Purpose 

This medical policy outlines Highmark Health Options services for esketamine.

Definitions

Highmark Health Options (HHO) – Managed care organization serving vulnerable populations that have complex needs and qualify for Medicaid. Highmark Health Options members include individuals and families with low income, expecting mothers, children, and people with disabilities. Members pay nothing to very little for their health coverage. Highmark Health Options currently services Delaware Medicaid: Diamond State Health Plan (DSHP), Delaware Healthy Children Program (DHCP), and Diamond State Health Plan Plus (DSHP) LTSS members.

SPRAVATO™- is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults.

Risk Evaluation and Mitigation Strategy (REMS)-is a strategy to manage known or potential risks associated with a drug and is required by the U.S. Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.

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, or an antidepressant and buspirone used concomitantly.

Prior Authorization

Prior Authorization may be required. Please validate codes on the Prior Authorization Lookup Tool https://www.highmarkhealthoptions.com/providers/prior-auth-lookup

Procedures

Required Criteria for Eligibility

Esketamine (Spravato) nasal spray may be medically necessary for treatment-resistant depression (TRD) or major depressive disorder (MDD) with acute suicidal ideation or behavior when all of the following criteria are met:

·         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 Scale [BDI], Hamilton Depression Rating Scale [HDRS], Montgomery-Asberg Depression Rating Scale [MADRS]); and

·         Member is 18 years of age or older; and

·         Requested drug will be administered under the direct supervision of a healthcare provider; and

·         Member will be monitored by a health care provider for at least 2 hours after administration; and

·         Requested drug will be used in combination with an oral antidepressant (e.g., duloxetine, escitalopram, sertraline, venlafaxine); and

·         Member meets either of the following criteria:

o    For treatment-resistant depression (TRD), member must meet both of the following:

·         Member has experienced 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); and

·         Member has experienced an inadequate response with an adequate trial of augmentation therapyFootnote1* or evidenced based psychotherapy (e.g.,            cognitive behavioral therapy) during the current depressive episode; or

 

·         For major depressive disorder (MDD) with acute suicidal ideation or behavior, member meets both of the following:

o    Member has major depressive disorder with current suicidal ideation with intent defined as both of the following:

o    Member has thoughts, even momentarily, of self-harm with at last some intent or awareness that they may die as a result, or member thinks about suicide; and

o    Member intends to act on thoughts of killing themselves; and

o    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.

 

All other indications as experimental and investigational.

 

Continuation of Therapy

Treatment-resistant depression (TRD)

Six months of esketamine therapy may be medically necessary 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 Scale [BDI], Hamilton Depression Rating Scale [HDRS], Montgomery-Asberg Depression Rating Scale [MADRS]).

Major depressive disorder (MDD) with acute suicidal ideation or behavior

Continued treatment with esketamine (for up to 4 weeks total) may be medically necessary for the treatment of depressive symptoms in patients with MDD with acute suicidal ideation or behavior when member meets all initial criteria for approval. The use of Spravato beyond 4 weeks has not been systematically evaluated in the treatment of depressive symptoms in members with MDD with acute suicidal ideation or behavior.

 

Provider Requirements

All prescribing and administering provider(s), regardless of setting, must be certified in the Spravato REMS in order to treat patients with SPRAVATO. This medication must be prescribed by or in consultation with a psychiatrist.

Outpatient healthcare settings are required to enroll patients prior to patient treatment and submit patient monitoring forms after each patient treatment to the SPRAVATO REMS (Spravatorems, 2023).

 

Utilization Parameters

Weeks 1 to 4: Administer twice per week

Weeks 5 to 8: Administer once weekly

Week 9 and after: Administer every 2 weeks or once weekly. Dosing frequency should be individualized to the least frequent dosing to maintain remission/response.

Frequency of administration exceeding the FDA label may be subject to medical review (i.e., maximum of 8 administrations first month; maximum of 4 administrations second month; maximum 4 administrations third and subsequent months).

 

Exclusion

Esketamine (Spravato) nasal spray is considered an exclusion for members with moderate or severe substance or alcohol use disorder that is not currently being treated or medically managed.

 

Post-payment Audit Statement

The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by Highmark Health Options at any time pursuant to the terms of your provider agreement.

 

Place of Service: Inpatient/Outpatient

 

NOTE:

S0013 Esketamine, nasal spray, 1 mg, is not reimursable for Medicaid and Medicare. It is not covered.

*Note: Codes F32.5 and F33.42 for major depressive disorder in full remission would only be appropriate for Maintenance Phase of treatment and would not be appropriate for Induction Phase of treatment.