Medicare AdvantagePrior AuthMedium impact
Iqirvo® (elafibranor) (Revised)
Humana·Gastroenterology, Internal Medicine·Medicare Advantage
Effective date
Sep 25, 2024
We identified it
Jul 21, 2026
Summary
Humana Medicare Advantage updated its prior authorization policy for Iqirvo® (elafibranor) for Primary Biliary Cholangitis treatment. The policy requires prior authorization and establishes five specific clinical criteria that must be met, including documented PBC diagnosis, absence of complete biliary obstruction, no history of decompensated cirrhosis, prescriber requirement (gastroenterologist or hepatologist), and either ursodiol intolerance or inadequate response to one year of ursodiol therapy.
Action Required
Before September 25, 2024 (or immediately if already past this date): Billing team must implement prior authorization requirements for Iqirvo® (elafibranor) claims. Update billing system to flag all Iqirvo® prescriptions for Medicare Advantage members and route to prior authorization department. Verify the following criteria are documented before submission: (1) PBC diagnosis supported by two of: elevated alkaline phosphatase ≥6 months, positive antimitochondrial antibody, or liver biopsy; (2) no complete biliary obstruction; (3) no prior decompensated cirrhosis; (4) prescriber is gastroenterologist or hepatologist; (5) documented ursodiol intolerance OR alkaline phosphatase ≥1.67x upper limit of normal OR total bilirubin above upper limit of normal after one-year ursodiol trial. Educate providers that claims submitted without prior authorization or missing clinical documentation will be denied. Add Iqirvo® prior auth requirement to denial prevention protocols.