IWILFIN (eflornithine)

Self-Administration – oral

Diagnosis considered for coverage:

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.

Coverage Criteria:

For diagnosis of high-risk neuroblastoma (HRNB):

  • 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:
    • 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
Reauthorization Criteria:
For diagnosis of high-risk neuroblastoma (HRNB):
  • 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.
Coverage Duration: 
  • Initial: 12 months
  • Reauthorization: 12 months
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
 

Additional Information:
  • Dosing:
    • The recommended IWILFIN dosage, based on body surface area (BSA), is provided in Table 1.
    • Recalculate the BSA dosage every 3 months during treatment with IWILFIN.
Policy Updates:
  • 6/1/2024 (policy effective date)- New Iwilfin Criteria (P&T 5/20/2024) (P&T Meeting May)
References:
  1. Iwilfin Prescribing Information. US WorldMeds, Louisville, KY, December 2023.
  2. PDQ® Pediatric Treatment Editorial Board. PDQ Neuroblastoma Treatment. Bethesda, MD: National Cancer Institute. Updated (02/13/2024). Available at: https://www.cancer.gov/types/neuroblastoma/hp/neuroblastoma-treatment-pdq. Accessed (2/28/2024). [PMID: 26389190]
  3. Consult with pediatric hematology/oncology consultant. 26 Feb 2024

Last review date: June 1, 2024

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