CurrentCignaPolicy IP0722

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

Defines Cigna's coverage and prior authorization requirements for Niktimvo intravenous infusion for treatment of chronic graft-versus-host disease in eligible patients; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

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

Policy CodePolicy IP0722

Change TypeNew policywording revised for initial therapy and duration

Effective Date08/01/2025

Next Review Date

Key ActionObtain prior authorization and submit documentation showing patient meets criteria (≥40 kg, chronic GVHD, failure of ≥2 systemic medications) and use appropriate billing codes.

SourceLink

POLICY UPDATE CHANGES

New policy added for Graft-Versus-Host Disease (Niktimvo).

For initial therapy the requirement language changed from 'conventional' therapies to 'medications' and an etanercept product was added to example therapies.

Removed 'for 1 year' under both Initial Therapy and Patient currently receiving Niktimvo sections.

0.3 mg/kgDosing per infusion

every 2 weeksDosing interval

≥40 kgMin weight

≥2 medsPrior therapy

Policy Summary

PayerCigna

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

Policy CodePolicy IP0722

Change TypeNew policywording revised for initial therapy and duration

Effective Date08/01/2025

Next Review Date

Key ActionObtain prior authorization and submit documentation showing patient meets criteria (≥40 kg, chronic GVHD, failure of ≥2 systemic medications) and use appropriate billing codes.

SourceLink

On This Page

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Coverage Criteria for Niktimvo (axatilimab-csfr)

inv-01: Initial Therapy

Approve for patients who meet ALL of the following:

Initial Therapy criteria: i. Patient is >= 40 kg; AND ii. Patient has chronic graft-versus-host disease; AND iii. Patient has tried at least two systemic medications for chronic graft-versus-host disease.

Examples of systemic therapy listed in policy include Jakafi (ruxolitinib), Rezurock (belumosudil), Imbruvica (ibrutinib), imatinib, hydroxychloroquine, methotrexate, rituximab, pentostatin, interleukin-2 (e.g., aldesleukin), methylprednisolone, cyclosporine, tacrolimus, sirolimus, an etanercept product, and mycophenolate mofetil.

inv-02: Patient Currently Receiving Niktimvo

Approve for patients currently receiving Niktimvo if they demonstrate benefit per prescriber

Current therapy: Patient currently receiving Niktimvo as per prescriber demonstrates a beneficial clinical response.

Examples of a beneficial response include a reduction in corticosteroid dose, disease stabilization, and/or symptomatic improvement.

Use of Niktimvo for any indication other than chronic graft‑versus‑host disease as described in this policy is considered not medically necessary.

Niktimvo for any other use is considered not medically necessary. Criteria will be updated as new published data are available.

Coding and Billing

Considered Medically Necessary when criteria metHCPCSCovered

J9038

Injection, axatilimab-csfr, 0.1 mg

inv-06: Minimum patient weight

Minimum patient weight>= 40 kg

Policy indication thresholdIndicated for patients weighing at least 40 kg (Overview)

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for Niktimvo (injection). Approval is recommended only for patients who meet the policy Criteria and Dosing. All approvals are time-limited as noted in the policy; requests for doses outside the documented dosing will be reviewed case-by-case by a clinician.

Prior authorization required
Approvals provided for the duration noted in the policy
Dose exceptions reviewed by Medical Director or Pharmacist

Step Therapy

Prior Therapy Requirement

Initial therapy requires prior failure of at least two systemic medications for chronic graft-versus-host disease. Examples of acceptable prior systemic therapies include Jakafi (ruxolitinib), Rezurock (belumosudil), Imbruvica (ibrutinib), imatinib, hydroxychloroquine, methotrexate, rituximab, pentostatin, interleukin-2 (e.g., Proleukin), systemic corticosteroids (e.g., methylprednisolone), cyclosporine, tacrolimus, sirolimus, etanercept products, and mycophenolate mofetil.

Initial Therapy Approval Criteria

inv-13: Initial Therapy

Initial therapy approval criteria

Initial therapy: Patient >= 40 kg; chronic graft-versus-host disease; tried at least two systemic medications for chronic GVHD.

Examples of systemic therapy include ruxolitinib, belumosudil, ibrutinib, imatinib, hydroxychloroquine, methotrexate, rituximab, pentostatin, interleukin-2 (e.g., aldesleukin), methylprednisolone, cyclosporine, tacrolimus, sirolimus, an etanercept product, and mycophenolate mofetil.

Continuation Therapy Criteria

inv-14: Continuation Therapy

Continuation approvals are allowed if patient continues to meet criteria.

Continuation approval: Patient demonstrates a beneficial clinical response as assessed by prescriber (examples: reduction in corticosteroid dose, disease stabilization, symptomatic improvement).

Step-Therapy Requirements

Requirement	Details
Prior trials of at least two systemic medications	Initial therapy requires documented prior failure or inadequate response to two or more systemic medications for chronic graft‑versus‑host disease. Examples of systemic therapies listed in the policy include ruxolitinib (Jakafi), belumosudil (Rezurock), ibrutinib (Imbruvica), imatinib, hydroxychloroquine, methotrexate, rituximab, pentostatin, interleukin‑2 (aldesleukin/Proleukin), methylprednisolone, cyclosporine, tacrolimus, sirolimus, an etanercept product (e.g., Enbrel), and mycophenolate mofetil.

Requirement

Details

Prior trials of at least two systemic medications

Initial therapy requires documented prior failure or inadequate response to two or more systemic medications for chronic graft‑versus‑host disease. Examples of systemic therapies listed in the policy include ruxolitinib (Jakafi), belumosudil (Rezurock), ibrutinib (Imbruvica), imatinib, hydroxychloroquine, methotrexate, rituximab, pentostatin, interleukin‑2 (aldesleukin/Proleukin), methylprednisolone, cyclosporine, tacrolimus, sirolimus, an etanercept product (e.g., Enbrel), and mycophenolate mofetil.

Site of Care

Note

No site‑of‑care restriction specified

Policy does not specify any site‑of‑care restriction; infusion at an infusion center is allowable per the policy's site‑of‑care statement.

Site‑of‑care section: "No site‑of‑care restriction specified in policy."

Background

Niktimvo (axatilimab‑csfr) is a monoclonal antibody that acts as a colony stimulating factor‑1 receptor (CSF‑1R) blocker. It is indicated for the treatment of chronic graft‑versus‑host disease after failure of at least two prior systemic therapies in adults and pediatric patients weighing at least 40 kg. The mechanism involves inhibition of CSF‑1R signaling to modulate macrophage and immune cell activity implicated in the pathophysiology of chronic GVHD.

Definitions

inv-12: chronic graft-versus-host disease

DefinitionChronic graft-versus-host disease (GVHD) is a complication of allogeneic hematopoietic cell transplantation characterized by immune-mediated damage to host tissues.

Indication contextNiktimvo is indicated for chronic GVHD after failure of at least two prior lines of systemic therapy.

Patient populationApplies to adult and pediatric patients weighing at least 40 kg.

Examples of clinical benefitBeneficial responses include reduction in corticosteroid dose, disease stabilization, and/or symptomatic improvement.