Iwilfin (eflornithine)

Indications for Prior Authorization

Iwilfin (eflornithine)
  • For diagnosis of High-risk neuroblastoma (HRNB)
    Indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.

Criteria

Iwilfin

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of high-risk neuroblastoma (HRNB)
  • AND
  • Patient has shown at least a partial response to prior multiagent, multimodality therapy as evidenced by ALL of the following [2]:
    • 30% or more decrease in longest diameter of primary site tumor
    • No new lesions
    • MIBG (or 18F-FDG PET) stable or improved
    • At least a 50% reduction in absolute MIBG bone score or a 50% or greater reduction in number of 18F-FDG PET-avid bone lesions
    AND
  • Prior therapy included anti-GD2 immunotherapy (e.g., Unituxin (dinutuximab))
  • AND
  • Treatment duration of Iwilfin has not exceeded a total of 24 months during the patient's lifetime
Iwilfin

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient does not show evidence of progressive disease while on therapy
  • AND
  • Treatment duration of Iwilfin has not exceeded a total of 24 months during the patient's lifetime
P & T Revisions

2025-01-08, 2024-03-20, 2024-02-12

  1. Iwilfin Prescribing Information. US WorldMeds, Louisville, KY, November 2024.
  2. PDQ® Pediatric Treatment Editorial Board. PDQ Neuroblastoma Treatment. Bethesda, MD: National Cancer Institute. Updated <11/12/2024>. Available at: https://www.cancer.gov/types/neuroblastoma/hp/neuroblastoma-treatment-pdq. Accessed <1/1/2025>. [PMID: 26389190]
  3. Consult with pediatric hematology/oncology consultant. 26 Feb 2024

  • 2025-01-08: 2025 Annual review. Background updates only
  • 2024-03-20: Per consultant feedback, updated criteria to define partial response and added treatment duration limit.
  • 2024-02-12: New Program.