Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAHCA Cerdelga Prior Auth Coverage | OpenPayer
    Ask Trek AI about this page
    CurrentAgency for Health Care AdministrationPolicy N/A

    Cerdelga (eliglustat) Prior Authorization Criteria

    Customize your policy alerts

    Sign up for all Agency for Health Care Administration policy alerts

    Know when Agency for Health Care Administration releases new policies or updates existing guidance.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    This policy establishes prior authorization criteria for Cerdelga (eliglustat) for adults with Gaucher disease Type I. It also defines continuation-of-therapy requirements and an authorization duration of up to one year.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyCerdelga (eliglustat) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateFebruary 9, 2024
    Next Review DateN/A
    Key ActionSubmit documentation of age, Gaucher disease Type I, an FDA-cleared CYP2D6 genotype test, and trial and failure of a preferred agent such as Elelyso or Zavesca.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    1 yearMaximum authorization
    ≥18Minimum age
    Type IRequired diagnosis
    84 mgDosage form

    Coverage Criteria

    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.

    Initial Therapy Criteria

    Covered when all of the following are met.

    Initial therapy

    • Age: Patient must be at least 18 years of age.≥18 years
    • Diagnosis: Patient has a documented diagnosis of Gaucher disease Type I in health conditions or medical records.Gaucher disease Type I
    • Genotype testing: An FDA-cleared test to determine the CYP2D6 genotype has been submitted.FDA-cleared CYP2D6 genotype test
    • Preferred-agent failure: Patient has a documented trial and failure on a preferred agent, such as Elelyso or Zavesca.Documented trial and failure

      Examples of preferred agents include Elelyso and Zavesca.

    Continuation Therapy Criteria

    Continuation is covered when all of the following are met.

    Continuation therapy

    • Initial criteria: Patient met the initial review criteria.Initial criteria met
    • Clinical response: Documentation shows an improved clinical response.Improved clinical response
    • Safety: Patient has not experienced any treatment-restricting adverse effects.No treatment-restricting adverse effects

    Provider Actions

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for Cerdelga (eliglustat). An authorization may be approved for up to one year.

    Step Therapy

    Preferred-Agent Trial Required

    Before Cerdelga can be authorized, document a trial and failure of a preferred agent, such as Elelyso or Zavesca.

    Documentation Required

    Initial Authorization Documentation

    Submit documentation supporting the initial request, including the patient's age, diagnosis of Gaucher disease Type I, CYP2D6 genotype testing, and trial and failure of a preferred agent.

    • Patient is 18 years of age or older.
    • Diagnosis of Gaucher disease Type I is documented in the health conditions or medical records.
    • An FDA-cleared test determining the CYP2D6 genotype is submitted.
    • Trial and failure of a preferred agent, such as Elelyso or Zavesca, is documented.
    Documentation Required

    Continuation Documentation

    For continuation of therapy, document that the patient met the initial review criteria and continues to meet clinical and dosing requirements.

    • Improved clinical response is documented.
    • The patient has not experienced treatment-restricting adverse effects.
    • Dosing is appropriate according to labeling or supported by compendia.
    Denial Risk

    Initial Criteria Not Met

    The request may be denied when the initial authorization criteria are not met, including required age, diagnosis, CYP2D6 genotype testing, preferred-agent trial and failure, or other required documentation.

    • Patient is under 18 years of age.
    • Gaucher disease Type I is not documented.
    • An FDA-cleared CYP2D6 genotype test is not submitted.
    • Trial and failure of a preferred agent is not documented.
    • Other initial review requirements are not satisfied.
    Denial Risk

    Continuation Criteria Not Met

    Continuation may be denied when the patient does not demonstrate improvement, experiences treatment-restricting adverse effects, has inappropriate dosing, or no longer meets the initial review criteria.

    • Improved clinical response is not documented.
    • Treatment-restricting adverse effects have occurred.
    • Dosing is not appropriate according to labeling or supported by compendia.
    • Initial review criteria were not met.

    Background

    Cerdelga (eliglustat) is reviewed for adults with Gaucher disease Type I. Coverage review requires documentation of the diagnosis, an FDA-cleared CYP2D6 genotype test, and a documented trial and failure of a preferred agent such as Elelyso or Zavesca.

    Definitions

    FDA-cleared CYP2D6 genotype test
    TermFDA-cleared CYP2D6 genotype test
    DefinitionA genetic test cleared by the U.S. Food and Drug Administration to determine the patient's CYP2D6 genotype.
    Coverage useSubmission of the test is required for Cerdelga (eliglustat) review.

    Initial Therapy Criteria

    Initial Review Criteria

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

    Initial review criteria

    • Age: Patient must be at least 18 years of age.≥18 years
    • Diagnosis: Patient has a documented diagnosis of Gaucher disease Type I in health conditions or medical records.Gaucher disease Type I
    • CYP2D6 genotype test: An FDA-cleared test to determine the CYP2D6 genotype has been submitted.FDA-cleared CYP2D6 genotype test
    • Preferred-agent trial and failure: Patient has a documented trial and failure on a preferred agent, such as Elelyso or Zavesca.Documented trial and failure

      Examples of preferred agents include Elelyso and Zavesca.

    Continuation of Therapy

    Continuation of Therapy

    Continuation is covered when all of the following are met.

    Continuation of therapy

    • Initial criteria: Patient met the initial review criteria.Initial criteria met
    • Clinical response: Documentation shows an improved clinical response.Improved clinical response
    • Safety: Patient has not experienced any treatment-restricting adverse effects.No treatment-restricting adverse effects
    • Dosing is appropriate according to labeling or is supported by compendia.Labeling- or compendia-supported dosing

    Step Therapy

    StepRequirementFailure criterion
    1Try a preferred agent such as Elelyso or Zavesca before Cerdelga authorization.Documented trial and failure of a preferred agent.
    Policy Summary
    PayerAgency for Health Care Administration
    PolicyCerdelga (eliglustat) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateFebruary 9, 2024
    Next Review DateN/A
    Key ActionSubmit documentation of age, Gaucher disease Type I, an FDA-cleared CYP2D6 genotype test, and trial and failure of a preferred agent such as Elelyso or Zavesca.
    SourceLink
    On This Page
    Coverage CriteriaProvider ActionsBackgroundDefinitionsInitial Therapy CriteriaContinuation of TherapyStep Therapy
    Dosing is appropriate according to labeling or is supported by compendia.Labeling- or compendia-supported dosing