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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsNew Hampshire Hemgenix Prior Authorization | OpenP…
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    CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

    Hemophilia B Gene Therapy Criteria

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    This policy governs prior authorization and coverage of Hemgenix (etranacogene dezaparvovec-drlb) for adult New Hampshire Medicaid fee-for-service members with qualifying congenital factor IX deficiency. It defines clinical eligibility, monitoring requirements, denial conditions, and the lifetime dose limitation.

    Policy Summary
    PayerNew Hampshire Department of Health and Human Services
    PolicyHemophilia B Gene Therapy Criteria
    Policy CodePolicy N/A
    Change TypeRevision with no material clinical or coverage change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation confirming all approval criteria, including eligibility, negative factor IX inhibitor testing, and required monitoring.
    SourceLink
    POLICY UPDATE CHANGES

    The revision history records a policy revision followed by approval.

    18+Minimum patient age
    ≤ 2%Factor IX activity threshold
    1 dose

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    Lifetime Hemgenix limit
    5 yearsAFP monitoring with risk factors
    3 monthsLiver function monitoring

    Hemgenix Coverage Criteria

    Initial Hemgenix coverage

    Covered when all of the following requirements are met:

    Hemgenix coverage criteria

    • Patient and treatment eligibility

      • Patient is at least 18 years of age.Age ≥ 18 years
      • Hemgenix is prescribed by a hematologist, and the patient is managed by a hemophilia treatment center.
      • The patient has moderately severe or severe congenital factor IX deficiency, confirmed by blood coagulation testing, such as factor IX activity ≤ 2%.Factor IX activity example: ≤ 2%

    • At least one qualifying prophylaxis or bleeding history

      • The patient currently uses factor IX prophylaxis therapy.
      • The patient has current or historical life-threatening hemorrhage.
      • The patient has repeated, serious spontaneous bleeding episodes.

    • Factor IX inhibitor testing

      • The patient has been tested and found negative for factor IX inhibitor titers. If the Hemgenix test result is positive, testing must be repeated within approximately 2 weeks; Hemgenix should not be given if the repeat test is also positive.Negative factor IX inhibitor titer

    • Required monitoring

      • Factor IX activity will be monitored periodically at the frequency specified in the Hemgenix package insert.
      • The provider will monitor for inhibitors if bleeding is not controlled. The patient will continue to require exogenous factor IX until a response occurs.
      • Liver function will be assessed at baseline before therapy and after therapy weekly for at least 3 months, with extended monitoring as specified in the Hemgenix package insert.Weekly for at least 3 months
      • Patients with preexisting risk factors for hepatocellular carcinoma will receive abdominal ultrasound screenings and regular monitoring, such as annual monitoring, for alpha-fetoprotein elevations for 5 years following administration.AFP monitoring for 5 years when risk factors are present

    Hemgenix should not be administered when the initial factor IX inhibitor test is positive and repeat testing performed approximately 2 weeks later is also positive. Coverage requires negative factor IX inhibitor titers before treatment.

    Initial Hemgenix Authorization

    Initial Hemgenix authorization

    Initial therapy is covered when all of the following criteria are met:

    Hemgenix initial therapy criteria

    • Patient and diagnosis

      • Patient is at least 18 years of age.Age ≥ 18 years
      • Treatment is prescribed by a hematologist, and the patient is managed by a hemophilia treatment center.
      • Patient has a diagnosis of moderately severe or severe congenital factor IX deficiency, confirmed by blood coagulation testing, such as factor IX activity ≤ 2%.Factor IX activity example: ≤ 2%

    Clinical Coding Threshold

    Factor IX Activity
    Factor IX activity threshold≤ 2%
    Clinical applicationExample threshold for moderately severe or severe congenital factor IX deficiency
    Confirmation methodBlood coagulation testing

    Authorization and Documentation Requirements

    Prior Authorization

    Hemgenix Prior Authorization Required

    Prior authorization is required for Hemgenix. Submit documentation demonstrating that all approval criteria are met before treatment is administered.

    Documentation Required

    Clinical Eligibility and Monitoring Documentation

    Submit documentation supporting the patient’s clinical eligibility, prescribing provider, treatment-center involvement, diagnosis, bleeding history or prophylaxis, inhibitor testing, and required monitoring plan.

    • Patient is at least 18 years of age.
    • Hemgenix is prescribed by a hematologist, and the patient is managed by a hemophilia treatment center.
    • The patient has moderately severe or severe congenital factor IX deficiency, such as factor IX activity ≤ 2%, confirmed by blood coagulation testing.
    • The patient currently uses factor IX prophylaxis, has a current or historical life-threatening hemorrhage, or has repeated serious spontaneous bleeding episodes.

