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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAdvanced Health Myrbetriq Coverage | OpenPayer
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    CurrentAdvanced HealthPolicy N/A

    Myrbetriq (mirabegron) Coverage Criteria

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    This policy governs initial and renewal authorization for Myrbetriq and mirabegron for Advanced Health members under the Oregon Health Plan. Coverage requires treatment of a funded condition or qualifying comorbid condition and generally requires trials of at least two lower-cost alternatives.

    Policy Summary
    PayerAdvanced Health
    PolicyMyrbetriq (mirabegron) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit documentation of at least two least-cost alternative trials or provide clinical rationale explaining why they cannot be used.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsMaximum approval duration
    2Least-cost alternatives required
    MPR ≥80%Renewal adherence threshold
    >5 daysFailing fill gap
    ≥3 yearsPediatric NDO minimum age
    Policy Summary
    PayerAdvanced Health
    PolicyMyrbetriq (mirabegron) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit documentation of at least two least-cost alternative trials or provide clinical rationale explaining why they cannot be used.
    SourceLink
    On This Page
    Coverage CriteriaOperational ThresholdsAuthorization and DocumentationClinical BackgroundDefinitionsInitial Therapy CriteriaContinuation CriteriaLeast-Cost Alternative Requirements

    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

    Initial requests are covered when all of the following pathway requirements are met.

    Initial therapy

    • Covered condition pathway

      • The medication is being used to treat a condition funded for coverage by the Oregon Health Plan.
      • The member has a comorbid condition that would allow coverage.

        If neither condition pathway applies, deny as below the line because the Oregon Health Plan does not pay for treatment of the condition.

    • Alternative therapy or clinical rationale

      • The member has used at least two least-cost alternatives, supported by fill history or documentation of previous trials.At least 2 alternatives

        Least-cost alternatives include oxybutynin immediate-release, oxybutynin extended-release, solifenacin, tolterodine immediate-release, tolterodine extended-release, darifenacin, trospium, and fesoterodine under the formulary and step-therapy rules.

      • The provider gives clinical rationale explaining why two least-cost alternatives could not be used.At least 2 alternatives

    Continuation Therapy

    Renewal requests are covered when one of the following pathways is met.

    Continuation therapy

    • Adherence and positive response

      • Fill history supports adherence to therapy.MPR ≥80% or no fill gap exceeding 5 days
      • The member has a positive response to therapy.

    • Prescriber rationale

      • Documented rationale

        • The prescriber provides clinical rationale explaining why the member was not adherent to the medication.

    Coverage is excluded when Myrbetriq or mirabegron is used for a condition that is not funded by the Oregon Health Plan and the member does not have a qualifying comorbid condition that would allow coverage. Such requests are denied as below the line.

    Initial therapy does not meet medical-necessity criteria unless the member has tried at least two least-cost alternatives, supported by fill history or prior-trial documentation. If two alternatives cannot be used, the provider must submit clinical rationale explaining why.

    Renewal requires fill history supporting adherence and a positive response to therapy. Adherence is defined as a Medication Possession Ratio of at least 80% or no fill gap exceeding 5 days. If these requirements are not met, the prescriber must provide clinical rationale explaining the nonadherence or why treatment should continue without a positive response.

    Operational Thresholds

    Renewal Adherence
    Renewal adherence MPR≥80%
    Applies toRenewal requests for Myrbetriq or mirabegron
    Approval period when metUp to 12 months
    Renewal Fill Gap
    Maximum fill gap≤5 days
    Adherence definitionNo gaps between fills that exceed 5 days
    Applies toRenewal requests

    Authorization and Documentation

    Prior Authorization

    Initial Prior Authorization

    Prior authorization is required for the initial request. Confirm that Myrbetriq is being used to treat a funded Oregon Health Plan condition, or document a comorbid condition that allows coverage.

    Prior Authorization

    Renewal Prior Authorization

    Prior authorization is required for renewal. Fill history must support adherence and a positive response to therapy. Adherence means a Medication Possession Ratio (MPR) of at least 80% or no fill gap exceeding 5 days.

    • If criteria are met, approval may be issued for up to 12 months.
    Step Therapy

    Least-Cost Alternative Trials

    Before requesting initial approval, document that the member has used at least two least-cost alternatives, unless a clinical rationale explains why they cannot be used.

    Clinical Background

    Mirabegron is a beta-3 adrenergic receptor agonist that relaxes detrusor smooth muscle during the urine-storage phase and increases bladder capacity. Its FDA-labeled clinical uses include overactive bladder in adults and neurogenic detrusor overactivity in pediatric patients aged 3 years and older, with weight- and formulation-specific dosing requirements.

