Alprolix®, BeneFIX®, Idelvion®, Ixinity®, Rebinyn®, Rixubis® (coagulation factor IX [recombinant]) AlphaNine SD® (coagulation factor IX [plasma-derived]) Profilnine® (factor IX complex [plasma-derived])

Covers the listed recombinant and plasma‑derived Factor IX products (Alprolix, BeneFIX, Idelvion, Ixinity, Rebinyn, Rixubis, AlphaNine SD, Profilnine) for IV on‑demand treatment, routine prophylaxis, and perioperative management of congenital hemophilia B only; long‑acting agents (Alprolix, Idelvion, Rebinyn) are limited for prophylaxis unless the patient has failed (≥3‑month trial), is intolerant to, or has a contraindication to TWO standard‑half‑life recombinant FIX products. Approval is up to 12 months and requires documentation of diagnosis and indication, patient weight, product/age/bleed‑specific dosing calculations (including observed recovery when used), target FIX levels/perioperative plan, and prior‑treatment history for long‑acting requests.

"Coagulation Factor IX (recombinant and plasma-derived) and Factor IX Complex (plasma-derived) are indicated in patients with hemophilia B (congenital Factor IX deficiency) for: On-demand treatment ..."