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    v1.0.28
    OpenPayerPolicy UpdatesHematology/Oncologyhusky_health Hemgenix coverage & Prior Auth | Open…
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    Currenthusky_healthPolicy N/A

    Hemgenix (etranacogene dezaparvovec) gene therapy coverage criteria

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    Prior authorization and medical necessity criteria for one-time Hemgenix gene therapy for adults with severe or moderately severe hemophilia B covered by HUSKY Health (Connecticut Medicaid). Affects providers requesting coverage under the Connecticut Medical Assistance Program (CMAP).

    Policy Summary
    Payerhusky_health
    PolicyHemgenix (etranacogene dezaparvovec) gene therapy coverage criteria
    Policy CodePolicy N/A
    Change TypeCriteria clarifiedmonitoring and documentation requirements added
    Effective DateJan 25, 2025
    Last ReviewMar 16, 2026
    Next Review DateN/A
    Key ActionSubmit a prior authorization request including the state Hemgenix form, baseline tests, letter of medical necessity, and signed provider attestation.
    SourceLink
    POLICY UPDATE CHANGES

    Removed Beqvez from policy as this medication has been discontinued as of late February 2025.

    Changed the title of the policy to Hemgenix and reworded sections of the criteria for clarity.

    Added criteria regarding monitoring liver function and factor IX activity after gene therapy administration.

    Edited procedure section to include a letter of medical necessity and provider attestation for applicable criteria.

    one-timedose authorized if approved
    ≤ 2%factor IX activity threshold

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    J1411billing code
    ≥ 18minimum age
    ≤ 0.6 BUinhibitor test threshold

    Coverage Criteria for Hemgenix

    Initial therapy - Medical necessity criteria

    Treatment with Hemgenix may be considered medically necessary when ALL of the following criteria are met:

    Root

    • Age 18 years or older
    • B: Severe or moderately severe factor IX deficiency (≤ 2% of normal circulating factor IX)≤ 2%
    • C: Treatment is prescribed by or in consultation with a hematologist
    • D: The individual has not previously received gene therapy for hemophilia B

    • E

      • E.a: Currently using factor IX prophylaxis
      • E.b: Current or history of a life‑threatening hemorrhage
      • E.c: History of repeated, serious spontaneous bleeding episodes

    • F

      • F.a: Negative factor IX inhibitor test (≤ 0.6 Bethesda Units) within the last 30 days≤ 0.6 BU within 30 days
      • F.b: No history of inhibitors to factor IX
    • G: No uncontrolled HIV infection: no serological evidence of HIV1/2 infection with CD4+ >200 mm3 and viral load ≤20 copies/mL (must not have uncontrolled infection)CD4>200 and viral load ≤20 copies/mL
    • H: No active hepatitis B or hepatitis C infection
    • I: Not on antiviral therapy for hepatitis B or hepatitis C

    • J

      • J.a: Provider attests no history of significant liver or biliary disease
      • J.b: All baseline liver health assessments performed per prescribing information (liver function tests and elastography/ultrasound for fibrosis)
      • J.c: Provider attests liver function and factor IX activity will be monitored after gene therapy per package insert

        post-administration monitoring required

    • K: Provider will follow all FDA recommendations for dosage, preparation, administration, additional monitoring, and patient education

    Hemgenix is considered investigational and not medically necessary for indications outside the specified use in adults with hemophilia B. This includes any uses that are not described in the coverage criteria and any clinical scenarios for which safety and efficacy have not been established.

    Repeat administration of Hemgenix has not been clinically evaluated. Therefore, repeat administration is investigational and not medically necessary and such requests will be denied.

    Coding and Key Clinical Thresholds

    Covered HCPCS CodesHCPCSCovered
    J1411Injection, etranacogene dezaparvovec-hyphendrlb, per therapeutic dose
    inv-05: Factor IX activity — clinical threshold for severe/moderately severe disease.
    Clinical thresholdSevere or moderately severe factor IX deficiency defined as ≤ 2% of normal circulating factor IX
    Age requirementPatient must be ≥ 18 years of age
    Evidence sourceEligibility derived from clinical guideline enrollment criteria and baseline testing requirements
    inv-06: Factor IX inhibitor — negative test definition (≤ 0.6 BU within last 30 days).
    Negative inhibitor test definitionNegative factor IX inhibitor test defined as ≤ 0.6 Bethesda Units (BU)
    Timing requirementTest must be performed within the last 30 days

    Provider Actions, Prior Authorization, and Documentation

    Prior Authorization

    Prior authorization required — one-time single-dose only

    Prior authorization is required for Hemgenix. If approved, authorization is for a one-time, single-dose intravenous infusion of Hemgenix.

