Coagadex® (coagulation factor X [Human])

Coagadex is covered only for FDA‑approved hereditary Factor X deficiency uses — routine prophylaxis, on‑demand treatment of bleeds, and perioperative management — and off‑label indications are not covered. Approval is IV only (initial 3 months, renewals 12 months) and requires documented diagnosis/indication, age and weight, weight‑based dosing calculations using age‑specific factors (prophylaxis: <12y 40 IU/kg twice weekly, ≥12y 25 IU/kg twice weekly; treatment: <12y 30 IU/kg then q24h until hemostasis, ≥12y 25 IU/kg q24h; perioperative dosing factor 0.6 for <12y and 0.5 for ≥12y targeting pre‑op 70–90 IU/dL and post‑op ≥50 IU/dL) and adherence to the policy’s safety criteria.

"Hereditary Factor X deficiency in adults and children — routine prophylaxis to reduce the frequency of bleeding episodes (FDA‑approved indication)."

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