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    OpenPayerPolicy UpdatesClinical/Medical PolicyWellpoint Spravato Prior Auth Coverage | OpenPayer
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    CurrentWellpointPolicy IAWP-CD-066141-24

    UM Clinical Guidelines - Spravato (esketamine nasal spray) PAM-021

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    This policy governs prior authorization and medical-necessity coverage for Spravato used with oral antidepressant therapy in adults with treatment-resistant depression or major depressive disorder with acute suicidal ideation or behavior. It applies to Wellpoint Iowa Medicaid members and specifies clinical criteria, REMS administration requirements, dosing limits, approval durations, and billing information.

    Policy Summary
    PayerWellpoint Iowa Medicaid
    PolicySpravato (esketamine nasal spray) coverage
    Policy CodePolicy IAWP-CD-066141-24
    Change TypeNo material change
    Effective DateFebruary 2025
    Last ReviewJun 27, 2024
    Next Review DateN/A
    Key ActionSubmit prior authorization requests that satisfy the applicable treatment-resistant depression or MDD with acute suicidal ideation or behavior criteria.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    18+Minimum member age
    2Required antidepressant therapy failures for TRD
    84 mgMaximum dose per administration
    3 / 12 mo

    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 and maintenance TRD approval
    4 weeksAcute suicidality approval
    2 hoursPost-administration monitoring

    Clinical Coverage Criteria

    Initial therapy for treatment-resistant depression

    Covered for initial treatment of treatment-resistant depression when ALL of the following are met.

    Initial TRD therapy

    • Diagnosis and age: Diagnosis of moderate to severe major depressive disorder meeting DSM-5 criteria within the previous four weeks; member is 18 years of age or older.Age >=18
    • Prior treatment response: Inadequate response to the maximum tolerated dose of two antidepressant therapies during the current major depressive episode, defined as less than a 50% reduction in symptom severity using a standard rating scale that reliably measures depressive symptoms.<50% symptom reduction
    • Concurrent therapy: Member will continue oral antidepressant therapy in addition to Spravato.
    • Prescriber and facility: Prescribed by or in consultation with a psychiatrist or psychiatric or mental health nurse practitioner, and administered at a facility certified under the Spravato REMS program.
    • Safety exclusions absent: Member has none of the policy-listed aneurysmal vascular disease or arteriovenous malformation, intracerebral hemorrhage, concurrent ketamine use, or severe hepatic impairment (Child-Pugh Class C), and the request is for a covered indication.
    • Dose limit: Dose does not exceed 84 mg (three nasal spray devices) twice weekly during the four-week induction phase.<=84 mg twice weekly during weeks 1-4

    Continuation therapy for treatment-resistant depression

    Covered for continuation of treatment-resistant depression therapy when ALL of the following are met.

    Continuation TRD therapy

    • Diagnosis and eligibility: Member has moderate to severe major depressive disorder and is currently receiving medication through the Iowa Medicaid benefit or previously met initial approval criteria.
    • Treatment response: Member has achieved at least a 50% reduction in depression symptoms compared with baseline using a standard rating scale that reliably measures depressive symptoms.>=50% reduction from baseline
    • Concurrent therapy: Member will continue oral antidepressant therapy in conjunction with Spravato.

    MDD with acute suicidal ideation or behavior

    Covered for major depressive disorder with acute suicidal ideation or behavior when ALL of the following are met.

    • Diagnosis and age: Diagnosis of major depressive disorder meeting DSM-5 criteria within the previous four weeks; member is 18 years of age or older.Age >=18
    • Suicide risk: A clinician judges the member to be at risk for suicide based on suicidal behavior, expressed suicidal ideation, or overall clinical assessment consistent with significant continuing suicide risk.
    • Concurrent oral antidepressant: Spravato is prescribed in combination with initiation or optimization of oral antidepressant therapy.
    • Safety exclusions absent:

    Intravenous ketamine infusion is not a covered benefit. Ketamine administered by IV infusion is not FDA-approved for this use and is excluded from coverage under this policy.

    Spravato is not approved for pediatric members. Covered use under this policy is limited to members who are 18 years of age or older for the specified treatment indications.

    Spravato is not approved as an anesthetic agent. The safety and effectiveness of Spravato when used as an anesthetic have not been established; anesthetic use is therefore not a covered indication under this policy.

    Treatment is not medically necessary when the applicable coverage criteria are not met, including use for unsupported indications or when the member has aneurysmal vascular disease involving the thoracic or abdominal aorta, intracranial or peripheral arterial vessels; an arteriovenous malformation; intracerebral hemorrhage; concurrent ketamine use; or severe hepatic impairment (Child-Pugh Class C).

