CurrentBaylor Scott & White Health PlanPolicy 257

Esketamine (Spravato®) — Coverage Criteria

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Defines medical necessity, prior authorization, and coverage criteria for esketamine (Spravato®) nasal spray for adults with treatment-resistant depression and related indications for Baylor Scott & White Health Plan members.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyEsketamine (Spravato®) — Coverage Criteria

Policy CodePolicy 257

Change TypeCriteria restructuringmaterial updates

Effective DateMar 1, 2026

Last ReviewFeb 26, 2026

Next Review DateFeb 26, 2027

Key ActionSubmit prior authorization with documentation of four adequate antidepressant trials (≥6 weeks each) and REMS attestation plus weekly psychotherapy plan.

SourceLink

POLICY UPDATE CHANGES

Restructured criteria to universal, initial, and renewal sections and allowed for monotherapy in alignment with new FDA indication.

Added PHQ-9 to the list of standardized rating scales and requirement for CBT or IPT or other therapy.

Adjusted authorization duration to 12 months.

12 months

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CurrentBaylor Scott & White Health PlanPolicy 257

Esketamine (Spravato®) — Coverage Criteria

Customize your policy alerts

Sign up for Baylor Scott & White Health Plan Policy 257 alerts

Get alerted when Policy 257 changes without checking for updates manually.

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Policy Summary

PayerBaylor Scott & White Health Plan

PolicyEsketamine (Spravato®) — Coverage Criteria

Policy CodePolicy 257

Change TypeCriteria restructuringmaterial updates

Effective DateMar 1, 2026

Last ReviewFeb 26, 2026

Next Review DateFeb 26, 2027

Key ActionSubmit prior authorization with documentation of four adequate antidepressant trials (≥6 weeks each) and REMS attestation plus weekly psychotherapy plan.

SourceLink

POLICY UPDATE CHANGES

Restructured criteria to universal, initial, and renewal sections and allowed for monotherapy in alignment with new FDA indication.

Added PHQ-9 to the list of standardized rating scales and requirement for CBT or IPT or other therapy.

Adjusted authorization duration to 12 months.

12 months

Coverage Criteria for Esketamine (Spravato)

Medical necessity criteria

Covered when ALL of the following universal criteria are met plus the listed initial or renewal criteria.

Universal criteria: Member has diagnosed treatment-resistant depression (TRD); confirmed severe major depressive disorder at baseline documented by a standardized rating scale (e.g., PHQ-9, BDI, HDRS, MADRS); age ≥18 years; esketamine is prescribed by or in consultation with a psychiatrist; provider attests that all REMS requirements have been met; and member does not have a contraindication (aneurysmal vascular disease, arteriovenous malformation, or history of intracerebral hemorrhage) OR current or recent (within 6 months) moderate or severe substance or alcohol use disorder.

Initial therapy criteria: Member meets all universal criteria AND documentation of failure of or intolerance to FOUR medication trials of minimum 6 weeks each for depression within the past five years (examples: four antidepressant agents including two different classes; or two antidepressants from different classes plus two augmentation trials) during the current depressive episode; AND pharmacotherapy must be provided in combination with weekly psychotherapy (e.g., CBT or IPT or other) for at least 8 weeks to yield improvement.minimum 6 weeks each

If no improvement after the course, clinician should review and reappraise the treatment plan.

Renewal therapy criteria: Member meets all universal criteria AND provider submits documentation of improvement or sustained improvement from baseline in depression symptoms using a standardized rating scale (e.g., PHQ-9, BDI, HDRS, MADRS); member has manageable or no side effects; AND pharmacotherapy remains in combination with weekly psychotherapy (e.g., CBT or IPT or other) for at least 8 weeks of treatment to yield improvement.

Include tolerability information and continued REMS adherence in documentation.

Esketamine (Spravato®) is covered with criteria only for the indications specified in this policy. Use of esketamine for all other indications not addressed by this policy is considered experimental and investigational because the effectiveness for those indications has not been established.

Treatment with esketamine is not medically necessary and is excluded when the member has any listed contraindication. Specifically, do not use esketamine in patients with aneurysmal vascular disease, arteriovenous malformation, or a history of intracerebral hemorrhage. Additionally, members with current or recent (within the last 6 months) moderate or severe substance or alcohol use disorder do not meet the universal criteria for coverage.

Providers must attest that REMS requirements are met and confirm absence of these contraindications and recent substance use prior to initiating therapy; failure to document contraindications or REMS adherence may result in denial of coverage.