    Step Therapy

    Therapy prerequisites and eligibility

    Confirm the member meets eligibility prerequisites: adult with severe or moderately severe hemophilia B and either current factor IX prophylaxis or history of life‑threatening or serious spontaneous bleeding; no prior gene therapy; and required negative inhibitor and viral/hepatic status.

    • Currently receiving routine factor IX prophylaxis OR history of life‑threatening hemorrhage OR history of repeated, serious spontaneous bleeding episodes (chunk 1, chunk 3)
    • Individual has not previously received gene therapy for hemophilia B (chunk 3)
    • Negative factor IX inhibitor test (≤ 0.6 BU) within 30 days and no history of inhibitors (chunk 3)
    • No uncontrolled HIV infection and no active hepatitis B or C; not on antiviral therapy for hepatitis B or C (chunk 3)

    Definitions

    inv-13: Hemgenix (etranacogene dezaparvovec-drlb) — one-time AAV5 vector-based gene therapy description.
    Product descriptionHemgenix (etranacogene dezaparvovec-drlb) is a one-time adeno-associated virus serotype 5 (AAV5) vector-based gene therapy delivering the factor IX‑Padua gene to hepatocytes
    Indication summaryFor treatment of adults with hemophilia B (congenital factor IX deficiency) to increase factor IX levels and reduce bleeding
    Dosing characteristicSingle-dose, single-infusion gene therapy administered intravenously
    inv-14: Medical Necessity — definition used in the policy.
    DefinitionMedical Necessity: health services required to prevent, identify, diagnose, treat, rehabilitate or ameliorate an individual's medical condition consistent with Connecticut statute and payer standards
    Standards

    Background

    Hemophilia B is an X-linked coagulation disorder caused by deficiency of factor IX that can lead to recurrent and potentially life‑threatening bleeding, particularly in individuals with severe or moderately severe disease. Hemgenix (etranacogene dezaparvovec-drlb) is a one‑time, AAV5 vector–based gene therapy that delivers the factor IX‑Padua transgene to hepatocytes with the goal of increasing circulating factor IX activity, reducing the need for prophylactic factor replacement, and lowering annualized bleeding rates based on clinical trial data. Coverage under this policy is limited to adults meeting the specific medical necessity criteria, including a baseline factor IX activity of ≤ 2% of normal and other eligibility and monitoring requirements.

    Policy Summary
    Payerhusky_health
    PolicyHemgenix (etranacogene dezaparvovec) gene therapy coverage criteria
    Policy CodePolicy N/A
    Change TypeCriteria clarifiedmonitoring and documentation requirements added
    Effective DateJan 25, 2025
    Last ReviewMar 16, 2026
    Next Review DateN/A
    Key ActionSubmit a prior authorization request including the state Hemgenix form, baseline tests, letter of medical necessity, and signed provider attestation.
    SourceLink
    On This Page
    Coverage Criteria for HemgenixCoding and Key Clinical ThresholdsProvider Actions, Prior Authorization, and DocumentationDefinitionsBackground
    No prior inhibitorsPatient must have no history of inhibitors to factor IX
    inv-07: HIV control — required virologic and immunologic parameters prior to therapy.
    HIV control requirementNo serological evidence of HIV‑1 or HIV‑2 infection with CD4+ cell count > 200 mm3 and viral load ≤ 20 copies/mL (must not have uncontrolled infection)
    DocumentationAbsence of uncontrolled HIV must be confirmed by baseline testing submitted with prior authorization
    Relation to eligibilityUncontrolled HIV (CD4 ≤ 200 and/or viral load >20 copies/mL) disqualifies the individual
    Documentation Required

    Required documentation for prior authorization

    Submit the State of Connecticut Hemgenix Prior Authorization Request form with physician's order and signature plus clinical documentation including baseline testing, a letter of medical necessity, and a signed provider attestation addressing required items and monitoring.

    • Completed State of Connecticut Hemgenix Prior Authorization Request form including physician's order and signature (chunk 7)
    • Baseline testing: factor IX level confirming ≤ 2% activity; negative inhibitor test within 30 days; absence of uncontrolled HIV; liver function tests, hepatitis B/C testing, and elastography/ultrasound for fibrosis (chunk 7)
    • Letter of medical necessity and signed provider attestation confirming eligibility criteria, lack of prior gene therapy, absence of significant liver/biliary disease, monitoring plans for liver function and factor IX activity per package insert, and adherence to FDA recommendations (chunk 7)
    Denial Risk

    Repeat administration not covered — investigational

    Requests for repeat administration of Hemgenix are considered investigational and not medically necessary and will be denied.

    Services must be consistent with generally-accepted standards of medical practice and clinically appropriate in type, frequency, timing, site, extent and duration
    Payment implicationAuthorization is based on medical necessity at time of issuance and is not a guarantee of payment