CurrentCignaPolicy IP0607

Zurzuvae (zuranolone) for postpartum depression

Coverage policy for Zurzuvae (zuranolone capsules) for treatment of postpartum depression in adults, describing medical necessity criteria, exclusions, and prescribing requirements for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyZurzuvae (zuranolone) for postpartum depression

Policy CodePolicy IP0607

Change TypeNew policylater annual revision (no criteria changes)

Effective Date05/15/2024

Next Review Date

Key ActionObtain prior authorization showing patient meets FDA‑approved indication criteria (≥18 years, severe postpartum depression with onset in third trimester to 4 weeks postdelivery, ≤12 months postpartum); initial approval duration: 14 days.

SourceLink

POLICY UPDATE CHANGES

New policy created for Zurzuvae with an effective date of 05/15/2024.

Annual revision on 02/15/2025 with no criteria changes.

14 daysinitial approval duration

≥18minimum age

≤12 monthspostpartum timeframe

≤4 wkssymptom onset window

CNS depression

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Coverage Criteria for Zurzuvae (zuranolone)

Initial therapy (FDA-approved indication)

Covered when ALL of the following are met

FDA-Approved Indication: Postpartum Depression: Patient is ≥ 18 years of age; AND patient has been diagnosed with severe depression; AND symptom onset began during the third trimester of pregnancy or up to 4 weeks postdelivery; AND patient is ≤ 12 months postpartum; AND patient is not currently pregnant; AND Zurzuvae is being prescribed by or in consultation with a psychiatrist or an obstetrician-gynecologist;

Initial approval duration: 14 days.

Any use of Zurzuvae (zuranolone) outside the FDA-approved indication for treatment of postpartum depression is considered experimental, investigational, or unproven and is not covered.

Specifically, previous treatment with Zurzuvae during the current episode of postpartum depression is listed as a condition not covered and is considered experimental/investigational.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for treatment of postpartum depression with Zurzuvae. Approvals are limited to 14 days and only when all FDA-approved indication criteria are met (patient ≥ 18 years, diagnosis of severe depression with symptom onset during third trimester or within 4 weeks postdelivery, patient ≤ 12 months postpartum, not currently pregnant, and prescription by or in consultation with a psychiatrist or obstetrician-gynecologist). Receipt of sample product does not satisfy prior authorization criteria. Dosage, frequency, duration, and site of care must be reasonable and supported by evidence-based literature.

Prior authorization required for Zurzuvae for postpartum depression
Approval duration: 14 days when all criteria met
Required prescriber: psychiatrist or obstetrician-gynecologist
Receipt of product samples does not satisfy authorization requirements

Step Therapy

No step therapy requirements or prior medication trial sequencing are specified for Zurzuvae in this policy. Providers should not substitute a mandatory trial of other therapies as a condition for coverage unless the member's specific benefit plan or a separate program requires step therapy.

No step therapy required per this policy
Check member's benefit plan for any plan-specific step therapy programs

Documentation Required

Required Clinical Documentation

Providers must document the member's age, diagnosis of severe postpartum depression, timing of symptom onset (third trimester or within 4 weeks postdelivery), postpartum duration (≤ 12 months), pregnancy status (not currently pregnant), and that the medication is prescribed by or in consultation with a psychiatrist or obstetrician-gynecologist. Include prior treatment history relevant to the current episode; previous treatment with Zurzuvae during the current episode is considered experimental/investigational and is not covered.

Document: patient age (≥ 18 years)
Document: diagnosis of severe postpartum depression
Document: symptom onset timing (third trimester or ≤ 4 weeks postdelivery)
Document: postpartum duration (≤ 12 months)
Document: current pregnancy status (not pregnant)
Document: prescribing clinician specialty or consultation (psychiatrist or obstetrician-gynecologist)
Document: prior treatments for the current episode (note prior Zurzuvae = experimental/not covered)

Denial Risk

Prior Zurzuvae in Current Episode Not Covered

Previous treatment with Zurzuvae during the current episode of postpartum depression is considered experimental, investigational, or unproven and is not covered.

Prior Zurzuvae in current episode = not covered / experimental

Oral Zuranolone (Zurzuvae) Treatment

Oral zuranolone (Zurzuvae)

Clinical trial evidence: Efficacy established in two Phase III randomized, double-blind, placebo-controlled studies in patients with severe postpartum depression initiating treatment within 6 or 12 months of delivery; eligible patients had onset no earlier than third trimester and no later than 4 weeks after delivery.

Definitions

Postpartum depression — definition (onset timing relative to delivery)

DefinitionPostpartum (peripartum) depression: a major depressive episode with onset during pregnancy or within 4 weeks of delivery.

Typical severityApproximately 40%–80% of cases are moderate to severe.

Clinical impactCan adversely affect the maternal‑infant bond and later infant development.

Zuranolone / Zurzuvae — drug definition and mechanism

Drug name (generic)Zuranolone

Brand nameZurzuvae

Mechanism of action

Background

Zuranolone (marketed as Zurzuvae) is an oral neuroactive steroid that acts as a GABA-A receptor positive modulator. It is indicated for the treatment of postpartum depression in adults; uses outside this FDA-approved context are considered experimental, investigational, or unproven.