ModifiedHealth NetPolicy N/A

Clinical Policy: Axatilimab-csfr (Niktimvo)

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Defines medical necessity criteria, dosing, and authorization requirements for Niktimvo for treatment of chronic graft-versus-host disease (cGVHD) after failure of prior systemic therapies for members covered by the payer.

Policy Summary

PayerHealth Net

PolicyAxatilimab-csfr (Niktimvo) — coverage criteria for cGVHD

Policy CodePolicy N/A

Change TypeCoding and dosage strengths addedHCPCS code J9038 added, J3590 and C93991 removed

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, prior therapy failures, and supporting evidence for dosing or off-label use.

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.

RT4 added new dosage strengths of 9 mg/0.18 mL and 22 mg/0.44 mL and added HCPCS code J9038.

HCPCS codes J3590 and C93991 were removed.

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ModifiedHealth NetPolicy N/A

Clinical Policy: Axatilimab-csfr (Niktimvo)

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Policy Summary

PayerHealth Net

PolicyAxatilimab-csfr (Niktimvo) — coverage criteria for cGVHD

Policy CodePolicy N/A

Change TypeCoding and dosage strengths addedHCPCS code J9038 added, J3590 and C93991 removed

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, prior therapy failures, and supporting evidence for dosing or off-label use.

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.

RT4 added new dosage strengths of 9 mg/0.18 mL and 22 mg/0.44 mL and added HCPCS code J9038.

HCPCS codes J3590 and C93991 were removed.

0.3 mg/kg Q2WFDA dosing

≥6 yrsMin age

≥40 kgMin weight

≥2Prior lines

2New strengths

J9038HCPCS added

Coverage Criteria

inv-01: 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 ruxolitinib (Jakafi), ibrutinib (Imbruvica), or belumosudil (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 for off‑label use the dose must be supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 10) Prior authorization and documentation submitted (provider must supply office chart notes, lab results, or other clinical information).

Follow Appendix B for examples of systemic corticosteroids and immunosuppressants.

inv-02: Continuation Therapy

Covered when ALL of the following are met for continued therapy

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

Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or applicable evidence of coverage documents.

For Medicaid members, if state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, the state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage provisions related to this policy.

Use of Niktimvo for indications other than the FDA‑approved chronic graft‑versus‑host disease (cGVHD) indication and other indications explicitly addressed by this policy will be considered not authorized unless the prescriber submits the required off‑label evidence per the referenced off‑label use policies or the member’s evidence of coverage.

Regimen	Indication	Coverage
0.3 mg/kg (up to 35 mg) IV infusion every 2 weeks	Chronic graft-versus-host disease (cGVHD) — FDA‑approved dosing	Covered with criteria

Coding

HCPCS Codes referencedHCPCS

J9038	HCPCS code added for axatilimab (document provides code but description not specified in text)
J3590	Previously referenced code removed
C93991	Previously referenced code removed

HCPCS Codes referenced/changedHCPCS

J9038
J3590
C93991

Maximum dose

Maximum dose and frequency0.3 mg/kg up to a maximum of 35 mg administered IV every 2 weeks

Dosing regimen contextFDA-approved dosing for chronic graft-versus-host disease (cGVHD)

Route of administrationIntravenous (IV) infusion

Maximum single-administration limitDo not exceed 35 mg per dose

Provider Actions and Requirements

Prior Authorization

Prior authorization required — demonstrate diagnostic & treatment history

Prior authorization is required. The provider must demonstrate the diagnostic and treatment history meeting initial approval criteria, including that the request is for cGVHD post hematopoietic cell transplantation, prescribed by or in consultation with an oncologist/hematologist/bone marrow transplant specialist, age/weight thresholds are met, prior therapy failures documented, dose limits respected, and prior authorization/documentation submitted.

Show diagnosis of cGVHD post hematopoietic cell transplantation
Document prescriber specialty or consultation
Confirm age ≥ 6 years and weight ≥ 40 kg
Provide evidence of prior therapy failures and that dose does not exceed 0.3 mg/kg (max 35 mg) Q2W
Submit prior authorization request and supporting documentation

Line of Therapy / Salvage Use

inv-20: salvage

Line requirement: Indicated for cGVHD after failure of at least two lines of systemic therapy>= 2 prior lines

Background

Niktimvo (axatilimab‑csfr) is a colony stimulating factor‑1 receptor (CSF‑1R)–blocking monoclonal antibody approved for the treatment of chronic graft‑versus‑host disease (cGVHD) following failure of prior systemic therapies. Use is limited to the FDA‑approved cGVHD indication or other uses supported by the off‑label policies and submitted clinical evidence.

Definitions

Definition: cGVHD

TermcGVHD

Definitionchronic graft-versus-host disease

Clinical contextIndication for Niktimvo (axatilimab-csfr) in this policy: cGVHD after failure of prior systemic therapies

Definition: CSF-IR

TermCSF-IR

Definitioncolony stimulating factor-1 receptor

RelevanceTarget of axatilimab-csfr (Niktimvo), a CSF-1R–blocking antibody

Policy Summary

PayerHealth Net

PolicyAxatilimab-csfr (Niktimvo) — coverage criteria for cGVHD

Policy CodePolicy N/A

Change TypeCoding and dosage strengths addedHCPCS code J9038 added, J3590 and C93991 removed

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, prior therapy failures, and supporting evidence for dosing or off-label use.

SourceLink

On This Page

Billing Rule

Use HCPCS code J9038 for axatilimab-csfr (per policy)

HCPCS code J9038 is referenced for axatilimab-csfr. Use current coding guidance and the payer's authorization process when requesting prior authorization and when submitting claims.

Reference J9038 on prior authorization requests where applicable
Follow most up-to-date professional coding guidance for claims

Step Therapy

Document required prior therapy failures (steroid + immunosuppressant)

Provider must document failure of a systemic corticosteroid and failure of a systemic immunosuppressant at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced.

Provide records showing prior systemic corticosteroid trial (see Appendix B examples)
Provide records showing prior systemic immunosuppressant trial (see Appendix B examples)
If contraindicated, include documentation explaining the contraindication or adverse effects

Documentation Required

Submit clinical documentation with authorization request

Provide all clinical documentation requested to support that the member meets the approval criteria; include office chart notes, laboratory results, and other relevant clinical information.

Include progress notes showing response to prior therapies and current disease status
Attach lab results and other objective data supporting diagnosis and therapeutic history

Documentation Required

Documentation required to support approval criteria

Provider must submit documentation (e.g., office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

Attach pertinent medical records demonstrating diagnosis, prior therapies, and dosing
Include specialist consultation notes when applicable

Billing Rule

Follow up-to-date professional coding guidance for claims

Providers should reference the most up-to-date sources of professional coding guidance for claim submission and reimbursement; codes in this policy are informational and guidance may change.

Verify current coding guidance before submitting claims
Use payer-specific billing instructions in addition to general coding resources

Denial Risk

Denial risk for non‑FDA indications without off‑label evidence

Requests for non–FDA approved indications not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per the applicable off-label use policies.

If requesting off‑label use, include supporting evidence per CP.CPA.09, HIM.PA.154, or CP.PMN.53 as applicable
Absent required off‑label evidence, coverage may be considered not authorized

Note

Coding listed is informational — it does not guarantee coverage

Inclusion or exclusion of any codes in this clinical policy does not guarantee coverage; providers should reference up-to-date coding guidance as improper coding could trigger denial.

Coding listed in the policy is informational only
Confirm code coverage and billing rules with payer prior to claim submission