Pharmacy Prior Authorization Criteria

Zulresso (brexanolone)

Indications for Prior Authorization

Zulresso (brexanolone)

• For diagnosis of Postpartum Depression (PPD)
  Indicated for the treatment of PPD in patients 15 years of age or older.

Criteria

Zulresso

Prior Authorization

Length of Approval: 30 Day(s)

• Diagnosis of postpartum depression (PPD)
AND
• Patient is 15 years of age or older
AND
• Onset of symptoms during the third trimester of pregnancy or within 4 weeks of delivery [1, 2]
AND
• Patient is 6 months postpartum or less [2]

P & T Revisions

2025-04-29, 2024-05-03, 2023-11-21, 2023-05-04, 2022-08-01, 2022-05-05, 2021-05-04, 2020-04-28

References

1. Zulresso Prescribing Information. Sage Therapeutics, Inc. Cambridge, MA. June 2022.
2. Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Meeting. FDA Briefing Document. November 2, 2018. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM624643.pdf. Accessed March 27, 2024.
3. ClinicalTrials.gov. A Multicenter, Randomized, Double-Blind, Parallel-Group, PlaceboControlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects with Severe Postpartum Depression and Adult Female Subjects with Moderate Postpartum Depression. Available at: https://cdn.clinicaltrials.gov/large-docs/04/NCT02942004/SAP_001.pdf. Accessed April 23, 2025.

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Revision History

• 2025-04-29: Annual review: References updated. No changes to criteria.
• 2024-05-03: Annual review: Background updates.
• 2023-11-21: Removal of prescriber requirements as per P&T meeting.
• 2023-05-04: Annual review: Background updates.
• 2022-08-01: Update Guideline
• 2022-05-05: Annual review: Background updates.
• 2021-05-04: Annual review: Background updates.
• 2020-04-28: Annual review: Background updates.

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