Subject: Spravato 2889-A SGM P2022
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SPRAVATO
(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. CRITERIA FOR INITIAL APPROVAL
A. Treatment-resistant depression (TRD)/Major
Depressive Disorder (MDD) with acute suicidal ideation
or behavior
Authorization of 1 month may be granted for treatment of
TRD or 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. The requested medication will be prescribed by or in
consultation with a psychiatrist.
3. Member is 18 years of age or older.
4. Requested drug will be administered under the direct
supervision of a healthcare provider.
5. Member will be monitored by a health care provider for at
least 2 hours after administration.
6. Requested drug will be used in combination with an oral
antidepressant (e.g., duloxetine, escitalopram, sertraline,
venlafaxine).
7. Member meets either of the following criteria:
i. Member must meet both of the following:
a. Member has experienced inadequate response
during the current depressive episode with two
antidepressants (e.g., selective serotonin
reuptake inhibitor [SSRI], serotonin-
norepinephrine reuptake inhibitor [SNRI],
tricyclic antidepressant [TCA], bupropion,
mirtazapine) from at least two different classes
(different mechanisms of action) at the
maximally tolerated labeled dose, each used for
at least 8 weeks;
• 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)
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:
º Two antidepressants with different
mechanisms of action used concomitantly
º An antidepressant and a second-
generation antipsychotic used
concomitantly
º An antidepressant and lithium used
concomitantly
º An antidepressant and thyroid hormone
used concomitantly
º An antidepressant and buspirone used
concomitantly
ii. Member has major depressive disorder with both of
the following:
a. Member has 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.
V. CONTINUATION OF THERAPY
A. Treatment-resistant depression (TRD)
Authorization of 3 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.; July 2020.
- American Psychological Association. Depression Assessment Instruments. Available at: https://www.apa.org/depression-guideline/assessment. Accessed October 5, 2022.
- Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Available at: www.micromedexsolutions.com [available with subscription]. Accessed October 5, 2022.
- 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 5, 2022.
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 15, 2023
