Treatment-Resistant Depression
Esketamine nasal spray may be considered medically necessary if all of the following conditions are met:
Initial Authorization for 28 Days
Individual is 18 years of age or older.
Individual meets the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria for a major depressive episode (See Table 1) by a structured clinical interview for DSM-5 disorders.
Individual current depressive episode is moderate or severe based on either of the following:
Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 28 (see policy guidelines) OR
Hamilton Rating Scale for Depression (HAM-D) score ≥ 17 (see policy guidelines).
Individual has tried and had an inadequate response to 2 antidepressant agents from 2 different antidepressant classes (i.e., selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, bupropion, or mirtazapine). An adequate trial of an antidepressant is defined by BOTH of the following:
The trial length was at least 6 weeks at generally accepted doses or of sufficient duration as determined by the treating physician at the generally accepted doses; AND
Individual was ≥80% adherent to the agent during the trial.
Individual is to receive esketamine nasal spray in conjunction with an oral antidepressant.
Individual does not have a current substance use disorder unless in remission (complete abstinence for a month).
Individual does NOT have any U.S. Food and Drug Administration (FDA) labeled contraindications to the requested agent and esketamine nasal spray is intended to be used consistently with the FDA approved label (see policy guidelines) including meeting Spravato Risk Evaluation and Mitigation Strategy (REMS) program requirements (see policy guidelines).
The prescriber is a specialist in the area of the individual’s diagnosis (e.g. psychiatrist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis.
Reauthorization for UP TO 1 Year
Esketamine nasal spray may be reauthorized for up to 1 year if all of the following conditions are met:
Individual has had improvement in depression symptoms as evaluated with an appropriate depression rating scale (e.g. Patient Health Questionnaireâ9, Clinically Useful Depression Outcome Scale, Quick Inventory of Depressive SymptomatologyâSelf Report 16 Item, MADRS, HAMâD).
Individual is to receive esketamine nasal spray in conjunction with an oral antidepressant.
Individual does not have a current substance use disorder.
Individual does NOT develop any FDA-labeled contraindications to the requested agent and esketamine nasal spray is intended to be used consistently with the FDA-approved label (see policy guidelines) including meeting Spravato REMS program requirements (see policy guidelines).
Major Depressive Disorder with Acute Suicidal Ideation or Behavior
Esketamine nasal spray may be considered medically necessary for a treatment period of 28 days if all of the following conditions are met:
Individual is 18 years of age or older.
Individual meets the DSM-5 criteria for a major depressive episode (See Table 1) by a structured clinical interview for DSM-5 disorders.
Individual current depressive episode is moderate or severe based on either of the following scales:
MADRS ≥ 28 (see policy guidelines) OR
HAM-D score ≥ 17 (see policy guidelines).
Individual is currently hospitalized and is at imminent risk of suicide as documented by
Individual response to a structured assessment for suicidal ideation indicative of imminent risk of suicide (see policy guidelines) AND
Confirmation of imminent risk of suicide by clinical assessment by a mental health professional/psychiatrist (see policy guidelines).
Individual is to receive esketamine nasal spray in conjunction with standard-of-care treatment based on clinical judgment and practice guidelines that may be comprised of oral antidepressant(s), an atypical antipsychotic, or a mood stabilizer.
Individual does NOT have any FDA-labeled contraindications to the requested agent and esketamine nasal spray is intended to be used consistently with the FDA-approved label (see policy guidelines) including meeting Spravato REMS program requirements (see policy guidelines).
The prescriber is a specialist in the area of the individual’s diagnosis (e.g. psychiatrist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis.
Esketamine nasal spray is considered investigational in all other situations.
