ModifiedPremera Blue Cross of WashingtonPolicy N/A

Zurzuvae (zuranolone) for postpartum depression

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This policy governs pharmacy-benefit coverage and prior authorization for Zurzuvae (zuranolone) used to treat postpartum depression. It applies to individuals seeking coverage and providers submitting medical-necessity documentation.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyZurzuvae (zuranolone) for postpartum depression

Policy CodePolicy N/A

Change TypeModified

Effective DateN/A

Last ReviewNov 1, 2026

Next Review DateN/A

Key ActionSubmit documentation supporting all applicable medical-necessity criteria for pharmacy prior authorization.

SourceLink

POLICY UPDATE CHANGES

Coverage criteria for Zulresso (brexanolone) were removed.

A Not Medically Necessary table was added for uses of Zurzuvae (zuranolone) that do not meet the policy criteria.

The policy clarified that Zurzuvae uses not meeting the stated medical necessity criteria are not medically necessary.

The policy removed the prior reference to non-formulary exception review.

14 daysInitial treatment course

1 courseMaximum course per pregnancy

18+Minimum age

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ModifiedPremera Blue Cross of WashingtonPolicy N/A

Zurzuvae (zuranolone) for postpartum depression

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Sign up for all premerabluecrossofwashington policy alerts

Know when premerabluecrossofwashington releases new policies or updates existing guidance.

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Policy Summary

PayerPremera Blue Cross of Washington

PolicyZurzuvae (zuranolone) for postpartum depression

Policy CodePolicy N/A

Change TypeModified

Effective DateN/A

Last ReviewNov 1, 2026

Next Review DateN/A

Key ActionSubmit documentation supporting all applicable medical-necessity criteria for pharmacy prior authorization.

SourceLink

POLICY UPDATE CHANGES

Coverage criteria for Zulresso (brexanolone) were removed.

A Not Medically Necessary table was added for uses of Zurzuvae (zuranolone) that do not meet the policy criteria.

The policy clarified that Zurzuvae uses not meeting the stated medical necessity criteria are not medically necessary.

The policy removed the prior reference to non-formulary exception review.

14 daysInitial treatment course

1 courseMaximum course per pregnancy

18+Minimum age

≤12 monthsPostpartum timing

50 mg dailyRecommended dose

Medical Necessity and Coverage Criteria

Initial Therapy

Zurzuvae (zuranolone) may be considered medically necessary for the treatment of postpartum depression when ALL of the following criteria are met:

ALL of the following

The individual is aged 18 years or older.
The medical record documents DSM-5 diagnostic criteria for Major Depressive Disorder with peripartum onset.
The current episode of depression is moderate to severe, demonstrated by documentation of the individual's symptoms and their severity or by one or more standardized depression rating scales.
The individual is 12 months or less postpartum.
Treatment follows the product's U.S. Food and Drug Administration (FDA) dosage and administration prescribing information.
Zurzuvae is subject to the product's FDA dosage and administration prescribing information.

Continuation Therapy

Coverage is limited to one 14-day single treatment course per pregnancy.

Continuation therapy limitation

Future re-authorization of Zurzuvae (zuranolone) beyond 14 days in a single treatment course per pregnancy is not medically necessary.

Zurzuvae Medical Necessity

Zurzuvae (zuranolone) is not medically necessary when the medical-necessity criteria are not met.

Not medically necessary

All uses of Zurzuvae (zuranolone) that do not meet the policy criteria within the Medical Necessity section are considered not medically necessary.

Uses of Zurzuvae (zuranolone) that do not qualify under the medical-necessity criteria are not medically necessary.

Re-authorization of Zurzuvae (zuranolone) beyond a 14-day single treatment course per pregnancy is not medically necessary.

Coverage criteria for Zulresso (brexanolone) were removed because the product has been removed from the market.

Zurzuvae (zuranolone) use that does not satisfy the medical-necessity criteria is not medically necessary.

Treatment beyond one 14-day Zurzuvae (zuranolone) course per pregnancy is not medically necessary.

Non-qualifying uses of Zurzuvae (zuranolone) are considered not medically necessary.

Coding and Severity Documentation

Removed HCPCS CodeHCPCSNot Covered

J1632

HCPCS code removed from the policy with removal of Zulresso (brexanolone) coverage criteria

HAM-D depression severity classifications

Remission<10

Mild10-13

Mild to moderate14-17

Moderate to severe≥18

MADRS depression severity classifications

None0-6

Mild7-19

Moderate

Authorization and Documentation Requirements

Prior Authorization

Pharmacy Prior Authorization Required

Zurzuvae (zuranolone) is managed through the pharmacy benefit and requires pharmacy prior authorization. Authorization is subject to medical-necessity review under the policy criteria and the product’s FDA dosage and administration prescribing information.

Submit the request through the pharmacy benefit for review.
Include documentation supporting each medical-necessity criterion.

Documentation Required

Medical Records and Office Notes Required

Medical records submitted for review must document that the medical-necessity criteria are met. Include office visit notes containing the relevant history and physical-evaluation information.

Submit pertinent medical records for the condition under review.

Clinical Background

Postpartum depression is a major depressive episode occurring after childbirth. Clinical features may include depressed mood, loss of interest or pleasure, impaired concentration, guilt, and suicidal thoughts. Zurzuvae (zuranolone) is a neuroactive steroid that positively modulates GABA-A receptors and is indicated for postpartum depression; clinical trials found it more effective than placebo, although no active-treatment comparisons were available.

