CurrentHealth NetPolicy N/A

Position Statement on the Utilization of Intranasal Spray of Spravato (esketamine) for Treatment-Resistant Depression

This position statement defines behavioral health requirements for use of intranasal Spravato (esketamine) in adults with treatment-resistant depression and describes prior authorization, initial and continued therapy criteria, and administrative workflows affecting providers and pharmacy coordination.

Policy Summary

PayerHealth Net

PolicyIntranasal esketamine (Spravato) for treatment-resistant depression

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 7, 2020

Next Review DateN/A

Key ActionObtain pharmacy prior authorization before behavioral health will approve Spravato administration.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Antidepressant failures required

2Augmentation strategies failed

>=15Baseline PHQ-9

50%Response needed to continue

Up to 23Initial approval quantity

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Coverage Criteria

inv-01: Initial Approval

Covered when ALL of the following are met:

Initial Approval: 1. Diagnosis of treatment-resistant depression; 2. Age > 18 years; 3. Documented baseline PHQ-9 score >= 15; 4. Failure of two antidepressants from at least two different classes, each used for 8 weeks at adequate doses unless contraindicated; 5. Failure of two augmentation therapies (e.g., second-generation antipsychotic, lithium, thyroid hormone, buspirone), each used for 4 weeks unless contraindicated; 6. Currently on an oral antidepressant for at least two weeks that was not one of the agents that previously failed; 7. Total dose does not exceed 168 mg (6 nasal spray devices) per week.

Approval duration: up to 23 nasal spray devices.

inv-02: Continued Therapy

Covered when ALL of the following are met:

Continued Therapy: 1. Currently receiving medication via Centene benefit or previously met initial approval criteria; 2. Positive response defined as at least a 50% reduction in PHQ-9 score from baseline; 3. Spravato is being used in combination with an oral antidepressant; 4. If requesting a dose increase, the new dose does not exceed 84 mg (3 nasal spray devices) per week.

Approval duration: 6 months; continued SCA approval contingent on pharmacy PA for continued therapy.

For Single Care Agreement (SCA) requests, the SCA will be denied when an in‑network behavioral health provider is available to administer Spravato. In such cases the file will be referred to a behavioral health medical director for secondary review and an SCA denial will be issued so the member may be treated through the in‑network provider approved by Pharmacy.

Continuation of Spravato (post‑acute phase) may be denied if the acute treatment phase does not demonstrate at least a 50% reduction in depression severity (for example, PHQ‑9) from baseline. If improvement is <50%, the case will be referred for behavioral health MD review; the MD may determine that treatment gains required by policy are not documented and may issue a medical necessity denial and recommend alternate treatments (IOP, PHP, ECT, TMS, or other available options).

Coding and Dosing

Pharmacy product codes / NDCNDC

NDC	Spravato intranasal esketamine product (refer to plan pharmacy for specific NDC and PA)

Maximum weekly dose

Initial maximum weekly dose168 mg per week (6 nasal spray devices)

Maintenance dose increase capMaintenance dose increase limited to 84 mg per week (3 nasal spray devices)

Approval duration noteInitial approval duration: up to 23 nasal spray devices

Initial approval quantity

Initial approval quantityUp to 23 nasal spray devices

Equivalent initial maximum weekly doseCorresponds with initial dose cap of 168 mg per week (6 devices)

Approval duration detail

Provider Actions & Administrative Workflow

Prior Authorization

Pharmacy PA Required

Pharmacy prior authorization (PA) is required before behavioral health will approve administration of Spravato. Providers must contact the member's Health Plan Pharmacy to obtain PA for the medication prior to requesting a Single Care Agreement (SCA). Administration of intranasal Spravato and the required post‑administration supervision are paid as pass-through only when a Pharmacy authorization is on file.

Providers directed to contact member's Health Plan Pharmacy for PA
Administration/supervision paid as pass-through if Pharmacy authorization on file
If PA obtained, behavioral health will confirm PA with Pharmacy before approving SCA

Documentation Required

Required Clinical Documentation

Providers must submit supporting clinical documentation (such as office chart notes and other clinical information) demonstrating the patient meets all approval criteria. Behavioral health will review documentation including baseline standardized depression severity score (PHQ‑9 ≥ 15 or equivalent) and ongoing severity measures to monitor response.

Background

Esketamine (Spravato) is an intranasal, non‑competitive NMDA receptor antagonist approved by the FDA for adults with treatment‑resistant depression when used in conjunction with an oral antidepressant. Typical administration follows FDA labeling with an acute induction phase (twice weekly for four weeks, starting at 56 mg with subsequent 56 mg or 84 mg doses as indicated) and an individualized maintenance phase at the least frequent schedule that maintains response. Monitoring for dissociation and blood pressure increases is required, including pre‑dose blood pressure assessment and post‑dose reassessment within approximately 40 minutes and periodically up to 2 hours.

Definitions

Treatment-Resistant Depression (TRD)

DefinitionMajor depressive disorder in adults who have failed trials of at least two antidepressants from different classes at adequate dose and duration.

Age criterionApplies to adults >18 years

Treatment failure specificsFailures refer to two antidepressants from at least two different classes, each used for 8 weeks at adequate doses unless contraindicated

PHQ-9

PHQ-9 descriptionStandardized 9-item multiple choice self-assessment questionnaire used for screening, diagnosis, monitoring and measuring severity of depression.

Severity thresholdBaseline PHQ-9 score of at least 15 indicates moderately severe major depression (required for initial approval)

Level of Care Criteria

Prior/Alternative Treatment Modalities

inv-16: ECT, TMS, IOP, PHP

ECT, TMS, IOP, PHP: If Spravato continuation is not supported by response (e.g., <50% reduction in depression severity), alternative treatment recommendations include intensive outpatient program (IOP), partial hospitalization program (PHP), electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS).

Behavioral health MD may advise alternatives on medical necessity review.

Administration Frequency & Visit Limits

Spravato intranasal administration

FDA-labeled induction frequencyInduction: administered twice weekly for the first 4 weeks (starting 56 mg, then 56 or 84 mg)

Maintenance frequency weeks 5-8Weeks 5-8: once weekly at 56 or 84 mg

Maintenance frequency after week 9Starting week 9: once weekly or every other week at 56 or 84 mg, individualized to the least frequent dosing that maintains response/remission