CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zurzuvae (zuranolone) for postpartum depression — coverage criteria

Criteria for coverage and prior authorization of Zurzuvae (zuranolone) for treatment of postpartum depression (PPD) in adults; applies to members of Neighborhood Health Plan of Rhode Island when prescribing and dispensing requirements are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZurzuvae (zuranolone) for postpartum depression — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 1, 2024

Next Review DateJul 1, 2025

Key ActionObtain prior authorization with documentation demonstrating age ≥18, severe PPD with standardized rating scales, appropriate timing (third trimester to 4 weeks postpartum), treatment initiation ≤6 months postpartum, prior inadequate SSRI/SNRI trial if appropriate, cessation of lactation during the treatment window, absence of listed contraindications, and psychiatrist prescribing or consultation.

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POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Initial authorization duration

≤6Maximum postpartum age at treatment start (months)

1Allowed courses per pregnancy/childbirth

14–28Quantity limit per pregnancy/childbirth (by strength)

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Authorization Criteria for Zurzuvae (zuranolone) — Postpartum Depression

Medically necessary — Postpartum depression (initial authorization)

Authorization of 1 month may be granted when ALL of the following are met:

ALL of the following

Member is 18 years of age or older
Member has severe postpartum depression with documentation of diagnosis provided
Member had a major depressive episode with onset no earlier than the third trimester and no later than 4 weeks postpartum, documented by standardized rating scales (e.g., BDI, HDRS, MADRS)
Member is 6 months postpartum or lessTreatment initiation ≤ 6 months postpartum; depressive episode onset no earlier than third trimester and no later than 4 weeks postpartum
Member is not currently pregnant
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 doseNo breastmilk feedings from just prior to first dose until 7 days after last dose
Member will not receive more than one 14-day treatment course per pregnancy/childbirth
Member has not received prior treatment with Zurzuvae after the most recent pregnancy
Member has experienced an inadequate treatment response from a 4-week trial of a formulary oral SSRI or SNRI for PPD, if appropriate, with documentation providedInadequate response after a 4-week trial of a formulary oral SSRI or SNRI
Zurzuvae will be used in combination with, or a recommendation will be given for, psychotherapy if appropriate
No history of the following
- Seizures
- Bipolar disorder
- Schizophrenia
- Schizoaffective disorder
The requested medication is prescribed by or in consultation with a psychiatrist
Prescriber specialty requirement

ALL of the following

(Administrative) Adhere to quantity limits: Zurzuvae 25 mg—2 capsules/day (28 capsules per pregnancy/childbirth); Zurzuvae 30 mg—1 capsule/day (14 capsules per pregnancy/childbirth)

ALL of the following

Initial authorization duration: 1 month (14-day treatment course maximum per pregnancy/childbirth)

Not covered / Investigational

All other indications outside FDA-approved use for postpartum depression are considered experimental/investigational and not medically necessary.

ANY of the following

Use of Zurzuvae for indications other than postpartum depression in adults

Drug Product and Dispensing Limits

Drug productNDC|internalCovered

Zurzuvae 25 mg capsule	25 mg capsules; quantity limit: 2 capsules/day, 28 capsules per pregnancy/childbirth
Zurzuvae 30 mg capsule	30 mg capsules; quantity limit: 1 capsule/day, 14 capsules per pregnancy/childbirth
Zurzuvae 20 mg capsule (for dose reduction)	Used to achieve 40 mg daily dose when dose reduction required; specialty pharmacy dose reduction program available

Drug product (internal note)internal

Specialty pharmacy dose reduction program

Limited network of specialty pharmacies will administer a dose reduction program at no cost to payers and patients per Biogen when 20 mg capsules are used to achieve 40 mg daily due to CNS depressant effects.