    Definitions

    Adherence
    AdherenceMedication Possession Ratio (MPR) ≥80% or no gaps between fills exceeding 5 days
    MPR criterionMPR must be at least 80%
    Fill-gap criterionNo fill gap may exceed 5 days
    Neurogenic Detrusor Overactivity
    NDONeurogenic detrusor overactivity
    Pediatric ageMyrbetriq is indicated for pediatric patients aged ≥3 years
    Tablet populationThe labeled tablet population weighs ≥35 kg

    Initial Therapy Criteria

    Initial Therapy

    Initial approval requires a covered condition pathway and either least-cost alternative trials or clinical rationale.

    Initial therapy

    • Condition eligibility

      • The medication is being used to treat a condition funded for coverage by the Oregon Health Plan.
      • The member has a qualifying comorbid condition that would allow coverage.

        Otherwise deny as below the line.

    • Step therapy or clinical rationale

      • The member has completed documented trials of at least two least-cost alternatives.At least 2 alternatives

    Continuation Criteria

    Renewal Therapy

    Renewal approval requires adherence and positive response, or documented prescriber rationale.

    Renewal therapy

    • Adherence and positive response

      • Fill history demonstrates adherence to therapy.MPR ≥80% or fill gaps ≤5 days
      • The member has a positive response to therapy.

    • Prescriber rationale

      • Documented rationale

    Least-Cost Alternative Requirements

    StepRequirementLeast-cost alternatives
    1Before Myrbetriq approval, the member must have tried at least 2 least-cost alternatives, supported by fill history or documentation of prior trials.Oxybutynin immediate-release (IR), oxybutynin extended-release (ER), and solifenacin are formulary without prior authorization. Tolterodine IR, tolterodine ER, darifenacin, trospium, and fesoterodine are available through step therapy after a trial of oxybutynin or solifenacin.
    The prescriber provides clinical rationale explaining why the member should continue the medication without a positive response.
    Pediatric NDO
    Minimum age≥3 years
    IndicationNeurogenic detrusor overactivity (NDO)
    ProductMyrbetriq
    Pediatric Tablet Eligibility
    Minimum labeled weight≥35 kg
    PopulationPediatric patients with neurogenic detrusor overactivity
    FormulationMyrbetriq tablets
    • Oxybutynin IR, oxybutynin ER, and solifenacin are formulary alternatives available without prior authorization.
    • Tolterodine IR, tolterodine ER, darifenacin, trospium, and fesoterodine are formulary alternatives available through step therapy after a trial of oxybutynin or solifenacin.
    Documentation Required

    Initial Request Documentation

    For the initial request, submit fill history or other documentation supporting trials of at least two least-cost alternatives. If the alternatives cannot be used, provide the provider's clinical rationale explaining why.

    • When the alternative-trial requirement or clinical rationale is documented, approval may be issued for up to 12 months.
    Documentation Required

    Renewal Documentation

    For renewal, submit documentation showing fill-history adherence and a positive response to therapy. If adherence or positive response is not supported, include the prescriber's clinical rationale explaining the nonadherence or why the member should continue without a positive response.

    • Adherence requires an MPR of at least 80% or no gaps between fills exceeding 5 days.
    • If the criteria or prescriber rationale is documented, approval may be issued for up to 12 months.
    Denial Risk

    Condition Is Below the Line

    The request may be denied as below the line when Myrbetriq is not being used for a funded Oregon Health Plan condition and the member does not have a qualifying comorbid condition that allows coverage.

    • The Oregon Health Plan does not pay for treatment of a condition that is below the line.
    Denial Risk

    Insufficient Alternative Therapy History

    The initial request may be denied when the member has not tried at least two least-cost alternatives and the provider has not supplied clinical rationale explaining why two alternatives could not be used.

    • Required alternatives include oxybutynin IR, oxybutynin ER, solifenacin, tolterodine IR, tolterodine ER, darifenacin, trospium, and fesoterodine, subject to formulary and step-therapy requirements.
    Denial Risk

    Renewal Criteria Not Met

    The renewal request may be denied when fill history does not support adherence and a positive response, and the prescriber provides no rationale for the nonadherence or continued therapy without a positive response.

    • The prescriber should provide documentation of counseling on the importance of medication adherence or change the member to another medication.
    Granules populationMyrbetriq Granules are indicated for pediatric patients aged ≥3 years

    Oxybutynin immediate-release, oxybutynin extended-release, and solifenacin are formulary without prior authorization. Tolterodine immediate-release, tolterodine extended-release, darifenacin, trospium, and fesoterodine are available through step therapy after oxybutynin or solifenacin.

  1. The provider documents clinical rationale explaining why at least two least-cost alternatives could not be used.At least 2 alternatives
    2. The prescriber provides clinical rationale explaining the member's nonadherence.
  2. The prescriber provides clinical rationale explaining why the member should continue without a positive response.