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    v1.0.31
    OpenPayerPolicy UpdatesClinical/Medical PolicyNH Medicaid Spravato Prior Auth Coverage | OpenPay…
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    CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

    Spravato (esketamine) Coverage Criteria

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    New Hampshire Medicaid Fee-for-Service prior authorization, renewal, authorization duration, and quantity limits for Spravato nasal spray in adults with treatment-resistant depression or major depressive disorder with acute suicidal ideation or behavior.

    Policy Summary
    PayerNew Hampshire Department of Health and Human Services
    PolicySpravato (esketamine) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateN/A
    Last ReviewApr 8, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation confirming the patient meets the initial approval criteria, including diagnosis, baseline assessment, safety screening, REMS certification, monitoring capability, and required treatment history.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥18Minimum patient age
    ≥2Failed antidepressant trials for TRD
    ≥6 weeksDuration per failed trial
    50%Symptom improvement for renewal

    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.

    2 hoursPost-administration monitoring
    2 kits/weekMaximum TRD induction quantity

    Coverage Criteria

    Initial therapy — general criteria

    Initial coverage is available when all of the following general requirements are met.

    General initial approval requirements

    • Diagnosis and prescribing

      • Patient is at least 18 years old; has a DSM-5 diagnosis of major depressive disorder (MDD); has a baseline depression assessment using a validated depression rating scale such as MADRS, HAM-D, PHQ-9, or BDI; and esketamine is prescribed by or in consultation with a psychiatrist or psychiatric mental health nurse practitioner (PMHNP).Age ≥18 years

    • Safety criteria

      • Patient does not have aneurysmal vascular disease.
      • Patient does not have an arteriovenous malformation.
      • Patient has no history of intracerebral hemorrhage.
      • Patient does not have uncontrolled hypertension.Blood pressure must not exceed 140/90 mmHg if younger than 65 years, or 150/90 mmHg if 65 years or older
      • Patient is not pregnant, does not have known hypersensitivity to any component of the product, and is not receiving concomitant ketamine therapy.

    • Medication and treatment-setting requirements

      • Patient is taking esketamine in conjunction with an antidepressant medication; monotherapy is accepted for treatment-resistant depression (TRD).
      • The prescriber's healthcare setting is certified in the Spravato Risk Evaluation and Mitigation Strategies (REMS) program.
      • The prescriber will check blood pressure before each administration and can monitor the patient following administration until the patient is stable for at least 2 hours, with baseline or decreasing blood pressure.Stable for ≥2 hours

    • Patient understanding and attendance

      • The prescriber has reviewed the dosing schedule with the patient.
      • The patient understands and is committed to receiving scheduled doses and can be available twice weekly with adequate transportation to and from the treatment facility.Availability twice weekly

    Initial therapy — treatment-resistant depression

    For treatment-resistant depression, all general initial approval requirements and all TRD-specific requirements must be met.

    Initial approval for TRD

    • General initial approval requirements

      • Patient is at least 18 years old; has a DSM-5 diagnosis of major depressive disorder (MDD); has a baseline depression assessment using a validated depression rating scale; and esketamine is prescribed by or in consultation with a psychiatrist or psychiatric mental health nurse practitioner (PMHNP).Age ≥18 years
      • Patient does not have aneurysmal vascular disease, an arteriovenous malformation, a history of intracerebral hemorrhage, uncontrolled hypertension, pregnancy, or known hypersensitivity to any component of the product; and is not receiving concomitant ketamine therapy.Blood pressure must not exceed 140/90 mmHg if younger than 65 years, or 150/90 mmHg if 65 years or older

    Renewal therapy

    Renewal requires all of the following.

    Renewal criteria

    • Patient continues to meet the initial approval criteria.
    • Patient demonstrates disease improvement and/or stabilization as a result of the medication, documented by a 50% reduction in symptom severity using a validated depression rating scale.50% reduction in symptom severity
    • Patient has not experienced unacceptable toxicity, such as dissociation or cognitive impairment.
    • Prescriber attests that the patient has committed to receiving all scheduled doses thus far in treatment and will continue to receive scheduled doses.

    Coverage is excluded or denied when the patient has aneurysmal vascular disease, an arteriovenous malformation, a history of intracerebral hemorrhage, uncontrolled hypertension above the applicable age-based threshold, or pregnancy. Authorization is also denied when the other approval criteria are not met.

