Lumasiran

This policy covers lumasiran (Oxlumo) for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary/plasma oxalate in pediatric and adult patients with genetically confirmed AGXT mutation or liver-proven AGT deficiency and clinical/biochemical evidence of disease. Coverage requires specified biochemical thresholds and prior pyridoxine failure, adheres to ILLUMINATE‑A dosing (3 mg/kg loading x3 monthly then every 3 months), includes age/eGFR–based criteria and stable hemodialysis patients, and excludes concurrent PH biologics, prior liver transplant, peritoneal dialysis, and populations not studied in the trials.

"Coverage of an FDA-approved drug when prescribed for an off‑label use recognized as safe and effective in one or more standard medical reference compendia adopted by the U."

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