Lumasiran (Oxlumo)

Oxlumo (lumasiran) is covered only for the FDA‑approved indication of primary hyperoxaluria type 1 (PH1) and is excluded for patients who previously received a liver transplant for PH1 and for off‑label uses. Approval requires AGXT genetic confirmation, documented elevated urinary oxalate (≥0.7 mmol/24h/1.73 m2 or age‑specific urine oxalate:creatinine ratio), prescription/consultation by a nephrologist or urologist, adherence to specified dosing (initial 6 mg/kg monthly ×3, then maintenance 3 mg/kg monthly or 6 mg/kg every 3 months), an initial 6‑month authorization, and 12‑month renewals showing objective benefit within the prior 6 months.

"For the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients"

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