CurrentColorado Rocky Mountain Health PlansPolicy CSOH2026D0135.B

Niktimvo (Axatilimab-Csfr) (for Ohio Only)

Ohio-specific UnitedHealthcare Medical Benefit Drug Policy for Niktimvo (axatilimab-csfr) describing clinical coverage criteria for initial and continuation therapy for chronic graft-versus-host disease (cGVHD), applicable codes, FDA info, clinical evidence, and policy history.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyNiktimvo (Axatilimab-Csfr) (for Ohio Only)

Policy CodePolicy CSOH2026D0135.B

Change TypeSupporting information updates (references)

Effective DateJun 1, 2026

Next Review Date

Key ActionAuthorization will be issued for no more than 12 months; initial and continuation approvals require documentation per the policy criteria including prior failure of specified therapies and documentation of clinical response for continuation.

POLICY UPDATE CHANGES

Updated References section to reflect the most current information and archived previous policy version CSOH2025D0135.A.

1Covered Indication (cGVHD after ≥2 prior systemic therapies)

>=40 kgMinimum patient weight

12 monthsMaximum authorization period

J9038Primary HCPCS code referenced

Coverage Summary

Ohio-specific UnitedHealthcare Medical Benefit Drug Policy CSOH2026D0135.B for Niktimvo (axatilimab-csfr). Coverage stance: covered_with_criteria. Covered indication: Niktimvo is covered for the treatment of chronic graft-versus-host disease (cGVHD) after failure of ≥2 prior systemic therapies in patients weighing ≥40 kg. Effective date: June 1, 2026; Last review date: June 1, 2026.

Quick facts & thresholds

Policy numberCSOH2026D0135.B

StatusCURRENT

Coverage stanceCovered with criteria (cGVHD after ≥2 prior systemic therapies)

Primary HCPCS codeJ9038

Minimum patient weight>= 40 kg

Authorization duration<= 12 months (initial and reauthorization)

Initial Therapy — Medically Necessary Criteria

Initial Therapy — medically necessary criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis of cGVHD
- Patient has undergone allogenic hematopoietic cell transplantation (HCT)
- Clinical symptoms and signs that are components of the National Institutes of Health (NIH) consensus criteria for diagnosis of cGVHD
- cGVHD is classified as moderate or severe based on grading scale (e.g., NIH disease grade, CIBMTR score)
History of prior therapy failure
- Steroid failure: Corticosteroid (e.g., prednisone, methylprednisolone) — failed
- AND failed one of the following
  - Bortezomib
  - Imbruvica (ibrutinib)
  - Immunosuppressant agent (e.g., cyclosporine, mycophenolate, tacrolimus)
  - Jakafi (ruxolitinib)
  - Rezurock (belumosudil)
  - Rituximab
Weight requirement: Patient weighs at least 40 kg>= 40 kg
Specialist involvement: Prescribed by or in consultation with a transplant specialist
Dosing per FDA label: Niktimvo dosing is in accordance with the United States Food and Drug Administration approved labeling
Authorization limit: Authorization will be issued for no more than 12 months<= 12 months

Prior Authorization

Prior authorization required with clinical criteria

Prior authorization is required. Authorizations (initial and reauthorization) will be issued for no more than 12 months. Initial approvals require documentation that the patient meets the policy clinical criteria, including prior failure of corticosteroids and at least one of the specified systemic agents and other criteria listed in the policy.

Continuation Therapy — Medically Necessary Criteria

Continuation Therapy — medically necessary criteria

Covered when ALL of the following are met:

Continuation Therapy

Clinical response: Documentation of a positive clinical response to Niktimvo therapy
Specialist involvement: Prescribed by or in consultation with a transplant specialist
Dosing per FDA label: Niktimvo dosing is in accordance with the United States Food and Drug Administration approved labeling
Reauthorization limit: Reauthorization will be issued for no more than 12 months<= 12 months

Documentation Required

Specialist involvement and clinical documentation

Prescriptions must be by or in consultation with a transplant specialist and include required clinical documentation for reauthorization: documentation of positive clinical response to Niktimvo, signs and symptoms per NIH-consensus criteria, cGVHD severity (moderate or severe), prior therapy failures as required by the policy, and patient weight.

