Medicare AdvantagePrior AuthMedium impact
Fabhalta® (iptacopan) capsule (Revised)
Humana·Hematology, Nephrology, Internal Medicine·Medicare Advantage
Effective date
May 22, 2024
We identified it
Jul 22, 2026
Summary
This is a revised Humana Medicare Advantage prior authorization policy for Fabhalta® (iptacopan) covering four indications: PNH (new start and stable), primary IgAN, and C3G. The policy establishes specific clinical criteria that must be met before approval, including diagnostic confirmations, laboratory markers, and documented disease severity or treatment failures. Billing teams must ensure prior authorization is obtained before dispensing and verify all clinical criteria are documented.
Action Required
By 2024-05-22, billing and pharmacy teams must: (1) Update billing system and pharmacy software to flag all Fabhalta (iptacopan) claims for Medicare Advantage members requiring prior authorization; (2) Create or update prior authorization request templates to capture all four indication pathways (PNH new start, PNH stable, IgAN, C3G) with corresponding clinical criteria; (3) Train pharmacy staff and billing staff to verify documentation includes: for PNH—hematologist/specialist diagnosis, flow cytometry results (granulocyte or monocyte clone >10%), hemolysis markers (LDH, reticulocyte count, bilirubin, haptoglobin), and anemia signs; for IgAN—biopsy confirmation, UPCR ≥1.5 g/g, ACEi/ARB trial-and-failure or contraindication, and optimized supportive care; for C3G—biopsy confirmation, mycophenolate and glucocorticoid trial-and-failure or inability to use, and no prior kidney transplant; (4) Communicate to all prescribing providers that Fabhalta requires prior authorization before dispensing; (5) Do not process claims without prior authorization approval—Humana will deny claims submitted without prior auth. Review policy online before each use as noted in document header.