CommercialPrior AuthMedium impact
Givosiran (Givlaari) (CPB 0961, reviewed 2026-01-09)
Aetna·Internal Medicine, Gastroenterology, Hematology +2 more·Medical Policy
Effective date
Jan 9, 2026
We identified it
Aug 15, 2026
Summary
Aetna has updated its clinical policy for Givosiran (Givlaari), a gene-based therapy for acute hepatic porphyria (AHP), effective immediately. The policy establishes coverage criteria requiring patient age 18+, active symptoms or 4+ annual attacks, and elevated porphobilinogen/porphyrin levels. Precertification is mandatory for all Aetna participating providers and members, with specific contact information provided.
Action Required
Immediately: Billing team must implement mandatory precertification process for all Givosiran (Givlaari) claims before submission. Update billing system to flag CPT 96372 (injection administration) and HCPCS J0223 (givosiran injection) claims for Aetna commercial plans and route to precertification team. Providers must verify patient meets ALL coverage criteria before treatment initiation: (1) age 18+, (2) actively symptomatic with hospitalizations/urgent visits/hemin use OR 4+ annual attacks, and (3) elevated urine PBG or porphyrin levels. Precertification contact: Call 866-752-7021 or fax 888-267-3277. Obtain Statement of Medical Necessity (SMN) form from Specialty Pharmacy Precertification portal before claim submission. Apply Site of Care Utilization Management Policy for specialty drug infusions. Claims submitted without precertification will be denied. Update encounter templates to include documentation of attack frequency and laboratory values (PBG/porphyrin levels).