Givlaari™ (givosiran)

Givlaari (givosiran) is covered for adults (≥18) with acute hepatic porphyria when diagnosis is confirmed by both compatible clinical features and elevated urinary ALA or PBG, the patient had ≥1 porphyria attack in the prior 6 months requiring hospitalization, urgent care, or IV hemin, and it is prescribed by or in consultation with a gastroenterologist, hepatologist, or AHP specialist. Not covered for patients <18 or non‑FDA indications; approval is limited to 12 months, recommended dose 2.5 mg/kg SC monthly, and required documentation and applicable safety criteria must be submitted.

"Treatment of adults (≥18 years) with acute hepatic porphyria (AHP) — FDA-approved indication."

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