Etranacogene dezaparvovec-drlb (Hemgenix) — Coverage Criteria (intravenous gene therapy for hemophilia B)
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Defines medical necessity, documentation, and coding requirements for coverage of etranacogene dezaparvovec-drlb (Hemgenix) intravenous gene therapy for adults with hemophilia B for Blue Cross Blue Shield North Carolina.
Added revenue codes 0891 and 0892 as applicable revenue codes associated with policy HCPCS code(s).
Updated moderately severe to severe disease definition to Factor IX baseline residual level ≤ 2 IU/dL (≤ 2% of normal).
Added HCPCS code J1411 as the dosing reference code for etranacogene dezaparvovec-drlb.
Coverage Criteria for Etranacogene dezaparvovec-drlb (Hemgenix)
Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
medical record documentation required
laboratory documentation required
medical record documentation required
medical record documentation required
lab documentation required within specified timeframes
medical record documentation required
medical record documentation required
medical record documentation required; prior authorization required
Patients with evidence of any bleeding disorder that is not related to congenital hemophilia B are excluded from coverage for etranacogene dezaparvovec-drlb. Medical record documentation verifying the absence of other bleeding disorders is required for coverage determination.
Use of etranacogene dezaparvovec-drlb that does not meet the listed medical necessity criteria is considered not medically necessary. Examples include, but are not limited to: requested dose outside the FDA-labeled dosing or requested quantity exceeding the maximum units allowed; any prior gene therapy including the requested agent; unacceptable anti-AAV antibody titers that exceed labeling administration instructions; incomplete or out-of-date infectious disease testing or active antiviral therapy for hepatitis B or C. Medical record documentation supporting compliance with all listed criteria is required.
Coding and Dose Information
| J1411 | etranacogene dezaparvovec-drlb, per HCPCS description (policy dosing reference) |
| 0891 | Special Processed Drugs - FDA Approved Cell Therapy (revenue code) |
| 0892 | Special Processed Drugs - FDA Approved Gene Therapy (revenue code) |
Provider Requirements, Prior Authorization, and Documentation
Prior Authorization and Dosing
Prior authorization is required. Ensure the requested dose matches the FDA-labeled dosing of 2 x 10^13 genome copies (gc) per kg body weight and the requested quantity does not exceed the maximum units allowed for the duration of approval (Maximum Units = 1). Distribution from a specialty pharmacy provider may be required when coverage is available; contact Blue Cross NC to coordinate.
- Requested dose must equal FDA labeled dosing: 2 x 10^13 gc/kg
- Requested quantity must not exceed maximum units allowed (Maximum Units = 1)
- Prior authorization required before administration
- Specialty pharmacy distribution may be required — coordinate with Blue Cross NC
Required Documentation and Denial Risk
The following medical record documentation is required and failure to provide it may result in denial: diagnosis of congenital hemophilia B, Factor IX baseline residual level (lab) demonstrating ≤ 2 IU/dL, absence of current or historical Factor IX inhibitors, HIV and hepatitis B/C testing results as specified, anti-AAV antibody titers within acceptable limits, documentation that the patient has not received prior gene therapy, and documentation supporting the requested dose/quantity.
- Diagnosis of congenital hemophilia B (medical record)
- Factor IX baseline residual level ≤ 2 IU/dL (laboratory report)
- History and current status of inhibitors to Factor IX (medical record)
- HIV status and pertinent labs (within past 3 months or within 12 months for viral load if HIV positive)
- Hepatitis B surface antigen negative (labs within past 3 months)
- HCV antibody and, if positive, HCV RNA negative (labs within past 3 months)
- Anti-AAV antibody titers (e.g., AAV-5) within labeling limits (labs within past 3 months)
- Documentation that the patient has not had previous gene therapy
- Documentation that requested dose/quantity aligns with FDA labeling
Prophylaxis or Clinical Need
Patient must either be on prophylactic Factor IX therapy with a minimum of 150 exposure days or have a clinician-documented need for improved protection (e.g., increased bleeding due to severely damaged joints, need for anticoagulation, or high fall-risk in elderly patients). Medical record evidence of prophylaxis or clinical need is required.
- Prophylaxis: documentation of Factor IX prophylactic therapy and ≥150 exposure days
- OR clinician-documented rationale for requiring improved protection from current therapy
Key Definitions
Background
Etranacogene dezaparvovec-drlb (Hemgenix) is an adeno-associated virus (AAV)-based, single-course intravenous gene therapy approved to treat adults with congenital hemophilia B (Factor IX deficiency). Per the policy, it is administered as a one-time treatment course with documented eligibility requirements including infectious disease testing, anti-AAV antibody titers within labeling limits, no prior gene therapy, and dosing within the FDA-labeled regimen. Duration of approval is 180 days (one treatment course per lifetime), and distribution from a specialty pharmacy provider may be required when coverage is available.
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