Oxlumo® (lumasiran) Injection

Oxlumo (lumasiran) is covered only for FDA‑approved treatment of primary hyperoxaluria type 1 (PH1) in pediatric and adult patients and is excluded for other indications and for patients with a prior liver transplant for PH1. Key requirements: genetic confirmation of an AGXT mutation, meeting at least one lab threshold (urinary oxalate ≥0.7 mmol/24 hr/1.73 m2 or urinary oxalate:creatinine ratio above age‑specific ULN or plasma oxalate ≥20 μmol/L), prescription by or in consultation with a nephrologist/urologist, weight‑based dosing and baseline labs, and objective evidence of benefit within the past 6 months for reauthorization (initial approval 6 months, renewals 12 months).

"Must have documented genetic confirmation of PH1 via identification of an AGXT mutation — absence of this genetic confirmation is a limitation to coverage."

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