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    v1.0.30
    OpenPayerPolicy UpdatesHap Caresource Mi Coordinated HealthHAP Caresource Cytogam Prior Auth | OpenPayer
    Ask Trek AI about this page
    CurrentHap Caresource Mi Coordinated HealthPolicy N/A

    Immune Globulin - Cytogam Utilization Management Medical Policy

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    This policy governs prior authorization and medical benefit coverage for Cytogam (human cytomegalovirus immune globulin intravenous infusion). It applies to patients requiring CMV prophylaxis after solid-organ transplantation, CMV-associated pregnancy treatment, or treatment of CMV infection who meet the specified specialist, clinical, and dosing criteria.

    Policy Summary
    PayerHap Caresource Mi Coordinated Health
    PolicyImmune Globulin - Cytogam Utilization Management Medical Policy
    Policy CodePolicy N/A
    Change TypeMaterial update
    Effective DateN/A
    Last ReviewFeb 4, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization for medical benefit coverage of Cytogam.
    SourceLink
    POLICY UPDATE CHANGES

    A new approval condition and criteria for treatment of cytomegalovirus were added.

    The solid-organ-transplant prophylaxis dosing regimen was revised to specify administration within 72 hours of transplant followed by doses at Weeks 2, 4, 6, 8, 12, and 16.

    A pregnancy dosing option of up to 200 mg/kg by intravenous infusion every 2 weeks was added.

    3Covered clinical indication groups
    7 infusionsMaximum transplant prophylaxis course
    150 mg/kg

    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.

    Maximum transplant prophylaxis dose
    4 monthsTransplant prophylaxis authorization
    6 monthsPregnancy or treatment authorization
    3 dosesMaximum pregnancy course

    Covered Indications

    CMV Prophylaxis After Solid-Organ Transplant

    Covered when all of the following are met:

    Solid-organ-transplant CMV prophylaxis

    • Specialist involvement

      • Cytogam is prescribed by or in consultation with a physician affiliated with a transplant center, a hematologist, or an infectious disease physician.Approval for 4 months

    • ONE permitted dosing regimen

      • Standard transplant regimen

        • Cytogam is administered by intravenous infusion within 72 hours of transplant and then at Weeks 2, 4, 6, 8, 12, and 16 post-transplant.Up to 150 mg/kg per infusion; 7 total infusions

      • Transplant-center protocol

        • The dosing regimen is based on a transplant center's protocol.

    CMV Associated With Pregnancy

    Covered when all of the following are met:

    CMV associated with pregnancy

    • Specialist involvement

      • Cytogam is prescribed by or in consultation with an infectious disease physician or an obstetrician-gynecologist.Approval for 6 months

    • ONE permitted pregnancy dosing regimen

      • Monthly regimen

        • Cytogam is administered by intravenous infusion no more frequently than every month.Up to 100 mg/kg per infusion; no more frequently than monthly

      • Every-2-week regimen

    CMV Treatment

    Covered when all applicable requirements are met:

    CMV treatment

    • ONE qualifying clinical-treatment pathway

      • CMV pneumonitis

        • The patient is being treated for cytomegalovirus pneumonitis.

      • CMV retinitis pathway

        • Systemic antiviral therapy

          • The patient has tried or is unable to use ganciclovir.
          • The patient has tried or is unable to use valganciclovir.

    Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria may be updated as new published data become available.

    Authorization and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is recommended for medical-benefit coverage of Cytogam. Follow the established indication-specific dosing; doses outside those regimens are reviewed case by case by a clinician, such as a Medical Director or Pharmacist.

    • Approval is provided only for the duration authorized for the applicable indication.
    • Extended approval requires the patient to continue meeting the applicable criteria and dosing requirements.
    Documentation Required

    Specialist Involvement Required

    Because Cytogam requires specialized evaluation, diagnosis, and monitoring, prescribing must be by or in consultation with a physician who specializes in the condition being treated.

    • Solid-organ transplant CMV prophylaxis: transplant-center physician, hematologist, or infectious disease physician.

    Therapy Overview

    Cytogam is human cytomegalovirus immune globulin administered by intravenous infusion. Its FDA-approved use is prophylaxis of CMV disease associated with kidney, lung, liver, pancreas, and heart transplantation. The policy also addresses pregnancy-associated CMV and selected CMV treatment situations, including CMV pneumonitis and certain CMV retinitis cases.

    Key Terms

    Cytogam
    ProductCytogam
    DescriptionHuman cytomegalovirus immune globulin intravenous infusion
    Drug classHuman cytomegalovirus immune globulin
    CMV prophylaxis associated with solid-organ transplant
    PurposePrevention of cytomegalovirus disease
    Transplant typesKidney, lung, liver, pancreas, or heart transplantation
    IndicationCMV disease prophylaxis associated with solid-organ transplantation

    Initial Approval Criteria

    Initial Approval Criteria

    Initial approval is recommended when the patient meets one of the following indication-specific criteria groups, including the applicable specialist-prescriber and dosing requirements:

    ONE covered Cytogam indication

    • Solid-organ-transplant CMV prophylaxis

      • Cytogam is prescribed by or in consultation with a physician affiliated with a transplant center, a hematologist, or an infectious disease physician.Approval for 4 months

      • ONE permitted dosing regimen

        • Cytogam is administered by intravenous infusion within 72 hours of transplant and then at Weeks 2, 4, 6, 8, 12, and 16 post-transplant.Up to 150 mg/kg per infusion; 7 total infusions

    Continued Eligibility

    Continued Eligibility

    Extended approval is allowed when the following requirement continues to be met:

    Continuation approval

    • The patient continues to meet the applicable indication criteria and dosing requirements for Cytogam.Extended approval permitted

      Approvals are provided for the duration authorized.

