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AetnaCommercial · Prior Auth · Medical Policy · Hematology, Gastroenterology, NeurologyMedium impact

Givosiran (Givlaari) (CPB 0961, reviewed 2026-01-09)

Effective date
Not stated in the notice
Identified
Aug 15, 2026

Summary

Aetna considers givosiran (Givlaari) medically necessary for acute hepatic porphyria (AHP) for commercial medical plans when the member is 18 years of age or older, is actively symptomatic or has had 4 or more porphyria attacks per year, and has an elevated urine porphobilinogen (PBG) or an elevated plasma or fecal porphyrin level. Continuation of therapy is considered medically necessary for members who are benefiting from it, such as through fewer porphyria attacks requiring hospitalization, urgent healthcare visits, or intravenous hemin. Aetna considers all other indications experimental, investigational, or unproven.

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What to do

Action · 4 steps
01Billing team: Givosiran (Givlaari) requires precertification, which the source states is required of all Aetna participating providers and members in applicable plan designs.
02Before billing HCPCS J0223 for AHP, confirm the member meets the initial approval criteria: age 18 or older, actively symptomatic or 4 or more porphyria attacks per year, and an elevated urine PBG or elevated porphyrin level.
03Givlaari is administered subcutaneously by a healthcare professional only, at 2.5 mg/kg once monthly based on actual body weight.
04The Site of Care Utilization Management Policy for specialty drug infusions applies to givosiran.

Codes mentioned

841108412696372J0223E80.20E80.21E80.29

Original notice

Givosiran (Givlaari) (CPB 0961, reviewed 2026-01-09)
aetna.com · Always check the source before changing claims.
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Related policy hubs

Aetna policiesHematologyGastroenterologyNeurologyCode 84110Code 84126Code 96372Code J0223Code E80.20Code E80.21Code E80.29

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