CurrentMass General Brigham Health PlanPolicy N/A

Spravato (esketamine) — Coverage Criteria

Prior authorization, quantity/step therapy, and specialty dispensing rules for Spravato (esketamine) for Mass General Brigham Health Plan members across medical and pharmacy benefits.

Policy Summary

PayerMass General Brigham Health Plan

PolicySpravato (esketamine) — Coverage Criteria

Policy CodePolicy N/A

Change TypeRevised — material change to TRD criteriaadded specialty designation

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and ensure prescriber attestation that Spravato will be administered under direct supervision with required specialist consultation when applicable.

SourceLink

POLICY UPDATE CHANGES

Updated criteria for TRD to no longer require concomitant use with an antidepressant to reflect updated package labeling; policy indicates Spravato is now a dual benefit drug.

Designated Spravato as specialty and required to be filled at a contracted specialty pharmacy.

18+minimum member age for indications

3 moinitial authorization duration (TRD)

1 moinitial authorization duration (MDD with acute SI/behavior)

12 mostandard reauthorization duration

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Coverage criteria for Spravato (esketamine)

Initial Therapy

Authorization may be granted when the criteria below are met (or for members new to the plan within the past 90 days who are currently receiving treatment):

MDD with Acute Suicidal Ideation or Behavior - Initial: Member is 18 years of age or older AND Member is diagnosed with major depressive disorder (MDD) with suicidal ideation or behavior AND Prescriber is a mental health specialist or consultation notes from a mental health specialist are provided AND Prescriber attests that Spravato will be administered under the direct supervision of a healthcare provider AND Member will be using Spravato in combination with an oral antidepressant

Initial approval 1 month

Treatment-Resistant Depression (TRD) - Initial: Member is 18 years of age or older AND Member is diagnosed with treatment-resistant depression (TRD) AND Prescriber is a mental health specialist or consultation notes from a mental health specialist are provided AND Prescriber attests that Spravato will be administered under the direct supervision of a healthcare provider AND Member has had an inadequate response or adverse reaction to one SSRI and one other antidepressant that is not an SSRI AND Member meets ONE of the following: (a) inadequate response or adverse reaction to an antidepressant augmentation strategy (including a second-generation antipsychotic, lithium, a second antidepressant from a different class, or thyroid hormone) OR (b) member has a contraindication to all augmentation strategies

Initial approval 3 months

Continuation of Therapy

Reauthorization/continuation criteria:

Continuation for TRD: Documentation is provided demonstrating improvement in the member's depressive symptoms

Reauthorizations may be granted for 12 months

Continuation for MDD with Acute Suicidal Ideation or Behavior: Member meets initial criteria (continues to meet the original indication and supervision/antidepressant use requirements)

Initial dosing period should be evaluated after 4 weeks for continued need; reauthorization may be granted for 12 months

Spravato (esketamine) is not approved as an anesthetic agent. The safety and effectiveness of Spravato when used as an anesthetic have not been established.

The effectiveness of Spravato in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of Spravato does not replace other indicated interventions — including hospitalization when clinically warranted — and its use as monotherapy or outside the labeled contexts for MDD with acute suicidal ideation or behavior is not supported by evidence.

Initial therapy and dosing requirements

Initial Therapy & Dosing

Initial therapy criteria and dosing notes:

MDD with acute suicidal ideation/behavior initial dosing: Recommended dosage: 84 mg intranasal twice weekly for 4 weeks; dosage may be reduced to 56 mg twice weekly for tolerability. After 4 weeks, evidence of therapeutic benefit should be evaluated to determine need for continued treatment. Spravato must be used in conjunction with an oral antidepressant for this indication.

Initial authorization: 1 month

TRD initial therapy: Meets TRD diagnostic criteria (inadequate response or adverse reaction to one SSRI and one non-SSRI antidepressant) and has failed or has a contraindication to augmentation strategies (second-generation antipsychotic, lithium, a second antidepressant from a different class, or thyroid hormone). Prescriber must attest supervised administration.

Initial authorization: 3 months

Reauthorization and continuation requirements

Continuation

Reauthorization requirements, response thresholds, monitoring, and duration for ongoing therapy:

TRD reauthorization requirements: Documentation of symptomatic improvement in depressive symptoms is provided (clinical notes, rating scales, or equivalent).

