CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Besremi (ropeginterferon alfa-2b-njft) — Coverage Criteria

Defines coverage, inclusion and exclusion criteria, and utilization management requirements for Besremi (ropeginterferon alfa-2b-njft) for treatment of cancer (notably polycythemia vera) for members whose medication requests are processed by Evolent/Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Besremi (ropeginterferon alfa-2b-njft) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date11/29/24

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent (UM); approval authority rests with the Utilization Management Committee.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

11/29/24effective date

11/13/24committee approval

Polycythemia veranamed indication

500 mcgsingle dose max

within 1 yrcontinuation exemption

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Coverage Criteria for Besremi (ropeginterferon alfa-2b-njft)

Polycythemia vera — initial/primary coverage

Covered when ANY ONE of the following is met for members with confirmed polycythemia vera:

Polycythemia vera monotherapy criteria: Member has confirmed diagnosis of polycythemia vera and meets at least one of: (a) contraindication to hydroxyurea (e.g., childbearing age), (b) intolerance to hydroxyurea, or (c) lack of therapeutic response to hydroxyurea.

Besremi (ropeginterferon alfa-2b-njft) used as monotherapy

Continuation requests — continuation criteria exempt from policy review when ALL conditions are met

Continuation requests exempt from policy review when ALL of the following are met:

Continuation exemption: (1) The requested medication was used within the last year; (2) the member has not experienced disease progression and/or intolerance to the requested medication; (3) additional medication(s) are not being added to the continuation request.

Exempt from Evolent policy review for continuation requests that meet these conditions

Concurrent use: Besremi (ropeginterferon alfa-2b-njft) is not covered for concurrent administration with other cytoreductive agents (for example, hydroxyurea), except when the other agent is being used solely as part of a documented transition to Besremi. Requests that include additional cytoreductive therapies with no documentation of an intended transition may be denied.

Investigational / off‑label use: Use of Besremi for indications that are not supported by FDA labeling or by sufficient evidence in CMS‑recognized compendia or acceptable peer‑reviewed literature is considered investigational and not medically necessary. Sufficient evidence is absent when the clinical population, regimen, or outcomes are not adequately represented in the published data, when only uncontrolled case reports or abstracts exist, or when study design or results do not meet accepted benchmarks for clinically meaningful benefit.

Initial Therapy Criteria

Initial therapy — monotherapy when hydroxyurea contraindicated/intolerant/ineffective

Initial use as monotherapy for polycythemia vera when prior hydroxyurea is contraindicated, not tolerated, or ineffective.

Initial therapy for PV: Member has confirmed polycythemia vera and has either (a) a contraindication to hydroxyurea (e.g., childbearing age), (b) intolerance to hydroxyurea, or (c) lack of therapeutic response to hydroxyurea.

Monotherapy with Besremi (ropeginterferon alfa-2b-njft)

Continuation Therapy Criteria

Continuation therapy — continuation requests may be exempt if criteria are met

Continuation requests may be exempt if ALL of the following are met:

Continuation exemption: (1) medication used within the last year; (2) member has not experienced disease progression and/or intolerance to the medication; (3) additional medications are not being added to the continuation request.

Continuation exemption for previously used medication

Provider Actions and Utilization Management

Prior Authorization

Prior Authorization Required

Prior authorization is required. Evolent (on behalf of the plan) processes all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Final approval authority rests with the Utilization Management Committee following review by the Utilization Management Department.

Prior authorization required for Besremi (ropeginterferon alfa-2b-njft) requests
Submit clinical documentation demonstrating indication and supporting evidence sources (FDA label, CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature)

Step Therapy

Hydroxyurea Requirement / Preceding Therapy

For polycythemia vera, hydroxyurea should be used first unless there is a documented contraindication, intolerance, or lack of therapeutic response to hydroxyurea. Providers must document which of these conditions applies when requesting Besremi as monotherapy.

Acceptable reasons to bypass hydroxyurea: documented contraindication (e.g., childbearing potential), documented intolerance, or documented lack of therapeutic response

Step Therapy Requirements

Step	Requirement	Notes
1	Prior use of hydroxyurea is required before Besremi monotherapy unless there is documentation of a contraindication or intolerance to hydroxyurea	Allowed exceptions: documented contraindication to hydroxyurea (e.g., childbearing age) or intolerance; lack of therapeutic response to hydroxyurea also meets requirement

Quantity Limits and Dosing

Quantity limit — single dose

DrugBesremi (ropeginterferon alfa-2b-njft)

Quantity limit (single dose)≤ 500 mcg

Unitmcg per single dose

Exclusion if dosing exceedsRequests exceeding a single dose of 500 mcg will be excluded

Definitions

Continuation request exemption — criteria

DefinitionA continuation request is exempt when all specified conditions are met

Condition 1Medication was used within the last year

Condition 2Member has not experienced disease progression and/or intolerance to the medication

Condition 3No additional medication(s) are being added to the continuation request

Background

Besremi (ropeginterferon alfa-2b-njft) is evaluated for the treatment of polycythemia vera against its FDA indication and recognized oncology compendia. The policy permits Besremi as monotherapy for polycythemia vera when members meet the documented criteria (for example, contraindication to, intolerance of, or lack of therapeutic response to hydroxyurea). The policy also identifies explicit exclusions relevant to clinical use: disease progression while on Besremi, concurrent use with other cytoreductive agents except during transition, and dosing that exceeds a single dose limit of 500 mcg. Finally, off‑label uses without sufficient supporting evidence per CMS compendia or acceptable peer‑reviewed literature are considered investigational and are not covered.