J3399, Injection, onasemnogene abeparvovec-xioi, per treatment, up to 5x10^15 vector
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
- Acceptable laboratory definitions for a negative anti-AAV9 ELISA may vary by facility (examples given: Athena <1:25; CTL <1:50).
- Recommended dosing: 1.1 × 10^14 vector genomes per kg IV over 60 minutes; administer systemic corticosteroids equivalent to oral prednisolone 1 mg/kg per the FDA label.
- Baseline anti-AAV9 antibody testing must be performed prior to infusion; retesting may be performed if titers are reported as >1:50 (safety/efficacy not evaluated above 1:50 per FDA label).
- Monitor liver function (clinical exam, AST, ALT, total bilirubin, PT), platelet counts, and troponin-I levels as specified in the prescribing label.
Key Coverage Criteria
- A one-time infusion of onasemnogene abeparvovec-xioi is consideredmedically necessaryin individuals with spinal muscular atrophy (SMA) whenallof the following criteria are met:
- Confirmed SMA diagnosis as documented by a bi-allelic SMN1 5q gene variant or deletions andeitherof the following:No more than 3 copies of SMN2;orOnset of SMA-associated signs and symptoms before 6 months of age;and
- No more than 3 copies of SMN2;or
- Onset of SMA-associated signs and symptoms before 6 months of age;and
- Two years of age or younger at the time of vector infusion;and
- Anti-adeno-associated viral vector, serotype 9 (AAV9) antibody titer less than or equal to 1:50;and
8 Active Policies
ANTHEM-MED.00129, MED.00129 Gene Therapy for Spinal Muscular Atrophy
BCBSIL-RX501.104, Onasemnogene abeparvovec-xioi
BCBSMT-RX501.104, Onasemnogene abeparvovec-xioi
BCBSNM-RX501.104, Onasemnogene abeparvovec-xioi
BCBSOK-RX501.104, Onasemnogene abeparvovec-xioi
Related Codes
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