Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Naxitamab (Danyelza) may be considered medically necessary for the following:
Food and Drug Administration (FDA) Indications
- For the treatment of individuals 1 year of age and older, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
The use of naxitamab (Danyelza) for any other indication than listed above is considered experimental/investigational and therefore, not covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.