Subject: Spravato 2889-A SGM P2023
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SPRAVATO nasal spray
(esketamine nasal spray)
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Policy:
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are
considered a covered benefit provided that all the approval criteria are met and the member
has no exclusions to the prescribed therapy.
FDA-Approved Indications
Spravato is indicated, in conjunction with an oral antidepressant, for the treatment of:
1. Treatment-resistant depression (TRD) in adults
2. Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal
ideation or behavior
Limitations of Use:
The effectiveness of Spravato in preventing suicide or in reducing suicidal ideation or behavior
has not been demonstrated. Use of Spravato does not preclude the need for hospitalization if
clinically warranted, even if patients experience improvement after an initial dose of Spravato.
Spravato is not approved as an anesthetic agent. The safety and effectiveness of Spravato as
an anesthetic agent have not been established.
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
A. For initial requests:
1. Pretreatment depression severity score(s) from standardized rating scale(s) that reliably
measure depressive symptoms (e.g., Beck Depression Inventory [BDI], Hamilton
Depression Rating Scale [HDRS], Montgomery-Asberg Depression Rating Scale
[MADRS], etc.)
2. Medical records documenting inadequate response with antidepressant and
augmentation agents for the current depressive episode (if applicable)
B. For continuation of therapy:
Current depression severity score(s) from standardized rating scale(s) that reliably measure
depressive symptoms (if applicable)
III. EXCLUSION
Coverage will not be provided for members with moderate or severe substance or alcohol use
disorder that is not currently being treated or medically managed.
IV. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a psychiatrist.
V. CRITERIA FOR INITIAL APPROVAL
A. Treatment-resistant depression (TRD)/Major Depressive Disorder (MDD) with acute
suicidal ideation or behavior
Authorization of 3 months may be granted for the treatment of TRD or 1 month for the
treatment of MDD with acute suicidal ideation or behavior when all of the following criteria
are met:
1. Member has a confirmed diagnosis of severe major depressive disorder (single or
recurrent episode), documented by standardized rating scales that reliably measure
depressive symptoms (e.g., Beck Depression Inventory [BDI], Hamilton Depression
Rating Scale [HDRS], Montgomery-Asberg Depression Rating Scale [MADRS]).
2. Member is 18 years of age or older.
3. The requested medication will be administered under the direct supervision of a
healthcare provider.
4. Member will be monitored by a health care provider for at least 2 hours after
administration.
5. Requested drug will be used in combination with an oral antidepressant (e.g., duloxetine,
escitalopram, sertraline, venlafaxine).
6. Member meets either of the following criteria:
i. For treatment-resistant depression (TRD), member must meet both of the following:
a. Member has experienced an inadequate response during the current depressive
episode with two antidepressants from at least two different classes (different
mechanisms of action) at the maximally tolerated labeled dose, each used for at
least 8 weeks. Examples of antidepressant classes include, but are not limited to:
• Aminoketone (Wellbutrin/SR/XL [bupropion])
• Monoamine oxidase inhibitors (MAOIs) (e.g., Marplan, Nardil, Parnate,
phenelzine, tranylcypromine)
• Noradrenaline and specific serotoninergic antidepressants (NASSAs) (e.g.,
amoxapine, maprotiline, mirtazapine/ODT, Oleptro ER, Remeron/Solutab,
trazodone)
• Selective serotonin reuptake inhibitors (SSRIs) (e.g., Celexa, citalopram,
escitalopram, fluoxetine, fluvoxamine, Lexapro, Luvox/CR, paroxetine,
Paxil/CR, Pexeva, Prozac/Weekly, sertraline, Zoloft)
• Serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g., Cymbalta,
desvenlafaxine/ER, duloxetine, Effexor/XR, Fetzima, Irenka, Khedezla,
Pristiq, venlafaxine/ER)
• Tricyclic antidepressants (TCAs) (e.g., amitriptyline, desipramine, doxepin,
Elavil, imipramine, Norpramin, nortriptyline, Pamelor, Surmontil, Tofranil,
trimipramine)
• Serotonin modulators (e.g., Trintellix, vortioxetine, Viibryd, vilazodone)
b. Member has experienced an inadequate response with an adequate trial of
augmentation therapy OR evidenced based psychotherapy (e.g., cognitive
behavioral therapy) during the current depressive episode
• Augmentation therapy is defined as:
• Two antidepressants with different mechanisms of action used concomitantly
• An antidepressant and a second-generation antipsychotic used concomitantly
• An antidepressant and lithium used concomitantly
• An antidepressant and thyroid hormone used concomitantly
• An antidepressant and buspirone used concomitantly
ii. For major depressive disorder (MDD) with acute suicidal ideation or behavior,
member meets both of the following:
a. Member has major depressive disorder with current suicidal ideation with intent
defined as both of the following:
• Member has thoughts, even momentarily, of self-harm with at least some
intent or awareness that they may die as a result, or member thinks about
suicide
• Member intends to act on thoughts of killing themselves
b. The prescriber represents that, in the absence of the requested drug, within the
next 24 to 48 hours the member will require confinement in an acute care
psychiatric institution.
VI. CONTINUATION OF THERAPY
A. Treatment-resistant depression (TRD)
Authorization of 6 months may be granted for the continuation of treatment of TRD when
there is improvement or sustained improvement from baseline in depressive symptoms
documented by standardized rating scales that reliably measure depressive symptoms
(e.g., Beck Depression Inventory [BDI], Hamilton Depression Rating Scale [HDRS],
Montgomery-Asberg Depression Rating Scale [MADRS]).
B. Major depressive disorder (MDD) with acute suicidal ideation or behavior
The use of Spravato beyond 4 weeks has not been systematically evaluated in the
treatment of depressive symptoms in patients with MDD with acute suicidal ideation or
behavior. Member must meet all initial criteria for approval.
Place of Service:
Outpatient
The above policy is based on the following references:
- Spravato [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; October 2023.
- American Psychological Association. Depression Assessment Instruments. Available at: https://www.apa.org/depression-guideline/assessment. Accessed October 2, 2023.
- Clinical Consult: CVS Caremark Clinical Program Review. Focus on Behavioral Health Clinical Programs. December 2020.
- Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Available at: www.micromedexsolutions.com [available with subscription]. Accessed October 2, 2023
- Thase, M and Connolly, R (2021) Unipolar depression in adults: Choosing treatment for resistant depression, UpToDate, Available at uptodate.com [available with subscription]. Accessed October 2, 2023
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
April 17, 2024
