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    v1.0.31
    OpenPayerPolicy UpdatesClinical/Medical PolicyWellcare Hawaii Factor VIIa Prior Auth | OpenPayer
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    ModifiedWellcare HawaiiPolicy CP.PHAR.220

    Factor VIIa, Recombinant (NovoSeven RT, SevenFact)

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    This policy governs medical-necessity and prior-authorization coverage for NovoSeven RT and SevenFact for specified bleeding disorders, bleeding episodes, and perioperative management. It applies to members under the Medicaid and HIM lines of business.

    Policy Summary
    PayerWellcare Hawaii
    PolicyFactor VIIa, Recombinant (NovoSeven RT, SevenFact)
    Policy CodePolicy N/A
    Change TypeModified
    Effective Date05.01.16
    Next Review DateN/A
    Key ActionSubmit documentation of the qualifying diagnosis, indication, hematologist involvement when required, age restrictions, clinical requirements, and dosing within policy limits for prior authorization.
    SourceLink
    POLICY UPDATE CHANGES

    Criteria for use in Glanzmann's thrombasthenia were added.

    Specific titer levels and factor VIII dose increases were removed from the policy.

    Acquired hemophilia was revised to require evidence of factor VIII inhibitors.

    Approval periods for non-prophylactic use were revised to provide three months of initial approval and one three-month reauthorization.

    An efficacy statement was added to renewal criteria.

    2Covered recombinant factor VIIa products
    3 monthsInitial approval period for non-prophylactic use
    12 yearsMinimum age for SevenFact requests

    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.

    90 mcg/kg
    Maximum dose for NovoSeven in hemophilia and Glanzmann's thrombasthenia
    75 mcg/kgMaximum dose for SevenFact

    Coverage Criteria

    Hemophilia A or B with Inhibitors and Congenital Factor VII Deficiency

    Covered when ALL of the following are met:

    ALL of the following

    • ONE of

      • Diagnosis of congenital or acquired hemophilia A or B with inhibitors.
      • Diagnosis of congenital factor VII deficiency; NovoSeven RT requests only.
    • Prescribed by or in consultation with a hematologist.
    • For SevenFact requests only: Member is age ≥ 12 years.

    • ONE of

      • Request is for control and prevention of bleeding episodes.
      • Request is for perioperative management.

    • ONE of the following maximum doses

      • NovoSeven requests — hemophilia

        • Dose does not exceed 90 mcg/kg every two hours.

      • NovoSeven requests — congenital factor VII deficiency

        • Dose does not exceed 30 mcg/kg every four hours.

      • SevenFact requests

        • Dose does not exceed 75 mcg/kg every two hours.

    Glanzmann's Thrombasthenia

    Covered when ALL of the following are met:

    ALL of the following

    • Diagnosis of Glanzmann's thrombasthenia; NovoSeven RT requests only.
    • Prescribed by or in consultation with a hematologist.
    • Condition is refractory to platelet transfusions.

    • ONE of

      • Request is for control and prevention of bleeding episodes.
      • Request is for perioperative management.

    Other Diagnoses and Indications

    Coverage for other diagnoses or indications follows one of the applicable pathways below:

    ONE of

    • Refer to the off-label use policy for the relevant line of business if the diagnosis is not specifically listed under Section III (Diagnoses/Indications for which coverage is NOT authorized): HIM.PHAR.21 for health insurance marketplace or CP.PMN.53 for Medicaid.
    • For non-FDA-approved indications not addressed in this policy, sufficient documentation of efficacy and safety is provided according to the applicable off-label use policy or evidence-of-coverage documents.

    Continued Therapy — All Indications

    Continued therapy is covered when ALL of the following are met:

    ALL of the following

    • Member is currently receiving the medication via the Centene benefit, or the member has previously met the initial approval criteria.
    • Member is responding positively to therapy.

    • If the request is for a dose increase, ONE of the following maximum doses applies

      • For NovoSeven requests for hemophilia: dose does not exceed 90 mcg/kg every two hours.
      • For NovoSeven requests for congenital factor VII deficiency: dose does not exceed 30 mcg/kg every four hours.

    Continued Therapy — Other Diagnoses and Indications

    Continued therapy for other diagnoses or indications is covered when at least ONE of the following is met:

    ONE of

    • Member is currently receiving the medication via the Centene benefit and documentation supports a positive response to therapy.
    • Refer to the off-label use policy for the relevant line of business if the diagnosis is not specifically listed under Section III (Diagnoses/Indications for which coverage is NOT authorized): HIM.PHAR.21 for health insurance marketplace or CP.PMN.53 for Medicaid.

