CurrentUnitedHealthcarePolicy CS2025D0135D

Niktimvo (axatilimab-csfr) for chronic graft-versus-host disease (cGVHD) — Medical Benefit Drug Policy

Defines UnitedHealthcare medical benefit coverage criteria for use of Niktimvo to treat chronic graft-versus-host disease (cGVHD) and who is affected (patients post-allogeneic hematopoietic cell transplantation and prescribing clinicians).

Policy Summary

PayerUnitedHealthcare

PolicyNiktimvo (axatilimab-csfr) for chronic graft-versus-host disease (cGVHD) — Medical Benefit Drug Policy

Policy CodePolicy CS2025D0135D

Change TypeNo material change

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation that all initial-therapy criteria are met; authorizations issued for up to 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

75%overall response rate (ORR) through 6 months in AGAVE-201

60%proportion maintaining response at 12 months (KM estimate)

12 monthsmaximum authorization period

≥40 kgminimum patient weight

J9038HCPCS code

Coverage Criteria for Niktimvo (axatilimab-csfr)

Initial Therapy — Covered when ALL of the following are met for initial therapy

Covered when ALL of the following are met for initial therapy:

Diagnosis of cGVHD: Diagnosis of chronic graft-versus-host disease (cGVHD) defined by all of the following: patient underwent allogeneic hematopoietic cell transplantation (HCT); clinical signs/symptoms consistent with NIH consensus criteria for cGVHD; and cGVHD classified as moderate or severe (e.g., NIH disease grade, CIBMTR score)

Prior therapy failures: Patient has history of failure with both of the following: corticosteroid (e.g., prednisone, methylprednisolone); AND at least one of: bortezomib; ibrutinib (Imbruvica); an immunosuppressant agent (e.g., cyclosporine, mycophenolate, tacrolimus); ruxolitinib (Jakafi); belumosudil (Rezurock); or rituximab

Step-therapy requirement: documented failures of listed agents prior to approval

Patient and prescriber requirements: Patient weighs at least 40 kg; prescribed by or in consultation with a transplant specialist; Niktimvo dosing consistent with FDA‑approved labeling; authorization will be issued for no more than 12 months

Policy Summary

PayerUnitedHealthcare

PolicyNiktimvo (axatilimab-csfr) for chronic graft-versus-host disease (cGVHD) — Medical Benefit Drug Policy

Policy CodePolicy CS2025D0135D

Change TypeNo material change

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation that all initial-therapy criteria are met; authorizations issued for up to 12 months.

SourceLink

On This Page

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Continuation Therapy — Covered for continuation when ALL of the following are met

Covered for continuation when ALL of the following are met:

Response requirement: Documentation of a positive clinical response to Niktimvo therapy

Response should be documented per clinical assessment (e.g., NIH 2014 response criteria)

Prescriber and dosing: Prescribed by or in consultation with a transplant specialist; Niktimvo dosing is in accordance with the United States Food and Drug Administration approved labeling; reauthorization will be issued for no more than 12 months

Reauthorization requires submitted evidence of clinical benefit

Regimen	Indication	Dosing / Duration	Coverage status
Axatilimab-csfr
Recurrent or refractory chronic graft-versus-host disease (cGVHD) after at least two prior systemic therapies
0.3 mg/kg IV every 2 weeks until disease progression, lack of efficacy by 9 months, or unacceptable toxicity (per AGAVE-201 trial dosing)
Covered with criteria

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorizations will be issued for up to 12 months and only when all initial-therapy criteria are met.

Authorization duration: up to 12 months
Prescriber requirement: prescribed by or in consultation with a transplant specialist
Dosing: in accordance with FDA-approved labeling

Step Therapy

Prior Therapy Requirement

Patient must have history of failure with corticosteroid therapy and at least one additional agent (for example: bortezomib, ibrutinib, immunosuppressants such as cyclosporine/mycophenolate/tacrolimus, ruxolitinib, belumosudil, or rituximab).

Required prior therapies: corticosteroid (e.g., prednisone, methylprednisolone) + one additional listed agent

Documentation Required

Documentation Requirement

Documentation of diagnosis is required per NIH consensus criteria: patient must have undergone allogeneic hematopoietic cell transplantation and present clinical signs/symptoms consistent with NIH cGVHD criteria, with disease classified as moderate or severe.

Diagnosis documentation: evidence of prior allogeneic HCT; clinical findings aligning with NIH consensus criteria; cGVHD graded as moderate or severe (e.g., NIH disease grade, CIBMTR score)

Denial Risk

Denial risk if the member does not meet all listed criteria for initial or continuation therapy (including diagnosis documentation, prior-therapy requirements, prescriber requirements, dosing per FDA labeling, weight ≥ 40 kg, and documented clinical response for continuation).

Potential denial triggers: missing NIH-based diagnostic documentation; absence of documented failure of corticosteroid plus an additional agent; prescriber not a transplant specialist or lack of consultation; weight < 40 kg; dosing not per FDA labeling; lack of documented positive clinical response for reauthorization

Definitions and Clinical Terms

inv-13: cGVHD definition

DefinitionChronic graft-versus-host disease (cGVHD) defined by NIH consensus criteria: patient underwent allogeneic hematopoietic cell transplantation; clinical signs/symptoms per NIH consensus components; cGVHD classified as moderate or severe (e.g., NIH disease grade, CIBMTR score).

Classification requirementcGVHD must be classified as moderate or severe based on grading scales such as NIH disease grade or CIBMTR score

DocumentationDiagnosis must include evidence of clinical symptoms/signs that are components of the NIH consensus criteria

inv-14: ORR definition

ORR definitionOverall response rate (ORR) includes complete response or partial response according to the 2014 NIH Consensus Development Project on Response Criteria

Measurement timepointPrimary endpoint measured through cycle 7 day 1 (within first six months of treatment in AGAVE-201)

Context of useORR used as primary efficacy endpoint in AGAVE-201 for Niktimvo in recurrent/refractory cGVHD

D89.811	Chronic graft-versus-host disease
D89.812	Acute on chronic graft-versus-host disease

OpenPayer

Niktimvo (axatilimab-csfr) for chronic graft-versus-host disease (cGVHD) — Medical Benefit Drug Policy

Coverage Criteria for Niktimvo (axatilimab-csfr)

Dosing and Regimens

Billing and Diagnosis Codes

Provider Actions and Authorization Requirements

Definitions and Clinical Terms

Background