    Billing and Coding

    HCPCS and bundled service codesHCPCS
    S0013Esketamine, nasal spray, 1 mg (Medicaid)
    G2082Bundled service code for esketamine drug and visit 56 m or less (Medicare cross over)
    G2083Bundled service code for esketamine drug and visit >56 m (Medicare cross over)
    Evaluation and management billingModifier
    E&MUse appropriate evaluation and management (E&M) codes when billing for healthcare provider services required for Spravato administration and post-administration observation.
    ICD-10 diagnosis codesICD-10
    F32.0Major depressive disorder, single episode, mild
    F32.1Major depressive disorder, single episode, moderate
    F32.2Major depressive disorder, single episode, severe without psychotic features
    F32.4Major depressive disorder, single episode, in partial remission
    F32.5Major depressive disorder, single episode, in full remission
    F32.9Major depressive disorder, single episode, unspecified
    F33.0Major depressive disorder, recurrent, mild
    F33.1Major depressive disorder, recurrent, moderate
    F33.2Major depressive disorder, recurrent, severe without psychotic features
    F33.40Major depressive disorder, recurrent, in remission, unspecified
    1–10 of 13
    1/2
    NDC product informationNDC
    50458-0028-0256 mg kit; Janssen Pharmaceuticals, Inc.; 1 mg; package size 1; package quantity 2; 56 units per package
    50458-0028-0384 mg kit; Janssen Pharmaceuticals, Inc.; 1 mg; package size 1; package quantity 3; 84 units per package
    TRD symptom response
    Response thresholdLess than 50% reduction in symptom severity
    Prior therapiesTwo antidepressant therapies
    Dose basisMaximum tolerated dose during the current major depressive episode
    Continuation symptom response
    Required responseAt least 50% reduction in symptoms of depression compared with baseline
    Measurement methodStandard rating scale that reliably measures depressive symptoms

    Authorization and Administration Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for Spravato. Requests must meet the applicable criteria for treatment-resistant depression (TRD) or major depressive disorder (MDD) with acute suicidal ideation or behavior.

    Documentation Required

    Document Failure of Two Antidepressant Therapies

    For TRD, document an inadequate response to the maximum tolerated dose of two antidepressant therapies during the current major depressive episode. Inadequate response means less than a 50% reduction in symptom severity on a reliable standard depression rating scale.

    Documentation Required

    Clinical Eligibility Documentation

    Medication Background

    Spravato (intranasal esketamine) is an N-methyl-D-aspartate (NMDA) receptor antagonist. Its effects involve transiently increasing glutamate release, followed by increased stimulation of postsynaptic AMPA receptors and neurotrophic signaling that may help restore synaptic function in relevant brain regions. Spravato is FDA-approved for adults with treatment-resistant depression (TRD) when used with an oral antidepressant and for depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior, also in conjunction with an oral antidepressant. The policy notes that Spravato has not been demonstrated to prevent suicide or reduce suicidal ideation or behavior and does not replace hospitalization when clinically warranted.

    Key Definitions

    Treatment-resistant depression (TRD)
    ConditionA major depressive episode
    Treatment historyInadequate response to the maximum tolerated dose of two antidepressant therapies during the current major depressive episode
    Symptom response thresholdLess than 50% reduction in symptom severity
    Assessment methodStandard rating scale that reliably measures depressive symptoms
    Risk Evaluation and Mitigation Strategy (REMS)
    ProgramRequired Risk Evaluation and Mitigation Strategy safety program
    Facility

    Covered Treatment Modality

    Spravato (intranasal esketamine)

    Spravato is covered when used within an applicable covered indication and all treatment, prescribing, facility, monitoring, and dose requirements are met.

    Spravato treatment: Intranasal esketamine must be used with oral antidepressant therapy, prescribed by or in consultation with a qualified psychiatric clinician, administered in a certified REMS facility under direct observation, and provided within the applicable indication, dose, and duration limits.

    Administration and Monitoring Limits

    Spravato administration and post-administration observation
    MedicationSpravato (intranasal esketamine)
    Administration settingCertified Spravato REMS healthcare setting
    ObservationAdministration under direct observation of a healthcare provider
    Post-administration monitoringAt least two hours after each administration
    Policy Summary
    PayerWellpoint Iowa Medicaid
    PolicySpravato (esketamine nasal spray) coverage
    Policy CodePolicy IAWP-CD-066141-24
    Change TypeNo material change
    Effective DateFebruary 2025
    Last ReviewJun 27, 2024
    Next Review DateN/A
    Key ActionSubmit prior authorization requests that satisfy the applicable treatment-resistant depression or MDD with acute suicidal ideation or behavior criteria.
    SourceLink
    On This Page
    Clinical Coverage CriteriaBilling and CodingAuthorization and Administration RequirementsMedication BackgroundKey DefinitionsCovered Treatment ModalityAdministration and Monitoring Limits
    Prescriber and facility:
    Prescribed by or in consultation with a psychiatrist or psychiatric or mental health nurse practitioner, and administered at a facility certified under the Spravato REMS program.
  1. Dose limit: Dose does not exceed 84 mg (three nasal spray devices) per week.<=84 mg weekly
    2. Member has none of the policy-listed aneurysmal vascular disease or arteriovenous malformation, intracerebral hemorrhage, concurrent ketamine use, or severe hepatic impairment (Child-Pugh Class C), and the request is for a covered indication.
  2. Prescriber and facility: Prescribed by or in consultation with a psychiatrist or psychiatric or mental health nurse practitioner, and administered at a facility certified under the Spravato REMS program.
  3. Dose limit: Dose does not exceed 84 mg (three nasal spray devices) twice weekly for a total of four weeks.<=84 mg twice weekly for 4 weeks
    4. Therapy statusContinuation of Spravato with oral antidepressant therapy
    Predose blood pressure risk evaluation
    Systolic thresholdGreater than 140 mmHg
    Diastolic thresholdGreater than 90 mmHg
    Required actionComplete a risk-benefit evaluation before dosing
    Post-administration monitoring
    Minimum monitoring periodAt least two hours after administration
    Administration settingCertified Spravato REMS healthcare setting
    Observation requirementDirect observation by a healthcare provider

