IWILFIN (eflornithine)

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