Traditional MedicarePrior AuthMedium impact
Soliris® (eculizumab) and biosimilars (Revised)
Humana·KY, SC · Hematology, Neurology, Nephrology·Medicaid
Effective date
Jan 1, 2025
We identified it
Jun 24, 2026
Summary
This is a new prior authorization policy effective January 1, 2025, for Soliris (eculizumab) and its biosimilars (Bkemv, Epysqli) covering four rare conditions: PNH, aHUS, generalized myasthenia gravis, and NMOSD. The policy establishes specific diagnostic criteria and step therapy requirements that vary by Medicare Part B, Part D, and Medicaid programs.
Action Required
By January 1, 2025: Billing team must implement prior authorization requirements for Soliris, Bkemv, and Epysqli infusions. Update system to verify diagnosis criteria for PNH, aHUS, generalized myasthenia gravis, and NMOSD before scheduling infusions. Ensure providers document required lab values, antibody tests, and step therapy trials per plan type (Medicare Part B requires Ultomiris trial, Medicare Part D requires Vyvgart trial for myasthenia gravis, Medicaid requires specific immunosuppressive therapy trials). Claims will be denied without proper prior authorization and documentation.