CurrentUnitedHealthcarePolicy 2025D0135B

Niktimvo (axatilimab-csfr) for chronic graft-versus-host disease (cGVHD)

Defines UnitedHealthcare coverage criteria for Niktimvo (axatilimab-csfr) for treatment of moderate-to-severe chronic graft-versus-host disease (cGVHD) after failure of ≥2 prior systemic therapies, and exclusions for other indications.

Policy Summary

PayerUnitedHealthcare

PolicyNiktimvo (axatilimab-csfr) for chronic graft-versus-host disease (cGVHD)

Policy CodePolicy 2025D0135B

Change TypeRevised coverage rationaleadded coding

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document failure of ≥2 prior systemic therapies including corticosteroid plus one additional listed agent.

SourceLink

POLICY UPDATE CHANGES

Coverage Rationale updated to specify requirement of prior failure with corticosteroid plus one additional listed agent before Niktimvo is considered medically necessary.

Applicable HCPCS and ICD-10 codes for Niktimvo and cGVHD were listed.

≥ 2prior systemic therapy lines required before Niktimvo

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

12 monthsmaximum authorization duration

0.3 mg/kg q2wapproved trial dose

Policy Summary

PayerUnitedHealthcare

PolicyNiktimvo (axatilimab-csfr) for chronic graft-versus-host disease (cGVHD)

Policy CodePolicy 2025D0135B

Change TypeRevised coverage rationaleadded coding

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document failure of ≥2 prior systemic therapies including corticosteroid plus one additional listed agent.

SourceLink

On This Page

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inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial therapy for Niktimvo: Diagnosis of chronic graft-versus-host disease (cGVHD) after allogeneic hematopoietic cell transplantation with clinical signs meeting NIH consensus criteria and cGVHD classified as moderate or severe; patient has history of failure with at least two prior lines of systemic therapy defined as failure of a corticosteroid (e.g., prednisone, methylprednisolone) plus at least one additional agent (bortezomib, ibrutinib, an immunosuppressant such as cyclosporine, mycophenolate, or tacrolimus, ruxolitinib, belumosudil, or rituximab); patient weighs at least 40 kg; prescribed by or in consultation with a transplant specialist; Niktimvo dosing is in accordance with FDA‑approved labeling; authorization will be issued for no more than 12 months.

inv-02: Continuation Therapy / Reauthorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Continuation therapy for Niktimvo: Documentation of a positive clinical response to Niktimvo therapy; prescribed by or in consultation with a transplant specialist; Niktimvo dosing is in accordance with FDA‑approved labeling; reauthorization will be issued for no more than 12 months.

inv-03: Unproven / Not Medically Necessary — 1 top-level node

Unproven indications: Use of Niktimvo for prevention or treatment of indications other than chronic graft-versus-host disease (including acute GVHD) is considered unproven and not medically necessary due to insufficient evidence of efficacy.

Niktimvo (axatilimab-csfr) is considered unproven and not medically necessary for prevention and/or treatment of indications other than chronic graft‑versus‑host disease (cGVHD). This includes, but is not limited to, use for acute graft‑versus‑host disease (aGVHD), due to insufficient evidence of efficacy.

Treatment of acute graft‑versus‑host disease (aGVHD) or other non‑cGVHD indications with Niktimvo is explicitly excluded and considered not medically necessary because current evidence does not support its efficacy for these uses.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Approval issued for up to 12 months for initial and continuation therapy when criteria are met.

Authorization duration: up to 12 months for initial and reauthorization

Step Therapy

Step Therapy Requirement

Patient must have history of failure with corticosteroid (e.g., prednisone, methylprednisolone) and at least one additional listed agent prior to approval.

Required prior agents: Bortezomib; Imbruvica (ibrutinib); an immunosuppressant agent (e.g., cyclosporine, mycophenolate, tacrolimus); Jakafi (ruxolitinib); Rezurock (belumosudil); or Rituximab

Documentation Required

Required Documentation

Documentation must include evidence of allogeneic hematopoietic cell transplantation (HCT), NIH criteria–based signs/symptoms for cGVHD, classification of cGVHD as moderate or severe, patient weight ≥ 40 kg, prescribing or consultation by a transplant specialist, and dosing consistent with FDA labeling.

Confirmation of prior allogeneic HCT
Evidence of NIH consensus criteria signs/symptoms for cGVHD
Documentation of cGVHD severity (moderate or severe by NIH disease grade or CIBMTR score)
Patient weight ≥ 40 kg
Prescription by or consultation with a transplant specialist
Dosing consistent with FDA‑approved labeling

Denial Risk

Denial Triggers

Requests will be denied when the patient has not failed at least two prior lines of systemic therapy (including a corticosteroid plus one of the listed agents) or when required documentation (e.g., prior HCT, NIH criteria, severity classification, specialist involvement) is missing.

Denial trigger: fewer than two prior lines of systemic therapy (must include corticosteroid + one listed agent)
Denial trigger: missing required documentation (allogeneic HCT, NIH criteria evidence, severity classification, transplant specialist involvement, dosing per FDA)

Evaluation and Assessment Requirements

Note

Evaluation per NIH consensus criteria and documentation of prior therapy failures

Perform evaluation using NIH consensus criteria to assess organ involvement and disease severity and document prior systemic therapy failures as specified in the coverage criteria.

NIH consensus assessment for cGVHD organ involvement and severity (mild/moderate/severe classification)
Clear documentation of prior systemic therapies and evidence of failure (corticosteroid plus one additional listed agent)

Background and Definitions

Chronic graft‑versus‑host disease (cGVHD) is a multisystem disorder that can occur after allogeneic hematopoietic cell transplantation. It presents with autoimmune‑like manifestations affecting multiple organs and is assessed using the NIH consensus criteria, which classify severity as mild, moderate, or severe. Severity classification guides treatment decisions; patients with moderate or severe cGVHD commonly require systemic therapy and may experience substantial morbidity and mortality.

inv-14: cGVHD — definition and NIH consensus criteria summary

DefinitionChronic graft-versus-host disease (cGVHD): a distinct syndrome following allogeneic hematopoietic cell transplantation with clinical signs and symptoms per NIH consensus criteria

Diagnostic elementsRequires prior allogeneic HCT and clinical symptoms/signs that are components of the NIH consensus criteria for cGVHD

Severity classificationcGVHD is classified as mild, moderate, or severe (e.g., NIH disease grade, CIBMTR score) to guide treatment decisions

Clinical manifestationsMultisystem disorder; skin is the primary manifestation but may involve mouth, liver, lung, eye, GI tract, and other organs

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)

Coverage Criteria for Niktimvo (axatilimab-csfr)

Coding and Patient Eligibility

Provider Actions and Authorization Requirements

Candidate Criteria for Niktimvo

Evaluation and Assessment Requirements

Center and Prescriber Requirements

Post-Transplant Therapy and Reauthorization

Background and Definitions