Besremi (ropeginterferon alfa-2b) — Prior Authorization
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Defines prior authorization requirements for Besremi (ropeginterferon alfa-2b) for treatment of high-risk polycythemia vera, including initial authorization and reauthorization criteria and approval length.
No material clinical or coverage changes in this revision.
Coverage Criteria for Besremi (ropeginterferon alfa-2b)
inv-01: Initial Authorization
Covered when ALL of the following are met for initial authorization
Approval length 12 months
inv-02: Reauthorization
Covered on reauthorization when ALL of the following are met
Approval length 12 months
No explicit exclusions are listed in this guideline. The policy’s approval criteria specify required diagnosis and prior treatment history but do not enumerate any separate exclusionary conditions.
Use of Besremi for indications other than high-risk polycythemia vera, or in patients who do not have documented resistance or intolerance to hydroxyurea, is not supported by the criteria and therefore is not covered under this prior authorization guideline.
Initial Therapy
inv-13: Initial Therapy
Initial authorization criteria for Besremi
Approval length 12 months
Reauthorization / Continuation Criteria
inv-14: Reauthorization
Reauthorization requirements
Approval length 12 months
Provider Requirements & Actions
Prior authorization required; 12-month approvals
Prior authorization is required for Besremi. When the coverage criteria are met, initial and reauthorization approvals are issued for 12 months.
Step therapy: hydroxyurea resistance/intolerance required
Patient must have documented resistance or intolerance to hydroxyurea before Besremi will be approved.
- Hydroxyurea trial with documented resistance or intolerance is required as the step-1 therapy prior to Besremi.
Prescriber requirement: hematology/oncology involvement
The medical record must show that Besremi is prescribed by, or in consultation with, a hematologist or oncologist.
Denial triggers: missing diagnosis or hydroxyurea failure
Requests lacking a documented diagnosis of high‑risk polycythemia vera or without documentation of resistance/intolerance to hydroxyurea may be denied.
- Absence of documentation that the patient meets the high‑risk polycythemia vera diagnosis criterion.
- Absence of documentation showing resistance or intolerance to hydroxyurea.
Coding & Key Values
Step Therapy Requirements
| Step | Requirement |
|---|---|
| 1 | |
| Hydroxyurea must have been tried and shown resistance or intolerance prior to approval (documented resistance or intolerance to hydroxyurea). |
Definitions
Background
Polycythemia vera is a myeloproliferative neoplasm characterized by increased red cell mass. Management of high-risk patients often includes cytoreductive therapy; this policy addresses use of ropeginterferon alfa-2b (Besremi) specifically for patients meeting the high-risk diagnosis and prior hydroxyurea intolerance/resistance requirements.
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