    The patient must not have a known hypersensitivity to any component of Spravato and must not be receiving concomitant ketamine therapy.

    For treatment-resistant depression, the patient must not have failed prior ketamine treatment for MDD and must not be receiving concomitant electroconvulsive therapy (ECT), vagus nerve stimulation (VNS), transcranial magnetic stimulation (TMS), or deep brain stimulation (DBS).

    Clinical Thresholds and Operational Limits

    Uncontrolled hypertension under age 65
    Blood pressure threshold> 140/90 mmHg
    Applies toPatients younger than 65 years
    Coverage treatmentUncontrolled hypertension above this threshold is excluded from approval
    Uncontrolled hypertension age 65 or older
    Blood pressure threshold> 150/90 mmHg
    Applies toPatients age 65 years or older
    Coverage treatmentUncontrolled hypertension above this threshold is excluded from approval

    Prior Authorization and Documentation Requirements

    Prior Authorization

    Initial Authorization Criteria

    Initial prior authorization requires documentation that the patient meets the applicable Spravato® criteria, including age, diagnosis, baseline assessment, qualified prescribing oversight, required antidepressant use, and all applicable attestations. For treatment-resistant depression (TRD), the additional treatment-history requirements must also be satisfied.

    • Patient is 18 years or older and has a DSM-5 diagnosis of major depressive disorder (MDD).
    • A validated baseline depression assessment must be documented.
    • Esketamine must be prescribed by or in consultation with a psychiatrist or psychiatric mental health nurse practitioner (PMHNP).
    • Esketamine must be used with an antidepressant; monotherapy is accepted when used for TRD.
    • The patient must not be pregnant, have product-component hypersensitivity, receive concomitant ketamine therapy, or have an applicable contraindication listed below.
    Prior Authorization

    Renewal Authorization Criteria

    Renewal authorization requires continued eligibility and documented clinical benefit or stabilization without unacceptable toxicity. The prescriber must also attest to the patient’s adherence to scheduled treatment and intent to continue.

    Policy Background

    Spravato (esketamine) nasal spray is covered for adults with treatment-resistant depression (TRD) or depressive symptoms associated with major depressive disorder (MDD) and acute suicidal ideation or behavior. Treatment is provided under prior authorization in a certified setting with psychiatric oversight, required safety screening, blood-pressure monitoring, and post-administration observation. Spravato may be used with an oral antidepressant; monotherapy is accepted for TRD.

    The policy states that effectiveness in preventing suicide or reducing suicidal ideation or behavior has not been demonstrated. Treatment with Spravato does not eliminate the need for hospitalization when hospitalization is clinically warranted.

    Key Definitions

    Treatment-resistant depression (TRD)
    Required failed treatmentsAt least 2 antidepressants from different classes
    Trial duration and doseEach antidepressant must be used for at least 6 weeks at generally accepted doses, unless contraindicated or clinically significant adverse effects occur
    Definition of failureLess than 50% reduction in symptom severity on a validated depression rating scale
    Oral therapy adherence
    Adherence standardCompliance with at least 80% of doses
    Measurement periodDuring the current depressive episode
    Evidence

    Covered Treatment

    Esketamine nasal spray (Spravato)

    Spravato (esketamine) nasal spray is covered when administered under the applicable initial or renewal criteria for one of the following indication pathways.

    Esketamine treatment modality

    • Applicable indication pathway

      • Treatment-resistant depression (TRD) in an adult, treated with esketamine as monotherapy or in conjunction with an oral antidepressant, with the applicable TRD treatment history and initial or renewal criteria met.
      • Depressive symptoms in an adult with major depressive disorder (MDD) and acute suicidal ideation or behavior, treated in conjunction with an oral antidepressant, with the applicable initial or renewal criteria met.
    • Treatment is prescribed by or in consultation with a psychiatrist or psychiatric mental health nurse practitioner and includes a validated depression assessment, required safety screening, and required treatment-setting attestations.
    Policy Summary
    PayerNew Hampshire Department of Health and Human Services
    PolicySpravato (esketamine) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateN/A
    Last ReviewApr 8, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation confirming the patient meets the initial approval criteria, including diagnosis, baseline assessment, safety screening, REMS certification, monitoring capability, and required treatment history.
    SourceLink
    On This Page
    Coverage CriteriaClinical Thresholds and Operational LimitsPrior Authorization and Documentation RequirementsPolicy BackgroundKey DefinitionsCovered Treatment
    Patient is taking esketamine in conjunction with an antidepressant medication, except that monotherapy is accepted for TRD; the setting is Spravato REMS certified; blood pressure will be checked before each administration; and the patient will be monitored until stable for at least 2 hours with baseline or decreasing blood pressure.
    Stable for ≥2 hours
  1. The prescriber has reviewed the dosing schedule; the patient understands and is committed to scheduled doses; and the patient can be available twice weekly with adequate transportation to and from the treatment facility.Availability twice weekly

