J1411, Injection, etranacogene dezaparvovec-drlb, per therapeutic dose
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 to the relevant standard medical reference compendium adopted by HHS showing the use is recognized as safe and effective, when relying on compendia support.
- Provide two articles from major peer‑reviewed professional medical journals that present data confirming safety and efficacy for the proposed off‑label use when relying on medical literature support.
- Clinical evidence should be from robust study designs (for example, randomized, double‑blind, placebo‑controlled trials) rather than case reports/series.
- Documentation that the patient meets all required policy criteria (as specified elsewhere in the policy) must be provided.
Key Coverage Criteria
- Beqvez is proven and medically necessary for the treatment of Hemophilia B (congenital factor IX deficiency) when all of the following criteria are met: 1) Patient is 18 years of age or older; and 2) One of the following: a) Both of the following: i) Diagnosis of severe hemophilia B; and ii) Documentation of endogenous factor IX levels less than 1% of normal factor IX (< 0.01 IU/mL) or b) All of the following: i) Diagnosis of moderately severe hemophilia B; and ii) Documentation of endogenous fa [...]
- 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-gene-therapies-hemophilia, Gene Therapies for Hemophilia B
RX501.151, Etranacogene dezaparvovec-drlb
BCBSIL-RX501.151, Etranacogene dezaparvovec-drlb
BCBSMT-RX501.151, Etranacogene dezaparvovec-drlb
Related Codes
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