    Hemophilia B and Hemgenix

    Hemophilia B is a congenital factor IX deficiency that may result in serious bleeding, including life-threatening hemorrhage or repeated serious spontaneous bleeding episodes. Hemgenix coverage applies to adults who have moderately severe or severe congenital factor IX deficiency, such as factor IX activity of ≤ 2%, and who currently use factor IX prophylaxis therapy or have a qualifying bleeding history.

    Key Clinical Definitions

    Hemophilia B
    ConditionHemophilia B
    TypeCongenital bleeding disorder
    CauseFactor IX deficiency
    Factor IX Inhibitor Titer
    DefinitionAn antibody level against factor IX
    Required result before treatmentNegative factor IX inhibitor titer
    If the initial test is positiveRepeat testing approximately 2 weeks later

    Lifetime Dose Limitation

    Hemgenix Quantity Limit
    MedicationHemgenix
    Quantity limitA single dose
    Lifetime limitOne dose per lifetime
    Policy Summary
    PayerNew Hampshire Department of Health and Human Services
    PolicyHemophilia B Gene Therapy Criteria
    Policy CodePolicy N/A
    Change TypeRevision with no material clinical or coverage change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation confirming all approval criteria, including eligibility, negative factor IX inhibitor testing, and required monitoring.
    SourceLink
    On This Page
    Hemgenix Coverage CriteriaInitial Hemgenix AuthorizationClinical Coding ThresholdAuthorization and Documentation RequirementsHemophilia B and HemgenixKey Clinical DefinitionsLifetime Dose Limitation

    One or more qualifying prophylaxis or bleeding-history criteria

    • Patient currently uses factor IX prophylaxis therapy.
    • Patient has current or historical life-threatening hemorrhage.
    • Patient has repeated, serious spontaneous bleeding episodes.

  1. Factor IX inhibitor testing

    • Patient has been tested and found negative for factor IX inhibitor titers. For Hemgenix, if the initial test result is positive, testing must be repeated within approximately 2 weeks; Hemgenix should not be given if the repeat test is also positive.Negative factor IX inhibitor titer

  2. Treatment monitoring

    • Patient factor IX activity will be monitored periodically at the frequency specified in the Hemgenix package insert.
    • The provider will monitor for inhibitors if bleeding is not controlled. The patient will continue to require exogenous factor IX until a response occurs.
    • Baseline liver function will be assessed before therapy and after therapy weekly for at least 3 months, with extended monitoring as specified in the Hemgenix package insert.Weekly for at least 3 months
    • Patients with preexisting risk factors for hepatocellular carcinoma, such as cirrhosis, advanced hepatic fibrosis, hepatitis C or B, non-alcoholic fatty liver disease, chronic alcohol consumption, non-alcoholic steatohepatitis, or advanced age, will receive abdominal ultrasound screenings and regular monitoring, such as annual monitoring, for alpha-fetoprotein elevations for 5 years following administration.AFP monitoring for 5 years when risk factors are present
  3. Factor IX inhibitor titers are negative; if the initial Hemgenix test is positive, repeat testing is performed in approximately 2 weeks and the repeat result is documented.
  4. Factor IX activity will be monitored periodically at the frequency specified in the Hemgenix package insert.
  5. The provider will monitor for inhibitors if bleeding is not controlled and will document that exogenous factor IX may be required until a response occurs.
  6. Baseline liver function is assessed before therapy and weekly for at least 3 months after therapy, with extended monitoring as specified in the Hemgenix package insert.
  7. For patients with preexisting hepatocellular carcinoma risk factors—including cirrhosis, advanced hepatic fibrosis, hepatitis B or C, NAFLD, NASH, chronic alcohol consumption, or advanced age—document abdominal ultrasound screening and regular, such as annual, alpha-fetoprotein monitoring for 5 years after administration.
    8. Denial Risk

    Approval Criteria Not Met

    Hemgenix will be denied when the criteria for approval are not met. The prior authorization submission must establish that every applicable approval requirement is satisfied.

    • Approval criteria include patient age, hematologist prescribing, hemophilia treatment center management, diagnosis and coagulation testing, qualifying prophylaxis or bleeding history, negative inhibitor testing, and required post-treatment monitoring.
    Denial Risk

    Persistent Factor IX Inhibitor

    Hemgenix should not be administered when repeat factor IX inhibitor testing remains positive.

    • If the initial factor IX inhibitor titer is positive, repeat testing should be performed within approximately 2 weeks.
    • If the repeat test is also positive, do not administer Hemgenix.
    Treatment restrictionHemgenix should not be given if the repeat test is also positive
    Moderately Severe or Severe Factor IX Deficiency
    DefinitionModerately severe or severe congenital factor IX deficiency
    Example factor IX activity threshold≤ 2%
    Confirmation methodBlood coagulation testing