CurrentCentenePolicy CP.PHAR.643

Clinical Policy: Fidanacogene Elaparvovec-dzkt (Beqvez)

Clinical policy governing prior authorization, coding, and coverage criteria for the gene therapy fidanacogene elaparvovec-dzkt (Beqvez) for members covered by the Health Plan (Centene). Affects providers requesting coverage/administration and billing for Beqvez.

Policy Summary

PayerCentene

PolicyFidanacogene Elaparvovec-dzkt (Beqvez) clinical policy

Policy CodePolicy CP.PHAR.643

Change TypeCoding, clinical criteria, and documentation updates

Effective DateApr 25, 2024

Next Review Date

Key ActionSubmit prior authorization with required documentation, including negative neutralizing antibody testing to AAVRh74var, HIV test results (with CD4/viral load documentation if positive), liver-related documentation or hepatologist attestation when indicated, and member body weight for dosing; use HCPCS code J1414 for billing.

SourceLink

POLICY UPDATE CHANGES

HCPCS code J1414 (Injection, fidanacogene elaparvovec-dzkt, per therapeutic dose) was added and prior miscellaneous codes [C9172, C9399, J3590] were removed.

Baseline severity and treatment history criteria revised to remove the requirement for ≥6 months of factor IX product use and to allow current or historical life‑threatening hemorrhage as qualifying events.

Requirements added for documentation of negative neutralizing antibodies to AAVRh74var and documentation related to HIV testing (minimum CD4 or maximum viral load) and liver-related conditions, including hepatologist attestation if abnormal.

Note that manufacturer will no longer develop and commercialize Beqvez was added to references/notes.

Prior authorization reviews are to be redirected to the Precision Drug Action Committee (PDAC) Utilization Management Review.

J1414HCPCS code added for Beqvez

Policy Summary

PayerCentene

PolicyFidanacogene Elaparvovec-dzkt (Beqvez) clinical policy

Policy CodePolicy CP.PHAR.643

Change TypeCoding, clinical criteria, and documentation updates

Effective DateApr 25, 2024

Next Review Date

SourceLink

On This Page

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Authorization Criteria

Diagnosis and FDA labeling: Clinical diagnosis of hemophilia B consistent with FDA prescribing information for fidanacogene elaparvovec-dzkt (Beqvez).as specified in PI
Laboratory and infectious disease testing
- Documentation of a negative neutralizing antibody test to AAVRh74var per prescribing information.
- If HIV positive, documentation of HIV test results including minimum CD4+ cell count or maximum viral load as specified in the PI.
Liver-related evaluation
- Documentation that the member does not have current liver-related conditions per the PI.
- If sustained liver enzyme elevations or radiologic liver abnormalities are present, documentation of hepatologist attestation of Beqvez eligibility per the PI.
Dose verification: Documentation of member body weight to allow verification of the weight‑based dose (dose calculation per Appendix E/PI).
Bleeding history / prior factor IX use (qualifying events)
- Current use of a factor IX product (time‑based ≥6 months requirement removed).
- Current or historical life‑threatening hemorrhage.
- Repeated serious spontaneous bleeding episodes consistent with FDA labeling and Hemgenix‑aligned criteria.

No new explicit medical exclusions are listed in this policy segment; however, the manufacturer has announced it will no longer develop or commercialize Beqvez, which may affect future product availability and coverage logistics. Providers and payers should be aware that operational impacts from the manufacturer’s decision could influence access even when clinical criteria are met.

For operational details and references, see the Beqvez Prescribing Information and the policy references that document the manufacturer announcement and related guidance.

Codes shown in this policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers must consult the most up-to-date professional coding guidance and payer-specific billing instructions prior to claim submission to determine appropriate coding and coverage.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J1414

Injection, fidanacogene elaparvovec-dzkt, per therapeutic dose

Removed / legacy codesHCPCSNot Covered

C9172	Previously referenced miscellaneous code (removed)
C9399	Previously referenced miscellaneous code (removed)
J3590	Previously referenced miscellaneous code (removed)

Baseline factor IX product prior use — inv-06

Prior time-based requirementRequirement that member have used a factor IX product for ≥6 months was removed; current use of a factor IX product or qualifying bleeding history now sufficient.

Replaced criterionPrevious requirement of ≥6 months continuous factor IX use with ≥1 serious spontaneous bleed changed to allow current use without a time frame.

Additional qualifying eventsAdded option of current or historical life‑threatening hemorrhage and modified repeated serious spontaneous bleeding episodes to align with FDA labeling and Hemgenix criteria.

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required & Billing

Prior authorization is required for Beqvez (fidanacogene elaparvovec-dzkt). Billing for Beqvez should use HCPCS code J1414 (Injection, fidanacogene elaparvovec-dzkt, per therapeutic dose). Operational routing: prior authorization reviews will be redirected to the Precision Drug Action Committee (PDAC) Utilization Management Review as indicated in policy updates.

HCPCS: J1414
Operational routing: PDAC Utilization Management Review

Documentation Required

Required Documentation for Authorization

Documentation required for prior authorization includes laboratory tests, specialist attestations, and weight-based dosing verification. Failure to include required documentation may delay or result in denial.

Negative neutralizing antibody test to AAVRh74var documented (per FDA labeling)

Definitions & Specialist Requirements

AAV neutralizing antibody testing requirement per PI — inv-12

Required antibody testDocumentation of a negative neutralizing antibody test to AAVRh74var per the prescribing information is required for authorization.

Source of requirementRequirement aligned with FDA labeling and clarified in policy language referencing the prescribing information.

Related documentationNegative neutralizing antibody result is listed among required authorization documentation and a trigger for denial if absent.

Specialist documentation required — inv-13

Specialist attestationHepatologist attestation of Beqvez eligibility is required if sustained liver enzyme elevations or radiologic liver abnormalities are present per prescribing information.

Liver-related condition criterion

Background

Fidanacogene elaparvovec-dzkt (Beqvez) is an adeno-associated virus (AAV)-based gene therapy indicated for hemophilia B (factor IX deficiency). The policy aligns eligibility and documentation requirements with the FDA Prescribing Information, including requirements for negative neutralizing antibody testing to the relevant AAV serotype, HIV testing parameters, liver-related evaluations, and weight documentation for dose verification. The prescribing information is cited as the primary clinical reference.

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