Subject: Besremi 5060-A SGM P2023
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BESREMI
(ropeginterferon alfa-2b-njft)
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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.
FDA-Approved Indication
Besremi is indicated for the treatment of adults with
polycythemia vera.
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
Polycythemia Vera
Authorization of 12 months may be granted for treatment of
polycythemia vera.
III. 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:
- Besremi [package insert]. Burlington, MA: PharmaEssentia USA Corporation; November 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.
June 18, 2023