    SevenFact is not indicated for treatment of congenital factor VII deficiency.

    Non-FDA-approved indications not addressed in this policy require sufficient documentation of efficacy and safety according to the applicable off-label use policy—HIM.PHAR.21 for health insurance marketplace or CP.PMN.53 for Medicaid—or applicable evidence-of-coverage documents.

    Initial Therapy

    Hemophilia A or B with Inhibitors and Congenital Factor VII Deficiency

    Initial approval requires all applicable criteria:

    All applicable criteria

    • Qualifying diagnosis

      • The member has congenital or acquired hemophilia A or B with inhibitors.
      • The member has congenital factor VII deficiency and the request is for NovoSeven RT.
    • The drug is prescribed by or in consultation with a hematologist.
    • For SevenFact requests, the member is at least 12 years old.Age ≥ 12 years for SevenFact

    Continuation Therapy

    All Indications

    Continued therapy requires the member to be receiving the medication through the Centene benefit or to have previously met initial approval criteria and to be responding positively to therapy.

    Continuation

    • Eligibility for continued therapy

      • The member is currently receiving the medication through the Centene benefit.
      • The member previously met the initial approval criteria.
    • The member is responding positively to therapy.

    • Dose limit when a dose increase is requested

    Product-Specific Dose Limits

    NovoSeven RT maximum policy doses
    ProductNovoSeven RT
    Hemophilia A or B with inhibitors90 mcg/kg every 2 hours
    Congenital factor VII deficiency30 mcg/kg every 4 hours
    SevenFact maximum policy dose
    ProductSevenFact
    Maximum policy dose75 mcg/kg every 2 hours
    Dose unitmcg/kg

    Referenced Billing Code

    Referenced HCPCS CodeHCPCS
    J7189Factor VIIa (antihemophilic factor, recombinant), per 1 mcg

    Authorization and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for NovoSeven RT and SevenFact. Requests must identify a qualifying diagnosis and covered indication and document that the medication is prescribed by, or used in consultation with, a hematologist.

    • Qualifying pathways include hemophilia A or B with inhibitors, congenital factor VII deficiency for NovoSeven RT only, and Glanzmann’s thrombasthenia for NovoSeven RT only.
    • Covered uses are control or prevention of bleeding episodes and perioperative management.
    Documentation Required

    Clinical Documentation Required

    Submit clinical documentation supporting that the member meets all applicable approval criteria. Documentation may include office chart notes, laboratory results, or other relevant clinical information.

    • Include the diagnosis, prescribing hematologist or hematology consultation, intended use, product requested, age when requesting SevenFact, and applicable clinical requirements.

    Background

    NovoSeven RT and SevenFact are recombinant coagulation factor VIIa products used to promote hemostasis in selected bleeding disorders. This policy addresses their use for qualifying bleeding episodes and perioperative management, including hemophilia A or B with inhibitors and other specified bleeding disorders.

    Clinical Definitions

    Definition
    ConditionCongenital hemophilia A
    DefinitionA deficiency of factor VIII
    Affected coagulation factorFactor VIII
    Definition
    ConditionCongenital hemophilia B
    DefinitionA deficiency of factor IX
    Affected coagulation factorFactor IX
    Policy Summary
    PayerWellcare Hawaii
    PolicyFactor VIIa, Recombinant (NovoSeven RT, SevenFact)
    Policy CodePolicy N/A
    Change TypeModified
    Effective Date05.01.16
    Next Review DateN/A
    Key ActionSubmit documentation of the qualifying diagnosis, indication, hematologist involvement when required, age restrictions, clinical requirements, and dosing within policy limits for prior authorization.
    SourceLink
    On This Page
    Coverage CriteriaInitial TherapyContinuation TherapyProduct-Specific Dose LimitsReferenced Billing CodeAuthorization and Documentation RequirementsBackgroundClinical Definitions
    Dose does not exceed 90 mcg/kg every two hours.
    For SevenFact requests: dose does not exceed 75 mcg/kg every two hours.

  1. Covered use

    • Control and prevention of bleeding episodes.
    • Perioperative management.

