CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

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

Defines clinical indications, exclusion criteria, and utilization management authority for Besremi (ropeginterferon alfa-2b-njft) for treating cancer (specifically polycythemia vera) and governs prior authorization decisions for network providers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBesremi (ropeginterferon alfa-2b-njft) — Coverage Criteria

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective Date11/29/24

Next Review DateN/A

Key ActionObtain prior authorization and support the request with FDA labeling, recognized compendia or guideline/peer‑reviewed evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Polycythemia veraexplicit covered indication

500 mcgsingle dose maximum

11/13/24committee approval

11/29/24effective

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

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Initial and continuation coverage criteria

Covered when ALL of the following are met

Continuation exemption: For continuation requests, ALL: the requested medication was used within the last year; the member has not experienced disease progression and/or intolerance to the requested medication; no additional medication(s) are being added to the continuation request.

from Section II.A

Polycythemia vera monotherapy criteria: Member has confirmed polycythemia vera AND any ONE of: (a) contraindication to hydroxyurea (e.g., childbearing age), (b) intolerance to hydroxyurea, or (c) lack of therapeutic response to hydroxyurea.

from Section II.B

Coverage exclusions and limitations for Besremi (ropeginterferon alfa-2b-njft) include the following. Claims will be denied if there is disease progression while taking Besremi. Concurrent use with other cytoreductive agents (for example, hydroxyurea) is excluded except when the patient is actively transitioning to Besremi. Requests that exceed the single dose limit of 500 mcg for Besremi will be excluded. Additionally, investigational use or off‑label indications that are not supported by sufficient evidence or are not generally accepted by the medical community are excluded.

Off‑label indications for Besremi that lack sufficient evidence are considered not medically necessary. Sufficient evidence is defined by the absence or inadequacy of supportive data in CMS‑recognized compendia or acceptable peer‑reviewed literature. Specific deficiencies include inadequate patient or regimen representation in studies, outcomes that are not clinically meaningful (ASCO‑recommended benchmarks such as a Hazard Ratio < 0.80 or at least a 3‑month OS/PFS benefit), inappropriate experimental design for the question, reliance solely on nonrandomized uncontrolled case reports or meeting abstracts without full peer‑reviewed articles, or other shortcomings that prevent general acceptance by the medical community.

Prior authorization, step therapy, and provider requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Evolent processes all medication requests from network ordering providers; final review is by the Utilization Management Department with final approval by the Utilization Management Committee. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Prior authorization and utilization management review required — initial review by Utilization Management Department; final approval by Utilization Management Committee.
All medication requests must be submitted to Evolent for review; unauthorized medications may not be reimbursed.

Step Therapy

Step Therapy — Hydroxyurea

Besremi may be used as monotherapy for polycythemia vera when the member has ONE of the following: contraindication to hydroxyurea (e.g., childbearing age), intolerance to hydroxyurea, or lack of therapeutic response to hydroxyurea.

Step therapy relative to hydroxyurea: Besremi permitted as monotherapy when ONE of the listed conditions is met.

Documentation Required

Required Supporting Evidence

Treatment use must be supported by one of the following sources: FDA approved product labeling, CMS‑approved compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS standards (see notes on acceptable evidence).

Required supporting evidence includes FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature that adequately represents the patient population, therapies, and clinically meaningful outcomes.
Peer‑reviewed evidence must meet CMS criteria (adequate representation of clinical characteristics, appropriate regimen representation, clinically meaningful outcomes, appropriate study design; nonrandomized trials with sufficient subjects may be supportive; case reports and abstracts without full articles are generally inadequate).

Denial Risk

Denial Triggers / Exclusions

Denial triggers and exclusions include disease progression while on Besremi; concurrent use with other cytoreductive agents (e.g., hydroxyurea) except during transition; dosing that exceeds a single‑dose limit of 500 mcg; and investigational or off‑label uses lacking sufficient evidence or general acceptance by the medical community per CMS/peer‑review criteria.

Exclusion: disease progression while taking Besremi.
Exclusion: concurrent use with other cytoreductive agents except when transitioning.
Exclusion: dosing exceeding single dose limit of 500 mcg.
Exclusion: investigational or off‑label indications without sufficient evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature (see Required Supporting Evidence).

Step	Requirement	Coverage status
1	Member must have ONE of: contraindication to hydroxyurea (e.g., childbearing age), intolerance to hydroxyurea, or lack of therapeutic response to hydroxyurea before initiating Besremi monotherapy for polycythemia vera.	Covered

Background

Besremi (ropeginterferon alfa-2b-njft) is an interferon alfa formulation used in the management of hematologic malignancies, and this policy specifically addresses its use for polycythemia vera. Policy application and coverage decisions should align with the drug labeling and the expectation that supporting clinical evidence be present in CMS‑recognized compendia or acceptable peer‑reviewed literature; evidence deficiencies described in this policy (for example, inadequate representation, lack of clinically meaningful outcomes, or reliance on case reports/abstracts) may render use investigational or not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBesremi (ropeginterferon alfa-2b-njft) — Coverage Criteria

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective Date11/29/24

Next Review DateN/A

Key ActionObtain prior authorization and support the request with FDA labeling, recognized compendia or guideline/peer‑reviewed evidence.

SourceLink

On This Page

OpenPayer

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

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

Initial therapy

Continuation therapy

Prior authorization, step therapy, and provider requirements

Step therapy requirements

Quantity limits and dosing constraints

Definitions and exemptions

Background