CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Spravato (esketamine) Criteria

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This policy governs New Hampshire Medicaid Fee-for-Service prior authorization, initial approval, renewal, quantity limits, and authorization durations for Spravato (esketamine) in adults with major depressive disorder, including treatment-resistant depression and major depressive disorder with acute suicidal ideation or behavior.

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicySpravato (esketamine) Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Last ReviewDec 8, 2023

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming all general approval criteria and any treatment-resistant depression requirements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum patient age

4 weeksInitial authorization

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CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Spravato (esketamine) Criteria

Customize your policy alerts

Sign up for all New Hampshire Department of Health and Human Services policy alerts

Know when New Hampshire Department of Health and Human Services releases new policies or updates existing guidance.

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Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicySpravato (esketamine) Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Last ReviewDec 8, 2023

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming all general approval criteria and any treatment-resistant depression requirements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum patient age

4 weeksInitial authorization

2 kits/weekTRD induction limit

1 kit/weekTRD maintenance limit

50% reductionRenewal improvement

≥2 hoursPost-dose monitoring

Coverage Criteria

General initial approval

Covered when ALL of the following general criteria are met:

Eligibility and diagnosis: Patient is at least 18 years old; has a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of major depressive disorder (MDD); and has a baseline depression assessment using a validated depression rating scale.Age ≥18

Examples include MADRS, HAM-D, PHQ-9, or BDI.

Prescriber and safety requirements: Esketamine is prescribed by or in consultation with a psychiatrist or psychiatric mental health nurse practitioner (PMHNP); the patient does not have aneurysmal vascular disease, an arteriovenous malformation, a history of intracerebral hemorrhage, or uncontrolled hypertension; the patient is not pregnant; and the patient does not have known hypersensitivity to any product component.Uncontrolled hypertension: >140/90 mmHg for patients under 65 years old or >150/90 mmHg for patients 65 years or older

Concomitant therapy and administration: The patient is not receiving concomitant ketamine therapy; esketamine is used with an antidepressant and not as monotherapy; the prescriber's healthcare setting is certified in the Spravato REMS program; blood pressure will be checked before each administration; the patient will be monitored after administration until stable for at least two hours with baseline or decreasing blood pressure; the dosing schedule has been reviewed; and the patient understands and is committed to scheduled doses, can attend twice weekly, and has adequate transportation to and from the treatment facility.Stable for ≥2 hours after administration

Treatment-resistant depression

For treatment-resistant depression, ALL of the following additional criteria are required:

Prior treatment history: The patient has demonstrated adherence with oral therapy during the current depressive episode; has tried psychotherapy alone or in combination with oral antidepressants when psychotherapy resources are available; and has failed at least two antidepressants from different classes for at least six weeks each at generally accepted doses, unless contraindicated or clinically significant adverse effects were experienced.Oral adherence ≥80%; ≥2 antidepressants from different classes; ≥6 weeks per trial

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

Prohibited prior or concomitant therapy: The patient has not failed prior ketamine treatment for MDD and is not receiving concomitant electroconvulsive therapy (ECT), vagus nerve stimulation (VNS), transcranial magnetic stimulation (TMS), or deep brain stimulation (DBS).

Continuation and renewal therapy

Renewal requires ALL of the following:

Continuation and renewal requirements: The patient continues to meet the initial approval criteria; demonstrates disease improvement and/or stabilization as a result of treatment; has not experienced unacceptable toxicity; and remains committed to receiving all scheduled doses.50% reduction in symptom severity

Improvement or stabilization must be documented using a validated depression rating scale. Unacceptable toxicity includes dissociation or cognitive impairment.

Coverage is not available when the patient has aneurysmal vascular disease, an arteriovenous malformation, a history of intracerebral hemorrhage, uncontrolled hypertension (>140/90 mmHg for patients younger than 65 or >150/90 mmHg for patients 65 or older), or is pregnant.

Coverage is not available for patients with known hypersensitivity to any product component, those receiving concomitant ketamine therapy, or when esketamine is prescribed as monotherapy rather than in conjunction with an antidepressant.

For treatment-resistant depression, coverage is not available when the patient has failed prior ketamine treatment for major depressive disorder or is receiving concomitant ECT, VNS, TMS, or DBS.

