ModifiedCareSourcePolicy N/A

PHARMACY POLICY STATEMENT Arkansas PASSE

Defines coverage and prior authorization criteria for Niktimvo (axatilimab) for treatment of chronic graft-versus-host disease (cGVHD) in members meeting specified clinical and dosing criteria under the Arkansas PASSE pharmacy policy.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeNew policy added

Effective DateJul 1, 2025

Next Review Date

Key ActionPrior authorization is required for Niktimvo (axatilimab) under the medical benefit for cGVHD per the specified initial and reauthorization criteria.

SourceLink

POLICY UPDATE CHANGES

New policy for Niktimvo created.

1Covered Indication (cGVHD after ≥2 systemic therapies)

40 kgMinimum weight requirement

0.3 mg/kgDose per administration

2 vials/28 daysQuantity limit

Coverage Summary

Coverage stance: covered_with_criteria for Niktimvo (axatilimab) for chronic graft-versus-host disease (cGVHD) after failure of ≥2 systemic therapies in members weighing ≥40 kg. Effective date: 2025-07-01. Scope summary: Defines coverage and prior authorization criteria for Niktimvo (axatilimab) for treatment of chronic graft-versus-host disease (cGVHD) in members meeting specified clinical and dosing criteria under the Arkansas PASSE pharmacy policy.

Initial Authorization - Chronic graft-versus-host disease (cGVHD)

Covered when ALL of the following are met:

Weight: Member weighs at least 40 kg>= 40 kg
Supported by indication requiring patients weighing at least 40 kg.
Prescriber: Medication is prescribed by or in consultation with a transplant or hematology/oncology specialist
Specialist prescribing or consultation required.
Diagnosis: Documented diagnosis of chronic graft-versus-host disease (cGVHD) following allogeneic hematopoietic stem cell transplantation (HSCT)
cGVHD occurs after allogeneic HSCT.
Prior therapy: Member has failed at least 2 prior lines of systemic therapy (examples: systemic corticosteroid plus another systemic agent such as calcineurin inhibitor, ruxolitinib [Jakafi], mycophenolate mofetil, sirolimus, methotrexate, ibrutinib [Imbruvica])failed >= 2 prior systemic therapies
Failure of ≥2 systemic therapies required.
Dosing and quantity limits: Administer IV infusion 0.3 mg/kg over 30 minutes every 2 weeks until progression or unacceptable toxicity; maximum single dose 35 mg; quantity limit 2 vials (2 mL) per 28 daysDose: 0.3 mg/kg IV q2 weeks; Max 35 mg; QL: 2 vials/28 days
Dosing, max dose, and quantity limit per policy.

Reauthorization (Continuation) - cGVHD

Covered for reauthorization when ALL of the following are met:

Clinical response: Chart notes demonstrate improvement of signs and symptoms of disease in at least one organ/site without progression in any other organ/site
Required documentation for reauthorization.

Not Medically Necessary / Off-Label

Not covered when for other indications:

Not Medically Necessary / Off-Label: Treatment of conditions not listed in this document (use for any other indication is considered not medically necessary)

Off-label use not covered per policy.

Provider Actions & Operational Rules

Prior Authorization

Prior authorization required

Prior authorization is required for Niktimvo (axatilimab) under the medical benefit for chronic graft‑versus‑host disease (cGVHD) per the specified initial and reauthorization criteria in the policy.

Documentation Required

Specialist involvement

Medication must be prescribed by or in consultation with a transplant or hematology/oncology specialist. Include documentation of the specialist involvement in the patient’s chart.

Documentation Required

Prior therapy documentation

Document failure of at least two prior lines of systemic therapy, including a systemic corticosteroid plus another systemic agent. Examples listed in the policy include calcineurin inhibitors, Jakafi (ruxolitinib), mycophenolate mofetil, sirolimus, methotrexate, and Imbruvica (ibrutinib).

Documentation Required

Reauthorization documentation

For reauthorization, chart notes must demonstrate improvement in signs and symptoms of disease in at least one organ/site without progression in any other organ/site.

Billing Rule

Dosing and quantity limit

Administer intravenously 0.3 mg/kg over 30 minutes every 2 weeks until progression or unacceptable toxicity. Maximum single dose 35 mg. Quantity limit: 2 vials (2 mL) per 28 days.

Background

Niktimvo (axatilimab) is a CSF-1R–blocking monoclonal antibody indicated for treatment of chronic GVHD after failure of at least two lines of systemic therapy in patients weighing at least 40 kg. cGVHD occurs after allogeneic HSCT, typically more than 100 days post-transplant, can involve multiple organ systems, and many patients require multiple lines of therapy beyond steroids.

cGVHD: Chronic graft-versus-host disease occurring following allogeneic HSCT, typically >100 days post-transplant and involving multiple organ systems.

Weight threshold>= 40 kg

Dose per administration0.3 mg/kg IV over 30 minutes every 2 weeks

Maximum single dose35 mg

Quantity limit2 vials (2 mL) per 28 days

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeNew policy added

Effective DateJul 1, 2025

Next Review Date

Key ActionPrior authorization is required for Niktimvo (axatilimab) under the medical benefit for cGVHD per the specified initial and reauthorization criteria.

SourceLink

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PHARMACY POLICY STATEMENT Arkansas PASSE

Coverage Summary

Provider Actions & Operational Rules

Applicable Codes

Clinical Evidence & References

Background

Revision History