Fidanacogene elaparvovec-dzkt (Beqvez) — Notification (coverage criteria)
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Policy governs medical necessity notification and coverage criteria for intravenous fidanacogene elaparvovec-dzkt (Beqvez) for adults with moderate to severe congenital hemophilia B; applies to Blue Cross NC members and their providers.
Added revenue codes 0891 and 0892 associated with policy HCPCS code(s).
Added HCPCS code J1414 to dosing reference table; deleted C9172, J3490, and J3590 (termed 12/31/2024).
Added HCPCS code C9172 to dosing reference table; deleted C9399 (termed 9/30/2024).
Coverage and Medical Necessity
Medical Necessity Criteria
Covered when ALL of the following are met:
Duration of approval 180 days; one treatment course per lifetime
See coding/revenue codes 0891 and 0892 as applicable
Coverage is denied when the patient has a history of prior gene therapy, unstable liver or biliary disease, significant liver fibrosis, or any bleeding disorder not related to hemophilia B. Documentation of these conditions is required in the medical record; examples of unstable liver or biliary disease include ascites, hepatic encephalopathy, portal hypertension, splenomegaly, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. The policy also requires that the requested dose fall within the FDA-labeled dosing and that the requested quantity does not exceed the maximum units allowed.
When coverage is available and medical necessity criteria are met for fidanacogene elaparvovec-dzkt (Beqvez), distribution via a specialty pharmacy may be required due to cost and channel restrictions; providers should contact Blue Cross NC to coordinate specialty distribution and prior authorization as applicable.
Patients are excluded from coverage if they have neutralizing antibodies to AAVRh74var; testing results must be documented in the medical record and obtained within the past 3 months. Requests are not eligible if the patient has active Factor IX inhibitors, uncontrolled HIV, is hepatitis B surface antigen positive, or has active hepatitis C viremia; required laboratory documentation timelines vary by test (see criteria).
Additional required testing and documentation prior to approval include: HIV testing (or documentation of well-controlled HIV with viral load <20 copies/mL or CD4 >200/mm3), hepatitis B surface antigen testing, HCV antibody and HCV RNA testing as indicated, and liver function tests (ALT, AST, ALP and total bilirubin) within the past 3 months to confirm values are within policy thresholds (ALT/AST/ALP ≤ 2× ULN; total bilirubin ≤ 1.5× ULN). Medical records must also document absence of current antiviral therapy for hepatitis B or C.
Billing and Coding
| J1414 | fidanacogene elaparvovec-dzkt (Beqvez) intravenous infusion |
| 0891 | Special Processed Drugs - FDA Approved Cell Therapy (revenue code) |
| 0892 | Special Processed Drugs - FDA Approved Gene Therapy (revenue code) |
Prior Authorization, Documentation, and Provider Requirements
Prior Authorization Required
Prior authorization is required before scheduling fidanacogene elaparvovec-dzkt (Beqvez, HCPCS J1414). Requests must include the exact HCPCS code J1414 and may be associated with revenue codes 0891 and 0892. Obtain prior authorization to confirm member eligibility, dosing (single IV dose, maximum units = 1), and distribution channel requirements (specialty pharmacy distribution may be required).
- Prior authorization required for HCPCS J1414 (Beqvez)
- Include revenue codes 0891, 0892 when applicable
- Specialty pharmacy distribution may be required to coordinate therapy
Prerequisite Therapy / Experience
The prescriber must document prior Factor IX therapy exposure OR clinical need for Beqvez as specified in the clinical criteria. Specifically, provide evidence that the patient has either: (a) been on prophylactic Factor IX replacement therapy and has ≥150 exposure days; OR (b) has documented clinical need for improved protection despite current therapy (examples: recurrent bleeding with severely damaged joints, need for anticoagulation, advanced age with fall risk).
- Documentation of ≥150 exposure days on a Factor IX prophylactic agent (e.g., Alprolix, BeneFIX, Idelvion, etc.) OR
- Prescriber narrative and supporting records demonstrating clinical need for improved protection despite current therapy
Required Documentation
Provide complete medical record documentation with the authorization request to support medical necessity. Required documents include diagnostic confirmation of congenital hemophilia B, baseline Factor IX level (≤2 IU/dL), inhibitor testing (history and current Bethesda units), AAVRh74var neutralizing antibody test (within 3 months), HIV and hepatitis B/C test results (timing as specified), liver function tests and imaging/ elastography results, and prior treatment history including gene therapy history. Include specialist consultation notes if prescriber is not a hematologist.
- Diagnosis of congenital hemophilia B (medical records)
- Baseline Factor IX level ≤2 IU/dL (lab report)
- Documentation of absence of Factor IX inhibitors and current Bethesda unit result
- AAVRh74var neutralizing antibody test results (within 3 months)
- HIV status and, if positive, viral load/CD4 results (within 3–12 months as specified)
- Hepatitis B surface antigen and HCV antibody/RNA results (within 3 months)
- Liver function tests (ALT, AST, ALP, total bilirubin) within 3 months and hepatic ultrasound/elastography report
- Record of prior Factor IX prophylaxis exposure days or prescriber justification for clinical need
- Documentation of no prior gene therapy and specialist involvement/consultation
Triggers for Denial
Requests lacking required clinical criteria or documentation will be denied. Common denial triggers include: age or sex outside criteria, diagnosis not congenital hemophilia B, baseline Factor IX level >2 IU/dL, history of inhibitors or current inhibitor ≥0.6 BU, presence of neutralizing antibodies to AAVRh74var, uncontrolled HIV or active hepatitis B/C, active antiviral therapy for hepatitis, elevated liver tests or unstable liver/biliary disease, significant liver fibrosis, prior gene therapy, or dosing requests exceeding FDA-labeled dosing or maximum units.
- Patient <18 years old or not male
- Diagnosis other than congenital hemophilia B
- Baseline Factor IX residual level >2 IU/dL
- History of Factor IX inhibitors or current inhibitor ≥0.6 Bethesda Units
- Positive neutralizing antibodies to AAVRh74var
- Uncontrolled HIV (viral load ≥20 copies/mL or CD4 ≤200) or active hepatitis B/C infection
- Current antiviral therapy for hepatitis B or C
- Elevated LFTs or evidence of unstable liver/biliary disease or significant fibrosis
- Prior receipt of any gene therapy
- Requested dose/quantity exceeding FDA-labeled dosing or maximum units (maximum units = 1)
Background and Clinical Context
Fidanacogene elaparvovec-dzkt (Beqvez) is an adeno-associated virus (AAV)-based, one-time intravenous gene therapy indicated for adults with moderate to severe congenital hemophilia B (Factor IX deficiency). The therapy is administered as a single intravenous infusion at the FDA-labeled dose and is intended as a one treatment course per lifetime. Coverage criteria emphasize pre-treatment assessment for AAVRh74var neutralizing antibodies, absence of active Factor IX inhibitors, assessment and acceptable limits of liver function and fibrosis, and required specialist involvement; when criteria are met, distribution from a specialty pharmacy may be required.
Key Definitions and Thresholds
Policy Changes and Revision History
Added revenue codes 0891 and 0892 associated with policy HCPCS code(s); policy notification given 2026-02-01 for effective date 2026-04-01.
Added HCPCS code J1414 to dosing reference table effective 2025-01-01; deleted C9172, J3490, and J3590 (termed 2024-12-31).
Added HCPCS code C9172 to dosing reference table effective 2024-10-01; deleted C9399 (termed 2024-09-30).
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