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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsFlorida Medicaid Abilify MyCite Prior Auth | OpenP…
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    CurrentAgency for Health Care AdministrationPolicy N/A

    Abilify MyCite Prior Authorization Criteria

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    This policy governs prior authorization for Abilify MyCite for eligible Florida Medicaid fee-for-service members and establishes clinical criteria, documentation requirements, alternate approval criteria, and a three-month authorization period.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyAbilify MyCite Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateApril 4, 2025
    Next Review DateN/A
    Key ActionDocument a qualifying trial and failure of a preferred atypical antipsychotic within the past 365 days, including at least 30 days of treatment.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    3 monthsAuthorization length
    18+ yearsMinimum patient age
    365 daysTrial lookback period
    30 daysRequired trial duration
    6

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    Available strengths

    Coverage Criteria

    Primary Review Criteria

    Approval under the primary review criteria requires all of the following:

    Primary review criteria

    • Age: Patient must be at least 18 years old.>=18 years
    • Diagnosis: A diagnosis of schizophrenia, bipolar I disorder, or major depressive disorder is documented.
    • Treatment history: The patient has a history within the past 365 days of trial and failure of a preferred atypical antipsychotic, with a minimum 30-day treatment period.Within past 365 days; minimum 30-day treatment period
    • Non-compliance with an atypical antipsychotic is documented and was not related to intolerance or an allergic reaction.

    Alternate Review Criteria

    Approval under the alternate review criteria requires all of the following:

    Alternate review criteria

    • Diagnosis: The patient has a diagnosis of schizophrenia, schizotypal disorder, or delusional disorder.
    • Drug use: The drug product or a medication of a similar drug class is prescribed for treatment of schizophrenia, schizotypal disorder, or delusional disorder.
    • Prior authorization history: Prior authorization has previously been granted for the prescribed drug.
    • Dispensing history: The medication was dispensed to the patient during the previous 12 months.Previous 12 months

    Provider Actions and Documentation

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required. Abilify MyCite may be approved through either the primary review criteria or the alternate review criteria. Authorizations are limited to three months.

    • Primary pathway: patient meets the standard review criteria.
    • Alternate pathway: clinical documentation establishes medical necessity and meets the alternate requirements.
    Step Therapy

    Preferred Atypical Antipsychotic Trial and Failure

    Document a history, within the past 365 days, of a trial and failure of a preferred atypical antipsychotic. The trial must include at least 30 days of treatment.

    • Lookback period: 365 days.
    • Minimum preferred atypical antipsychotic treatment period: 30 days.

    Background

    Abilify MyCite is a drug-device combination product containing aripiprazole and a sensor embedded in the tablet. The sensor is intended to track drug ingestion through the smartphone application. Most ingestions are detected within 30 minutes, although detection may take up to two hours; the product is not intended for real-time ingestion or emergency monitoring.

    Definitions

    Definitions
    Product typeDrug-device combination product
    Active ingredientAripiprazole tablets
    Embedded technologySensor embedded in the tablets to track drug ingestion
    Ingestion detectionMost ingestions are detected within 30 minutes, but detection on the smartphone app may take up to two hours
    Use limitationNot intended for real-time ingestion or emergency monitoring

    Initial Therapy Criteria

    Initial Therapy Criteria

    Initial approval requires all primary review criteria:

    Initial approval criteria

    • Age: Patient must be at least 18 years old.>=18 years
    • Diagnosis: A diagnosis of schizophrenia, bipolar I disorder, or major depressive disorder is documented.
    • Treatment history: The patient has a history within the past 365 days of trial and failure of a preferred atypical antipsychotic, with a minimum 30-day treatment period.Within past 365 days; minimum 30-day treatment period

    Continuation and Alternate Review Pathway

    Alternate Review Pathway

    Alternate approval requires clinical documentation of medical necessity and all of the following:

    Alternate review pathway

    • Diagnosis: The patient has a diagnosis of schizophrenia, schizotypal disorder, or delusional disorder.
    • Drug use: The drug product or a medication of a similar drug class is prescribed for treatment of schizophrenia, schizotypal disorder, or delusional disorder.
    • Prior authorization history: Prior authorization has previously been granted for the prescribed drug.
    • Dispensing history:

    Step Therapy

    StepRequired prior therapyQualifying criteria
    1Preferred atypical antipsychoticTrial and failure within the past 365 days, including a minimum 30-day treatment period, before Abilify MyCite approval.
    Policy Summary
    PayerAgency for Health Care Administration
    PolicyAbilify MyCite Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateApril 4, 2025
    Next Review DateN/A
    Key ActionDocument a qualifying trial and failure of a preferred atypical antipsychotic within the past 365 days, including at least 30 days of treatment.
    SourceLink
    On This Page
    Coverage CriteriaProvider Actions and DocumentationBackgroundDefinitionsInitial Therapy CriteriaContinuation and Alternate Review PathwayStep Therapy
    Documentation Required

    Age and Diagnosis Documentation

    Document that the patient is at least 18 years old and has an eligible diagnosis of schizophrenia, bipolar I disorder, or major depressive disorder.

    • Minimum age: ≥18 years.
    • Eligible diagnoses: schizophrenia, bipolar I disorder, or major depressive disorder.
    Documentation Required

    Document the Qualifying Trial

    Submit clinical records identifying the preferred atypical antipsychotic, the qualifying treatment period, and the documented failure within the required 365-day timeframe.

    • Identify the preferred atypical antipsychotic trial.
    • Document at least 30 days of treatment and treatment failure.
    • Ensure the trial and failure occurred within the past 365 days.
    Documentation Required

    Non-Compliance Documentation

    Document non-compliance with an atypical antipsychotic when the non-compliance was not caused by intolerance or an allergic reaction.

    • The non-compliance documentation must distinguish non-compliance from intolerance or allergic reaction.
    Documentation Required

    Alternate Medical Necessity Documentation

    If the primary criteria are not met, provide clinical documentation of medical necessity for the alternate pathway. The documentation must identify the diagnosis and the prescribed drug or a similar drug-class product.

    • Diagnosis must be schizophrenia, schizotypal disorder, or delusional disorder.
    • The prescribed drug or a medication from a similar drug class must be intended to treat the qualifying disorder.
    • Document the clinical rationale supporting medical necessity.
    Denial Risk

    Failure to Meet Primary Review Criteria

    Approval may be denied when the primary review requirements are not satisfied. Verify and document every required element before submitting the request.

    • Patient is under 18 years old.
    • No documented diagnosis of schizophrenia, bipolar I disorder, or major depressive disorder.
    • No qualifying preferred atypical antipsychotic trial and failure within the past 365 days.
    • Preferred treatment did not include at least 30 days of therapy.
    • Required non-compliance documentation is absent or indicates intolerance or allergic reaction instead.
    Denial Risk

    Failure to Meet Alternate Criteria

    Approval may be denied under the alternate pathway when any alternate requirement is missing or cannot be verified.

    • No clinical documentation establishes medical necessity.
    • Diagnosis is not schizophrenia, schizotypal disorder, or delusional disorder.
    • The prescribed drug or similar drug-class medication is not documented as treating the qualifying disorder.
    • Prior authorization has not previously been granted for the prescribed drug.
    • The medication was not dispensed to the patient during the previous 12 months.
  1. Non-compliance with an atypical antipsychotic is documented and was not related to intolerance or an allergic reaction.
    2. The medication was dispensed to the patient during the previous 12 months.
    Previous 12 months