Medicare AdvantagePrior AuthMedium impact
Danyelza® (naxitamab-gqgk) (Revised)
Humana·FL, KY, SC · Oncology, Pediatrics, Hematology·Medicaid
Effective date
Jun 24, 2026
We identified it
Jun 25, 2026
Summary
Humana revised its Danyelza (naxitamab-gqgk) prior authorization policy effective June 24, 2026, affecting Medicare and three state Medicaid programs (Florida, Kentucky, South Carolina). The policy clarifies coverage criteria for this anti-GD2 monoclonal antibody used to treat relapsed/refractory high-risk neuroblastoma, requiring combination use with Leukine (sargramostim) and prior authorization for all claims. Key exclusions include monotherapy use and cases with documented disease progression on Danyelza.
Action Required
By June 24, 2026: Billing and prior authorization teams must implement the following: (1) Update billing system rules to require prior authorization for ALL Danyelza (naxitamab-gqgk) claims across Medicare and Medicaid members in FL, KY, and SC; (2) Configure system to DENY claims when Danyelza is billed as monotherapy (Exclusion #1) or when member has documented disease progression on Danyelza (Exclusion #2); (3) Ensure prior auth submission templates include verification of ALL five approval criteria: diagnosis of relapsed/refractory high-risk neuroblastoma, disease in bone or bone marrow, member age ≥1 year, prior response/stable disease documentation, and concurrent Leukine (sargramostim) use; (4) Train prior authorization staff on the clinical warnings regarding infusion-related reactions and neurotoxicity to support medical director reviews; (5) Update claim submission instructions to providers emphasizing the mandatory Danyelza + Leukine combination requirement. Claims submitted without prior authorization or missing required criteria documentation will be denied. Verify this is the current version on Humana's website before processing.