Subject: Koselugo 3770-A SGM P2022a

Drug

KOSELUGO  (selumetinib)

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 Indications
       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:

1. Koselugo [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2021.
2. The NCCN Drugs & Biologics Compendium^® © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed June 6, 2022.

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.

July 15, 2022