CurrentBlue Cross Blue Shield - North CarolinaPolicy N/A

Fidanacogene elaparvovec-dzkt (Beqvez) — Notification (coverage criteria)

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.

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyFidanacogene elaparvovec-dzkt (Beqvez) — Notification (coverage criteria)

Policy CodePolicy N/A

Change TypeCoding updatesrevenue code additions

Effective DateApr 1, 2026

Next Review Date2027-Q2

Key ActionSubmit prior authorization for Beqvez (HCPCS J1414) with required documentation including baseline Factor IX ≤2 IU/dL, AAVRh74var neutralizing antibody test, HIV/HBV/HCV and liver tests.

SourceLink

POLICY UPDATE CHANGES

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).

J1414HCPCS code for Beqvez

5 x 10^11 vg/kgFDA single-dose IV dosing

180 daysDuration of approval

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Coverage and Medical Necessity

Medical Necessity Criteria

Covered when ALL of the following are met:

Core patient eligibility: 1) Age ≥ 18 years; 2) Male sex; 3) Diagnosis of congenital hemophilia B (Factor IX deficiency) with medical record documentation; 4) Baseline Factor IX residual level ≤ 2 IU/dL (≤ 2% of normal circulating Factor IX) with laboratory documentation; 5) ONE of: a) Patient is on prophylactic Factor IX therapy and has ≥ 150 exposure days; OR b) Prescriber documents that the patient requires improved protection beyond current therapy (examples: severely damaged joints, need for anticoagulation, elderly at risk for falls); 6) No history of inhibitors to Factor IX (documentation required); 7) No active inhibitors to Factor IX (≥ 0.6 Bethesda Units defines active; documentation required); 8) No neutralizing antibodies to AAVRh74var (test results within past 3 months required); 9) ONE of: a) HIV negative; OR b) HIV positive but well controlled (viral load < 20 copies/mL and/or CD4 > 200/mm3; documentation within timeframes specified); 10) Hepatitis B surface antigen negative (documentation required); 11) ONE of: a) HCV antibody negative; OR b) HCV antibody positive with HCV RNA negative (documentation required); 12) Not currently using antiviral therapy for hepatitis B or C (documentation required); 13) No evidence of any bleeding disorder unrelated to hemophilia B (documentation required); 14) Liver tests not > 2× ULN (ALT, AST, ALP) and total bilirubin ≤ 1.5× ULN (labs within past 3 months); 15) No unstable liver or biliary disease (examples: ascites, hepatic encephalopathy, portal hypertension, splenomegaly, coagulopathy, hypoalbuminemia, esophageal/gastric varices, persistent jaundice, cirrhosis); 16) No significant liver fibrosis by hepatic ultrasound and elastography (documentation required); 17) No prior gene therapy (including requested agent); 18) Prescriber is a specialist (e.g., hematologist) or has consulted a specialist (documentation required); 19) Requested dose is within FDA-labeled dosing for the indication and requested quantity does not exceed maximum units allowed for duration of approval.see node text

Duration of approval 180 days; one treatment course per lifetime

Dosing and administration: FDA dosing: single IV infusion of 5 × 10^11 vector genomes per kg as a one-time single-dose infusion; HCPCS = J1414; Maximum Units = 1; distribution from a specialty pharmacy provider may be required.single-dose

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

Covered HCPCS CodesHCPCSCovered

J1414

fidanacogene elaparvovec-dzkt (Beqvez) intravenous infusion

Applicable Revenue CodesRevenue

0891	Special Processed Drugs - FDA Approved Cell Therapy (revenue code)
0892	Special Processed Drugs - FDA Approved Gene Therapy (revenue code)

Historically used/removed codesHCPCS

C9172	Previously listed HCPCS (deleted 12/31/2024 or earlier per history)
C9399	Previously listed HCPCS (deleted 9/30/2024)
J3490	Previously listed HCPCS (deleted 12/31/2024)
J3590	Previously listed HCPCS (deleted 12/31/2024)

inv-07: Factor IX baseline residual level

Factor IX baseline residual level≤ 2 IU/dL (≤ 2% of normal circulating Factor IX)

Documentation requiredMedical record documentation including lab test demonstrating baseline level

Clinical significanceDefines moderately severe to severe congenital hemophilia B

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

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

Step 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).

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

inv-13: Factor IX baseline residual level definition

DefinitionFactor IX baseline residual level ≤ 2 IU/dL (≤ 2% of normal)

Associated severityModerately severe to severe hemophilia B

RequirementMedical record documentation required, including lab test

inv-14: Controlled HIV infection definition

Viral load thresholdViral load < 20 copies/mL

CD4+ cell count thresholdCD4+ cell count > 200/mm3

Documentation timing

Policy Changes and Revision History

2026-04-01coding_updateLatest

Added revenue codes 0891 and 0892 associated with policy HCPCS code(s); policy notification given 2026-02-01 for effective date 2026-04-01.

2025-01-01coding_update

Added HCPCS code J1414 to dosing reference table effective 2025-01-01; deleted C9172, J3490, and J3590 (termed 2024-12-31).

2024-10-01coding_update