Overview

This document addresses the use of Zulresso (brexanolone intravenous). Zulresso is FDA approved for the treatment of postpartum depression in women. Zulresso is a positive allosteric modulator of gamma-aminobutyric-acid type A (GABAA) receptors. Postpartum depression is a common complication of childbirth and affects all socioeconomic levels. According to the American College of Obstetricians and Gynecologists (ACOG), perinatal depression (depression occurring either during pregnancy or the first 12 months following childbirth) affects in one in seven women. (ACOG 2016) Brexanolone is given as a single 60-hour continuous infusion.

In clinical studies, women with moderate to severe post-partum depression showed an improvement compared to placebo at hour 60 (after the infusion time). Zulresso has a black box warning regarding the risk for excessive sedation and sudden loss of consciousness during administration. Because of this, individuals must be monitored for these adverse events and must have continuous pulse oximetry monitoring. Individuals must be accompanied during interactions with their child(ren). Zulresso is available only through the Zulresso REMS.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Zulresso (brexanolone)

Requests for Zulresso (brexanolone) may be approved if the following criteria are met (Meltzer-Brody 2018):

1. Individual is 15 years of age or older; AND
2. Individual is 6 months postpartum or less; AND
3. Individual has a diagnosis of moderate to severe postpartum depression consistent with a qualifying score using a standardized screening tool for depression (such as, but not limited to, Hamilton Rating Scale for Depression [HAM-D], Patient Health Questionnaire [PHQ-9], Beck Depression Inventory [BDI], Montgomery-Asberg Depression Rating Scale [MADRS], Edinburgh Postnatal Depression Scale [EPDS]).

Requests for Zulresso (brexanolone) may not be approved for the following:

• Individual has end stage renal disease (ESRD) with eGFR < 15 mL/minute/1.73 m2; OR
• When the above criteria are not met and for all other indications.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

• J1632 - Injection, brexanolone, 1 mg (Effective 10/1/2020)

• F32.0-F32.9 - Major depressive disorder
• F53.0 - Postpartum depression

Document History

Revised: 02/24/2023