Medicare AdvantagePrior AuthMedium impact
Orladeyo (berotralstat) (Revised)
Humana·SC · Allergy & Immunology, Internal Medicine·Medicaid
Effective date
Jan 1, 2025
We identified it
Jul 21, 2026
Summary
This is a revised Humana prior authorization policy for Orladeyo (berotralstat) for hereditary angioedema (HAE) prophylaxis effective January 1, 2025, revised July 22, 2026. The policy applies to Medicare and Medicaid (South Carolina) and requires prior authorization with 8 specific clinical criteria, including HAE diagnosis confirmation via lab work, documentation of recurrent angioedema, specialist treatment, and prior trial/contraindication/intolerance to Haegarda. For Medicaid requests, step therapy requirements do not apply.
Action Required
By January 1, 2025: Billing team must implement prior authorization workflow for Orladeyo (berotralstat) capsules and oral pellets for all Medicare Advantage and Medicaid (South Carolina) claims. Update billing system to flag Orladeyo requests requiring prior auth submission. Clinical staff must verify all 8 approval criteria are met before claim submission, including: (1) HAE Type 1 or 2 diagnosis, (2) lab documentation of C4 level and C1INH levels or mutation, (3) history of recurrent angioedema without urticaria, (4) no concomitant ACE/ARB use, (5) treatment by allergist/immunologist specialist, (6) C1q lab values included, (7) use for HAE prophylaxis only (not acute attacks), and (8) prior trial/contraindication/intolerance documentation for Haegarda. Add prior auth checklist to EMR or encounter forms. Note: Medicaid requests do NOT require step therapy documentation per policy. Providers must submit required lab reports and medical records with all prior auth requests. Claims without complete prior authorization will be denied.