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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAHCA Cerezyme Prior Authorization | OpenPayer
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    CurrentAgency for Health Care AdministrationPolicy N/A

    Cerezyme (imiglucerase) Prior Authorization Criteria

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    This policy establishes prior authorization criteria for Cerezyme (imiglucerase) for patients with Type I or Type 3 Gaucher disease, including initial and continuation coverage, documentation, specialist prescribing, and authorization duration.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyCerezyme (imiglucerase) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage changes
    Effective DateMarch 4, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation showing Type I or Type 3 Gaucher disease, a qualifying manifestation, and a documented trial and failure of Elelyso.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Up to 1 yearMaximum authorization duration
    2Covered Gaucher disease types
    Elelyso failureStep-therapy requirement
    Specialist involvementPrescriber or consultation requirement

    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.

    Coverage Criteria

    Initial therapy

    Covered when all of the following are met:

    • Patient has a documented diagnosis of Type I or Type 3 Gaucher disease.

    • Qualifying disease manifestation

      • Anemia.
      • Thrombocytopenia.
      • Bone disease.
      • Hepatomegaly or splenomegaly.
    • Patient has tried and failed Elelyso; clinical documentation is required.
    • Medication is prescribed by or in consultation with a geneticist, hematologist, or metabolic disease specialist.

    Continuation therapy

    Continuation is covered when all of the following are met:

    • Patient met the initial review criteria.
    • Documentation shows an improved clinical response, such as increased platelet count and/or hemoglobin concentration or improved radiologic studies.
    • Patient has not experienced treatment-restricting adverse effects, such as infusion-related reactions or antidrug antibody development.
    • Dosing is appropriate according to labeling or is supported by compendia.

    Authorization and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for Cerezyme (imiglucerase). An initial authorization may be issued for up to one year.

    Step Therapy

    Elelyso Trial and Failure Required

    Before requesting initial Cerezyme therapy, document that the patient has tried and failed Elelyso. Clinical documentation supporting the trial and failure is required.

    Documentation Required

    Initial Clinical Documentation

    Initial clinical documentation must establish the qualifying diagnosis and disease manifestations. The medication must be prescribed by or in consultation with an appropriate specialist.

    • Documented diagnosis of Type I or Type 3 Gaucher disease in the patient’s health conditions or medical records.
    • The diagnosis results in at least one qualifying manifestation: anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly.
    • Provide supporting documentation, such as official laboratory results or radiology reports, for the diagnosis and qualifying manifestation(s).
    • Prescriber is a geneticist, hematologist, or metabolic disease specialist, or treatment is prescribed in consultation with one of these specialists.
    Documentation Required

    Continuation Documentation

    For continuation of Cerezyme, document that the patient met the initial review criteria, is demonstrating clinical benefit, and is tolerating treatment. Dosing must be consistent with labeling or supported by compendia.

    • Documentation that the patient met the initial review criteria.
    • Documentation of improved clinical response, such as increased platelet count and/or hemoglobin concentration or improved radiologic studies.
    • Documentation that the patient has not experienced treatment-restricting adverse effects, including infusion-related reactions or antidrug antibody development.
    • Dosing is appropriate according to labeling or is supported by compendia.
    Denial Risk

    Initial Criteria Not Met

    Initial Cerezyme therapy will be denied when the initial review requirements are not met. The request must establish the qualifying diagnosis and manifestation, Elelyso trial and failure, required clinical documentation, and specialist involvement.

    • No documented diagnosis of Type I or Type 3 Gaucher disease.
    • The diagnosis does not result in at least one qualifying manifestation.
    • Required supporting documentation is absent or insufficient.
    • The patient has not tried and failed Elelyso, or clinical documentation of the trial and failure is absent.
    • The medication is not prescribed by or in consultation with a geneticist, hematologist, or metabolic disease specialist.
    Denial Risk

    Continuation Criteria Not Met

    Continuation of Cerezyme will be denied when continuation criteria are not met. Continued coverage requires documented initial eligibility, clinical improvement, treatment tolerance, and appropriate dosing.

    • The patient did not meet the initial review criteria.
    • Improved clinical response is not documented.
    • The patient has experienced treatment-restricting adverse effects, such as infusion-related reactions or antidrug antibody development.
    • Dosing is not appropriate according to labeling and is not supported by compendia.

    Policy Background

    This policy addresses Cerezyme (imiglucerase), an enzyme replacement therapy for patients with documented Type I or Type 3 Gaucher disease. Coverage requires at least one qualifying manifestation, such as anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly, supported by appropriate clinical documentation. Initial treatment also requires a documented trial and failure of Elelyso and prescribing by, or consultation with, a geneticist, hematologist, or metabolic disease specialist. For continued therapy, documentation must show improved clinical response, no treatment-restricting adverse effects, and dosing consistent with labeling or supported by compendia.

    Cerezyme Initial Therapy

    Cerezyme initial therapy

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

    • Patient has a documented diagnosis of Type I or Type 3 Gaucher disease.

    • Qualifying disease manifestation

      • Anemia.
      • Thrombocytopenia.
      • Bone disease.
      • Hepatomegaly or splenomegaly.
    • Patient has tried and failed Elelyso; clinical documentation is required.
    • Medication is prescribed by or in consultation with a geneticist, hematologist, or metabolic disease specialist.

    Cerezyme Continuation Therapy

    Cerezyme continuation therapy

    Continuation is covered when all of the following are met:

    • Patient met the initial review criteria.
    • Documentation shows an improved clinical response, such as increased platelet count and/or hemoglobin concentration or improved radiologic studies.
    • Patient has not experienced treatment-restricting adverse effects, such as infusion-related reactions or antidrug antibody development.
    • Dosing is appropriate according to labeling or is supported by compendia.

    Required Prior Therapy

    StepRequirementCoverage implication
    1Try and fail Elelyso; clinical documentation is required.Cerezyme coverage requires a documented trial and failure of Elelyso.
    Policy Summary
    PayerAgency for Health Care Administration
    PolicyCerezyme (imiglucerase) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage changes
    Effective DateMarch 4, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation showing Type I or Type 3 Gaucher disease, a qualifying manifestation, and a documented trial and failure of Elelyso.
    SourceLink
    On This Page
    Coverage CriteriaAuthorization and Documentation RequirementsPolicy BackgroundCerezyme Initial TherapyCerezyme Continuation TherapyRequired Prior Therapy