Subject: Pemazyre 3822-A SGM P2021
Policy:
- 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
Pemazyre is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as
detected by an FDA-approved test.
B. Compendial Uses
Myeloid/lymphoid neoplasms with eosinophilia and FGFR1 rearrangement in chronic phase or blast phase
All other indications are considered experimental/investigational and not medically necessary.
- DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: Documentation of FGFR2 fusion or rearrangement or FGFR1 rearrangement (where applicable)
- CRITERIA FOR INITIAL APPROVAL
A. Cholangiocarcinoma
Authorization of 12 months may be granted for treatment of members with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement.
B. Myeloid/Lymphoid Neoplasms with Eosinophilia
Authorization of 12 months may be granted for treatment of myeloid and/or lymphoid neoplasms with eosinophilia and FGFR1 rearrangement in the chronic phase or blast phase.
- 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. Pemazyre [package insert]. Incyte Corporation: Wilmington, DE; February 2021.
2. The NCCN Drugs & Biologics Compendium® © 2021 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed February 25, 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 01, 2021
