CurrentHAP CareSource MI Coordinated HealthPolicy N/A

Graft-Versus-Host Disease - Niktimvo Utilization Management Medical Policy

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This policy governs prior authorization and medical-benefit coverage of Niktimvo (axatilimab-csfr intravenous infusion) for chronic graft-versus-host disease. It applies to adult and pediatric patients weighing at least 40 kg who meet the specified prior-treatment or continuation-response criteria.

Policy Summary

PayerHAP CareSource MI Coordinated Health

PolicyGraft-Versus-Host Disease - Niktimvo Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeRevised

Effective DateN/A

Last ReviewMay 13, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient meets the clinical criteria and dosing requirements for Niktimvo.

SourceLink

POLICY UPDATE CHANGES

The policy separated graft-versus-host disease criteria into initial therapy and patient-currently-receiving-Niktimvo pathways.

The prior-treatment requirement changed from two conventional systemic therapies to two systemic medications.

The policy added examples of beneficial clinical response for patients currently receiving Niktimvo.

≥40 kgMinimum patient weight

2Prior systemic medications for initial therapy

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CurrentHAP CareSource MI Coordinated HealthPolicy N/A

Graft-Versus-Host Disease - Niktimvo Utilization Management Medical Policy

Customize your policy alerts

Sign up for all hap_caresource_mi_coordinated_health policy alerts

Know when hap_caresource_mi_coordinated_health releases new policies or updates existing guidance.

Monitor payer policy activity

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Policy Summary

PayerHAP CareSource MI Coordinated Health

PolicyGraft-Versus-Host Disease - Niktimvo Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeRevised

Effective DateN/A

Last ReviewMay 13, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient meets the clinical criteria and dosing requirements for Niktimvo.

SourceLink

POLICY UPDATE CHANGES

The policy separated graft-versus-host disease criteria into initial therapy and patient-currently-receiving-Niktimvo pathways.

The prior-treatment requirement changed from two conventional systemic therapies to two systemic medications.

The policy added examples of beneficial clinical response for patients currently receiving Niktimvo.

≥40 kgMinimum patient weight

2Prior systemic medications for initial therapy

Recommended Authorization Criteria

FDA-approved indication: chronic graft-versus-host disease

Approve for 1 year when the patient meets ONE of the following pathways:

Initial or continuation pathway

Initial therapy
- Weight: Patient weighs at least 40 kg.≥40 kg
- Diagnosis: Patient has chronic graft-versus-host disease.Chronic graft-versus-host disease
- Prior systemic medications: Patient has tried at least two systemic medications for chronic graft-versus-host disease.At least two systemic medications
  Examples include Jakafi (ruxolitinib), Rezurock (belumosudil), Imbruvica (ibrutinib), imatinib, hydroxychloroquine, methotrexate, rituximab, pentostatin, Proleukin (aldesleukin), methylprednisolone, cyclosporine, tacrolimus, sirolimus, an etanercept product, and mycophenolate mofetil.
Patient currently receiving Niktimvo
- Current treatment: Patient is currently receiving Niktimvo.Currently receiving Niktimvo
- Clinical response: According to the prescriber, the patient demonstrates a beneficial clinical response.Beneficial clinical response
  Examples include reduction in corticosteroid dose, disease stabilization, and/or symptomatic improvement.

Requests for circumstances not listed in the Recommended Authorization Criteria are not recommended for coverage.

Coverage and Dosing Parameters

Minimum patient weight

Minimum patient weightAt least 40 kg

Prior systemic treatment

Prior systemic treatmentAt least two systemic medications for chronic graft-versus-host disease

Niktimvo dose

Niktimvo dose0.3 mg/kg, up to a maximum of 35 mg, once every 2 weeks

Authorization and Documentation Requirements

Prior Authorization

Medical-Benefit Prior Authorization Required

Prior authorization is recommended for medical-benefit coverage of Niktimvo. Approval depends on the patient meeting the applicable clinical criteria and dosing requirements for the listed indication. Extended approvals may be allowed when the patient continues to meet the criteria and dosing.

Requests for doses outside the established dosing may be reviewed case-by-case by a clinician, such as a Medical Director or Pharmacist.
For chronic graft-versus-host disease, the established dose is 0.3 mg/kg by intravenous infusion once every 2 weeks, up to a maximum dose of 35 mg.

Step Therapy

Two Prior Systemic Medications

For initial therapy of chronic graft-versus-host disease, document that the patient has tried at least two systemic medications, in addition to meeting the other applicable clinical criteria.

Examples include ruxolitinib, belumosudil, ibrutinib, imatinib, hydroxychloroquine, methotrexate, rituximab, pentostatin, interleukin-2, methylprednisolone, cyclosporine, tacrolimus, sirolimus, an etanercept product, and mycophenolate mofetil.

Niktimvo Clinical Context

Niktimvo (axatilimab-csfr) is a colony-stimulating factor-1 receptor-blocking antibody indicated for chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy. The policy applies to adult and pediatric patients weighing at least 40 kg.

Initial Therapy

Initial therapy

Approve for 1 year when ALL initial-therapy requirements are met:

Weight: Patient weighs at least 40 kg.≥40 kg
Disease: Patient has chronic graft-versus-host disease.Chronic graft-versus-host disease
Prior systemic medications: Patient has tried at least two systemic medications for chronic graft-versus-host disease.At least two systemic medications

Patient Currently Receiving Niktimvo

Patient currently receiving Niktimvo

Approve for 1 year when the patient is currently receiving Niktimvo and meets the response requirement:

Continuation therapy

Current Niktimvo use: Patient is currently receiving Niktimvo.Currently receiving Niktimvo
Beneficial response: According to the prescriber, the patient demonstrates a beneficial clinical response.Beneficial clinical response
Examples include reduction in corticosteroid dose, disease stabilization, and/or symptomatic improvement.

Prior Treatment Requirements

Step	Requirement	Applies to
1	Patient has tried at least two systemic medications for chronic graft-versus-host disease before starting Niktimvo.	Initial Niktimvo therapy

Niktimvo Administration Limits

Niktimvo

Dose limit0.3 mg/kg, up to a maximum of 35 mg, administered as an intravenous infusion once every 2 weeks