Brexanolone (Zulresso™)

•  brexanolone (Zulresso™) intravenous infusion for administration by a healthcare professional 

• For treatment of postpartum depression in patients 15 years of age and older 

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The patient is 15 years of age or older; AND

2. The patient has a diagnosis of moderate to severe postpartum depression (PPD); AND

3. The patient has a confirmed diagnosis of a major depressive episode using DSM criteria; AND

4. The patient has moderate to severe PPD, as defined by a HAM-D total score of at least 20 or as scored by a comparable standardized rating scale that reliably measures depressive symptoms; AND

5. The patient had onset of depressive symptoms no sooner than the third trimester of pregnancy and no later than within 4 weeks after delivery; AND

6. The patient is ≤ 6 months postpartum; AND

7. The patient has NOT received Zurzuvae during the existing postpartum period; AND

8. The patient will NOT utilize the requested agent with Zurzuvae during the same postpartum period; AND

9. The patient does NOT have active psychosis; AND

10. The patient is not lactating or actively breastfeeding upon initiation and during treatment with the requested agent; AND

11. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., psychiatrist) or has consulted with a specialist in the area of the patient’s diagnosis; AND

12. The requested agent will be administered under direct supervision of a healthcare professional at a treatment facility that is certified through the Zulresso REMS program; AND

13. The infusion facility administering the requested agent is equipped and staffed with the following:

a. Continuous pulse oximetry; AND

b. Healthcare professionals trained to handle possible excessive sedation and/or sudden loss of consciousness, including acute airway management; AND

14. The patient will NOT be using the requested agent beyond one infusion course per pregnancy; AND

15. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).

Duration of Approval: 60 days (one infusion per pregnancy)

Healthcare provider must be available on site to continuously monitor patient, and intervene as necessary, for the duration of the infusion

*Maximum units allowed for duration of approval 

Hamilton Rating Scale for Depression (HAM-D): 17-item rating scale to determine the severity level of depression in a patient before, during, and after treatment. The total score ranges from 0 to 52. 

All information referenced is from FDA package insert unless otherwise noted below.

1. Kanes S, Colquhoun H, Gunduz-Bruce H, et al. Brexanolone (SAGE-547 injection) in postpartum depression: a randomized controlled trial. Lancet. 2017;390:480-489.

2. Meltzer- Brody S, Colquhoun H, Riesenberg R, et al. Brexanolone injection in post-partum depression: two multicenter, double-blind, randomized, placebo-controlled, phase 3 trials. Lancet. 2018;392:1058-1070.

3. Stewart CM and Vigod S. Postpartum depression. N Engl J Med. 2016;375:2177-2186. 

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually. 

November 2023: Criteria change: Added requirement for no use in combination with newly approved Zurzuvae during the same postpartum period.

July 2022: Criteria change: Expanded indication criteria and dosing table to age 15 years or older.

June 2021: Criteria change: Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.