CurrentEmblemHealthPolicy N/A

Besremi (ropeginterferon alfa-2b-njft) coverage policy

Defines indications, inclusion and exclusion criteria, prior authorization/continuation rules, dosing limit, and evidentiary sources for Besremi (ropeginterferon alfa-2b-njft) use, primarily for treatment of polycythemia vera; applies to medication requests processed by Evolent for EmblemHealth lines of business.

Policy Summary

PayerEmblemHealth

PolicyBesremi (ropeginterferon alfa-2b-njft) coverage policy

Policy CodePolicy N/A

Change TypeClarified committee review and effective date

Effective DateNov 29, 2024

Next Review Date

Key ActionEvolent must process all medication requests and require support from FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Chapter 15 requirements.

SourceLink

POLICY UPDATE CHANGES

Committee reviewed and approved policy on 11/13/24; effective date set to November 29, 2024.

1Primary covered indication (Polycythemia Vera)

500Single dose limit (mcg)

5Committee review dates listed

Coverage Summary

This policy covers Besremi (ropeginterferon alfa-2b-njft) for the treatment of polycythemia vera under a covered_with_criteria stance. Use of Besremi for this indication requires prior authorization by Evolent and is governed by the policy's inclusion, continuation, and exclusion criteria. Authorization and processing of medication requests are the responsibility of Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Support for use must meet evidentiary standards: FDA labeling, CMS-recognized compendia, NCCN/ASCO clinical guidelines, or peer-reviewed literature that satisfies CMS Medicare Benefit Policy Manual Chapter 15 requirements.

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Continuation Therapy & Exemptions

Continuation exemption

Continuation requests for a medication that would otherwise be not-approvable under this policy are exempt from Evolent's prior authorization requirements when ALL of the following are met:

{

"operator":"all",

"children":[

{"text":"The requested medication was used within the last year."},

{"text":"The member has not experienced disease progression and/or no intolerance to the requested medication."},

No additional medication(s) are being added to the continuation request (i.e., the request is for continuation of the same regimen only).

]

}

Prior Authorization

Medication requests must be processed by Evolent

Evolent processes all medication requests. Medication requests for this drug must be submitted to and processed by Evolent Specialty Services. Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable. Providers must include supportive evidence with requests; lack of adequate supporting evidence or presence of exclusion criteria may result in denial.

Supportive evidence requirement: Requests must be supported by one of the following — FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets the standards described in the Medicare Benefit Policy Manual Chapter 15.
Denial for exclusion criteria: Requests meeting any exclusion criteria (for example: disease progression on Besremi, concurrent use with other cytoreductive agents except during transition, doses exceeding single‑dose limit of 500 mcg, investigational/off‑label uses lacking sufficient evidence) are subject to denial.

Exclusion Criteria (Not Approvable)

Exclusion criteria (Not approvable)

Do not approve if any of the following apply:

ANY of the following

Disease progression while taking Besremi (ropeginterferon alfa-2b-njft)
Concurrent use with other cytoreductive agents (e.g., hydroxyurea); except when transitioning to Besremi
Dosing exceeds single dose limit of Besremi 500 mcgsingle dose limit = 500 mcg
Evidence insufficiency criteria (examples)
- Patient and cancer clinical characteristics not adequately represented in published evidence
- Administered chemo/biologic/immune/targeted/other oncologic therapy regimen not adequately represented in published evidence
- Reported study outcomes do not represent clinically meaningful outcomes (ASCO recommended: HR < 0.80; OS/PFS benefit >= 3 months)
- Experimental design is inappropriate to address the investigative question
- Non-randomized trials may be supportive if large subject numbers, but case reports are generally inadequate
- Abstracts without full peer-reviewed article lack supporting clinical evidence

Denial Risk

Potential denial risk for exclusion criteria

Claims may be denied if any exclusion criteria are met. Key exclusion triggers include: disease progression while taking Besremi; concurrent use with other cytoreductive agents (e.g., hydroxyurea) except when transitioning to Besremi; dosing that exceeds the single dose limit of 500 mcg; and investigational or off‑label use without sufficient supporting evidence.

Disease progression while taking Besremi
Concurrent use with other cytoreductive agents (except when transitioning)
Dosing exceeds single dose limit — 500 mcg (single dose)
Investigational/off‑label use without sufficient evidence

Provider Actions & Documentation Requirements

Documentation Required

Documentation: supportive evidence requirements

Use of Besremi must be supported by one of the following: FDA‑approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15. Peer‑reviewed evidence must address adequacy of patient and regimen representation, clinically meaningful outcomes, appropriate study design, and generally acceptable levels of evidence per the policy (e.g., randomized or large nonrandomized trials; case reports and abstracts without full articles are inadequate).

Supportive sources: FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or peer‑reviewed literature meeting Medicare Benefit Policy Manual Chapter 15
Peer‑reviewed evidence must adequately represent patient/therapy characteristics and demonstrate clinically meaningful outcomes (ASCO guidance applies)
Case reports and abstracts without full peer‑reviewed articles are generally inadequate

Billing Rule

Billing rule: single dose limit (500 mcg)

The policy sets a single dose limit for Besremi of 500 mcg. Dosing requests that exceed a single dose of 500 mcg exceed the policy limit and may be denied.

Single dose limit = 500 mcg

Clinical Evidence & References

Key evidentiary sources cited by the policy include: Gisslinger et al. 2015 and 2020 (studies of ropeginterferon alfa-2b in polycythemia vera), the Besremi prescribing information (PharmaEssentia USA, 2024), and guideline/compendium sources such as NCCN and ASCO guidance and CMS-recognized compendia. The policy references these trials, the 2024 prescribing information, clinical guideline compendia, and methodological guidance (e.g., ASCO criteria and Medicare Benefit Policy Manual Chapter 15) as the basis for coverage decisions.

Background & Definitions

Background: This policy defines and governs use of Besremi (ropeginterferon alfa-2b-njft) for cancer treatment, specifically for polycythemia vera, and requires authorization by Evolent for medication requests. The policy scope includes defining indications, inclusion and exclusion criteria, prior authorization and continuation rules, and dosing limits (including a single dose limit), and applies to medication requests processed by Evolent for EmblemHealth lines of business in accordance with applicable CMS and NCQA requirements.

Definitions: Continuation request exemption — A continuation request for a not-approvable medication is exempt if the drug was used within the last year, the member has not experienced disease progression and/or no intolerance to the requested medication, and no additional medication(s) are being added to the continuation request.