ModifiedCentenePolicy N/A

Clinical Policy: Axatilimab-csfr (Niktimvo) for chronic graft-versus-host disease

Defines medical necessity and prior authorization criteria for Niktimvo (axatilimab-csfr) for treatment of chronic graft-versus-host disease (cGVHD) after failure of prior systemic therapies for members covered under Centene lines of business.

Policy Summary

PayerCentene

PolicyAxatilimab-csfr (Niktimvo) for cGVHD

Policy CodePolicy N/A

Change TypeCoding update — added J9038removed J3590, C93991

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, prior therapy failures, weight/age, and specialist consultation to demonstrate medical necessity.

SourceLink

POLICY UPDATE CHANGES

Added new dosage strengths of 9 mg/0.18 mL and 22 mg/0.44 mL and added HCPCS code J9038; removed codes J3590 and C93991.

Added new dosage strengths of 9 mg/0.18 mL and 22 mg/0.44 mL and added HCPCS code J9038.

Removed HCPCS codes J3590 and C93991.

J9038HCPCS code added

J3590, C93991HCPCS codes removed

0.3 mg/kgFDA dosing (q2w)

>= 40 kgMinimum weight

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Coverage Criteria for Axatilimab-csfr (Niktimvo)

Initial Therapy

Covered when ALL of the following are met:

Initial Approval Criteria: 1) Diagnosis of chronic graft-versus-host disease (cGVHD) post hematopoietic cell transplantation; 2) Prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialist; 3) Age >= 6 years; 4) Weight >= 40 kg; 5) Failure of a systemic corticosteroid at up to maximally indicated doses unless contraindicated or clinically significant adverse effects; 6) Failure of a systemic immunosuppressant at up to maximally indicated doses unless contraindicated or clinically significant adverse effects; 7) Niktimvo is not prescribed concurrently with Jakafi, Imbruvica, or Rezurock; 8) Dose does not exceed 0.3 mg/kg (up to a maximum of 35 mg) every 2 weeks; 9) Prescribed regimen must be FDA‑approved or recommended by NCCN, or dose is supported by practice guidelines or peer‑reviewed literature with prescriber submitting supporting evidence.

Continuation Therapy

Covered when ALL of the following are met:

Continued Therapy Criteria: 1) Member is currently receiving Niktimvo via the Centene benefit or documentation supports the member has received Niktimvo for a covered indication for at least 30 days; 2) Member is responding positively to therapy; 3) Niktimvo is not prescribed concurrently with Jakafi, Imbruvica, or Rezurock; 4) If request is for a dose increase, the new dose must either (a) not exceed 0.3 mg/kg (maximum 35 mg every 2 weeks) or (b) be supported by practice guidelines or peer‑reviewed literature for the relevant use with prescriber submitting supporting evidence; 5) Prescribed regimen must be FDA‑approved or recommended by NCCN.

Requests for indications that are not FDA‑approved and are not specifically addressed in this policy are excluded unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP PMN.53 for Medicaid) or other evidence of coverage. When submitting an off‑label request, include supporting clinical information such as peer‑reviewed literature, practice guidelines, or other evidence that demonstrates the proposed use is medically necessary.

For members covered under state Medicaid programs, state Medicaid coverage provisions take precedence when there is a conflict between a state Medicaid policy and this clinical policy. Providers should consult the applicable state Medicaid manual for any specific coverage rules or exceptions that apply to Niktimvo (axatilimab‑csfr).

Regimen	Indication	Coverage
0.3 mg/kg IV every 2 weeks (up to a maximum of 35 mg)	Chronic graft‑versus‑host disease (cGVHD)	Covered with criteria: dose must not exceed 0.3 mg/kg (max 35 mg) every 2 weeks and other policy criteria must be met (e.g., prior therapy failures, age/weight, specialist involvement)

Line of Therapy Requirements

second-line_or_later

Line of therapy: Indicated after failure of at least two lines of systemic therapy; policy requires failure of a systemic corticosteroid and a systemic immunosuppressant at up to maximally indicated doses unless contraindicated.

Coding and Billing

HCPCS Codes (documented additions/removals)HCPCS

J9038	HCPCS code added for axatilimab (Niktimvo) new dosage strengths
J3590	Previously referenced code removed (unspecified)
C93991	Previously referenced code removed (unspecified)

Referenced HCPCS Codes (current)HCPCSCovered

J9038

Referenced HCPCS Codes (removed)HCPCSNot Covered

J3590
C93991

Maximum dose — FDA dosing metric (inv-08)

FDA dosing metric0.3 mg/kg IV every 2 weeks up to a maximum of 35 mg

Maximum single‑dose cap35 mg

Dosing frequencyEvery 2 weeks (biweekly)

Administration routeIntravenous (IV) infusion

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization may be required for Niktimvo; submit requests to the member's health plan prior to initiating therapy.

Prior authorization required when initiating therapy — confirm benefit and obtain authorization before administration.
Prescriber must be an oncologist, hematologist, or bone marrow transplant specialist or have documented consultation per policy criteria.

Step Therapy

Step Therapy — Prior Treatment Failures

Step therapy / prior treatment failures are required unless contraindicated or intolerable. Document prior trials and reasons for failure or contraindication.

Failure of a systemic corticosteroid at up to maximally indicated doses is required unless contraindicated or causes clinically significant adverse effects (see Appendix B for examples).
Failure of a systemic immunosuppressant at up to maximally indicated doses is required unless contraindicated or causes clinically significant adverse effects (see Appendix B for examples).

Background

Axatilimab‑csfr (Niktimvo) is a monoclonal antibody that blocks the colony stimulating factor‑1 receptor (CSF‑1R) and is indicated for treatment of chronic graft‑versus‑host disease (cGVHD) after failure of at least two lines of systemic therapy in adults and pediatric patients meeting policy age and weight criteria. The FDA‑approved dosing for cGVHD is 0.3 mg/kg administered intravenously every 2 weeks, up to a maximum of 35 mg.

Definitions

Definition — cGVHD (inv-18)

TermcGVHD (chronic graft-versus-host disease)

ContextListed in policy appendix as abbreviation for chronic graft-versus-host disease

Related indicationPrimary treated condition for axatilimab (Niktimvo) coverage in this policy

Definition — CSF-IR (inv-19)

TermCSF-IR (colony stimulating factor-1 receptor)

Mechanistic roleTarget receptor blocked by axatilimab (Niktimvo)

Abbreviation sourceDefined in Appendix A: Abbreviation/Acronym Key of the policy document