Clinical Definitions and Assessment

DSM-5 diagnostic criteria for a major depressive episode

Symptom count and durationFive or more symptoms must be present during the same two-week period and represent a change from previous functioning.

Required symptomAt least one symptom must be depressed mood or loss of interest or pleasure.

Functional impactSymptoms must cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.

Medical or substance exclusionThe episode must not be attributable to the direct physiological effects of a substance or another medical condition.

Psychotic-spectrum exclusionThe episode must not be better explained by schizoaffective disorder, schizophrenia, schizophreniform disorder, delusional disorder, or another specified or unspecified schizophrenia-spectrum or psychotic disorder.

Mania or hypomania exclusion

Initial Zurzuvae Authorization

Zurzuvae (zuranolone) may be considered medically necessary for postpartum depression when all of the following criteria are met:

Initial authorization criteria

Age: The individual is aged 18 years or older.≥18 years
Diagnosis: The medical record documents DSM-5 diagnostic criteria for major depressive disorder with peripartum onset.DSM-5 criteria
Severity: The current episode of depression is moderate to severe, demonstrated by documentation of the individual's symptoms and their severity or by one or more standardized depression rating scales.

Continuation and Re-authorization

No Extended Re-authorization

Coverage is limited to one 14-day treatment course per pregnancy.

No extended re-authorization: A treatment course beyond 14 days in a single pregnancy is not medically necessary and is not eligible for re-authorization.One 14-day course per pregnancy

Treatment Quantity Limits

Zurzuvae quantity limit

MedicationZurzuvae (zuranolone)

Quantity limit14 days

Course limitationOne single treatment course per pregnancy

Re-authorizationTreatment beyond 14 days in a single treatment course per pregnancy is not medically necessary and is not eligible for re-authorization.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyZurzuvae (zuranolone) for postpartum depression

Policy CodePolicy N/A

Change TypeModified

Effective DateN/A

Last ReviewNov 1, 2026

Next Review DateN/A

Key ActionSubmit documentation supporting all applicable medical-necessity criteria for pharmacy prior authorization.

SourceLink

On This Page

QIDS-SR depression severity classifications

None0-5

Mild6-10

Moderate11-15

Severe16-20

Very severe≥21

PHQ-9 depression severity classifications

None0-4

Mild5-9

Moderate10-14

Moderately severe15-19

Severe≥20

Ensure office notes support the diagnosis, symptom severity, postpartum timing, and treatment request.

Documentation Required

Clinical Eligibility Documentation

Document all clinical eligibility requirements for Zurzuvae treatment of postpartum depression. The individual must be 18 years or older, have DSM-5 diagnostic criteria for Major Depressive Disorder with peripartum onset, have a current moderate-to-severe depressive episode supported by symptom-severity documentation or one or more standardized depression rating scales, and be 12 months or less postpartum.

Age: 18 years or older.
Diagnosis: Major Depressive Disorder with peripartum onset under DSM-5 criteria.
Severity: Current episode is moderate to severe, supported by documented symptoms and severity or standardized depression rating scale results.
Postpartum status: 12 months or less postpartum.
Use the product’s FDA dosage and administration prescribing information.

Denial Risk

Non-Qualifying Uses Are Not Medically Necessary

Zurzuvae uses that do not satisfy the Medical Necessity criteria are not medically necessary and are not eligible for coverage under this policy.

Non-qualifying uses include requests that fall outside the covered postpartum-depression criteria or otherwise fail a required eligibility condition.

Denial Risk

One 14-Day Course per Pregnancy

Initial authorization may be approved for one 14-day single treatment course per pregnancy. Treatment beyond 14 days within a single pregnancy is considered not medically necessary.

Quantity limit: one 14-day treatment course per pregnancy.
Future re-authorization beyond the single 14-day course per pregnancy is not medically necessary.

Denial Risk

Failure to Meet Criteria Results in Non-Coverage

If the medical-necessity criteria are not met, the affected Zurzuvae (zuranolone) use is considered not medically necessary. Requests must demonstrate that all required criteria are satisfied before authorization can be issued.

Failure to meet any required policy criterion may result in non-authorization.
Document the clinical rationale and supporting records for every criterion included in the request.

There must have been no manic or hypomanic episode, unless all such episodes were substance-induced or attributable to another medical condition.

Depression severity rating scales

HAM-D<10 remission; 10-13 mild; 14-17 mild to moderate; ≥18 moderate to severe.

MADRS0-6 none; 7-19 mild; 20-34 moderate; ≥35 severe.

QIDS-SR0-5 none; 6-10 mild; 11-15 moderate; 16-20 severe; ≥21 very severe.

PHQ-90-4 none; 5-9 mild; 10-14 moderate; 15-19 moderately severe; ≥20 severe.

Postpartum period

Postpartum definitionWithin 12 months after delivery.

ACOG timing referenceACOG describes the postpartum period as within 12 months postpartum.

ACOG depression-onset contextACOG recommended consideration of zuranolone for depression with onset in the third trimester or within 4 weeks postpartum.

Moderate to severe depression

Symptom documentationModerate to severe depression may be demonstrated by documentation of the individual's symptoms and their severity.

Standardized scalesModerate to severe depression may also be demonstrated by one or more standardized depression rating scales.

PHQ-9 interpretationA PHQ-9 score of ≥10 indicates likely major depression; 10-14 is moderate, 15-19 moderately severe, and ≥20 severe.

Postpartum timing: The individual is 12 months or less postpartum.≤12 months postpartum