CurrentAvMedPolicy Pub. 100-2

Beqvez (fidanacogene elaparvovec‑dzkt) prior authorization for Hemophilia B

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Form and clinical criteria governing prior authorization for use of Beqvez (fidanacogene elaparvovec-dzkt) for members with moderate to severe congenital factor IX deficiency (Hemophilia B); applies to AvMed providers requesting medical (J3590) coverage. Affects prescribers, administering sites, and specialty pharmacy workflows.

Policy Summary

PayerAvMed

PolicyBeqvez (fidanacogene elaparvovec‑dzkt) prior authorization for Hemophilia B

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization for Beqvez billed under J3590 with required documentation and prescriber signature; coverage limited to a single-dose kit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

single doseCoverage limited to one infusion (not renewable)

≥18Minimum patient age for eligibility

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CurrentAvMedPolicy Pub. 100-2

Beqvez (fidanacogene elaparvovec‑dzkt) prior authorization for Hemophilia B

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Sign up for AvMed Policy Pub. 100-2 alerts

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Policy Summary

PayerAvMed

PolicyBeqvez (fidanacogene elaparvovec‑dzkt) prior authorization for Hemophilia B

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization for Beqvez billed under J3590 with required documentation and prescriber signature; coverage limited to a single-dose kit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

single doseCoverage limited to one infusion (not renewable)

≥18Minimum patient age for eligibility

Coverage Criteria for Beqvez (fidanacogene elaparvovec-dzkt)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial eligibility

Age and specialist care: Member is at least 18 years of age and under the care of a hematology specialist
Diagnosis and severity: Diagnosis of moderate to severe congenital Factor IX deficiency confirmed by blood coagulation testing with baseline Factor IX activity ≤ 2% of normal<= 2% FIX activity
Prior prophylaxis exposure: Member is on continuous routine Factor IX prophylaxis (unless contraindicated or intolerant) and has been stabilized on prophylaxis for at least 2 months with ≥150 exposure days prior to treatment>=150 exposure days
Continuous routine prophylaxis defined in medical record (pre‑defined frequency of infusions)
Bleeding or prophylaxis indication (at least one): Member must have at least ONE of the following: currently using Factor IX prophylaxis therapy, or history of life‑threatening hemorrhage, or repeated serious spontaneous bleeding episodes (e.g., intramuscular hematomas requiring hospitalization, hemarthrosis, CNS bleeding, pulmonary hemorrhage, life‑threatening GI hemorrhage)
Check all that apply; at least one required
Inhibitor and antibody tests: Negative Factor IX inhibitor titer (<0.6 Bethesda Units) with no prior history of inhibitors; if initial test is positive, re‑test in ~2 weeks and do not treat if persistently positive; AAVRh74var neutralizing antibody negative by an FDA‑approved or CLIA‑compliant testinhibitor <0.6 BU
If inhibitor persists after re‑test, Beqvez should not be given
Liver and infectious disease screening: Baseline liver function assessment prior to and after therapy per product labeling; no current liver‑related coagulopathy, hypoalbuminemia, persistent jaundice, cirrhosis, portal hypertension, splenomegaly, hepatic encephalopathy, hepatic fibrosis, or active viral hepatitis; tested for HIV and no active infection
Patients with hepatocellular carcinoma risk factors require abdominal ultrasound and periodic AFP monitoring after administration; counsel to avoid hepatotoxic substances
Dosing and quantity limits: Planned administration is a single‑dose intravenous infusion of 5 × 10^11 vg/kg with dose volume and vial/kit selection calculated per weight/BMI; quantity limit = one kit (based on weight chart) and coverage is for one dose only (may NOT be renewed)5 × 10^11 vg/kg; 1 kit max
Dose weight calculation uses actual weight if BMI ≤30 kg/m^2; if BMI >30 kg/m^2, dose weight = 30 × (height in meters)^2; number of vials and NDC determined by weight ranges

The member is not eligible if they have previously received a hemophilia AAV‑vector‑based gene therapy (for example, etranacogene dezaparvovec) or if they have persistent positive Factor IX inhibitor titers after re‑testing. Baseline requirements include a negative Factor IX inhibitor titer (<0.6 Bethesda Units) with no prior history of inhibitors; if an initial inhibitor test is positive, re‑test approximately 2 weeks later and with persistent positivity do not administer Beqvez.

Coverage is limited to a single-dose administration. Quantity limits restrict coverage to one kit per member and the therapy will be provided for one dose only; additional doses or renewal beyond one kit are not covered.

Coding and Dose Information

Affected HCPCSHCPCS

J3590

Unclassified biologics (Beqvez listed as Medical)

NDCs per kit sizeNDC

00069-2004-04	NDC for 4-vial kit (≤75 kg)
00069-2005-05	NDC for 5-vial kit (>75 to ≤95 kg)
00069-2006-06	NDC for 6-vial kit (>95 to ≤115 kg)
00069-2007-07	NDC for 7-vial kit (>115 to ≤135 kg)

inv-06: Dose calculation — dosing (5 × 10^11 vg/kg), dose volume formula, BMI >30 adjustment

Per‑kg dose5 × 10^11 vector genomes per kg (vg/kg) as a single intravenous infusion

Dose volume formulaDose volume (mL) = dose weight (kg) ÷ 20 (division factor 20 = 1×10^13 vg/mL ÷ 5×10^11 vg/kg)

Dose‑weight determination (BMI ≤30 kg/m^2)Use actual body weight as dose weight

Dose‑weight determination (BMI >30 kg/m^2)If BMI > 30 kg/m^2, calculate dose weight = 30 kg/m^2 × [height (m)]^2 (use this dose weight in volume formula)

Provider Actions, Authorization & Documentation

Prior Authorization

Prior authorization and single‑dose billing limits

Prior authorization is required for Beqvez when billed as J3590 (Unclassified biologics). Coverage is limited to a single-dose kit and quantity limits restrict reimbursement to one kit per member.

Billing HCPCS: J3590
Quantity limit: 1 kit (based on weight chart)
Coverage provided for one dose and may NOT be renewed

Step Therapy

Require stabilization on routine Factor IX prophylaxis

Member must be on continuous routine Factor IX prophylaxis and stabilized on that prophylaxis for at least 2 months with a minimum of 150 exposure days prior to treatment with fidanacogene elaparvovec‑dzkt.

Continuous routine prophylaxis defined as intent to treat with a predefined infusion frequency documented in medical records

Definitions

inv-12: Continuous routine prophylaxis — definition and examples (frequency intent, e.g., twice weekly)

DefinitionContinuous routine prophylaxis: intent to treat with a pre‑defined frequency of infusions (e.g., twice weekly, once every two weeks) as documented in the medical record

Stabilization requirementMember must be stabilized on FIX prophylaxis for at least 2 months with ≥150 exposure days prior to treatment

Examples of frequency intentExamples include twice weekly or once every two weeks (frequency must be predefined and documented)

Background

Beqvez (fidanacogene elaparvovec‑dzkt) is an adeno‑associated viral (AAV) vector–based gene therapy indicated for adults with moderate to severe congenital Factor IX deficiency (Hemophilia B). The approved regimen is a single‑dose intravenous infusion dosed at 5 × 10^11 vector genomes per kg (vg/kg), with dosing calculated by body weight (and adjusted for BMI per the dosing chart). Recipients must be ≥18 years of age and managed by a hematology specialist; baseline FIX activity must be ≤2% and patients must be on continuous routine Factor IX prophylaxis (or have a documented contraindication/intolerance) and stabilized on prophylaxis prior to treatment. Monitoring of Factor IX activity and liver function is required after administration.