Not Medically Necessary / Unproven

Not covered when ANY of the following apply:

Not medically necessary / Unproven: Use of Niktimvo for prevention and/or treatment of all other indications, including but not limited to acute graft-versus-host disease (aGVHD), due to insufficient evidence of efficacy

Denial Risk

Coverage/denial risk for non‑covered indications or criteria deviations

Use of Niktimvo for indications outside the covered cGVHD population (e.g., prevention or treatment of other indications, including aGVHD) or not meeting the policy criteria (such as without the required prior systemic therapy failures) is considered not medically necessary and may be denied.

Applicable Codes

HCPCS — drug codeHCPCS

J9038

Injection, axatilimab-csfr, 0.1 mg

ICD-10 — diagnoses referencedICD-10

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

Billing Rule

Dosing per FDA label

Niktimvo dosing must follow the United States FDA–approved labeling. Billing for axatilimab‑csfr should use HCPCS code J9038 (Injection, axatilimab‑csfr, 0.1 mg).

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required with clinical criteria

Prior authorization is required with clinical criteria. Affected codes include HCPCS J9038 and diagnosis codes D89.811 and D89.812. Authorizations (initial and reauthorization) will be issued for no more than 12 months.

J9038
D89.811
D89.812

Documentation Required

Specialist involvement and clinical documentation

Prescriptions must be by or in consultation with a transplant specialist. Required documentation elements: NIH‑consensus signs and symptoms for cGVHD, cGVHD severity classified as moderate or severe, prior therapy failures (corticosteroid plus at least one of: bortezomib, ibrutinib, immunosuppressants such as cyclosporine, mycophenolate or tacrolimus; ruxolitinib; belumosudil; or rituximab), patient weight ≥ 40 kg, and documentation of positive clinical response for continuation/reauthorization.

NIH‑consensus signs/symptoms
cGVHD severity (moderate or severe)
Prior therapy failures: corticosteroid plus at least one of bortezomib, ibrutinib, cyclosporine, mycophenolate, tacrolimus, ruxolitinib, belumosudil, rituximab
Patient weight ≥ 40 kg
Documentation of positive clinical response for continuation

Billing Rule

Dosing per FDA label

Dosing must follow the FDA‑approved labeling for Niktimvo (axatilimab‑csfr). Billing for the drug should use HCPCS code J9038 (Injection, axatilimab‑csfr, 0.1 mg).

Clinical Evidence

75%ORR within first 6 months (n=79) at 0.3 mg/kg q2w

1.5 moMedian time to response

60%Proportion maintaining response at 12 months (KM)

1.9 moMedian duration of response (95% CI: 1.6–3.5)

56%mLSS ≥7‑point improvement (exploratory)

Niktimvo is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody indicated for treatment of cGVHD after failure of at least two prior lines of systemic therapy in patients weighing at least 40 kg. The pivotal evidence supporting efficacy comes from the AGAVE-201 trial (adult and pediatric patients with recurrent or refractory cGVHD after ≥2 systemic therapies) which demonstrated clinical responses and is summarized in the policy metric cards. Definition: cGVHD — chronic graft‑versus‑host disease diagnosed by NIH consensus criteria and classified as mild, moderate, or severe.

Background

Niktimvo is described in the policy background as a CSF‑1R‑blocking antibody indicated for the treatment of chronic graft‑versus‑host disease (cGVHD) after failure of at least two prior systemic therapies in patients weighing at least 40 kg. cGVHD is characterized as a multisystem disorder that can involve nearly any organ (commonly skin, mouth, liver, lung, eye, and gastrointestinal tract) occurring after allogeneic hematopoietic cell transplantation (HCT). Diagnosis, staging, and response assessment are guided by the National Institutes of Health (NIH) consensus criteria, which delineate clinical signs and symptoms and classify disease severity as mild, moderate, or severe to guide management and prognosis.

Definitions

TermcGVHD (chronic graft-versus-host disease)

DefinitionMultisystem disorder after allogeneic hematopoietic cell transplant (HCT) diagnosed by NIH consensus criteria; classified as mild, moderate, or severe.

Diagnostic guidanceNIH consensus criteria signs/symptoms and grading (mild, moderate, severe) guide treatment decisions.

Relevant thresholdsPatient must weigh >= 40 kg; authorization issued for no more than 12 months.