CurrentColorado Rocky Mountain Health PlansPolicy CSOH2025D0135.A

Niktimvo (Axatilimab-Csfr) — Medical Benefit Drug Policy (Ohio)

Defines medical necessity criteria and prior authorization requirements for Niktimvo (axatilimab-csfr) for treatment of chronic graft‑versus‑host disease (cGVHD) for members in Ohio; applies to Medical Benefit Drug coverage determinations.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyNiktimvo (Axatilimab-Csfr) — Medical Benefit Drug Policy (Ohio)

Policy CodePolicy CSOH2025D0135.A

Change TypeNo material change

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization; approval limited to up to 12 months when criteria are met.

SourceLink

75%ORR (AGAVE-201)

0.3 mg/kg q2wApproved dosing

>=40 kgMin patient weight

12 monthsMax auth duration

Coverage Criteria for Niktimvo (axatilimab-csfr)

Initial Therapy

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Initial Authorization Criteria: 1) Diagnosis of chronic graft-versus-host disease (cGVHD) defined by: prior allogeneic hematopoietic cell transplantation; clinical signs/symptoms consistent with NIH consensus criteria; and cGVHD classified as moderate or severe (e.g., NIH disease grade or CIBMTR score). 2) Patient has history of failure with both of the following: a corticosteroid (e.g., prednisone, methylprednisolone); AND one additional systemic agent (one of: bortezomib; ibrutinib; an immunosuppressant such as cyclosporine, mycophenolate, or tacrolimus; ruxolitinib; belumosudil; or rituximab). 3) Patient weight >= 40 kg. 4) Prescribed by or in consultation with a transplant specialist. 5) Niktimvo dosing consistent with United States FDA–approved labeling. 6) Authorization will be issued for no more than 12 months.

Do not flatten conjunctive prior-therapy requirement; both steroid failure and failure of one additional agent are required.

Continuation (Reauthorization) Therapy

Covered when ALL of the following are met:

Reauthorization Criteria: 1) Documentation of a positive clinical response to Niktimvo therapy. 2) Prescribed by or in consultation with a transplant specialist. 3) Niktimvo dosing consistent with United States FDA–approved labeling. 4) Reauthorization will be issued for no more than 12 months.

Response-based continuation required.

Niktimvo (axatilimab-csfr) is unproven and not medically necessary for prevention and/or treatment of indications other than chronic graft-versus-host disease (cGVHD). This includes, but is not limited to, use for acute graft-versus-host disease (aGVHD), for which there is insufficient evidence of efficacy.

Coding and Eligibility Parameters

HCPCS/Covered drug codeHCPCS

J9038

Injection, axatilimab-csfr, 0.1 mg

Relevant diagnosis codesICD-10

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

inv-07: Minimum patient weight

Minimum patient weight>= 40 kg

Applies toAdult and pediatric patients weighing at least 40 kg

Relevance to authorizationPatient weight >= 40 kg required for coverage and prior authorization

Regimen	Dose / Frequency	Route	Patient weight	Indication / Line of therapy	Authorization duration
Axatilimab-csfr (Niktimvo)	0.3 mg/kg every 2 weeks	Intravenous	>= 40 kg	Treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy	Up to 12 months (initial authorization and reauthorization when criteria are met)

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required for J9038

Prior authorization is required for Niktimvo (HCPCS J9038). Approval is limited to no more than 12 months for both initial authorization and reauthorization when criteria are met.

Step Therapy

Required prior therapy: steroid plus one additional agent

Patient must have history of failure with both a corticosteroid (e.g., prednisone, methylprednisolone) AND at least one additional systemic agent before authorization will be granted.

Examples of additional agents: bortezomib; Imbruvica (ibrutinib); immunosuppressants (e.g., cyclosporine, mycophenolate, tacrolimus); Jakafi (ruxolitinib); Rezurock (belumosudil); rituximab.

Documentation Required

Required clinical documentation for medical necessity

Documentation must demonstrate diagnosis of cGVHD per NIH consensus criteria, record of prior allogeneic HCT, classification as moderate or severe, and prior therapy details including failure of corticosteroid and at least one listed agent; include patient weight and that dosing/prescribing follow FDA labeling and transplant specialist involvement.

Confirm prior allogeneic hematopoietic cell transplantation (HCT).
Document clinical signs/symptoms consistent with NIH consensus criteria and cGVHD classified as moderate or severe.
Record prior therapy history showing corticosteroid failure and failure of at least one additional agent (see examples).
Include patient weight (≥ 40 kg), prescribing/transplant specialist consult, and dosing per FDA label.

Denial Risk

Denial risk when criteria are unmet

Requests that do not meet the medical necessity criteria listed in the policy are at risk for denial.

Non-cGVHD diagnoses (e.g., aGVHD) or indications other than those specified.
Insufficient prior therapy failures — both corticosteroid failure and failure of an additional listed agent are required.
Patient weight less than 40 kg.
Dosing not consistent with FDA-approved labeling or lack of transplant specialist prescribing/consultation.

Definitions and Diagnostic Criteria

inv-13: cGVHD diagnosis per NIH consensus

Required prior allogeneic HCTPatient has undergone allogeneic hematopoietic cell transplantation (HCT)

Clinical signs/symptomsPresence of clinical symptoms and signs that are components of the NIH consensus criteria for cGVHD

Severity classificationcGVHD must be classified as moderate or severe using accepted grading scales (e.g., NIH disease grade, CIBMTR score)

Background

Chronic graft-versus-host disease (cGVHD) is an immune-mediated, multisystem disorder that occurs after allogeneic hematopoietic cell transplantation (HCT). It is distinct from acute GVHD and commonly affects the skin, mouth, liver, lungs, eyes, and gastrointestinal tract. cGVHD is a leading cause of morbidity and mortality after allogeneic HCT; severity is classified as mild, moderate, or severe and guides treatment decisions aiming to reduce disease activity while limiting therapy-related toxicity.