J0223 — Injection, givosiran, 0.5 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Documentation of diagnosis of an acute hepatic porphyria (specific AHP subtype when available).
- For initial therapy: documentation of at least 2 porphyria attacks in the prior 6 months (attacks defined as requiring hospitalization, urgent healthcare visit, or IV hemin at home).
- OR, if patient is on prophylactic hemin: provider attestation and documentation of the patient's baseline (pre-givosiran) hemin administration requirements (prophylactic or treatment) and the rate and/or number of porphyria attacks prior to initiation of givosiran.
- For continuation/reauthorization: documentation that the patient has experienced a positive clinical response while on Givlaari (e.g., reduced attack rate, reduced hemin use, clinical notes describing improvement).
Key Coverage Criteria
- Treatment of acute hepatic porphyrias (AHP).
- Diagnosis of an acute hepatic porphyria (examples listed: acute intermittent porphyria, hereditary coproporphyria, variegate porphyria, ALA dehydratase deficient porphyria).
- Initial therapy permitted when patient has active disease as defined by the clinical trial: at least 2 documented porphyria attacks within the past 6 months (attacks requiring hospitalization, urgent healthcare visit, or intravenous hemin administration at home).
- Initial therapy permitted when patient is currently receiving prophylactic hemin to prevent porphyria attacks (with required provider attestation/documentation of baseline hemin requirements and attack rate/number).
- Continuation therapy for patients who have previously received Givlaari for AHP and have documentation of a positive clinical response while on Givlaari.
- Use consistent with the FDA indication: Givlaari is indicated for the treatment of adults with acute hepatic porphyria (dose per FDA label: 2.5 mg/kg subcutaneously once monthly).
14 Active Policies
UHC-POL-givlaari-givosiran — Givlaari (Givosiran)
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-givlaari-givosiran — Givlaari (Givosiran)
UMR-POL-UMR-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
SUREST-POL-SUREST-givlaari-givosiran
Related Codes
Have a follow-up question?
Ask Verity about documentation requirements, denial risks, or coverage in your state.