Individuals may be considered for a 1 time use of brexanolone per pregnancy if they meet all of the following criteria:
Individual is 15 years of age or older and ≤6 months postpartum at the time of infusion.
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 has a onset of depressive episode between 3rd trimester through 4 weeks postpartum.
Individual has a diagnosis of moderate to severe postpartum depression based on either of the following:
Hamilton Rating Scale for Depression (HAM-D) score ≥ 20 (see policy guidelines) OR
Edinburgh Postnatal Depression Scale (EPDS) score ≥ 13 (see policy guidelines)
Individual meets 1 of the following:
Has tried and had an inadequate response to 2 antidepressant agents from 2 different antidepressant classes (i.e. SSRIs, SNRIs, TCAs, 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; OR
Has a documented intolerance or U.S. Food and Drug Administration (FDA) labeled contraindication, to major classes of antidepressant agents; OR
Shows a potential risk of immediate harm to self and/or others as determined by the treating physician and supported by documentation.
Individual does NOT have any FDA labeled contraindications to the requested agent and is intended to be used consistently with the FDA approved label (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.
Brexanolone is considered investigational when the above criteria are not met.
Brexanolone is considered investigational for all other indications.