Coding and Billing Guidance

Applicable HCPCS / ICD-10 codes (examples listed)mixed

S0013	Esketamine, nasal spray, 1 mg.
J3490	Unclassified drugs or biologicals
C9399	Unclassified drugs or biologicals
F33.0-F33.9	Major depressive disorder [treatment-resistant depression]

Antidepressant trial duration — minimum 6 weeks each

Required trial durationEach antidepressant trial must be a minimum of 6 weeks in duration

Number of trials for initial coverageDocumentation of failure or intolerance to FOUR medication trials within the past five years (examples: four antidepressant agents including 2 different classes, or two antidepressants from different classes plus two augmentation trials)

Timeframe for prior trialsTrials must be within the past 5 years and during the current depressive episode

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — submit supporting clinical documentation as described in policy.

Service: Esketamine (Spravato®)
Policy Number: 257
Effective Date: 03/01/2026

Step Therapy

Step Therapy / Prior Treatment Requirement

Step therapy / prior treatment requirement — documented failure or intolerance to four adequate antidepressant trials (minimum 6 weeks each) within the past five years during the current depressive episode, OR equivalent regimen such as two antidepressant agents from different classes plus two augmentation trials.

Minimum of four medication trials (examples: four antidepressant agents including ≥2 different classes; or two antidepressant agents from different classes with two augmentation trials)
Each trial: minimum 6 weeks

Definitions and Program Requirements

TRD — Treatment-resistant depression definition and related key terms

Definition of TRDTreatment-resistant depression (TRD): diagnosis of TRD required as part of universal criteria

Severity confirmationConfirmed severe major depressive disorder at baseline documented by a standardized rating scale (e.g., PHQ-9, BDI, HDRS, MADRS)

Prior treatment requirementFailure or intolerance to FOUR adequate medication trials (minimum 6 weeks each) within the past 5 years during the current depressive episode

Age requirementPatient must be 18 years of age or older

REMS — Risk Evaluation and Mitigation Strategy requirements

REMS enrollment and certified settingsProvider must attest REMS requirements met; esketamine must be dispensed and administered only in REMS-certified, medically supervised healthcare settings

Administration Setting and Level of Care

Outpatient REMS-certified administration in supervised healthcare setting

Covered when administration occurs in a REMS-certified, medically supervised outpatient healthcare setting that meets REMS requirements.

Setting-level requirements: Esketamine must be dispensed and administered only in a medically supervised healthcare setting that monitors patients for sedation and dissociation; the administering pharmacy/setting must be REMS-certified; each patient must be informed about serious adverse outcomes and need for monitoring; and outpatients must be enrolled in the REMS registry per FDA REMS program requirements.

See FDA REMS details for certification and registry instructions.

Concurrent Treatments and Psychotherapy Requirements

Esketamine plus psychotherapy

Requirement for combination treatment — psychotherapy must accompany pharmacotherapy both for initiation and continuation of esketamine.

Combined psychotherapy requirement: For both initial authorization and renewals, esketamine pharmacotherapy must be delivered in combination with weekly psychotherapy (e.g., cognitive behavioral therapy [CBT], interpersonal psychotherapy [IPT], or other) for at least 8 weeks to yield improvement; documentation of the psychotherapy plan and attendance/response must be submitted with authorization requests.at least 8 weeks

Clinician should document weekly therapy sessions and clinical response on a standardized rating scale.

Authorization Duration and Treatment Course

Esketamine treatment course — authorization duration and visit limits

Authorization durationEsketamine treatment authorizations are issued for 12 months

Visit / course limitsTreatment must be provided in a REMS-certified, medically supervised outpatient setting with ongoing monitoring and weekly psychotherapy for at least 8 weeks to yield improvement

Renewal documentationRenewal requires documentation of improvement or sustained improvement on a standardized rating scale and tolerability information; continued weekly psychotherapy and REMS adherence must be documented

Clinical Background

Major depressive disorder (MDD) is a common, serious, and often disabling condition. A subset of patients develop treatment-resistant depression (TRD), defined in this policy as failure to respond to prior adequate antidepressant treatments. Esketamine is an intranasal NMDA receptor antagonist approved for use in adults with TRD and related indications under a REMS program because of risks such as sedation and dissociation. Administration is restricted to REMS-certified, medically supervised healthcare settings, and coverage is contingent on meeting the policy's clinical criteria and documentation requirements. Authorization, when approved, is issued for 12 months.