Niktimvo™

Drug - Niktimvo™ (axatilimab-csfr) [Incyte Corporation]

January 2026

Therapeutic area - Chronic graft versus host disease (cGVHD)

Initial approval criteria

  • Patient is at least 6 years of age; AND

Universal Criteria 

  • Patient weighs at least 40 kg; AND

Chronic Graft versus Host Disease (cGVHD)

  • Patient has recurrent or refractory disease; AND 
  • Used as a single agent or in conjunction with systemic steroids, calcineurin inhibitors (e.g., cyclosporin, etc.) or mTOR inhibitors (e.g., sirolimus, everolimus, etc.); AND 
  • Patient is post-allogeneic stem cell transplant (generally 3 or more months); AND 
  • Patient has failed two or more previous lines of systemic therapy for the treatment of cGVHD; AND 
  • Patient has had an inadequate response to an adequate trial of, or contraindication or intolerance to belumosudil ; AND
  • Niktimvo is prescribed by or in consultation with a specialist in the area of the patient’s diagnosis
  • Initial approval is for 6 months

Renewal criteria

  • Patient continues to meet the universal and other indication-specific relevant criteria identified in the initial approval; AND 
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include severe infusion related reactions, etc.; AND 
  • Response to therapy with an improvement in one or more of the following: 
    • Clinician assessments (e.g., NIH Skin Score, Upper GI Response Score, NIH Lung Symptom Score, etc.) OR 
    • Patient-reported symptoms (e.g., Lee Symptom Scale, etc.) 
  • Renewal approval is for 6 months

Quantity limits

  • For patients weighing at least 40 kg, administer Niktimvo 0.3 mg/kg, up to a maximum dose of 35 mg, as an intravenous infusion over 30 minutes every 2 weeks until progression or unacceptable toxicity.
  • Patient’s weight (in kg) must be provided at time of request

Billing for Niktimvo

Niktimvo must be billed as a professional claim.

Questions?

Provider Call Center: (844) 575-7887