  2. TRD-specific requirements

    • Patient has a history of adherence with oral therapy during the current depressive episode, demonstrated by compliance with at least 80% of doses through refill history or prescriber attestation.≥80% of doses
    • Patient has tried psychotherapy alone or in combination with oral antidepressants when a psychotherapy resource is available.
    • Patient has not failed prior ketamine treatment for MDD and is not receiving concomitant ECT, VNS, TMS, or DBS.
    • Patient has failed trials of at least two antidepressants from different classes, with each trial lasting at least 6 weeks at generally accepted doses, unless contraindicated or clinically significant adverse effects occurred.≥2 antidepressants; ≥6 weeks each

      A failed trial means less than a 50% reduction in symptom severity using a validated depression rating scale.

    3. Oral antidepressant adherence
    Minimum adherenceAt least 80% of doses
    Measurement periodDuring the current depressive episode
    EvidenceRefill history or prescriber attestation
    Failed antidepressant trial duration
    Minimum durationAt least 6 weeks per antidepressant
    Required treatment historyAt least 2 antidepressants from different classes
    Dose standardGenerally accepted doses, unless contraindicated or clinically significant adverse effects occur
    Failed antidepressant trial response
    Failed-trial responseLess than 50% reduction in symptom severity
    Assessment methodValidated depression rating scale
    Applies toEach antidepressant trial used to establish treatment-resistant depression
    Post-administration monitoring
    Monitoring durationThe patient must remain stable for at least 2 hours after administration
    Blood pressure statusBaseline or decreasing blood pressure
    Pre-administration requirementBlood pressure must be checked before each administration
    Renewal clinical response
    Required response50% reduction in symptom severity
    Assessment methodValidated depression rating scale
    Renewal contextDemonstrated disease improvement and/or stabilization as a result of the medication
    • The patient continues to meet the initial authorization criteria.
    • Disease improvement and/or stabilization is demonstrated by a 50% reduction in symptom severity on a validated depression rating scale.
    • The patient has not experienced unacceptable toxicity, such as dissociation or cognitive impairment.
    • The patient has committed to receiving all scheduled doses to date and will continue to do so.
    Step Therapy

    Required Antidepressant Trials for TRD

    For TRD, the patient must have failed adequate trials of at least two antidepressants from different classes before authorization.

    • At least 2 antidepressants of different classes must each have been tried for at least 6 weeks at generally accepted doses.
    • A trial may be considered adequate despite a contraindication or clinically significant adverse effect.
    • A failed trial is defined as less than a 50% reduction in symptom severity on a validated depression rating scale.
    Documentation Required

    Oral Therapy and Psychotherapy History

    For TRD, the record must document adherence to oral therapy and the patient’s psychotherapy history. Psychotherapy must have been tried alone or with oral antidepressants when psychotherapy resources are available.

    • Document compliance with at least 80% of oral-antidepressant doses during the current depressive episode, demonstrated by refill history or prescriber attestation.
    • Document a trial of psychotherapy alone or in combination with oral antidepressants when a psychotherapy resource is available.
    • Include the relevant treatment history and response in the authorization record.
    Documentation Required

    Diagnosis and Baseline Assessment

    The initial clinical record must establish the patient’s age, DSM-5 MDD diagnosis, and baseline depressive symptom severity before treatment begins.

    • Patient is 18 years or older.
    • Document a DSM-5 diagnosis of major depressive disorder (MDD).
    • Document a baseline assessment using a validated depression rating scale, such as MADRS, HAM-D, PHQ-9, or BDI.
    Documentation Required

    TRD Treatment History

    When Spravato® is requested for TRD, document the required prior treatment history and exclusions before submitting the request.

