J1412, Injection, valoctocogene roxaparvovec-rvox, per ml, containing nominal 2 x
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
- Citation or documentation from one or more HHS‑adopted standard medical reference compendia supporting the use when relying on compendia.
- When relying on medical literature, submission of two articles from major peer‑reviewed professional medical journals that present data confirming safety and efficacy for the proposed off‑label use.
- Clinical evidence meeting the policy's evidence standard (preferably randomized, double-blind, placebo-controlled clinical trials).
- Medical record documentation demonstrating the patient meets all policy-specified medical necessity criteria.
Key Coverage Criteria
- Roctavian is proven and medically necessary for the treatment of Hemophilia A (factor VIII Deficiency) when all of the following criteria are met: Patient is 18 years of age or older; and Diagnosis of severe hemophilia A; Documentation of endogenous factor VIII levels < 1% of normal; and one of the following: patient on non-factor replacement therapy or on factor VIII prophylaxis with at least 150 exposure days, or appropriate HTC candidate with monitoring adherence and no inhibitors ≥0.6 BU, no [...]
- Etranacogene dezaparvovec-drlb is consideredmedically necessaryin individuals who meetallof the following criteria:
- Diagnosis of hemophilia B;and
- Age 18 years or older;and
- Baseline factor IX level is less than 1 international unit (IU)/deciliter (dL) (or 1% endogenous factor IX);and
- No contraindications to infusion (if any of the following are present, treatment is contraindicated):Active infection;orImmunosuppressive disorder;orLiver cirrhosis;orActive hepatitis B or C;orAlanine transaminase (ALT) greater than 3 times the upper limit of normal;orBilirubin greater than 3 times the upper limit of normal;orAlkaline phosphatase greater than 3 times the upper limit of normal;orInternational normalized ratio (INR) greater than1.4.;orPrior infusion of gene therapy for hemophilia [...]
9 Active Policies
ANTHEM-MED.00135, MED.00135 Gene Therapy for Hemophilia
UHC-POL-roctavian, Roctavian (Valoctocogene Roxaparvovec-Rvox)
BCBSIL-RX501.128, Valoctocogene Roxaparvovec-rvox
BCBSMT-RX501.128, Valoctocogene Roxaparvovec-rvox
BCBSNM-RX501.128, Valoctocogene Roxaparvovec-rvox
Related Codes
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