CurrentEmblemHealthPolicy MG.MM.PH.413

Beqvez (fidanacogene elaparvovec-dzkt) intravenous gene therapy — Coverage Criteria

Clinical coverage policy governing one-time administration of Beqvez for adults with moderate to severe hemophilia B; defines eligibility, required documentation, dosing limits, and coding for preauthorization decisions affecting EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyBeqvez (fidanacogene elaparvovec-dzkt) intravenous gene therapy — Coverage Criteria

Policy CodePolicy MG.MM.PH.413

Change TypeNo material change

Effective DateJun 28, 2024

Next Review DateFeb 27, 2025

Key ActionObtain prior authorization demonstrating eligibility and required documentation for a one-time dose of Beqvez at 5 x 10^11 vg/kg.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

one per lifetimedose frequency covered

5 x 10^11 vg/kgrecommended dose

18+ yrsminimum age

<2%baseline Factor IX

J1414applicable J-code

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Coverage Criteria for Beqvez (fidanacogene elaparvovec-dzkt)

Initial Therapy (Adults with Hemophilia B)

Approve a one-time (per lifetime) single dose if the patient meets ALL of the following:

Age and sex: Patient is male AND patient is > 18 years of age

Prior gene therapy: Patient has not received a gene therapy for hemophilia B (verification in claims history required; if claims history unavailable, prescribing physician confirms no prior Beqvez or Hemgenix)

Severity: Moderately severe or severe hemophilia B as evidenced by baseline (without Factor IX replacement therapy) Factor IX level < 2% of normal< 2%

documentation required

Factor IX exposure: According to the prescribing physician, the patient has a history of use of Factor IX therapy for >150 exposure days>150 exposure days

Clinical bleeding history: Patient has one of: current or historical life-threatening hemorrhage; currently uses Factor IX prophylaxis; or has repeated, serious spontaneous bleeding episodes

On-demand use of Factor IX for the hemorrhage/episodes may be required as documented by the prescriber

AAV neutralizing antibodies: Patient does not have neutralizing antibodies to AAVRh74 capsid as detected by an FDA-approved testnegative on approved test

documentation required

Factor IX inhibitors: Factor IX inhibitor titer testing performed within 30 days; patient is negative for Factor IX inhibitors and has no history of inhibitorsnegative

documentation required

Infection and antiviral status: No active infection with hepatitis B virus or hepatitis C virus and patient is not currently receiving antiviral therapy for prior HBV/HCV exposure

documentation required

HIV status: Patient does not have uncontrolled human immunodeficiency virus infection as reported by the prescribing physician

Liver function testing within 30 days with ALT and AST < 2x ULN, alkaline phosphatase < 2x ULN, and total bilirubin < 1.5x ULN; no evidence of advanced liver impairment or advanced fibrosisas stated

documentation required; example elastography criteria provided

Renal function: Creatinine < 2.0 mg/dL within 30 days< 2.0 mg/dL

documentation required

Hematology: Platelet count > 100 x 10^9/L within 30 days>100 x10^9/L

documentation required

Prescriber specialty: Medication is prescribed by a hemophilia specialist physician

Weight and dosing verification: Current patient body weight obtained within 30 days; dose to provide a one-time single dose of 5 x 10^11 vector genomes per kg by intravenous infusion (dose weight adjusted for BMI > 30 kg/m^2 as specified)5 x 10^11 vg/kg

documentation and verification required; one dose per lifetime

Prior receipt of gene therapy for hemophilia B is an exclusion and will preclude coverage of Beqvez. Verification of prior gene therapy should be performed via claims history when available; if claims history is not available, the prescribing physician must confirm that the patient has not previously received Beqvez or Hemgenix.

Requests that document prior receipt of any gene therapy for hemophilia B will be denied, consistent with the policy exclusion.

Coding, Dose, and Diagnostic Codes

Applicable Procedure CodesHCPCSCovered

J1414

Injection, fidanacogene elaparvovec-dzkt, per therapeutic dose

Applicable NDCsNDC

00069-0422-01	Beqvez 1X10E13/ML
00069-2004-XX
00069-2005-XX	Beqvez 5x1mL
00069-2006-XX	Beqvez 6x1mL
00069-2007-XX	Beqvez 2x1mL

Applicable ICD-10 DiagnosesICD-10Covered

D67	Hereditary Factor IX Deficiency

inv-06: Dose — single lifetime dose value and related dosing note

Dose (single lifetime)One-time (per lifetime) single dose of 5 x 10^11 vector genomes per kg of body weight by intravenous infusion

Dose weight adjustmentUse adjusted body weight for BMI > 30 kg/m^2 using: Dose Weight (kg) = 30 kg/m^2 x [Height (m)]^2

VerificationApproval provides one dose (vials in a kit) to deliver the 5 x 10^11 vg/kg therapeutic dose; number of vials per kit and NDCs specified in table

inv-07: Baseline Factor IX level — required threshold information

Required baseline Factor IX levelBaseline (off‑factor) Factor IX level < 2% of normal is required (documentation required)

ContextSeverity criterion: moderately severe or severe hemophilia B demonstrated by the <2% baseline Factor IX threshold

DocumentationBaseline measurement must be without Factor IX replacement therapy

inv-08: Laboratory timing — required labs and timing (e.g., within 30 days)

Required labs within 30 daysFactor IX inhibitor titer testing, liver function tests (ALT, AST, alkaline phosphatase, total bilirubin), platelet count, creatinine, and current body weight must be obtained within 30 days

LFT thresholdsALT and AST < 2x ULN; alkaline phosphatase < 2x ULN; total bilirubin < 1.5x ULN

Hematology/renal thresholdsPlatelet count > 100 x 10^9/L; creatinine < 2.0 mg/dL

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required. Coverage is for a one-time (per lifetime) single dose; approval is contingent on meeting the clinical criteria and submission of required documentation.

