Subject: Besremi SGM 5060-A P2026a

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 Indication

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

Compendial Uses²

·        Myeloproliferative neoplasms

o   Essential thrombocythemia

o   Myelofibrosis

o   Polycythemia vera

·        Chronic myeloid leukemia

·        Systemic mastocytosis

·        Mycosis fungoides/Sézary syndrome

·        Primary cutaneous CD30+ T-cell lymphoproliferative disorders

·        Adult T-cell leukemia/lymphoma

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

Coverage Criteria

Myeloproliferative Neoplasms^1-2

Authorization of 12 months may be granted for treatment of essential thrombocythemia when either of the following criteria is met:

·        Member has had an inadequate response or loss of response to prior cytoreductive therapy (e.g., anagrelide, hydroxyurea, or peginterferon alfa-2a (Pegasys)).

·        peginterferon alfa-2a (Pegasys) is unavailable

Authorization of 12 months may be granted for treatment of myelofibrosis, if peginterferon alfa-2a (Pegasys) is unavailable.

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

Chronic Myeloid Leukemia²

Authorization of 12 months may be granted for initial treatment of chronic myeloid leukemia in pregnancy.

Systyemic Mastocytosis²

Authorization of 12 months may be granted for treatment of systemic mastocytosis, if peginterferon alfa-2a (Pegasys) is unavailable.

Mycosis Fungoides/Sézary Syndrome²

Authorization of 12 months may be granted for treatment of mycosis fungoides/Sézary syndrome, if peginterferon alfa-2a (Pegasys) is unavailable.

Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders²

Authorization of 12 months may be granted for treatment of primary cutaneous CD30+ T-cell lymphoproliferative disorders, if peginterferon alfa-2a (Pegasys) is unavailable.

Adult T-Cell Leukemia/Lymphoma²

Authorization of 12 months may be granted for treatment of adult T-cell leukemia/lymphoma, if peginterferon alfa-2a (Pegasys) is unavailable.

Continuation of Therapy

Myeloproliferative Neoplasms

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).

All Other Indications

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for all other indications in the coverage criteria section, not previously listed, 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.      Besremi [package insert]. Burlington, MA: PharmaEssentia USA Corporation; April 2024.

2.     The NCCN Drugs & Biologics Compendium® © 2026 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed May 5, 2026.

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 4, 2026