CurrentCignaPolicy N/A

Beqvez (gene therapy for hemophilia B) — Coverage Criteria and Prior Authorization

Prior authorization requirements and medical necessity criteria for use of Beqvez (gene therapy) for adult males with moderately severe to severe hemophilia B; applies to Cigna members/providers requesting coverage. Form and supporting documentation requirements are specified.

Policy Summary

PayerCigna

PolicyBeqvez (gene therapy for hemophilia B) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeMinor editorial — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization using the Cigna Gene Therapy form and fax with required supporting documentation to 833-910-1625.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18min age

≤2%Factor IX threshold

≥150 daysprior Factor IX exposure

ALT/AST ≤2xliver tests

≥100 x10^9/Lplatelets

Coverage Criteria for Beqvez (hemophilia B)

Medical Necessity Criteria (Initial therapy)

Beqvez is considered medically necessary when ALL of the following are met (provider must check each):

Demographics: Patient is male AND patient is ≥ 18 years of age

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Prior gene therapy: Patient has not received a gene therapy for hemophilia B in the past (verification in claims history required or physician attestation)

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Disease severity: Baseline (without Factor IX replacement) Factor IX level ≤ 2% of normal≤ 2%

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Policy Summary

PayerCigna

PolicyBeqvez (gene therapy for hemophilia B) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeMinor editorial — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization using the Cigna Gene Therapy form and fax with required supporting documentation to 833-910-1625.

SourceLink

On This Page

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Therapy history or bleeding history: Either: (i) history of use of Factor IX therapy for ≥ 150 exposure days; OR (ii) history of life‑threatening hemorrhage with on‑demand Factor IX therapy required; OR (iii) history of repeated, serious spontaneous bleeding episodes requiring on‑demand Factor IX therapy

AAV antibody: No neutralizing antibodies to adeno‑associated virus serotype Rh74var (AAVRh74var) capsid by an approved test

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Factor IX inhibitors: Factor IX inhibitor titer testing performed within 30 days AND negative for inhibitors30 days

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Hepatitis and antiviral therapy: No active hepatitis B or C infection AND not currently receiving antiviral therapy for prior hepatitis B or C exposure

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HIV status: No uncontrolled human immunodeficiency virus infection (per prescribing physician assessment)

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Liver function tests within 30 days meeting ALL: ALT ≤ 2× ULN; AST ≤ 2× ULN; total bilirubin ≤ 1.5× ULN; ALP ≤ 2× ULN; and no evidence of advanced liver impairment or advanced fibrosis30 days

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Hematology and renal: Platelet count within 30 days ≥ 100 x10^9/L AND creatinine within 30 days ≤ 2.0 mg/dL30 days

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Prescriber specialty: Medication is prescribed by a hemophilia specialist physician

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Weight documentation: Current patient body weight has been obtained within 30 days30 days

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Any use of Beqvez that does not meet the specific medical necessity criteria listed in this policy is considered experimental, investigational, or unproven. Providers must either meet all required criteria or supply clinical justification and supporting documentation if they believe use outside the criteria is medically necessary.

Checkboxes on the Cigna Gene Therapy form must be completed to document exclusions or circumstances that render the patient outside the studied population (for example, prior receipt of gene therapy or a history of Factor IX inhibitors). If any of the listed exclusion checkboxes apply, provide clinical support and rationale for use.

Any other use of Beqvez that is not explicitly described in the medical necessity criteria is considered experimental, investigational, or unproven. The form includes an explicit section where the provider must check applicable exclusions (e.g., prior receipt of gene therapy; history of Factor IX inhibitors) and provide supporting rationale if requesting coverage despite those factors.

Billing and Coding

Additional CPT and Administration Codes for ConsiderationCPT

CPT (administration) codes - unspecified

Providers should supply all associated CPT codes for administration of Beqvez following medical necessity determination.

Laboratory thresholds

ALT and AST≤ 2× upper limit of normal (within 30 days)

Total bilirubin≤ 1.5× upper limit of normal (within 30 days)

Alkaline phosphatase (ALP)≤ 2× upper limit of normal (within 30 days)

Platelet count≥ 100 x10^9/L (within 30 days)

Creatinine≤ 2.0 mg/dL (within 30 days)

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Beqvez. Submit the completed Cigna Gene Therapy prior authorization form and all supporting clinical documentation via fax to 833-910-1625. Questions may be directed to the Gene Therapy Program at 855.678.0051 or GeneTherapyProgram@Cigna.com.

Fax: 833-910-1625
Gene Therapy Program: 855.678.0051
Email: GeneTherapyProgram@Cigna.com

Denial Risk

Form Completion Required

Failure to complete the required prior authorization form in its entirety may result in delayed processing or an adverse determination for insufficient information. Include the Gene Therapy Product Name (Beqvez) and complete all checklist items on the form.

Include Gene Therapy Product Name: Beqvez
Complete all form sections before faxing

Documentation Required

Required Supporting Documentation

Supportive documentation must be submitted with the prior authorization form. Documentation may include chart notes, laboratory results, genetic test results, claims records, prescription receipts, and other pertinent information to verify clinical criteria.

Examples: chart notes, lab results, genetic test results, claims history, prescription receipts
Documentation required for specific criteria (e.g., baseline Factor IX level, AAVRh74var antibody status, liver tests, platelet count, creatinine, body weight)

Documentation Required

Prior Gene Therapy Attestation

Provider must attest that the patient has not received prior gene therapy for hemophilia B. Verify via claims history when available; if no claim exists or claims history is unavailable, the prescribing physician must confirm the patient has not previously received Beqvez or Hemgenix.

If prior claims for Beqvez or Hemgenix are absent, physician attestation is required
Prior receipt of gene therapy was an exclusion in the pivotal study

Background

Beqvez is a designated gene therapy for hemophilia B included in Cigna’s Gene Therapy Provider Network. Prior authorization is required via the Cigna Gene Therapy form; the form captures eligibility elements used to determine coverage such as patient demographics, baseline Factor IX level, absence of neutralizing antibodies to the AAVRh74var capsid, relevant laboratory results, confirmation of no prior gene therapy exposure, and documentation of body weight within 30 days.

The completed form must include required attestation (for example, that the prescribing physician confirms the patient has not previously received Beqvez) and supporting documentation (recent history and physical, lab work, claims history, genetic test results, and records of prior Factor IX therapy) to substantiate eligibility for coverage.

Definitions and Key Terms

Neuralizing antibodies to AAVRh74var

RequirementAbsence of neutralizing antibodies to AAVRh74var capsid by an approved test is required prior to therapy

DocumentationNeutralizing antibody test results must be provided as documentation

TimingTesting should be performed and documented prior to administration

Moderately severe or severe hemophilia B

DefinitionModerately severe or severe hemophilia B is defined as baseline (without Factor IX replacement therapy) Factor IX level ≤ 2% of normal

DocumentationBaseline Factor IX level must be documented and obtained without recent Factor IX replacement therapy

Use in eligibilityThis threshold is required to meet medical necessity for Beqvez