MedicaidPrior AuthMedium impact
Empaveli (pegcetacoplan) (Revised)
Humana·KY, SC, VA · Nephrology, Hematology, Internal Medicine·Medicaid
Effective date
Jan 1, 2024
We identified it
Jul 22, 2026
Summary
This is a revised Humana prior authorization policy for Empaveli (pegcetacoplan) effective January 1, 2024, with the most recent revision dated July 22, 2026. The policy covers two indications: Paroxysmal Nocturnal Hemoglobinuria (PNH) and Complement 3 Glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN). For PNH, prior authorization requires documented diagnosis with specific clone size and LDH levels, plus transfusion dependence or thrombotic history. For C3G/IC-MPGN, authorization requires biopsy confirmation, age 12+, and documented failure or contraindication to immunosuppressive therapies and glucocorticoids. All requests require prior authorization before dispensing.
Action Required
By January 1, 2024 (or immediately if current date is after this): Billing and prior authorization teams must implement prior authorization requirements for all Empaveli (pegcetacoplan) claims. For PNH diagnoses: Ensure medical records documentation includes granulocyte/monocyte clone size >5%, LDH level ≥1.5x upper limit normal, and evidence of transfusion dependence (Hgb ≤7 g/dL, or ≤9 g/dL with anemia symptoms) OR major thrombotic events before submitting authorization. For C3G/IC-MPGN diagnoses: Verify biopsy confirmation, patient age ≥12 years, and documented trial or contraindication to mycophenolate AND glucocorticoids (e.g., prednisone, dexamethasone, methylprednisolone) before submission. Claims submitted without meeting these criteria will be denied. Update PA submission templates to include checkboxes for these requirements. Route all Empaveli requests through Humana's PAL system (www.humana.com/PAL). For continuation therapy, require documentation of positive clinical response (increased/stabilized hemoglobin or reduced transfusions) for renewal approval. Flag any patient with unresolved serious encapsulated bacterial infection as contraindicated per Black Box Warning.