Medicare AdvantagePrior AuthMedium impact
Mylotarg® (gemtuzumab ozogamicin) (Revised)
Humana·FL, KY, SC · Oncology, Hematology·Medicaid
Effective date
Jan 1, 2020
We identified it
Jun 25, 2026
Summary
This is a revised Humana prior authorization policy for Mylotarg (gemtuzumab ozogamicin), a CD33-positive acute myeloid leukemia treatment, updated December 17, 2025. The policy applies to Medicare and three state Medicaid programs (Florida, Kentucky, South Carolina) and requires prior authorization before dispensing. Key coverage criteria include diagnosis confirmation, CD33-positive disease documentation, and specific patient age/disease status requirements.
Action Required
REQUIREMENTS:
- By January 31, 2026: Billing and prior authorization teams must update their Humana PA submission protocols to reflect this December 17, 2025 revision for all Mylotarg claims across Medicare and Medicaid-FL, Medicaid-KY, and Medicaid-SC plans.
- Verify all Mylotarg prior authorization requests include: (1) confirmed AML diagnosis, (2) documented CD33-positive disease status, (3) indication type (newly-diagnosed vs. relapsed/refractory) with patient age verification (≥1 month for newly-diagnosed; ≥2 years for relapsed/refractory).
- Before claim submission: Billing team must confirm no prior disease progression on Mylotarg is documented (Exclusion #1), as this will result in PA denial.
- For newly-diagnosed AML: Set PA approval duration expectation at 6 months maximum (1 induction cycle + 8 consolidation cycles). For relapsed/refractory: Set at 3 months maximum (1 cycle total).
- Update internal documentation templates and EMR PA request forms to capture CD33-positive status as mandatory field.
- Communicate to oncology providers that claims submitted without proper PA will be denied by Humana for these plans.
- Reference updated policy at www.humana.com/PAL for any medically-billed request coding questions.