Clinical Thresholds and Treatment Measures

Uncontrolled hypertension: under age 65

Threshold> 140/90 mmHg

Applies toPatients younger than 65 years

Policy contextBlood pressure above this threshold is considered uncontrolled hypertension for approval purposes.

Uncontrolled hypertension: age 65 or older

Threshold> 150/90 mmHg

Applies toPatients 65 years or older

Policy contextBlood pressure above this threshold is considered uncontrolled hypertension for approval purposes.

Prior Authorization and Provider Requirements

Prior Authorization

Initial Approval Requirements

Initial approval requires documentation that the patient meets the general clinical, diagnostic, safety, treatment, and administration criteria for esketamine. The prescriber must submit the required attestations and supporting records before treatment is authorized.

Patient is 18 years of age or older and has a DSM-5 diagnosis of major depressive disorder (MDD).
A baseline assessment using a validated depression rating scale is documented, such as MADRS, HAM-D, PHQ-9, or BDI.
Esketamine is prescribed by or in consultation with a psychiatrist or psychiatric mental health nurse practitioner (PMHNP).
The patient is not pregnant, has no known hypersensitivity to any product component, is not receiving concomitant ketamine therapy, and will use esketamine with an antidepressant rather than as monotherapy.
For treatment-resistant depression (TRD), all TRD-specific requirements in this section must also be documented.

Prior Authorization

Renewal Requirements

For renewal, the patient must continue to meet the initial approval criteria and demonstrate clinically meaningful improvement or stabilization attributable to treatment. The prescriber must document adherence, response, and absence of unacceptable toxicity.

Policy Background

Spravato (esketamine) nasal spray is covered for adults with major depressive disorder, including treatment-resistant depression and major depressive disorder with acute suicidal ideation or behavior. Administration must occur in a certified healthcare setting with blood-pressure assessment and post-dose monitoring. The policy notes that effectiveness in preventing suicide or reducing suicidal ideation or behavior has not been demonstrated, and treatment does not eliminate the need for hospitalization when clinically warranted.

Definitions

Treatment-resistant depression (TRD)

DefinitionDepression for which the patient has failed trials of at least two antidepressants from different classes.

Trial durationEach antidepressant trial must last at least 6 weeks at generally accepted doses, unless contraindicated or clinically significantly not tolerated.

Treatment failureLess than a 50% reduction in symptom severity using a validated depression rating scale.

Major depressive disorder (MDD)

DiagnosisMajor depressive disorder (MDD)

Diagnostic standardDiagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

Initial Therapy Criteria

Initial approval

Initial therapy requires ALL general approval criteria. When coverage is requested for treatment-resistant depression, the additional TRD criteria below must also be met.

General initial approval criteria: Patient is at least 18 years old; has a DSM-5 diagnosis of MDD; has a baseline validated depression assessment; has psychiatric prescriber involvement; does not have the listed medical exclusions; is not pregnant or hypersensitive to any product component; is not receiving concomitant ketamine; uses esketamine with an antidepressant; and meets the Spravato REMS, monitoring, dosing, scheduling, and transportation requirements.Age ≥18; post-administration monitoring ≥2 hours

Additional TRD criteria when applicable: For treatment-resistant depression, the patient has demonstrated adherence with oral therapy during the current depressive episode; has tried psychotherapy alone or with oral antidepressants when psychotherapy resources are available; has not failed prior ketamine treatment for MDD; is not receiving concomitant ECT, VNS, TMS, or DBS; and has failed at least two antidepressants from different classes for at least six weeks each at generally accepted doses, unless contraindicated or clinically significant adverse effects were experienced.Oral adherence ≥80%; ≥2 antidepressant classes; ≥6 weeks per trial

Continuation and Renewal Criteria

Renewal criteria

Renewal requires ALL of the following:

Renewal criteria: The patient continues to meet the initial approval criteria; demonstrates disease improvement and/or stabilization with a 50% reduction in symptom severity using a validated depression rating scale; has not experienced unacceptable toxicity; and remains committed to receiving all scheduled doses.50% reduction in symptom severity

Unacceptable toxicity includes dissociation or cognitive impairment.