Reauthorizations granted for 12 months; prescriber must continue to attest to supervised administration

MDD with Acute Suicidal Ideation or Behavior reauthorization requirements: After the initial 4-week evaluation period, evidence of therapeutic benefit is provided to justify continued use beyond the acute phase. Member continues to meet initial criteria including concomitant oral antidepressant use and supervised administration.

Continued therapy beyond the acute 4-week period should be based on demonstrated benefit; reauthorizations may be granted for 12 months

Provider actions, prior authorization, and dispensing rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Spravato (esketamine). Requests for members who are new to the plan may be denied if the member has been enrolled for more than 90 days and is not currently receiving the medication; authorization may be granted for members new to the plan within the past 90 days who are currently receiving treatment with the requested medication (excluding samples or manufacturer patient assistance program supplies). Documentation must support current therapy when applicable.

Prior authorization required
New-to-plan members: may be granted only if current therapy and enrollment ≤ 90 days; risk of denial if new > 90 days and not currently receiving therapy
Contact specialty pharmacy for fills: Medical and Specialty Medications phone 877-519-1908; Non-Specialty Medications phone 800-711-4555, fax 844-403-1029

Prior medication and step therapy requirements

Requirement	Details
Prior antidepressant trials
Documentation of inadequate response or adverse reaction to at least one SSRI and one other antidepressant that is not an SSRI
Augmentation strategy failure or contraindication
Evidence of inadequate response or adverse reaction to at least one antidepressant augmentation strategy: a second‑generation antipsychotic, lithium, a second antidepressant from a different class, or thyroid hormone; OR documented contraindication to all augmentation strategies
Prescriber qualifications
Prescriber is a mental health specialist (e.g., psychiatrist or behavioral‑health‑specialty nurse prescriber) or consultation notes from a mental health specialist are provided
Administration attestation
Prescriber attests that Spravato will be administered under the direct supervision of a healthcare provider

Quantity limits and benefit designation

Spravato (esketamine) — specialty and quantity limits

Specialty designationProduct designated specialty and must be filled at a contracted specialty pharmacy (medical and specialty medications).

Benefit-specific quantity limitsQuantity limits and step therapy apply per benefit (pharmacy and medical benefits).

Contact for specialty dispensingAll Plans specialty phone: 877-519-1908; Non-specialty medications phone: 800-711-4555, fax: 844-403-1029.

Administration site and monitoring requirements

Step Therapy

Direct supervision and ≥2 hours post‑administration monitoring required

Spravato must be administered under the direct supervision of a healthcare provider with patient monitoring for at least two hours after each administration; ensure site‑of‑care meets REMS and safety monitoring requirements.

Administer under direct supervision of a healthcare provider
Monitor the patient for at least two hours post‑administration
Comply with REMS program and appropriate site‑of‑care safety protocols

Key definitions used in the policy

Treatment-resistant depression (TRD) — definition and prior therapy

DefinitionTreatment-resistant depression (TRD): depression not adequately responsive to prior antidepressant therapy; indication includes use as monotherapy or in conjunction with an oral antidepressant.

Prior therapy requirementPolicy requires inadequate response or adverse reaction to one SSRI and one other antidepressant that is not an SSRI.

Augmentation failure or contraindicationMember must also have either inadequate response/adverse reaction to an antidepressant augmentation strategy (e.g., second-generation antipsychotic, lithium, a second antidepressant from a different class, or thyroid hormone) OR a contraindication to all augmentation strategies.

MDD with acute suicidal ideation or behavior — definition and concomitant antidepressant

DefinitionMajor depressive disorder (MDD) with acute suicidal ideation or behavior: depressive symptoms in adults with MDD with acute suicidal ideation or behavior.

Background and drug information

Spravato (esketamine) is an intranasal NMDA receptor antagonist. It is indicated for adults with treatment‑resistant depression (TRD) and for depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in the contexts described by the labeling. Spravato carries a boxed warning for the risks of sedation, dissociation, respiratory depression, abuse/misuse, and suicidal thoughts/behaviors, is only available through a REMS program, and must be administered under the direct supervision of a healthcare provider with monitoring for at least two hours after administration.