Beqvez (fidanacogene elaparvovec-dzkt) — Prior Authorization Criteria
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Prior authorization criteria for the use of Beqvez (fidanacogene elaparvovec-dzkt) in adults with moderate-to-severe hemophilia B under Alaska Medicaid, including approval, denial, monitoring, quantity limits, and duration of approval.
No material clinical or coverage changes in this revision.
Coverage Criteria for Beqvez (fidanacogene elaparvovec-dzkt)
Initial approval criteria
Covered when ALL of the following are met:
FDA indications and listed safety screening required
Coverage excludes patients with active viral infections or advanced liver disease that increase risk or contraindicate administration. Specifically, patients with active hepatitis B or hepatitis C infection are excluded. Also excluded are patients with uncontrolled HIV infection, those with evidence of advanced hepatic impairment, and patients who have previously received gene therapy for hemophilia B.
If the patient does not meet all listed approval criteria, prior authorization for Beqvez is not approved and the request will be denied.
Coding and Clinical Thresholds
| J3590 | Unclassified biologics (listed under Quantity Limit / HCPCS in document) |
Provider Requirements, Documentation, and Denial Triggers
Prior authorization, one-infusion lifetime limit, initial approval 3 months
Prior authorization is required for Beqvez; requests must meet the listed approval criteria. Quantity is limited to one infusion per lifetime. Initial approval is limited to 3 months; no reauthorization will be approved.
- HCPCS: J3590
Required treatment history per FDA indications
Patient must meet the FDA-indication treatment history: currently use Factor IX prophylaxis OR have current/historical life‑threatening hemorrhage OR have repeated, serious spontaneous bleeding episodes.
Required clinical documentation and testing
Provide documentation verifying disease severity, exposure history, antibody/inhibitor testing, and hepatic evaluation prior to administration.
- Factor IX level ≤2% of normal or <2 IU/dL
- >150 prior exposure days to factor IX
- No neutralizing antibodies to AAVRh74var per an FDA‑approved test
- Inhibitor screen within two weeks prior to administration negative (≤0.5 Bethesda units)
- Hepatic ultrasound and elastography performed prior to administration
Denial triggers and exclusions
Deny authorization if the patient fails to meet approval criteria or has listed exclusionary conditions.
- Active hepatitis B or hepatitis C infection
- Uncontrolled HIV infection
- Evidence of advanced hepatic impairment
- Prior treatment with gene therapy for hemophilia B
Background
Beqvez (fidanacogene elaparvovec-dzkt) is an adeno-associated virus (AAV) vector–based, single-administration gene therapy indicated for adults with moderate-to-severe hemophilia B to reduce bleeding and the need for factor IX replacement. Candidate selection requires careful screening for viral infections and hepatic function prior to administration.
Definitions
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