CurrentEmblemHealthPolicy N/A

Evolent Clinical Guideline 3225 for Besremi (ropeginterferon alfa-2b-njft)

Defines accepted indications, contraindications, exclusions, continuation criteria, evidence standards, and coding for Besremi (ropeginterferon alfa-2b-njft) for use in cancer treatment—specifically polycythemia vera—and describes documentation/evidence sources required for authorization by Evolent.

Policy Summary

PayerEmblemHealth

PolicyEvolent Clinical Guideline 3225 for Besremi (ropeginterferon alfa-2b-njft)

Policy CodePolicy N/A

Change TypeTemplate conversion and administrative wording updates

Effective Date

Next Review Date

Key ActionEvolent must process and authorize medication requests; medications not authorized by Evolent may be considered not approvable and not reimbursable.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1454 Besremi guideline

Updated NCH verbiage to Evolent

1Covered Indications (explicit)

5Contraindications / Warnings listed

4Exclusion criteria items

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: Defines accepted indication for Besremi (ropeginterferon alfa-2b-njft) as treatment of adult patients with confirmed polycythemia vera when used as monotherapy for patients with one of the following: contraindication to hydroxyurea (e.g., childbearing age), intolerance to hydroxyurea, or lack of therapeutic response to hydroxyurea. Exclusions include disease progression on Besremi, concurrent use with other cytoreductive agents except when transitioning, dosing that exceeds the single dose limit of 500 mcg, and investigational/off-label uses not supported by CMS-recognized compendia or acceptable peer-reviewed literature. Required evidence sources for authorization and continuation include FDA product labeling, CMS-approved compendia, NCCN, ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

Initial Authorization - Polycythemia Vera

Covered when ALL of the following are met:

ALL of the following

ONE of
- Member is an adult with a confirmed diagnosis of polycythemia vera
- Contraindication to hydroxyurea (e.g., childbearing age)
- Intolerance to hydroxyurea
- Lack of therapeutic response to hydroxyurea

Continuation Therapy Criteria

Continuation Authorization (exemption from policy for not-approvable medication continuation)

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorizationno lapse > 30 days within last year
Additional medication(s) are not being added to the continuation request

Exclusions / Not Medically Necessary

Exclusion / Not Medically Necessary

Not covered when 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 (ropeginterferon alfa-2b-njft)
Dosing exceeds single dose limit of Besremi (ropeginterferon alfa-2b-njft) 500 mcgsingle dose > 500 mcg
Investigational use note: Investigational use for an off-label indication that is not supported by CMS-recognized compendia or acceptable peer-reviewed literature
Insufficient evidence defined by criteria listed (patient representation, regimen representation, clinically meaningful outcomes e.g., HR <0.80 or OS/PFS benefit ≥3 months, study design appropriateness; case reports and abstracts without full articles generally insufficient)

Contraindications / Warnings (exclusionary clinical conditions)

Not appropriate when any of the following contraindications are present:

ANY of the following

Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation or suicide attempt
Hypersensitivity to interferons, including interferon alfa-2b, or any component of the formulation
Hepatic impairment (Child-Pugh B or C)
History or presence of active serious or untreated autoimmune disease
History of transplantation and receiving immunosuppressant agents

Provider Actions & Authorization Requirements

Prior Authorization

Authorization required

Evolent must process and authorize all medication requests for Besremi. Medications that are not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

J9999

Documentation Required

Support with recognized evidence

Use must be supported by one of the following recognized evidence sources: FDA approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO) clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Documentation Required

Continuation request evidence

For continuation exemption of a medication that would otherwise be not-approvable, document that all of the following are met: the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medication(s) are being added to the continuation request.

Denial Risk

Investigational/off-label denials

Requests for off-label or investigational indications that lack sufficient evidence as defined by the policy may be denied. The policy defines sufficient evidence by criteria including adequate patient and regimen representation, clinically meaningful outcomes (for example ASCO-recommended benchmarks such as HR < 0.80 or OS/PFS benefit ≥ 3 months), and appropriate experimental design; non-randomized trials with sufficient subjects may support use. Case reports and abstracts without full articles are generally insufficient.

Thresholds

Single dose limit<= 500 mcg (single dose)

Continuation authorization lapse allowanceno lapse > 30 days within last year

Clinical Evidence & References

Key randomized evidence: PROUD-PV and CONTINUATION-PV phase 3 randomized trial (Gisslinger et al.) evaluating ropeginterferon alfa-2b in polycythemia vera (Lancet Haematol. 2020) is cited as the primary randomized evidence supporting efficacy. Additional long-term randomized/extension results from Gisslinger and colleagues are referenced. Supporting regulatory/label information: Besremi prescribing information, PharmaEssentia USA Corporation, 2024 is listed as the prescribing information source.

Definition

TermSufficient evidence

DefinitionEvidence supported by CMS-recognized compendia or acceptable peer-reviewed literature meeting criteria for patient/regimen representation, clinically meaningful outcomes (e.g., HR <0.80 or OS/PFS benefit ≥3 months), and appropriate experimental design; excludes case reports and abstracts without full articles generally.

Background

Background: The Evolent Clinical Guideline describes accepted indications for Besremi including FDA-approved and off-label uses supported by recognized evidence sources and establishes utilization management processes and criteria for authorization and continuation. Continuation exemption criteria require no disease progression on the medication, prior use within the last year without a lapse of more than 30 days of active authorization, and that no additional medications are being added to the continuation request.