Criteria
Esketamine (Spravato) may be considered medically necessary for the treatment of individuals 18 years of age and older when the following criteria are met:
Treatment Resistant Major Depressive Disorder (MDD)
-
Prescribed by or in consultation with a licensed mental health professional with prescriptive authority (e.g., psychiatrist, psychiatric or mental health nurse practitioner, etc.);
and
-
Diagnosis of treatment resistant MDD based on the current DSM by a mental health professional;
and
- Individual has failed to adequately respond to at least three (3) different antidepressants which may be defined as:
-
Individual has had no response at minimal therapeutic dose for four (4) weeks of therapy resulting in therapy change;
or
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Individual has had no response or a partial response with dose limiting side effects resulting in therapy change;
or
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Individual has had a partial response at or above maximum therapeutic dose for a treatment duration of at least eight (8) weeks resulting in therapy change;
and
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At least one of these antidepressant trials must be in the current episode of depression
; and
-
Individual has failed to adequately respond to at least one (1) trial of augmentation with a second agent along with one of the antidepressant trials;
and
-
Esketamine (Spravato) is not to be used as monotherapy and is being prescribed in conjunction with least one oral antidepressant;
and
-
Individual is not receiving esketamine (Spravato) in conjunction with transcranial magnetic stimulation (TMS);
and
- Healthcare setting and pharmacy are certified, and individual will be enrolled in the Spravato Risk Evaluation and Mitigation Strategy (REMS) program, providing the appropriate monitoring to include at least two (2) hours of observation by the healthcare provider after administration of esketamine (Spravato) by the individual in the healthcare setting
Continuation of Therapy
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Individual has demonstrated sustained improvement from baseline in depressive symptoms as documented by standardized rating scales that reliably measure depressive symptoms;
and
-
Individual will continue to receive esketamine (Spravato) in conjunction with an oral antidepressant;
and
- Dosing is in accordance with the FDA approved labeling and does not exceed 84 mg per week.
MDD with Acute Suicidal Ideation
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Prescribed by or in consultation with a licensed mental health professional with prescriptive authority (e.g., psychiatrist, psychiatric or mental health nurse practitioner, etc.);
and
-
Diagnosis of MDD based on the current DSM by a mental health professional;
and
-
Individual has suicidal ideation with intent, confirmed by individual, and may warrant potential hospitalization;
and
-
Individual may not have a current DSM-5 diagnosis of bipolar (or related) disorder, obsessive-compulsive disorder (OCD), antisocial personality disorder or borderline personality disorder;
and
.
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Individual may not have a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis;
and
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Individual may not have a history of moderate to severe substance or alcohol use disorder within six (6) months of screening;
and
.
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Individual may not have a positive urine test result for phencyclidine, cocaine or amphetamines;
and
-
Esketamine (Spravato) is not to be used as monotherapy and is being prescribed in conjunction with least one oral antidepressant;
and
-
Individual is not receiving esketamine (Spravato) in conjunction with transcranial magnetic stimulation (TMS);
and
-
Healthcare setting and pharmacy are certified by and individual will be enrolled in the Spravato Risk Evaluation and Mitigation Strategy (REMS) program, providing the appropriate monitoring to include at least two (2) hours of observation by the healthcare provider after administration of esketamine (Spravato) by the individual in the healthcare setting;
and
- Treatment with esketamine (Spravato) does not exceed four (4) weeks.
The use of Esketamine (Spravato) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Codes