Postpartum age windowTreatment initiation ≤ 6 months postpartum; depressive episode onset no earlier than third trimester and no later than 4 weeks postpartum

Prior SSRI/SNRI trialInadequate response after a 4-week trial of a formulary oral SSRI or SNRI for PPD, if appropriate

Lactation restrictionNo breastmilk feedings from just prior to first dose until 7 days after last dose

Clinical and Authorization Requirements — What Providers Must Do

Prior Authorization

Authorization required with clinical documentation

Prior authorization is required. Documentation must demonstrate the member is ≥18 years old; has severe postpartum depression with diagnosis and symptom timing documented by standardized rating scales (onset no earlier than third trimester and no later than 4 weeks postpartum); is ≤6 months postpartum; is not currently pregnant; lactation has ceased or breastmilk will not be used for feedings from just prior to day 1 until 7 days after the last dose; the member will not receive more than one 14‑day treatment course per pregnancy/childbirth and has not received Zurzuvae after the most recent pregnancy; an inadequate response to a 4‑week trial of a formulary oral SSRI or SNRI for PPD should be documented if appropriate; and the prescriber is a psychiatrist or has consulted with one.

Documentation Required

Psychiatric consultation and psychotherapy plan

The prescription must be written by a psychiatrist or in consultation with a psychiatrist, and documentation should state that Zurzuvae will be used in combination with, or that a recommendation for, psychotherapy will be provided when appropriate.

Billing Rule

Dose and quantity limits

Adhere to the specified dose and quantity limits for the course per pregnancy/childbirth.

Zurzuvae 25 mg capsules: 2 capsules/day, up to 28 capsules per pregnancy/childbirth.
Zurzuvae 30 mg capsules: 1 capsule/day, up to 14 capsules per pregnancy/childbirth.
If a dose reduction to 40 mg daily is required (using 20 mg capsules), the limited network of specialty pharmacies dispensing Zurzuvae will administer a dose reduction program at no cost to payers and patients.

Denial Risk

Exclusion/contraindication denials

Requests will be denied if the member has a history of seizures, bipolar disorder, schizophrenia, or schizoaffective disorder, is currently pregnant, or intends to breastfeed during the treatment window (breastmilk must not be used from just prior to the first dose until 7 days after the last dose).

Clinical Background and Policy Scope

Zurzuvae (zuranolone) is an FDA-approved medication for the treatment of postpartum depression (PPD) in adults. Coverage is limited to the FDA‑approved peripartum indication and requires prior authorization with documentation of diagnosis and severity using standardized rating scales (e.g., BDI, HDRS, MADRS). The policy authorizes a 1‑month course when all clinical criteria are met, including that the major depressive episode had onset no earlier than the third trimester and no later than 4 weeks postpartum, and that treatment is initiated at ≤ 6 months postpartum.

Use of Zurzuvae under this policy is restricted by timing and safety requirements: the member must be ≥ 18 years old, not currently pregnant, and lactation must have ceased or breastmilk not be used for feedings from just prior to the first dose until 7 days after the last dose. Only one 14‑day treatment course per pregnancy/childbirth is allowed, and the member must not have received Zurzuvae after the most recent pregnancy. The policy also requires documentation of inadequate response to a 4‑week trial of a formulary oral SSRI or SNRI for PPD, if appropriate, and that Zurzuvae will be used in combination with or accompanied by a recommendation for psychotherapy when appropriate.

Safety exclusions are enforced: treatment is denied if the member has a history of seizures, bipolar disorder, schizophrenia, or schizoaffective disorder. Additionally, the medication must be prescribed by or in consultation with a psychiatrist. Quantity limits apply by strength (e.g., 25 mg: 2 capsules/day, up to 28 capsules per pregnancy; 30 mg: 1 capsule/day, up to 14 capsules per pregnancy), with a specialty pharmacy dose‑reduction program available when a 40 mg daily dose is required using 20 mg capsules.

Policy ScopeCriteria for coverage and prior authorization of Zurzuvae (zuranolone) for treatment of postpartum depression (PPD) in adults; applies to members of Neighborhood Health Plan of Rhode Island when prescribing and dispensing requirements are met.

SubjectZurzuvae (zuranolone) for postpartum depression

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZurzuvae (zuranolone) for postpartum depression — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 1, 2024

Next Review DateJul 1, 2025

SourceLink

On This Page

OpenPayer

Zurzuvae (zuranolone) for postpartum depression — coverage criteria

Authorization Criteria for Zurzuvae (zuranolone) — Postpartum Depression

Drug Product and Dispensing Limits

Clinical and Authorization Requirements — What Providers Must Do

Clinical Background and Policy Scope

Defined Terms

Policy Dates