Givosiran for Acute Hepatic Porphyria

Covers givosiran (subcutaneous therapy) for treatment of acute hepatic porphyria (AIP, HCP, VP, ADP) in adults to reduce hepatic ALAS1 mRNA and lower neurotoxic ALA/PBG levels. Authorization requires age ≥18 with biochemical confirmation (elevated urine/plasma ALA or PBG within the past year) and either ≥2 porphyria attacks in the prior 6 months or need for prophylactic hemin; initial approval is 12 months with reauthorization contingent on documented clinical response and stable/improved ALA/PBG, and therapy is excluded if ALT >5×ULN or given concurrently with prophylactic hemin.

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