One lifetime dose only (single dose by intravenous infusion).
Prescribing physician must be a hemophilia specialist.
Verification in claims history required to confirm no prior receipt of Beqvez or Hemgenix.

Note

Clinical Sequencing / Requirements

Clinical sequencing/requirements. Approve a one-time dose only when ALL of the Initial Criteria are met for adult males with moderately severe or severe hemophilia B. Key requirements include documented baseline Factor IX activity, prior exposure to Factor IX therapy, absence of neutralizing antibodies to AAVRh74 capsid, absence of Factor IX inhibitors, appropriate liver and renal function, and no evidence of advanced liver impairment.

Patient is male and > 18 years of age.
Baseline (off replacement) Factor IX level < 2% of normal (documentation required).
History of > 150 exposure days to Factor IX therapy (per prescribing physician) OR documentation of life‑threatening hemorrhage OR repeated serious spontaneous bleeding episodes requiring on‑demand Factor IX.
Patient has not previously received gene therapy for hemophilia B (verification in claims history required).
Negative for neutralizing antibodies to AAVRh74 capsid by an FDA‑approved test (documentation required).
Factor IX inhibitor testing performed within 30 days and negative (documentation required); no history of Factor IX inhibitors.
Prophylactic Factor IX therapy will not be continued after Beqvez once adequate Factor IX levels achieved (episodic Factor IX allowed for bleeds/surgery).
No active hepatitis B or C infection; not currently receiving antiviral therapy for prior hepatitis B or C exposure (documentation required).
Liver function tests within 30 days: ALT, AST, alkaline phosphatase each < 2x ULN; total bilirubin < 1.5x ULN; no advanced liver impairment/fibrosis (documentation required).
Within 30 days: creatinine < 2.0 mg/dL and platelet count > 100 x 10^9/L (documentation required).
If criteria A–P are met, approve one dose of 5 x 10^11 vector genomes/kg IV (dose weight verification within 30 days; adjusted body weight dosing for BMI > 30 kg/m2).

Documentation Required

Required documentation for prior authorization. Submit documentation to verify all inclusion/exclusion criteria and baseline testing; lack of required documentation may result in denial.

Verification of no prior gene therapy for hemophilia B (claims history or prescriber attestation).
Baseline Factor IX level (off replacement therapy) demonstrating < 2% of normal.
Evidence of >150 exposure days to Factor IX OR documentation of life‑threatening hemorrhage OR documentation of repeated serious spontaneous bleeding episodes and need for on‑demand Factor IX.
AAVRh74 neutralizing antibody test result (FDA‑approved assay) showing absence of neutralizing antibodies.
Factor IX inhibitor titer test performed within 30 days showing negative result and documentation of no history of inhibitors.
Recent liver function tests (ALT, AST, alkaline phosphatase, total bilirubin) within 30 days and assessment for advanced liver disease (e.g., elastography if available).
Recent renal function (creatinine within 30 days) and platelet count within 30 days.
Prescribing hemophilia specialist physician name and attestation that prophylactic Factor IX will not be continued after gene therapy once adequate Factor IX levels achieved.
Current body weight within 30 days for dose calculation (note on adjusted body weight for BMI > 30).

Denial Risk

Denial Triggers

Triggers for denial. Requests will be denied when exclusion criteria are met or required clinical criteria/documentation are not satisfied.

Prior receipt of any gene therapy for hemophilia B (exclusion).
Presence of neutralizing antibodies to AAVRh74 capsid on an FDA‑approved test.
Active hepatitis B or C infection or currently receiving antiviral therapy for prior hepatitis B or C exposure (unless criteria for exclusion are resolved and documented).
Uncontrolled HIV infection.
Evidence of advanced liver impairment or advanced fibrosis (e.g., elastography consistent with METAVIR Stage 3 or greater).
Baseline Factor IX level >= 2% of normal (does not meet severity requirement).
Positive Factor IX inhibitor testing or history of inhibitors.
Missing or inadequate documentation to confirm fulfillment of the Initial Criteria (e.g., absent lab results, missing prescriber attestation, no proof of prior Factor IX exposure when required).

OpenPayer

Beqvez (fidanacogene elaparvovec-dzkt) intravenous gene therapy — Coverage Criteria

Coverage Criteria for Beqvez (fidanacogene elaparvovec-dzkt)

Coding, Dose, and Diagnostic Codes

Prior Authorization, Documentation, and Denial Triggers

Background

Definitions and Indication

Revision History