J1412 — Injection, valoctocogene roxaparvovec-rvox, per ml, containing nominal 2 x 10^13 vector genomes
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 severe hemophilia A (factor VIII deficiency) and endogenous factor VIII levels less than 1% (<0.01 IU/mL, <1 IU/dL)
- Documentation of patient age (>=18 years)
- Evidence of one of the following treatment/exposure conditions: current chronic prophylactic Hemlibra (emicizumab) or Hympavzi (marstacimab) therapy; OR documentation that patient currently uses factor VIII prophylaxis therapy and has had >=150 exposure days to a factor VIII agent; OR documentation from Hemophilia Treatment Center that patient is an appropriate candidate based on willingness to adhere to monitoring and management
- Documentation of no history of inhibitors to factor VIII >= 0.6 Bethesda units (BU)
Key Coverage Criteria
- Patient has not previously received treatment with Roctavian or other gene therapy product for the treatment of hemophilia A in the patient's lifetime;
- Roctavian is prescribed and managed by a bleeding disorder specialist on staff at a Hemophilia Treatment Center (HTC) that holds Federal designation as evidenced by being listed within the CDC's HTC directory;
- Roctavian is proven and medically necessary for the treatment of Hemophilia A (factor VIII Deficiency, Classical Hemophilia) when all of the following criteria are met:
- Patient is 18 years of age or older;
- Diagnosis of severe hemophilia A;
- Documentation of endogenous factor VIII levels less than 1% of normal factor VIII (<0.01 IU/mL, < 1 IU/dL);
9 Active Policies
ANTHEM-MED.00135 — MED.00135 Gene Therapy for Hemophilia
UHC-POL-roctavian — Roctavian (Valoctocogene Roxaparvovec-Rvox)
UMR-POL-UMR-roctavian — Roctavian (Valoctocogene Roxaparvovec-Rvox)
SUREST-POL-SUREST-roctavian — Roctavian (Valoctocogene Roxaparvovec-Rvox)
BCBSIL-RX501.128 — Valoctocogene Roxaparvovec-rvox
Related Codes
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