Oncology - Iwilfin Prior Authorization Policy
This policy governs prior authorization and medical necessity criteria for coverage of Iwilfin (eflornithine tablets) for reduction of relapse risk in high-risk neuroblastoma patients who have responded to prior multimodality therapy including anti-GD2 immunotherapy; it applies to Cigna-administered health benefit plans.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
FDA-Approved Indication — Neuroblastoma (Initial/Continuation Therapy)
Approve for 1 year if the patient meets ALL of the following (A, B and C):
Approvals provided for 1 year.
| Regimen | Indication | Prior therapies required | Approval duration |
|---|---|---|---|
| Iwilfin (eflornithine tablets) as continuation therapy following multiagent therapy and anti-GD2 immunotherapy (e.g., dinutuximab) | Continuation therapy to reduce relapse risk in high-risk neuroblastoma after partial response to prior multimodality therapy | Prior multiagent, multimodality therapy with at least a partial response and completion of post-consolidation anti-GD2 immunotherapy (e.g., Unituxin/dinutuximab) | 1 year |
Iwilfin (eflornithine tablets) is not medically necessary for any indication other than the specified neuroblastoma use described in this policy. Criteria and coverage determinations will be updated if new published data become available.
Specifically, any use other than reduction of relapse risk in high-risk neuroblastoma following at least a partial response to prior multiagent, multimodality therapy that included anti-GD2 immunotherapy is considered not medically necessary and may be denied.
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