    Required Prior Therapies

    StepTherapy requirementRequirement before Cytogam approval
    1Systemic antiviral therapy: ganciclovir or valganciclovirThe patient must have tried or be unable to use one of these therapies.
    1Foscarnet (Foscavir intravenous infusion)The patient must have tried or be unable to use foscarnet.

    Dosing and Course Limits

    Cytogam quantity limit
    Maximum per infusionUp to 150 mg/kg
    Total course7 total infusions
    ScheduleWithin 72 hours of transplant, then at Weeks 2, 4, 6, 8, 12, and 16 post-transplant
    Cytogam quantity limit
    Maximum daily doseUp to 400 mg/kg daily
    RouteIntravenous infusion
    FrequencyDaily

    Administration Setting

    Billing Rule

    Administer by intravenous infusion

    Cytogam must be administered by intravenous infusion. The policy does not specify a required administration setting, including a required infusion center.

    Policy Summary
    PayerHap Caresource Mi Coordinated Health
    PolicyImmune Globulin - Cytogam Utilization Management Medical Policy
    Policy CodePolicy N/A
    Change TypeMaterial update
    Effective DateN/A
    Last ReviewFeb 4, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization for medical benefit coverage of Cytogam.
    SourceLink
    On This Page
    Covered IndicationsAuthorization and Documentation RequirementsTherapy OverviewKey TermsInitial Approval CriteriaContinued EligibilityRequired Prior TherapiesDosing and Course LimitsAdministration Setting
  1. Cytogam is administered by intravenous infusion every 2 weeks.Up to 200 mg/kg per infusion

  2. Limited-course regimen

    • Cytogam is administered by intravenous infusion and the number of doses does not exceed 3 doses total.Up to 200 mg/kg per infusion; 3 doses maximum
    3. The patient has tried or is unable to use foscarnet (Foscavir intravenous infusion).

  3. Qualified prescriber or consultant

    • Cytogam is prescribed by or in consultation with an infectious disease specialist, an ophthalmologist, a physician associated with a transplant center, an oncologist, or a hematologist.

  4. ONE permitted treatment dosing regimen

    • Daily treatment regimen

      • Cytogam is administered by intravenous infusion daily.Up to 400 mg/kg daily

    • Transplant-center protocol

      • The dosing regimen is based on a transplant center's protocol.

  5. Approval duration

    • The requested treatment meets the criteria for approval for 6 months.Approval for 6 months
  6. CMV associated with pregnancy: infectious disease physician or obstetrician-gynecologist.
  7. CMV treatment: infectious disease specialist, ophthalmologist, transplant-center physician, oncologist, or hematologist.
    8. Step Therapy

    Required Systemic Antiviral Therapy

    For the CMV treatment pathway involving CMV retinitis, document that the patient has tried or is unable to use the required systemic antiviral therapy before requesting Cytogam.

    • The patient must have tried or be unable to use ganciclovir or valganciclovir.
    • The patient must also have tried or be unable to use foscarnet (Foscavir intravenous infusion).
    • Intravitreal medications or an ocular implant do not replace the systemic-therapy requirement.
    Denial Risk

    Indication Outside Policy Criteria

    Coverage is not recommended when the requested circumstance is not listed in the Recommended Authorization Criteria. Criteria may be updated as new published data become available.

    • Submit requests under one of the listed Cytogam indications and include the applicable clinical documentation.
    Denial Risk

    Failure to Meet Approval Criteria

    Requests may be denied when the applicable specialist involvement, clinical indication, treatment history, or dosing requirements are not met or documented.

    • The patient must meet the criteria for the requested indication.
    • The request must use an established dosing regimen, unless an outside dose is approved through case-by-case clinical review.
    • The prescription must meet the applicable physician-specialist requirement.
  8. The dosing regimen is based on a transplant center's protocol.

  9. CMV associated with pregnancy

    • Cytogam is prescribed by or in consultation with an infectious disease physician or an obstetrician-gynecologist.Approval for 6 months

    • ONE permitted dosing regimen

      • Cytogam is administered by intravenous infusion no more frequently than every month.Up to 100 mg/kg per infusion; no more frequently than monthly
      • Cytogam is administered by intravenous infusion every 2 weeks.Up to 200 mg/kg per infusion
      • Cytogam is administered by intravenous infusion and the number of doses does not exceed 3 doses total.Up to 200 mg/kg per infusion; 3 doses maximum

  10. CMV treatment

    • ONE qualifying clinical-treatment pathway

      • The patient is being treated for cytomegalovirus pneumonitis.

      • CMV retinitis pathway

        • Systemic antiviral therapy

          • The patient has tried or is unable to use ganciclovir.
          • The patient has tried or is unable to use valganciclovir.
        • The patient has tried or is unable to use foscarnet (Foscavir intravenous infusion).
    • Cytogam is prescribed by or in consultation with an infectious disease specialist, an ophthalmologist, a physician associated with a transplant center, an oncologist, or a hematologist.

    • ONE permitted dosing regimen

      • Cytogam is administered by intravenous infusion daily.Up to 400 mg/kg daily
      • The dosing regimen is based on a transplant center's protocol.
    • The requested treatment meets the criteria for approval for 6 months.Approval for 6 months
    11. Cytogam quantity limit
    Maximum per infusionUp to 200 mg/kg
    Maximum total dosesNo more than 3 total doses
    RouteIntravenous infusion