Beqvez (fidanacogene elaparvovec) — Coverage Criteria
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Coverage policy for a single-dose AAV-based gene therapy (Beqvez / fidanacogene elaparvovec) for adults with moderate-to-severe congenital Factor IX deficiency, including authorization, dosing, monitoring, and coding guidance for BCBSKS members.
New medical policy added to the BCBSKS web site for Beqvez (fidanacogene elaparvovec).
Coverage Criteria for Beqvez (fidanacogene elaparvovec)
Initial Approval Criteria
Covered when ALL of the following are met
Continuous routine prophylaxis is defined as intent to treat with a predefined frequency of infusions (e.g., twice weekly, once every two weeks) as documented in the medical record.
Examples of repeated/serious spontaneous bleeding include intramuscular hematomas requiring hospitalization, hemarthrosis, CNS bleeding (including intracranial hemorrhage), pulmonary hemorrhage, life‑threatening gastrointestinal hemorrhage, and umbilical cord bleeding.
If an inhibitor test is positive, re‑test within approximately 2 weeks; if re‑test is also positive, fidanacogene elaparvovec should not be given.
Active HIV infection defined as CD4+ <200/mm3 or viral load ≥20 copies/mL in seropositive cases.
Exogenous Factor IX or other hemostatic products may still be required perioperatively or for bleeds and may impede assessment of endogenous fidanacogene elaparvovec‑derived FIX activity.
Exclusions: Patients with prior hemophilia AAV‑vector–based gene therapy (for example, etranacogene dezaparvovec) are not eligible for coverage. Coverage is also excluded for patients with active uncontrolled liver disease or active viral hepatitis, or other liver-related contraindications listed in the policy (e.g., cirrhosis, portal hypertension, splenomegaly, hepatic encephalopathy, hepatic fibrosis).
Antibody and inhibitor considerations: before administration patients must be negative for Factor IX inhibitor titers (<0.6 Bethesda Units) with no prior history of inhibitors. If the initial inhibitor test is positive, a repeat test should be performed in approximately 2 weeks; if the repeat test remains positive, fidanacogene elaparvovec should not be given. In addition, patients must be AAVRh74var neutralizing antibody negative as determined by an FDA‑approved or CLIA‑compliant test.
Persistent inhibitors and contraindications: administration is not appropriate for patients with confirmed persistent positive Factor IX inhibitor titers after retesting; such patients should not receive fidanacogene elaparvovec. The policy also excludes patients with significant liver‑related contraindications (including ongoing liver‑related coagulopathy, hypoalbuminemia, persistent jaundice, cirrhosis, portal hypertension, splenomegaly, hepatic encephalopathy, or hepatic fibrosis) or those with an active HIV infection (defined in the policy as CD4+ <200/mm3 or viral load ≥20 copies/mL in seropositive cases).
Monitoring and counseling requirements that affect eligibility: baseline and post‑treatment liver function assessment is required with corticosteroid treatment for elevations, and patients with preexisting hepatocellular carcinoma risk factors require abdominal ultrasound and AFP surveillance. Patients must be counseled to avoid potentially hepatotoxic substances (e.g., alcohol) that may reduce therapy efficacy.
Coding and Dosing Information
| J1414 | Injection, fidanacogene elaparvovec-dzkt, per therapeutic dose; 1 billable unit = 1 kit (based on weight chart below) (Effective 01/01/2025) |
| J3590 | Unclassified biologics (Discontinue use on 01/01/2025) |
| C9172 | Injection, fidanacogene elaparvovec-dzkt, per therapeutic dose; 1 billable unit = 1 kit (based on weight chart below) (Discontinue use on 01/01/2025) |
| 00069-2004-04 | Beqvez NDC for kit size (≤75) — Multi-vial kit |
| 00069-2005-05 | Beqvez NDC for kit size (>75 to ≤95) |
| 00069-2006-06 | Beqvez NDC for kit size (>95 to ≤115) |
| 00069-2007-07 | Beqvez NDC for kit size (>115 to ≤135) |
Provider Requirements, Authorization, and Documentation
Prior Authorization and HCPCS
Prior authorization is required for fidanacogene elaparvovec (Beqvez). Submit PA requests through the payer's prior authorization web portal or by fax. Include the appropriate HCPCS code(s) on the request.
Documentation Requirement
Submission of medical records (chart notes) related to the medical necessity criteria is REQUIRED on all authorization requests. Requests without supporting documentation may be delayed or denied. Provide documentation via direct upload through the PA web portal or by fax.
- Required records: diagnosis confirmation (labs showing ≤2% Factor IX activity), documentation of continuous routine Factor IX prophylaxis or documented contraindication/intolerance, genetic/mutation testing when applicable, inhibitor testing results, HIV and liver disease testing, and baseline liver function tests
- Include documentation of counseling and monitoring plans (e.g., liver monitoring, steroid plans) when applicable
Clinical Eligibility Risks
Patients who do not meet the clinical eligibility criteria (e.g., age <18, Factor IX activity >2% without qualifying bleed history, prior AAV-vector gene therapy, positive AAV neutralizing antibodies, active HIV with immunosuppression, or active significant liver disease) are at risk for denial. Requests lacking required lab results or documentation of prophylaxis/serious bleeding history may be denied.
- Denial risk examples: age under 18; Factor IX activity >2% without qualifying bleeding history; prior AAV-vector gene therapy; positive AAVRh74 neutralizing antibodies; active uncontrolled hepatic disease; positive inhibitor titers ≥0.6 BU not re-tested
- Incomplete submissions (missing medical records, dose calculations, or inhibitor and antibody testing) increase likelihood of denial
Dosing Calculation Records
Provide detailed dosing calculation records with the authorization request. Calculations must include the patient's height, BMI, dose weight (kg), and calculated dose volume (mL) based on the product's vg/mL concentration.
- Dose calculation: Dose = 5 × 10^11 vg/kg × patient dose weight (kg)
- Dose weight calculation example: Dose Weight (kg) = 30 kg/m^2 × [Height (m)]^2 (per product guidance)
- Dose volume calculation: Dose weight (kg) ÷ 20 = dose in mL (based on 1×10^13 vg/mL concentration and 5×10^11 vg/kg dosing)
- Include documented math showing conversion from weight to vg and from vg to mL
Prophylaxis / Bleeding History Requirement
For Hemophilia B coverage, the patient must be on continuous routine Factor IX prophylaxis or have documented serious bleeding history. Continuous routine prophylaxis should be documented (e.g., planned infusion frequency) in the medical record. Historical life‑threatening hemorrhage or repeated serious spontaneous bleeding episodes are acceptable alternatives.
- Acceptable bleeding history: life-threatening hemorrhage, intramuscular hematomas requiring hospitalization, hemarthrosis, CNS bleeding, pulmonary hemorrhage, life‑threatening GI hemorrhage, or significant umbilical cord bleeding
- If contraindication/intolerance to prophylaxis is claimed, include clinical justification and supporting records
- Provide inhibitor testing showing <0.6 Bethesda Units (retest ~2 weeks if initially positive) and documentation of AAVRh74var neutralizing antibody negativity
Definitions
Background
Background: Beqvez (fidanacogene elaparvovec) is an adeno‑associated virus (AAV)‑based, single‑dose gene therapy designed to increase endogenous Factor IX activity in adults with moderate‑to‑severe congenital Factor IX deficiency (Hemophilia B). Use requires pre‑treatment evaluation including AAVRh74var neutralizing antibody testing and baseline liver assessment, and post‑treatment monitoring per the product labeling with corticosteroids used for hepatic transaminase elevations.
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