Pharmacy Prior Authorization Criteria

Niktimvo (axatilimab-csfr)

Indications for Prior Authorization

Niktimvo (axatilimab-csfr)

• For diagnosis of Chronic Graft Versus Host Disease (cGVHD)
  Indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

Criteria

Niktimvo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of chronic graft versus host disease (cGVHD)
AND
• Trial and failure of at least two other systemic therapies [e.g., corticosteroids (e.g., prednisone, methylprednisolone), mycophenolate]
AND
• Patient weighs at least 40kg

Niktimvo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2025-03-05, 2025-03-21

References

1. Niktimvo Prescribing Information. Incyte Corporation. Wilmington, DE 19803. January 2025.
2. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Hematopoietic Cell Transplantation (HCT). V2.2024. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/hct.pdf. Accessed February 14, 2025.
3. Wolff D, Cutler C, Lee SJ, et al. Axatilimab in Recurrent or Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2024;391(11):1002-1014.

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Revision History

• 2025-03-05: New program.
• 2025-03-21: New program

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