CurrentCareSourcePolicy N/A

Zulresso (brexanolone) utilization management — medical policy

Defines prior authorization, clinical eligibility, dosing, safety monitoring, and coverage stance for Zulresso (brexanolone) one-time 60‑hour IV infusion for postpartum depression patients; affects providers requesting medical-benefit coverage from CareSource.

Policy Summary

PayerCareSource

PolicyZulresso (brexanolone) utilization management — medical policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJun 12, 2024

Key ActionRequest prior authorization and authorize for 30 days if patient meets clinical criteria (age ≥15, appropriate diagnosis, <6 months postpartum, prescribed by or in consultation with a psychiatrist or OB‑GYN).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

60 hinfusion duration

≤90 mcg/kg/hrmax rate

≥15min age

≤6 moinitiation window

boxed warningREMS risk

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Initial Therapy

Covered when ALL of the following are met

Age and Indication: Patient is ≥ 15 years of age AND diagnosis of moderate to severe postpartum depression with symptom onset during the third trimester of pregnancy or within 4 weeks post-delivery.

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Timing and pregnancy status: Patient is less than 6 months postpartum at treatment initiation AND is not currently pregnant.< 6 months postpartum

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Prescriber requirement: Zulresso is prescribed by or in consultation with a psychiatrist or an obstetrician-gynecologist.

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Dosing and administration: Administration as a one-time continuous IV infusion over 60 hours with the specified titration schedule; dosing may be titrated up to 90 mcg/kg/hour per protocol.60 hours; up to 90 mcg/kg/hour

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Safety and monitoring: Facility must monitor for excessive sedation and sudden loss of consciousness per boxed warning, including continuous pulse oximetry and sedative-effect checks every 2 hours during planned non-sleep periods; if excessive sedation occurs the infusion must be stopped until symptoms resolve and may be restarted at same or lower dose; Zulresso is available only through a REMS program.

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Previous treatment with Zulresso (brexanolone) during the same episode of postpartum depression is not recommended for approval. If the member has already received Zulresso for the current episode, coverage should generally be denied because repeat administration in the same episode is explicitly listed among the conditions not recommended for approval.

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for medical benefit coverage of Zulresso. Approval is recommended for those who meet the Criteria and Dosing for the listed indication. All approvals are provided for the duration noted below. In cases where the approval is authorized in months, 1 month is equal to 30 days. Because of the specialized skills required for evaluation and diagnosis of patients treated with Zulresso as well as the monitoring required for adverse events and long-term efficacy, approval requires Zulresso to be prescribed by or in consultation with a physician who specializes in the condition treated (psychiatrist or obstetrician-gynecologist). A 1-month (30 days) approval duration is applied to allow for the scheduling and administration of the one-time, 60-hour infusion of Zulresso.

Prescribing requirement: Must be prescribed by or in consultation with a psychiatrist or obstetrician-gynecologist.
Approval duration: 1 month = 30 days (to allow scheduling/administration of the one-time, 60-hour infusion).
Dosing: Approve up to 90 mcg/kg/hour IV as a one-time, 60-hour infusion once per postpartum period.

Denial Risk

Prior Authorization Not Recommended for Repeat Use

Prior authorization is not recommended for reuse of Zulresso during the current episode of postpartum depression. Coverage of repeated administration within the same episode is not recommended.

Not recommended for approval: Previous treatment with Zulresso during the current episode of postpartum depression.

Step Therapy

No Step Therapy or Sequencing Required

No step therapy requirements or sequencing with other antidepressants are specified for Zulresso in this policy.

No step therapy or required trialing of other antidepressants prior to coverage is specified.

Note

FDA-Approved Indication and Eligibility

FDA-approved indication and key eligibility criteria for approval: Approve for 1 month (30 days) if the patient meets ALL of the following: (A) age ≥ 15 years; (B) diagnosis of moderate to severe postpartum depression with symptom onset during the third trimester of pregnancy or within 4 weeks post-delivery; (C) patient is < 6 months postpartum; (D) patient is not currently pregnant; and (E) Zulresso is prescribed by or in consultation with a psychiatrist or obstetrician-gynecologist.

Indication: Postpartum depression.
Age: ≥ 15 years.
Timing: Symptom onset during third trimester or within 4 weeks post-delivery; patient < 6 months postpartum.
Pregnancy status: Not currently pregnant.
Prescriber: Psychiatrist or obstetrician-gynecologist (or in consultation with).

Brexanolone (Zulresso) IV Infusion Details

Brexanolone (Zulresso) IV infusion

Zulresso infusion: One-time continuous IV infusion administered over 60 hours with the dose titration schedule per protocol (0–4 hr: 30 mcg/kg/hr; 4–24 hr: 60 mcg/kg/hr; 24–52 hr: 90 mcg/kg/hr with possible reduction to 60 mcg/kg/hr; 52–56 hr: 60 mcg/kg/hr; 56–60 hr: 30 mcg/kg/hr); maximum infusion rate up to 90 mcg/kg/hour.60 hours; up to 90 mcg/kg/hour

Monitor for excessive sedation and loss of consciousness; stop infusion if these occur and restart at same or lower dose after resolution; product available only through REMS.

Background

Postpartum (peripartum) depression is a major depressive episode with onset during pregnancy or within 4 weeks of delivery and can adversely affect maternal–infant bonding and infant development. Zulresso (brexanolone) is an FDA‑approved, GABA‑A positive modulator indicated for this condition; however, the policy specifies limits on use and monitoring requirements. The document notes that prior authorization criteria apply and that certain situations — including prior treatment with Zulresso during the current episode — are not recommended for coverage, reflecting the clinical and safety considerations guiding appropriate use.