Spravato (esketamine) Nasal Spray
Policy governs medical-benefit coverage, criteria, documentation, dosing limits, approval duration, investigational uses, coding, and monitoring requirements for Spravato (esketamine) nasal spray for treatment of major depressive disorder (including treatment-resistant depression and MDD with acute suicidal ideation/behavior) for adults.
2025 Update removed separate coverage criteria for MDD with acute suicidal ideation or behavior; criteria for MDD now apply to individuals with or without acute suicidal ideation or behavior.
2024 Update clarified investigational/not medically necessary distinctions and removed stipulation regarding second antidepressant as augmenting agent.
2023 Update clarified DSM-5 documentation, substance use abstinence/remission timelines, and concurrent substance restrictions; required naming of oral antidepressant used in conjunction.
2022 Update added criteria for a 'new course' and expanded substance restrictions (no concurrent mind-altering substances) and re-authorization clarifications.
2021 Update added that Spravato must continue to be used in conjunction with an oral antidepressant and added dosage limits per FDA prescribing information.
2020 Update added new indication and evidence summary for MDD with acute suicidal ideation or behavior (ASPIRE trials).
Reviewed prescribing information for Spravato and literature; no changes to policy statements (06/01/26 Annual Review).
HCPCS code J0013 added and S0013 termed effective January 1, 2026 (01/01/26 history).
Clarified maintenance dose limit: week 5 and after limited to 84 mg once weekly for the rest of the first 12 months and for re-authorization (12/01/25).
Removed requirement that an oral antidepressant must be used in conjunction with Spravato consistent with FDA Jan 21, 2025 approval of monotherapy (03/01/25 history).
Documentation requirement for prior failed therapies.
Substance use disorder remission definitions clarified several times (dates through 06/01/25).