    Document the member’s diagnosis and applicable indication, DSM-5 timing, age, prescriber qualification, Spravato dose and frequency, and required oral antidepressant therapy. TRD requires moderate-to-severe MDD meeting DSM-5 criteria within the previous four weeks; acute suicidal ideation or behavior requires MDD meeting DSM-5 criteria within the previous four weeks and oral antidepressant initiation or optimization.

    • Member must be 18 years of age or older.
    • Treatment must be prescribed by, or provided in consultation with, a psychiatrist or psychiatric/mental health nurse practitioner.
    • For TRD, oral antidepressant therapy must continue with Spravato.
    • For MDD with acute suicidal ideation or behavior, Spravato must be prescribed with initiation or optimization of oral antidepressant therapy.
    Documentation Required

    TRD Treatment History and Response

    For TRD authorization, document inadequate response during the current episode to two antidepressant therapies given at their maximum tolerated doses. The response assessment must use a standard rating scale that reliably measures depressive symptoms and show less than a 50% reduction in symptom severity.

    Documentation Required

    REMS Facility Documentation

    Document that treatment will occur through a facility certified under the Spravato REMS program and that the required REMS administration and monitoring process is available.

    • Healthcare setting must be Spravato REMS certified.
    • Spravato must be administered under direct observation of a healthcare provider.
    • The member must be monitored for at least two hours after administration.
    • The dispensing pharmacy must also be certified and may dispense only to certified healthcare settings.
    Documentation Required

    Suicide-Risk Assessment

    For MDD with acute suicidal ideation or behavior, document that a clinician has determined the member has significant continuing suicide risk based on suicidal behavior, expressed suicidal ideation, or the overall clinical assessment.

    Unsupported block type: prior_auth

    Denial Risk

    Contraindications and Unsupported Indications

    Coverage is not medically necessary when a listed contraindication or unsupported indication applies.

    • Aneurysmal vascular disease involving the thoracic or abdominal aorta, intracranial or peripheral arterial vessels, or an arteriovenous malformation.
    • Intracerebral hemorrhage.
    • Concurrent use with ketamine.
    • Severe hepatic impairment (Child-Pugh Class C).
    • All other indications when the applicable coverage criteria are not met.
    Billing Rule

    REMS Administration Requirement

    Spravato must be administered in a certified Spravato REMS healthcare setting under direct observation, with monitoring for at least two hours after each administration.

    • Assess blood pressure before and after dosing; if predose blood pressure exceeds 140 mmHg systolic or 90 mmHg diastolic, perform a risk-benefit evaluation.
    • Administer on an empty stomach, avoiding food for at least two hours before dosing.
    • Monitor for sedation, dissociation, misuse or abuse, urinary or bladder symptoms, and increased risk associated with moderate hepatic impairment.
    Billing Rule

    Dose and Frequency Limits

    Apply the phase- and indication-specific dose and frequency limits. The maximum dose is 84 mg (three nasal spray devices) per administration.

    • TRD induction: no more than 84 mg twice weekly for four weeks.
    • TRD maintenance: no more than 84 mg once weekly.
    • MDD with acute suicidal ideation or behavior: no more than 84 mg twice weekly for a total four-week course; approval duration is four weeks.
    • TRD authorization limits: initial approval is three months; continuation approval is 12 months, with four kits per 28 days after the first 28 days.
    • MDD with acute suicidal ideation or behavior: initial limit is eight kits for the 28-day course; continuation is not applicable.
    Denial Risk

    Pediatric Use

    Spravato is not approved for pediatric members. Covered criteria require the member to be 18 years of age or older for both TRD and MDD with acute suicidal ideation or behavior.

    Spravato must be administered in a certified healthcare setting
    AdministrationDirect observation by a healthcare provider is required
    MonitoringThe member must be monitored for at least two hours after administration