    • History of adherence with oral therapy during the current depressive episode, with at least 80% of doses taken.
    • Psychotherapy was tried alone or with oral antidepressants when a resource was available.
    • The patient has not failed prior ketamine treatment for MDD.
    • The patient is not receiving concomitant ECT, VNS, TMS, or DBS.
    • At least two different-class antidepressant trials were unsuccessful under the required duration and dosing criteria.
    Documentation Required

    REMS, Monitoring, and Adherence Attestations

    The prescriber and treatment setting must satisfy the Spravato REMS and monitoring requirements before administration.

    • Attest that the healthcare setting is certified in the Spravato Risk Evaluation and Mitigation Strategies (REMS) program.
    • Attest that blood pressure will be checked before every administration.
    • Attest that the patient can be monitored as directed after administration and will remain stable for at least 2 hours, with baseline or decreasing blood pressure, before monitoring ends.
    • Attest that the dosing schedule has been reviewed with the patient.
    • Attest that the patient understands and is committed to scheduled doses and can attend twice weekly with adequate transportation to and from the treatment facility.
    Documentation Required

    Renewal Documentation

    Renewal submissions must include current documentation showing that treatment remains effective, tolerated, and clinically appropriate.

    • Provide a validated depression rating-scale result demonstrating a 50% reduction in symptom severity and/or disease stabilization.
    • Document continued eligibility under the initial criteria.
    • Document absence of unacceptable toxicity, including dissociation or cognitive impairment.
    • Include the prescriber’s attestation that the patient received all scheduled doses to date and will continue scheduled treatment.
    Denial Risk

    Clinical Contraindications or Unmet Criteria

    Authorization is denied when a listed contraindication or exclusion is present, including conditions that create unacceptable vascular, pregnancy, hypersensitivity, or treatment-combination risk.

    • Aneurysmal vascular disease.
    • Arteriovenous malformation.
    • History of intracerebral hemorrhage.
    • Uncontrolled hypertension: >140/90 mmHg for patients younger than 65 years or >150/90 mmHg for patients 65 years or older.
    • Pregnancy.
    • Known hypersensitivity to any product component.
    • Concomitant ketamine therapy.
    • For TRD, concomitant ECT, VNS, TMS, or DBS, or prior failed ketamine treatment for MDD.
    Denial Risk

    Incomplete Clinical or Attestation Requirements

    Requests may be denied or delayed when required clinical records or prescriber attestations are incomplete. Submit documentation supporting every applicable initial, TRD, monitoring, and adherence criterion.

    • Missing age, DSM-5 MDD diagnosis, or baseline validated depression assessment.
    • Missing documentation of qualified psychiatric prescribing oversight or required antidepressant use.
    • Missing oral-therapy adherence, psychotherapy, failed-medication, or related TRD treatment history.
    • Missing REMS certification, blood-pressure monitoring, post-administration observation, dosing-schedule, transportation, or adherence attestations.
    • Missing documentation of contraindication screening or relevant concurrent therapies.
    Denial Risk

    Unsuccessful Renewal

    A renewal request is unsuccessful when the patient no longer meets the criteria or the record does not demonstrate meaningful benefit, stabilization, tolerability, and continued commitment to treatment.

    • The patient no longer meets the applicable initial or continuation criteria.
    • A 50% reduction in symptom severity and/or disease improvement or stabilization is not demonstrated using a validated depression rating scale.
    • Unacceptable toxicity has occurred, such as dissociation or cognitive impairment.
    • The prescriber cannot attest that the patient received all scheduled doses or will continue scheduled treatment.
    Refill history or prescriber attestation
    Certified treatment setting
    SettingHealthcare setting certified in the Spravato Risk Evaluation and Mitigation Strategies (REMS) program
    Pre-administration capabilityBlood-pressure checks before each administration
    Post-administration capabilityMonitoring until the patient is stable for at least 2 hours, with baseline or decreasing blood pressure, before monitoring ends
    Treatment is administered in a Spravato REMS-certified healthcare setting with blood-pressure checks before each administration and post-administration monitoring until the patient is stable for at least 2 hours with baseline or decreasing blood pressure.Stable for ≥2 hours
  3. The patient understands and is committed to scheduled treatment and can attend as required with adequate transportation.