Subject: Besremi SGM 5060-A P2025

Drug

BESREMI  (ropeginterferon alfa-2b-njft)

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.

FDA-Approved Indications

Besremi is indicated for the treatment of adults with polycythemia vera.

All other indications are considered experimental/investigational and not medically necessary.

Coverage Criteria

Polycythemia Vera¹

Authorization of 12 months may be granted for treatment of polycythemia vera.

Continuation of Therapy

Authorization of 12 months may be granted if the member is experiencing benefit from therapy as evidenced by improvement in symptoms and/or disease markers (e.g., morphological response, reduction or stabilization in spleen size, improvement of thrombocytosis/leukocytosis, etc.)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Besremi [package insert]. Burlington, MA: PharmaEssentia USA Corporation; April 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.

June 02, 2025