrocytoma
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
pediatric members 2 years of age and older with
neurofibromatosis type 1 (NF1) who have symptomatic,
inoperable plexiform neurofibromas (PN).
B. Pilocytic Astrocytoma
Authorization of 12 months may be granted for treatment of
recurrent or progressive pilocytic astrocytoma with a BRAF
fusion or BRAF V600E activating mutation, as a single agent.
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; December 2021.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed February 27, 2023.
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
