Pharmacy Prior Authorization Criteria

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

2024-03-20, 2024-02-12

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

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Revision History

• 2024-03-20: Per consultant feedback, updated criteria to define partial response and added treatment duration limit.
• 2024-02-12: New Program.

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