  2. Dose limit

    • The requested NovoSeven dose for hemophilia does not exceed 90 mcg/kg every two hours.90 mcg/kg every 2 hours
    • The requested NovoSeven RT dose for congenital factor VII deficiency does not exceed 30 mcg/kg every four hours.30 mcg/kg every 4 hours
    • The requested SevenFact dose does not exceed 75 mcg/kg every two hours.75 mcg/kg every 2 hours

    3. Glanzmann's Thrombasthenia

    Initial approval requires all criteria:

    All applicable criteria

    • The member has Glanzmann's thrombasthenia and the request is for NovoSeven RT.
    • The drug is prescribed by or in consultation with a hematologist.
    • The condition is refractory to platelet transfusions.

    • Covered use

      • Control and prevention of bleeding episodes.
      • Perioperative management.
    • The dose does not exceed 90 mcg/kg every two hours.90 mcg/kg every 2 hours
    The increased NovoSeven dose for hemophilia does not exceed 90 mcg/kg every two hours.90 mcg/kg every 2 hours
  3. The increased NovoSeven RT dose for congenital factor VII deficiency does not exceed 30 mcg/kg every four hours.30 mcg/kg every 4 hours
  4. The increased SevenFact dose does not exceed 75 mcg/kg every two hours.75 mcg/kg every 2 hours

    5. Other Diagnoses or Indications

    For other diagnoses or indications, continued coverage requires one of the following pathways:

    Other-diagnosis continuation pathway

    • The member is currently receiving the medication through the Centene benefit, and documentation supports a positive response to therapy.Approval duration is the duration of the request or 3 months, whichever is less
    • If the diagnosis is not specifically listed under the diagnoses or indications for which coverage is not authorized, refer to the applicable off-label use policy: HIM.PHAR.21 for health insurance marketplace members or CP.PMN.53 for Medicaid members.
    NovoSeven RT maximum policy dose
    ProductNovoSeven RT
    Maximum policy dose90 mcg/kg every 2 hours
    Applicable indicationGlanzmann's thrombasthenia
    Documentation Required

    Continuation Response Documentation

    For continuation requests, document that the member is currently receiving the medication through the applicable benefit or previously met initial approval criteria and is responding positively to therapy. Requests for other diagnoses or indications must also support the applicable continuation or off-label pathway.

    • For other diagnoses or indications, submit documentation of a positive response when the member is receiving the medication through the benefit, or reference the applicable off-label use policy when the diagnosis is not listed in the noncovered-indications section.
    • Standard approval duration is 3 months; for other diagnoses or indications, approval is for the requested duration or 3 months, whichever is less.
    Denial Risk

    Noncovered Indications

    Coverage is not authorized for congenital factor VII deficiency when SevenFact is requested, because SevenFact is not indicated for that condition. Non-FDA-approved indications not addressed by this policy are also not covered unless sufficient efficacy and safety documentation supports coverage under the applicable off-label use policy or evidence of coverage documents.

    • Congenital factor VII deficiency is a NovoSeven RT-only pathway.
    • For unaddressed non-FDA-approved indications, refer to HIM.PHAR.21 for health insurance marketplace coverage or CP.PMN.53 for Medicaid coverage, as applicable.
    Denial Risk

    Dose Exceeds Policy Limit

    Do not approve doses exceeding the applicable product- and indication-specific limits. The same limits apply to a dose increase requested during continued therapy.

    • NovoSeven RT—hemophilia: 90 mcg/kg every 2 hours.
    • NovoSeven RT—congenital factor VII deficiency: 30 mcg/kg every 4 hours.
    • NovoSeven RT—Glanzmann’s thrombasthenia: 90 mcg/kg every 2 hours.
    • SevenFact: 75 mcg/kg every 2 hours.
    Denial Risk

    Approval Criteria Not Met

    Approval is not supported when required criteria are absent or the request falls outside an authorized pathway. Verify the diagnosis, hematologist involvement, product-specific eligibility, intended use, and applicable clinical requirements before submitting the request.

    • The diagnosis must be hemophilia A or B with inhibitors, congenital factor VII deficiency for NovoSeven RT only, or Glanzmann’s thrombasthenia for NovoSeven RT only.
    • The medication must be prescribed by or used in consultation with a hematologist.
    • SevenFact requires an age of at least 12 years.
    • The request must be for control or prevention of bleeding episodes or perioperative management.
    • Glanzmann’s thrombasthenia requests require refractoriness to platelet transfusions.
    Definition
    ConditionAcquired hemophilia
    DefinitionHemophilia evidenced by the presence of coagulation factor inhibitors
    Characteristic findingCoagulation factor inhibitor autoantibodies