Currentsierra health and lifePolicy 2026D0135C

Niktimvo (axatilimab-csfr) — chronic graft-versus-host disease (cGVHD) coverage criteria

Defines medical necessity criteria, coding, and authorization guidance for Niktimvo (axatilimab-csfr) in treating chronic graft-versus-host disease (cGVHD) for applicable UnitedHealthcare benefit plans and related populations.

Policy Summary

Payersierra health and life

PolicyNiktimvo (axatilimab-csfr) — chronic graft-versus-host disease (cGVHD) coverage criteria

Policy CodePolicy 2026D0135C

Change TypeNo material change

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization with documentation of cGVHD diagnosis, failure of at least two prior systemic therapies, patient weight ≥40 kg, specialist consultation, and dosing per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

75%ORR (AGAVE-201, 6 mo)

≥40 kgMin weight

≥2Prior lines required

J9038HCPCS

12 moMax auth period

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Coverage Criteria for Niktimvo (axatilimab-csfr)

Initial Therapy Criteria

Niktimvo is medically necessary when ALL of the following are met for initial therapy:

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

Prior therapy failures: History of failure with BOTH: a corticosteroid (e.g., prednisone, methylprednisolone) AND one additional agent from the following list: bortezomib; ibrutinib (Imbruvica); an immunosuppressant agent (e.g., cyclosporine, mycophenolate, tacrolimus); ruxolitinib (Jakafi); belumosudil (Rezurock); or rituximab.

Patient characteristics and prescriber: Patient weighs at least 40 kg; prescribed by or in consultation with a transplant specialist; and Niktimvo dosing is in accordance with the FDA‑approved labeling.>= 40 kg

Authorization duration: Authorization will be issued for no more than 12 months for initial therapy.<= 12 months

Continuation Therapy Criteria

For continuation of therapy, ALL of the following must be met:

Clinical response: Documentation of a positive clinical response to Niktimvo therapy.

Prescriber and dosing: Prescribed by or in consultation with a transplant specialist and Niktimvo dosing is in accordance with the FDA‑approved labeling.

Reauthorization duration: Reauthorization will be issued for no more than 12 months.<= 12 months

Unproven/Not Medically Necessary Indications

Not covered indications: Use of Niktimvo is unproven and not medically necessary for prevention and/or treatment of all other indications, including acute graft‑versus‑host disease (aGVHD).

Niktimvo is considered unproven and not medically necessary for the prevention and/or treatment of indications other than chronic graft-versus-host disease (cGVHD). This explicitly includes acute graft-versus-host disease (aGVHD), for which there is insufficient evidence of efficacy to support coverage.

Use of Niktimvo for any indication beyond the covered cGVHD indication is not medically necessary. Requests for prevention or treatment of other conditions (including, but not limited to, acute GVHD) will be considered unproven and not eligible for authorization due to insufficient supporting evidence.

Coding and Administration Details

Listed HCPCSHCPCS

J9038

Injection, axatilimab-csfr, 0.1 mg.

Relevant ICD-10 Diagnosis CodesICD-10

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

inv-08: Minimum patient weight

Minimum patient weightPatient must weigh at least 40 kg.

Authorization durationAuthorizations issued for no more than 12 months.

Prescriber requirementPrescribed by or in consultation with a transplant specialist.

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation of the diagnosis of chronic graft-versus-host disease (cGVHD), prior systemic therapy history demonstrating failure of at least two systemic lines of therapy, and supporting clinical information as detailed below.

Prior authorization required for Niktimvo (axatilimab-csfr).
Authorization will be issued for no more than 12 months for initial and reauthorization requests.

Step Therapy

Required Prior Therapy Failures

Documentation must show history of failure with corticosteroid therapy and at least one additional agent from the list below. Failure may be intolerance, contraindication, or lack of adequate response to therapy.

Corticosteroid (e.g., prednisone, methylprednisolone)
One of the following additional agents: bortezomib; ibrutinib (Imbruvica); an immunosuppressant agent (e.g., cyclosporine, mycophenolate, tacrolimus); ruxolitinib (Jakafi); belumosudil (Rezurock); or rituximab.

