Subject: Zurzuvae SGM 6270-A P2024

Drug

ZURZUVAE  (zuranolone)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications¹

Zurzuvae is indicated for the treatment of postpartum depression (PPD) in adults.

All other indications are considered experimental/investigational and not medically necessary.

Coverage Criteria

Post-Partum Depression (PPD)¹

Authorization of 1 month may be granted for treatment of post-partum depression in adults when all of the following criteria are met:

• Member has moderate to severe post-partum depression and had a major depressive episode with onset of symptoms that began no earlier than the third trimester of pregnancy and no later than the first 4 weeks following delivery, documented by standardized rating scales that reliably measure depressive symptoms (e.g., Beck Depression Inventory [BDI], Hamilton Depression Rating Scale [HDRS], Montgomery-Asberg Depression Rating Scale [MADRS], etc.).
• Member is 12 months postpartum or less.
• Member will not receive more than one 14-day treatment course per pregnancy/childbirth.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Zurzuvae [package insert]. Cambridge, MA: Sage Therapeutics, Inc.; July 2024.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 20, 2025