CurrentUnitedHealthcarePolicy CSOH2025D0135.A

Niktimvo (Axatilimab‑Csfr) — Medical Benefit Drug Policy (Ohio)

Covers UnitedHealthcare Community Plan medical benefit drug policy for Niktimvo in Ohio; governs coverage criteria and authorization requirements for treating chronic graft‑versus‑host disease (cGVHD) in eligible members.

Policy Summary

PayerUnitedHealthcare

PolicyNiktimvo (Axatilimab‑Csfr) — Medical Benefit Drug Policy (Ohio)

Policy CodePolicy CSOH2025D0135.A

Change TypeNo material change

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization in Ohio with documentation of cGVHD diagnosis, ≥2 prior systemic therapy failures, weight ≥40 kg, transplant specialist involvement, and dosing per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2required prior systemic therapy failures before Niktimvo

40 kgminimum patient weight for eligibility

12 momaximum authorization duration

J9038HCPCS code listed

75%ORR in pivotal trial

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Coverage Criteria for Niktimvo (axatilimab-csfr)

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

Covered when ALL of the following are met

Initial therapy requirements: Member has a diagnosis of chronic graft-versus-host disease (cGVHD) per NIH consensus criteria after allogeneic hematopoietic cell transplantation, classified as moderate or severe; AND history of failure with both: corticosteroid therapy (e.g., prednisone, methylprednisolone) AND at least one additional systemic agent (examples include bortezomib; ibrutinib; immunosuppressants such as cyclosporine, mycophenolate, tacrolimus; ruxolitinib; belumosudil; or rituximab); AND patient weighs at least 40 kg; AND prescribed by or in consultation with a transplant specialist; AND Niktimvo dosing is in accordance with the U.S. FDA–approved labeling; AND authorization requested for no more than 12 months.

Agents listed as examples: bortezomib; ibrutinib; cyclosporine; mycophenolate; tacrolimus; ruxolitinib; belumosudil; rituximab.

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

Covered when ALL of the following are met

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

Documentation should include objective and/or clinical evidence of benefit per treating clinician.

Niktimvo (axatilimab-csfr) is covered only for the treatment of chronic graft‑versus‑host disease (cGVHD) when the policy’s specified coverage criteria are met. Uses outside those criteria are considered investigational or unsupported by evidence. Specifically, Niktimvo is unproven and not medically necessary for prevention and/or treatment of all other indications (see exclusions for examples). Requests that do not document the required diagnosis, prior therapy failures, minimum weight, prescriber specialty, dosing per FDA labeling, or that exceed the authorization limits may be denied.

Use of Niktimvo for indications other than chronic graft‑versus‑host disease (cGVHD) is considered not medically necessary. This includes, but is not limited to, acute graft‑versus‑host disease (aGVHD) due to insufficient evidence of efficacy.

Coding and Eligibility Metrics

HCPCS / DrugHCPCS

J9038

Injection, axatilimab-csfr, 0.1 mg

Relevant Diagnosis CodesICD-10

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

inv-07: Minimum patient weight — eligibility weight threshold

Minimum patient weightMember must weigh at least 40 kg to be eligible for Niktimvo therapy

Source contextFDA indication specifies adults and pediatric patients weighing at least 40 kg

Policy thresholdPolicy requires patient weight ≥ 40 kg as an eligibility criterion for initial and continuation therapy

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required (up to 12 months)

Prior authorization is required in Ohio and will be issued for up to 12 months when the coverage criteria are met; include supporting clinical documentation and use HCPCS J9038 for billing.

Authorization limit: up to 12 months for initial requests and reauthorization.

Step Therapy

Step therapy — prior treatment failures required

Member must have failed corticosteroid therapy and at least one additional systemic agent (examples listed in policy) prior to initiation of Niktimvo.

Examples of additional systemic agents: bortezomib; ibrutinib (Imbruvica); immunosuppressants (cyclosporine, mycophenolate, tacrolimus); ruxolitinib (Jakafi); belumosudil (Rezurock); or rituximab.
Policy requires failure of both a corticosteroid (e.g., prednisone, methylprednisolone) AND one of the listed agents.

Line of Therapy / Salvage Use

inv-15: salvage — 1 top-level node describing salvage line positioning (e.g., after ≥2 prior systemic therapies)

Line of therapy requirement: Treatment is indicated after failure of at least two prior lines of systemic therapy for cGVHD.>= 2 prior systemic therapies

AGAVE-201 enrolled patients with ≥2 prior lines of systemic therapy; FDA indication and policy require prior failure of at least two systemic therapies.

Dose and Regimen Information

Regimen	Indication	Dose / Schedule	Coverage status
Axatilimab-csfr (Niktimvo)	Treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy	0.3 mg/kg administered intravenously every 2 weeks (dose and schedule per FDA labeling; same regimen used in pivotal AGAVE-201 trial)	Covered with criteria

Definitions and Agent Description

inv-13: cGVHD (NIH criteria) — diagnostic standard and severity classification

Diagnostic standardcGVHD must be diagnosed per National Institutes of Health (NIH) consensus criteria with compatible clinical signs and symptoms following allogeneic hematopoietic cell transplantation

Required classificationcGVHD must be classified as moderate or severe based on NIH disease grade (or equivalent such as CIBMTR score)

Clinical assessment focusAssessment should identify affected organ systems and extent/severity of involvement to guide prognosis and management

inv-14: Niktimvo (axatilimab-csfr) — agent description and indication statement

Agent descriptionNiktimvo (axatilimab‑csfr) is a colony stimulating factor‑1 receptor (CSF‑1R)–blocking monoclonal antibody

Indication statement

Background — Clinical Context

Chronic graft‑versus‑host disease (cGVHD) is a multisystem, immune‑mediated complication that can occur after allogeneic hematopoietic cell transplantation. It often involves organs such as the skin, mouth, liver, lungs, eyes, and gastrointestinal tract and can present with features resembling autoimmune disorders. Disease severity is categorized as mild, moderate, or severe; severity guides management and many patients require systemic therapy, with a substantial proportion of allogeneic transplant recipients developing disease that requires systemic treatment.