Givlaari (givosiran)

Givlaari is covered for adults (≥18) with acute hepatic porphyria only when diagnosis is confirmed by clinical features plus elevated urinary ALA or PBG, the patient had at least one porphyria attack in the prior 6 months requiring hospitalization/urgent care/IV hemin, and the drug is prescribed by or in consultation with a gastroenterologist, hepatologist, or AHP specialist; approval is for up to 12 months with recommended dosing 2.5 mg/kg subcutaneously once monthly. Patients <18, without diagnostic confirmation, without a qualifying recent attack, or not managed by an approved specialist are excluded.

"FDA-Approved Indication: Givlaari is indicated for the treatment of adults with acute hepatic porphyria (AHP)."

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