Step Therapy Requirements

Step	Requirement	Threshold / Documentation
1	For treatment-resistant depression, the patient must have failed at least two antidepressants from different classes.	Each trial must last at least 6 weeks at generally accepted doses, unless contraindicated or clinically significant adverse effects are experienced. Failure means less than a 50% reduction in symptom severity on a validated depression rating scale.

Step	Requirement	Threshold / Documentation
2	Demonstrate adherence with oral therapy during the current depressive episode and try psychotherapy alone or in combination with oral antidepressants when psychotherapy resources are available.	Oral therapy adherence must be at least 80% of doses, documented by refill history or prescriber attestation. Psychotherapy may be used alone or with oral antidepressants.

Quantity Limits

Spravato for treatment-resistant depression

Weeks 1–4: induction phase2 kits per week

Week 5 and thereafter: maintenance phase1 kit per week

Kit strengthEach kit is 56 mg or 84 mg.

Spravato for MDD with acute suicidal ideation or behavior

Quantity limit2 kits per week

IndicationMajor depressive disorder with acute suicidal ideation or behavior

Kit strengthEach kit is 56 mg or 84 mg.

Site of Care and Administration

Billing Rule

Use a REMS-certified administration site

Administer Spravato only in a healthcare setting certified in the Spravato REMS program. Check blood pressure before each administration and monitor the patient after administration until stable for at least two hours with baseline or decreasing blood pressure.

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicySpravato (esketamine) Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Last ReviewDec 8, 2023

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming all general approval criteria and any treatment-resistant depression requirements.

SourceLink

On This Page

Oral antidepressant adherence

Minimum adherenceAt least 80% of oral antidepressant doses

Measurement periodDuring the current depressive episode

DocumentationDemonstrated by refill history or prescriber attestation.

Antidepressant trials for treatment-resistant depression

Number of trialsAt least 2 antidepressants

Treatment classesThe antidepressants must be from different classes.

Trial durationAt least 6 weeks for each trial at generally accepted doses, unless contraindicated or clinically significant adverse effects are experienced.

Renewal symptom improvement

Required improvement50% reduction in symptom severity

Assessment methodDocumented using a validated depression rating scale.

Renewal responseImprovement and/or stabilization must be demonstrated as a result of treatment.

Document at least a 50% reduction in symptom severity using a validated depression rating scale.
Document that the patient has not experienced unacceptable toxicity, including dissociation or cognitive impairment.
Provide prescriber attestation that the patient has received all scheduled doses to date and will continue receiving scheduled doses.
Confirm that all applicable initial safety, diagnostic, concomitant-treatment, and TRD criteria remain satisfied.

Billing Rule

Authorization Duration

Authorization is limited to the periods specified by the policy for TRD and MDD with acute suicidal ideation or behavior. A new authorization is required for each renewal period.

Initial authorization: 4 weeks.
First renewal: 4 weeks.
Subsequent renewals: 3 months.

Step Therapy

Required Antidepressant Trials

For TRD, document an adequate history of oral antidepressant treatment. The required trials must generally be at accepted doses and durations unless a contraindication or clinically significant adverse effect prevented completion.

The patient has failed trials of at least 2 antidepressants from different classes.
Each trial lasted at least 6 weeks at generally accepted doses, unless contraindicated or stopped because of clinically significant adverse effects.
Failure is defined as less than a 50% reduction in symptom severity on a validated depression rating scale.

Documentation Required

Psychotherapy and Oral-Treatment History

When esketamine is requested for TRD, the record must include the required psychotherapy and oral-treatment history. Psychotherapy must have been tried alone or with oral antidepressants when psychotherapy resources are available.

Document a history of psychotherapy alone or in combination with oral antidepressants, when a psychotherapy resource is available.
Document the patient’s oral antidepressant treatment history and the required failed trials.
Document adherence with oral therapy during the current depressive episode, supported by refill history or prescriber attestation.

Documentation Required

Diagnosis and Baseline Assessment

Submit diagnostic and baseline clinical documentation supporting the request. The baseline depression assessment must use a validated rating scale and establish the symptom severity before treatment.

Document age of at least 18 years.
Document a DSM-5 diagnosis of major depressive disorder.
Include baseline results from MADRS, HAM-D, PHQ-9, BDI, or another validated depression rating scale.

Documentation Required

Prescriber, Safety, and Administration Documentation

The prescriber must document appropriate specialty involvement and confirm that the treatment setting and patient can safely support administration and follow-up monitoring. Required attestations must accompany the authorization request.

