CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zurzuvae (zuranolone) — Coverage Criteria for Postpartum Depression

This document governs coverage and authorization criteria for Zurzuvae (zuranolone) for treatment of postpartum depression in adult members of Neighborhood Health Plan of Rhode Island (Medicaid scope referenced). It outlines eligibility, documentation, quantity limits, and prescribing requirements.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZurzuvae (zuranolone) — Coverage Criteria for Postpartum Depression

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date05/01/2024

Next Review Date07/2025

Key ActionObtain prior authorization with documentation of severe PPD, specialist involvement, timing criteria, and inadequate response to a 4-week SSRI/SNRI trial if appropriate.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 monthinitial authorization duration

28max 25 mg capsules

14max 30 mg capsules

18+min member age

<=6 momax postpartum age

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Coverage Criteria

Initial Authorization Criteria

Covered when ALL of the following are met:

Zurzuvae for PPD initial authorization: A. Member is 18 years of age or older; B. Prescription by or in consultation with a specialist in the management of patients with postpartum depression (e.g., psychiatrist, obstetrician-gynecologist); C. Documentation that member has a diagnosis of severe postpartum depression; D. Documentation that member has 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 (e.g., BDI, HAM-D, MADRS); E. Member is 6 months postpartum or less; F. Member is not currently pregnant; G. Lactation has ceased or breastmilk produced will not be used for feedings from just prior to receiving treatment on day 1 until 7 days after the last dose; H. Member will not receive more than one 14-day treatment course per pregnancy/childbirth; I. Member has not received prior treatment with Zurzuvae after the most recent pregnancy; J. Member is not currently pregnant; K. Documentation that member has experienced an inadequate treatment response from a 4-week trial of a formulary oral SSRI or SNRI for PPD, if appropriate; L. Zurzuvae will be used in combination with, or a recommendation will be given for psychotherapy, if appropriate; M. Member does not have a past medical history of seizures, bipolar disorder, schizophrenia, or schizoaffective disorder

The policy lists these as concurrent AND requirements; duplicates (pregnancy listed twice) retained as in source.

All indications other than the FDA‑approved indication for postpartum depression (PPD) are considered experimental/investigational and not medically necessary. This policy therefore limits coverage of Zurzuvae (zuranolone) to its FDA‑approved use for treatment of PPD in adults; requests for other diagnoses should be denied as not medically necessary.

Use of Zurzuvae for any non‑PPD indication is not medically necessary and will not be covered. Clinicians should submit requests only for the FDA‑approved indication (postpartum depression in adults); therapies prescribed for other mood disorders or conditions fall outside coverage under this policy.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — A 1-month course may be approved for treatment of postpartum depression (PPD) in adults when the listed clinical criteria are met. The medication must be prescribed by or in consultation with a specialist experienced in managing PPD (e.g., psychiatrist, obstetrician-gynecologist).

Authorization limited to 1 month when criteria are met
Specialist prescriber or consultation required

Step Therapy

Step Therapy Requirement

Step therapy applies — documentation of inadequate response to a 4-week trial of a formulary oral SSRI or SNRI for postpartum depression is required prior to approval, if appropriate.

4-week trial of formulary oral SSRI or SNRI required (if appropriate)

Background

Zurzuvae (zuranolone) is approved by the FDA specifically for the treatment of postpartum depression (PPD) in adults. This policy’s scope is limited to that FDA‑approved indication and requires documentation that the member’s presentation meets PPD criteria; all other uses are considered experimental/investigational and are excluded from coverage.

Definitions

Postpartum depression (PPD) — definition and timing

DefinitionA 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 (e.g., BDI, HAM-D, MADRS).

Onset timing windowNo earlier than the third trimester and no later than the first 4 weeks postpartum.

Assessment methodOnset and severity must be documented by standardized rating scales that reliably measure depressive symptoms (e.g., Beck Depression Inventory, HAM-D, MADRS).

Age requirementApplies to adults (member is 18 years of age or older).

Postpartum limit for eligibilityMember must be 6 months postpartum or less to meet authorization criteria.

Pharmacotherapy (Zurzuvae)

Pharmacotherapy (Zurzuvae) - Administration conditions: Treatment limited to adults with severe PPD meeting timing and safety criteria; psychotherapy to be used in combination or recommended where appropriate; dosing limited as per quantity limits.

Dosing & Supply Limits

Zurzuvae (zuranolone) dosing and quantity limits

25 mg capsule dosingUp to 2 capsules per day (total 50 mg/day); maximum 28 capsules per pregnancy/childbirth.

30 mg capsule dosingUp to 1 capsule per day (30 mg/day); maximum 14 capsules per pregnancy/childbirth.

Dose-reduction provisionFor members requiring a dose reduction to 40 mg daily (using 20 mg capsules) due to CNS depressant effects, specialty pharmacies will administer a dose reduction program at no cost to payers and patients per Biogen.

Documentation Required

Required Clinical Documentation

Required clinical documentation — include diagnosis of severe postpartum depression, timing of symptom onset, postpartum age, pregnancy/lactation status, prior exposure to Zurzuvae, and exclusions (e.g., seizure disorder, bipolar disorder, schizophrenia, schizoaffective disorder). Standardized rating scale documentation (e.g., BDI, HAM-D, MADRS) confirming onset no earlier than third trimester and no later than 4 weeks postpartum is required. Member must be ≥18 years old, ≤6 months postpartum, not currently pregnant, and lactation must have ceased or breastmilk not used from just prior to treatment on day 1 until 7 days after last dose. Only one 14-day treatment course allowed per pregnancy/childbirth.

Diagnosis of severe PPD
Onset timing documented with standardized rating scale (BDI, HAM-D, MADRS, etc.)
Member age ≥18
≤6 months postpartum
Not currently pregnant (twice-specified in source)
Lactation ceased or no breastfeeding during treatment and 7 days after last dose
No prior Zurzuvae after most recent pregnancy
Limit: one 14-day course per pregnancy
Exclude history of seizures, bipolar disorder, schizophrenia, schizoaffective disorder
Recommendation for psychotherapy or use in combination with psychotherapy, if appropriate