CurrentBlue Cross Blue Shield - IowaPolicy 05.05.56

Beqvez (fidanocogene elaparvovec‑dzkt) — Coverage and Prior Authorization Criteria for Hemophilia B

Covers prior authorization, documentation, and medical necessity criteria for one-time Beqvez (fidanocogene elaparvovec-dzkt) intravenous gene therapy in eligible adults with moderate to severe hemophilia B for members under Blue Cross Blue Shield - Iowa/Wellmark.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyBeqvez (fidanocogene elaparvovec‑dzkt) — Coverage and Prior Authorization Criteria for Hemophilia B

Policy CodePolicy 05.05.56

Change TypeNo material change

Effective DateOctober 17, 2024

Next Review Date

Key ActionObtain prior authorization and submit chart notes and labs documenting age ≥18, Factor IX ≤2%, negative AAVRh74var antibody, absence of Factor IX inhibitors, and qualifying bleeding history or prophylaxis use.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

one-timedose administration

5 x 10^11 vg/kgFDA dosing per kg

≥18min age (yrs)

≤2%Factor IX level

J1414

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Coverage Criteria

Initial Therapy (Hemophilia B)

Covered when ALL of the following are met

Beqvez initial therapy criteria: A. Member is 18 years of age or older>=18 years

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Factor IX inhibitor testing: B.a Member has a negative Factor IX inhibitor test result within the past 30 days OR B.b if member has a positive Factor IX inhibitor test result within the past 30 days, there is a negative test result within 2 weeks of the initial positive resulttest timing as specified

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Disease severity and clinical history: C Member has severe or moderately severe Factor IX deficiency (<=2% of normal circulating Factor IX) AND meets at least one of: currently using Factor IX prophylactic therapy; current or history of life‑threatening hemorrhage; history of repeated, serious spontaneous bleeding episodes<=2% Factor IX

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AAV antibody and hypersensitivity: D Member has a negative AAVRh74var antibody test result; E Member does not have hypersensitivity to factor IX replacement productnegative AAVRh74var antibody

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Infectious disease and liver status: F Member is HIV negative or has controlled HIV infection; member does not have active liver-related coagulopathy, hypoalbuminemia, persistent jaundice, cirrhosis, portal hypertension, splenomegaly, hepatic encephalopathy, hepatic fibrosis, or active viral hepatitis

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Prior gene therapy: G Member has not previously received gene therapy treatment

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All uses of Beqvez (fidanocogene elaparvovec-dzkt) other than the FDA-approved indication for adults with moderate to severe hemophilia B are considered experimental/investigational and not medically necessary. Coverage is limited to the specific, labeled indication when all policy clinical criteria are met.

Repeat treatment of Beqvez for any indication is considered investigational. Safety and efficacy beyond a single dose have not been studied, and therefore repeat dosing is not approved under this policy.

Initial Therapy

Initial Therapy — Initial authorization for hemophilia B

Initial authorization for hemophilia B

Eligibility: See Coverage.criteria_sets Initial Therapy for the complete AND logic (age, inhibitor testing, Factor IX level and clinical history, AAVRh74var antibody negative, hypersensitivity, HIV/liver status, and no prior gene therapy)

chunks 6,4

Continuation of Therapy

Continuation of Therapy — Continuation / repeat dosing

Continuation / repeat dosing

Repeat dosing: Repeat treatment is considered investigational and is not approved because safety and efficacy beyond one dose have not been studied

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Coding and Billing

Billing and HCPCS/CPT codesmixed

J1414	Injection, fidanacogene elaparvovecdzkt, per therapeutic dose (effective 1/1/2025)
C9172	Injection, fidanocogene elaparvovec-dzkt, per therapeutic dose (canceled 1/1/2025)
J3490	Unclassified drugs (when specified as [ Beqvez] ((fidanocogene elaparvovec-dzkt))
J3590	Unclassified biologics (when specified as [ Beqvez] (fidanocogene elaparvovec-dzkt))
C9399	Unclassified drugs or biologics (when specified as [ Beqvez] (fidanocogene elaparvovec-dzkt))

inv-05: Dose per kg

Dose per kg5 x 10^11 vector genomes per kg (vg/kg)

Administration routeSingle intravenous infusion (one-time)

Dosing basisCalculated by patient dose weight (kg) using actual or adjusted weight per BMI rule

inv-06: BMI dosing adjustment

BMI threshold for adjustmentIf BMI > 30 kg/m2

Adjusted dose weight formulaDose weight (kg) = 30 kg/m2 x height (m)

No adjustment when BMI ≤ 30

Provider Actions / Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization of 1 month for one dose total may be granted when all clinical criteria are met.

Authorization duration: 1 month for one dose total
Applicable condition: Hemophilia B (adult, single-dose gene therapy)
Prior authorization required before service

Step Therapy

No step therapy sequence is described for this single-dose gene therapy; it is intended as a one-time treatment and there are no prerequisite medications or step requirements listed.

Documentation Required

Step Therapy

Step	Description
1
No prior step therapy specified; Beqvez (single‑dose gene therapy) is intended as a one‑time treatment. Authorization of one month for one therapeutic dose may be granted when initial therapy criteria are met (see Initial Therapy: age ≥18; negative or appropriately timed Factor IX inhibitor testing; severe or moderately severe Factor IX deficiency ≤2% with qualifying bleeding history or prophylaxis use; negative AAVRh74var antibody; no hypersensitivity to factor IX replacement; HIV/liver status acceptable; no prior gene therapy).

Step

Description

No prior step therapy specified; Beqvez (single‑dose gene therapy) is intended as a one‑time treatment. Authorization of one month for one therapeutic dose may be granted when initial therapy criteria are met (see Initial Therapy: age ≥18; negative or appropriately timed Factor IX inhibitor testing; severe or moderately severe Factor IX deficiency ≤2% with qualifying bleeding history or prophylaxis use; negative AAVRh74var antibody; no hypersensitivity to factor IX replacement; HIV/liver status acceptable; no prior gene therapy).

Quantity Limits

inv-16: Beqvez (fidanocogene elaparvovec-dzkt)

Quantity limitOne dose per course (authorization of 1 month for one dose total may be granted)

ProductBeqvez (fidanocogene elaparvovec-dzkt)

Dosing regimenSingle infusion of 5 x 10^11 vg/kg

Site of Care

Billing Rule

Infusion center dosing and approval limits

Beqvez is administered as a single intravenous infusion; approvals may be subject to dosing limits consistent with labeling and guidelines, including the single‑dose 5 x 10^11 vg/kg regimen and BMI-based dosing weight adjustment.

Dosing: single infusion of 5 x 10^11 vector genomes per kg (vg/kg).
Approvals may be limited per FDA labeling, compendia, or evidence‑based guidelines.

Background

Beqvez is an AAV-vector based, one-time intravenous gene therapy designed to enable endogenous Factor IX production in adults with moderate to severe hemophilia B who have a qualifying bleeding history or use prophylactic Factor IX. Treatment requires demonstrated absence of neutralizing antibodies to AAVRh74var and meets other clinical eligibility criteria (age, Factor IX level, inhibitor status, liver and HIV status) as specified in the coverage criteria.

Definitions

inv-12: AAVRh74var antibody negative

DefinitionNo detectable neutralizing antibodies to adeno-associated virus serotype Rh74var as determined by an FDA-approved test

Requirement for eligibilityRequired for treatment of hemophilia B with Beqvez (per FDA indication)

Clinical implicationMember must have negative AAVRh74var antibody test result prior to authorization