CurrentMass General Brigham Health PlanPolicy N/A

Niktimvo (axatilimab-csfr) — Coverage Criteria for chronic graft-versus-host disease (cGVHD)

Policy governs prior authorization, quantity limits, and coverage criteria for Niktimvo (axatilimab-csfr) for treatment of chronic graft-versus-host disease (cGVHD) for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyNiktimvo (axatilimab-csfr) — Coverage Criteria for cGVHD

Policy CodePolicy N/A

Change TypeNew drug addedprior authorization required

Effective DateAug 11, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of cGVHD diagnosis, patient weight (>=40 kg), prescriber specialty or consult notes, prior therapy history, and dosing.

SourceLink

POLICY UPDATE CHANGES

New drug (Niktimvo) was added requiring prior authorization.

>=2required prior lines of therapy for indication

>=40 kgminimum patient weight for use

6 monthsapproval duration

Onc/Het consultprescriber requirement

Coverage Criteria for Niktimvo (axatilimab-csfr)

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Continuation Therapy

Authorization may be granted when ALL of the following are met

Initial authorization criteria

Diagnosis of chronic graft-versus-host disease (cGVHD)
Weight: Member weight is >= 40 kg>= 40 kg
Prescriber is an oncologist or hematologist, or consult notes from an oncologist or hematologist are provided
Steroid failure or contraindication: Inadequate response or adverse reaction to ONE systemic glucocorticoid OR contraindication to ALL systemic glucocorticoids
Prior non-steroid therapy: Prior therapy for cGVHD with at least ONE prior line of non-steroid systemic therapy (refer to NCCN Hematopoietic Cell Transplantation guidelines)
Dosing: Appropriate dosing

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title": "Initial Therapy"

Requests for members who are new to the plan and currently receiving Niktimvo may be reviewed on a case-by-case basis; however, this does not apply when the product is obtained as samples or through the manufacturer's patient assistance programs — such requests are excluded from case-by-case review.

Use of Niktimvo for diagnoses other than chronic graft-versus-host disease (cGVHD), or for patients who do not meet all of the authorization criteria listed below (including weight, prescriber specialty/consult documentation, prior steroid failure/intolerance, prior non‑steroid systemic therapy, and appropriate dosing), would not meet authorization criteria.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Niktimvo (axatilimab-csfr). New-to-plan members currently receiving Niktimvo may be reviewed on a case-by-case basis; authorization is not required when product is obtained as samples or via manufacturer's patient assistance programs.

Contact: Phone 877-519-1908; Fax 855-540-3693 (Specialty)
Commercial/Exchange plans — Prior Authorization applies
Quantity limits and specialty limits may apply

Step Therapy

Therapy Prerequisites and Step Therapy

Step therapy prerequisites must be documented before approval. Niktimvo is considered only after documented inadequate response or intolerance to systemic glucocorticoids and at least one prior non-steroid systemic therapy for cGVHD.

Documented inadequate response or adverse reaction to ONE systemic glucocorticoid, or contraindication to all systemic glucocorticoids
At least ONE prior line of non-steroid systemic therapy for chronic graft-versus-host disease (cGVHD)
Appropriate dosing per prescribing information

Documentation Required

Required Documentation

Provide documentation to support medical necessity and dosing. Required documentation includes confirmation of cGVHD diagnosis, patient weight, prescriber specialty or consult notes, and detailed prior therapy history.

Confirm diagnosis: chronic graft-versus-host disease (cGVHD)
Patient weight documented and ≥ 40 kg
Prescriber is an oncologist or hematologist OR provide consult notes from these specialists
Document prior therapies tried, reasons for discontinuation, and response (including systemic glucocorticoids and non-steroid systemic agents)
Provide planned dosing regimen

Denial Risk

Triggers for Denial

Requests may be denied if required criteria or documentation are missing or not met. Common triggers for denial include unsupported diagnosis, weight below eligibility threshold, prescriber not a specialist without consult notes, and lack of prior therapy documentation.

Diagnosis other than chronic graft-versus-host disease (cGVHD)
Patient weight < 40 kg
Prescriber is not an oncologist or hematologist and no specialist consult notes provided
No documentation of inadequate response/intolerance to systemic glucocorticoids
No documentation of ≥1 prior non-steroid systemic therapy for cGVHD
Incomplete or missing dosing information

Definitions

cGVHD — Chronic graft-versus-host disease definition required for coverage

Required diagnosisDiagnosis of chronic graft-versus-host disease (cGVHD)

Prescriber requirementPrescriber is an oncologist or hematologist, or consult notes from an oncologist/hematologist are provided

Prior therapy prerequisitePrior therapy with at least one prior non-steroid systemic therapy for cGVHD (per NCCN HCT guidelines)

Steroid failure/contraindicationInadequate response or adverse reaction to one systemic glucocorticoid OR contraindication to all systemic glucocorticoids

DosingAppropriate dosing required

Background

Niktimvo (axatilimab-csfr) is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of prior systemic therapies. Authorization criteria require the member to have a diagnosis of cGVHD, weigh >= 40 kg, have treatment documented or prescribed by an oncologist or hematologist (or have consult notes), demonstrate inadequate response or intolerance to at least one systemic glucocorticoid (or a contraindication to all systemic glucocorticoids), have received at least one prior non‑steroid systemic therapy for cGVHD per NCCN Hematopoietic Cell Transplantation guidance, and have documentation of appropriate dosing.