Regimens and Dosing

Regimen	Indication	Dosing / Schedule	Coverage status
Niktimvo (axatilimab-csfr) administered intravenously	Chronic graft-versus-host disease (cGVHD) after failure of at least 2 prior lines of systemic therapy	0.3 mg/kg IV every 2 weeks (dosing and schedule as studied in AGAVE-201); continue until disease progression, lack of efficacy by 9 months, or unacceptable toxicity	Covered with criteria

Salvage-line Use

Approved line of therapy (salvage): Indicated for chronic graft‑versus‑host disease (cGVHD) after failure of at least two prior lines of systemic therapy (salvage line).

Definitions

inv-14: cGVHD definition

DefinitionChronic graft-versus-host disease (cGVHD) is a multisystem immune‑mediated syndrome distinct from acute GVHD and not simply a chronological extension; it can affect skin, mouth, liver, lung, eye, and GI tract and is classified by severity (mild, moderate, severe) using NIH consensus criteria.

Clinical featuresResembles autoimmune and other immunologic disorders; skin is the primary manifestation though nearly any organ can be involved.

Clinical importancecGVHD is a leading cause of morbidity and mortality after allogeneic HCT; >1/3 of transplant recipients may require systemic treatment for severe disease.

inv-15: Niktimvo (axatilimab-csfr)

Generic name and mechanismNiktimvo (axatilimab‑csfr) — a colony stimulating factor‑1 receptor (CSF‑1R) blocking antibody.

FDA indication

Background

Chronic graft-versus-host disease (cGVHD) is a multisystem, immune-mediated syndrome that arises after allogeneic hematopoietic cell transplantation and is distinct from acute GVHD. cGVHD commonly affects organs such as skin, mouth, liver, lung, eye, and gastrointestinal tract and often requires systemic therapy; severity is graded using NIH consensus criteria to guide management.

Policy Summary

Payersierra health and life

PolicyNiktimvo (axatilimab-csfr) — chronic graft-versus-host disease (cGVHD) coverage criteria

Policy CodePolicy 2026D0135C

Change TypeNo material change

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

Documentation Required

Required Documentation

Provide clear clinical documentation with the prior authorization request. Include: diagnosis of cGVHD; detailed prior systemic therapy history demonstrating failure of at least two systemic lines (names of agents, doses, dates, and reason for discontinuation or failure); patient weight to confirm ≥ 40 kg; documentation of prescribing or consultation with a transplant specialist; and planned Niktimvo dosing consistent with FDA-approved labeling. For continuation requests, include documentation of positive clinical response to Niktimvo.

Diagnosis: chronic graft-versus-host disease (ICD-10: D89.811; if applicable D89.812 for acute on chronic).
Prior systemic therapy history: list agents, treatment duration, outcome, and reason for failure/intolerance.
Patient weight ≥ 40 kg.
Prescriber is a transplant specialist or documentation of specialist consultation.
Planned/actual Niktimvo dosing consistent with FDA labeling.
For reauthorization: documentation of positive clinical response to therapy.

Denial Risk

Denial Risk if Criteria Not Met

Requests that do not meet the clinical criteria are at high risk for denial. Common reasons for denial include missing documentation of the cGVHD diagnosis, insufficient prior therapy failures (fewer than two systemic lines including corticosteroid plus one agent listed), patient weight < 40 kg, prescribing clinician not a transplant specialist or lacking consultation, or dosing that is inconsistent with FDA-approved labeling.

Denial risks: insufficient prior therapy documentation; absence of corticosteroid failure; patient weight < 40 kg; lack of transplant specialist involvement; dosing not per FDA labeling.
Niktimvo is considered unproven and not medically necessary for indications other than the specified cGVHD criteria (e.g., prevention or treatment of aGVHD).

Indicated for treatment of chronic graft‑versus‑host disease (cGVHD) after failure of at least two prior lines of systemic therapy in patients weighing at least 40 kg.

Dosing and administration notesDosing must be in accordance with U.S. FDA‑approved labeling; prescribed by or in consultation with a transplant specialist per policy instructions.