Esketamine is prescribed by or in consultation with a psychiatrist or PMHNP.
The healthcare setting is certified in the Spravato REMS program.
Blood pressure will be checked before each administration, and the patient will be monitored as directed afterward until stable for at least 2 hours with baseline or decreasing blood pressure.
The prescriber has reviewed the dosing schedule with the patient.
The patient understands and is committed to scheduled doses and can attend twice-weekly treatment with adequate transportation to and from the facility.

Documentation Required

Treatment-Resistant Depression History

For TRD requests, document adherence and the complete treatment-resistant depression history. The record must show adequate oral treatment exposure and must address prohibited prior or concomitant therapies.

Document compliance with at least 80% of oral therapy doses during the current depressive episode, using refill history or prescriber attestation.
Document the psychotherapy history and failed trials of at least two antidepressants from different classes.
Document that the patient has not failed prior ketamine treatment for MDD.
Document that the patient is not receiving concomitant ECT, VNS, TMS, or DBS.

Documentation Required

Renewal Documentation

Renewal requests must include current documentation showing that the patient remains eligible and is benefiting from therapy. Continued authorization requires both clinical response or stabilization and acceptable tolerability.

Document continued satisfaction of all applicable initial and TRD criteria.
Provide a validated rating-scale result showing at least a 50% reduction in symptom severity.
Document no unacceptable toxicity, including dissociation or cognitive impairment.
Provide attestation of adherence to all scheduled doses to date and commitment to future scheduled doses.

Denial Risk

Failure to Meet Criteria or Safety Exclusions

Authorization may be denied when the approval criteria are not met or when a policy-defined safety exclusion is present. The request must resolve these conditions before coverage can be approved.

The patient does not meet the applicable approval criteria.
The patient has aneurysmal vascular disease, an arteriovenous malformation, a history of intracerebral hemorrhage, or uncontrolled hypertension.
Uncontrolled hypertension is greater than 140/90 mmHg in patients younger than 65 or greater than 150/90 mmHg in patients 65 or older.
The patient is pregnant.

Denial Risk

Contraindication or Inappropriate Concomitant Therapy

Requests may be denied when contraindications or inappropriate concomitant therapy are documented. These exclusions apply even when other approval criteria are satisfied.

Known hypersensitivity to any component of the product.
Concomitant ketamine therapy.
Use of esketamine as monotherapy rather than with an antidepressant.
Aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, or uncontrolled hypertension.
Pregnancy.

Denial Risk

TRD-Specific Criteria Not Met

A TRD request may be denied when the required treatment-resistant depression history is not established. The record must demonstrate adequate prior treatment and must exclude prohibited prior or concomitant therapies.

No documented adherence of at least 80% to oral therapy during the current depressive episode.
No documented psychotherapy trial when a psychotherapy resource is available.
Failure to try at least two antidepressants from different classes for at least 6 weeks each at generally accepted doses, absent a documented contraindication or clinically significant adverse effect.
Prior ketamine treatment for MDD was failed, or the patient is receiving concomitant ECT, VNS, TMS, or DBS.

Prior Authorization

REMS, Monitoring, and Administration Requirements

Approval is contingent on completion of the required REMS, monitoring, administration, and patient-commitment requirements. Missing or incomplete attestations may prevent authorization or require correction before treatment begins.

Attest that the healthcare setting is certified in the Spravato REMS program.
Attest that blood pressure will be checked before every administration and that post-administration monitoring will continue until the patient is stable for at least 2 hours with baseline or decreasing blood pressure.
Attest that the dosing schedule was reviewed with the patient.
Attest that the patient understands and is committed to scheduled dosing and has reliable transportation for twice-weekly visits.

The policy covers adults with MDD, including MDD with acute suicidal ideation or behavior.

Spravato REMS

MeaningSpravato Risk Evaluation and Mitigation Strategies certification

Who must be certifiedThe healthcare setting in which treatment is administered must be certified in the Spravato REMS program.

Related administration requirementsThe prescriber must check blood pressure before each administration and monitor the patient until stable for at least 2 hours, with baseline or decreasing blood pressure.

A failed antidepressant trial is defined as less than a 50% reduction in symptom severity using a validated depression rating scale.