CurrentMass General Brigham Health PlanPolicy N/A

Zurzuvae (zuranolone) — Pharmacy Coverage Criteria for Postpartum Depression

Defines prior authorization, quantity limits, and coverage criteria for Zurzuvae (zuranolone) for members of Mass General Brigham Health Plan; applies to pharmacy benefit prescribing for adults with postpartum depression.

Policy Summary

PayerMass General Brigham Health Plan

PolicyZurzuvae (zuranolone) — Pharmacy Coverage Criteria for Postpartum Depression

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization with documentation: specialist prescriber or consult, delivery date confirming <12 months postpartum, diagnosis of postpartum depression, and evidence of oral antidepressant failure/intolerance or clinical rationale for not trying one.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14 daysinitial and reauthorization approval duration

28quantity limit (20/25 mg)

14quantity limit (30 mg)

18+minimum age

<12 mopostpartum window

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Coverage Criteria for Zurzuvae (zuranolone)

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial approval: Member has a diagnosis of postpartum depression; member is 18 years of age or older; member is not currently pregnant; member is <12 months postpartum (date of delivery required); prescriber is a specialist or a specialist consult is provided; medical charts document prior treatment failure, intolerance, or contraindication to an oral antidepressant OR document clinical rationale that a trial of an oral antidepressant is not appropriate due to severity of depression.

Requests from new-to-plan members currently receiving the medication may be authorized; treatment obtained only as samples or via manufacturer patient assistance programs is excluded from that provision.

Provider actions: Prior authorization required; prescriber should be a specialist or provide a specialist consult; medical records must document date of delivery and prior antidepressant trial details or rationale for not trialing an oral antidepressant.

inv-02: Continuation Therapy

Continued authorization may be granted when ALL of the following are met:

Continuation: Member has a diagnosis of postpartum depression; member is not currently pregnant; member is <12 months postpartum (date of delivery required); last dose of the requested agent was within 45 days prior to the current request; clinical benefit from prior treatment is implied by the reauthorization request.45 days

Reauthorizations are granted for 14 days per policy limitations.

New member provision: Requests for members new to the plan who are currently receiving treatment may be considered for authorization; treatment supplied only as samples or via manufacturer patient assistance programs is excluded from this provision.

Treatment obtained only as samples or through a manufacturer's patient assistance program is excluded from the policy provision that allows authorization for new members currently receiving the requested medication. In other words, a new-to-plan member whose only supply of the drug was from samples or a manufacturer assistance program does not meet the "currently receiving treatment" exception for expedited authorization.

If a member is otherwise currently receiving treatment with the requested agent (from sources other than samples or manufacturer assistance), requests from new members may be considered for authorization when the full coverage criteria are met and required documentation is provided.

Prescriber and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests may be approved when ALL of the following are documented in the medical record: prescriber is a specialist (e.g., obstetrician-gynecologist, family medicine, or psychiatrist) or a specialist consult is provided; member has a diagnosis of postpartum depression; member is 18 years of age or older; member is not currently pregnant; member is <12 months postpartum (date of delivery must be documented); AND medical records document either treatment failure, intolerance, or contraindication to an oral antidepressant OR a clear clinical rationale that a trial of an oral antidepressant is not appropriate due to severity of depression.

Required: specialist prescriber or specialist consult (OB-GYN, family medicine, or psychiatry).
Required: diagnosis of postpartum depression documented in chart.
Required: member age ≥ 18 years.
Required: member not currently pregnant.
Required: member < 12 months postpartum with date of delivery documented.
Required: documentation of ONE of the following: (a) treatment failure, intolerance, or contraindication to an oral antidepressant; OR (b) documented clinical rationale that an oral antidepressant trial is inappropriate due to severity.

Initial Therapy Requirements

inv-10: Initial Therapy

Initial therapy requirements

Initial therapy nodes: Prescriber is a specialist (e.g., obstetrician-gynecologist, family medicine, or psychiatrist) or a specialist consult is provided; member is ≥18 years; member is not pregnant; member is <12 months postpartum with date of delivery documented; medical charts document prior treatment failure, intolerance, or contraindication to an oral antidepressant OR document clinical rationale that a trial of an oral antidepressant is not appropriate due to severity of depression.

Prior authorization is required.

Step therapy/antidepressant trial: Documentation of treatment failure, intolerance, or contraindication to an oral antidepressant OR documentation that an oral antidepressant trial is not appropriate.

Step therapy requirement: trial and failure of an oral antidepressant required unless clinical rationale documents inappropriateness.

Continuation Therapy Requirements

inv-11: Continuation Therapy

Continuation approvals

Continuation approval nodes: Member has a diagnosis of postpartum depression; member is not currently pregnant; member is <12 months postpartum with date of delivery documented; last treatment with the requested agent was within 45 days of the current request.45 days

Reauthorizations are granted for 14 days.

Documentation: Clinical benefit from prior treatment should be evident (implied by reauthorization request) and medical records should support the member's postpartum status and ongoing treatment.

Step Therapy / Antidepressant Trial

Step	Requirement
1	Trial and failure, intolerance, or contraindication to an oral antidepressant; OR documented clinical rationale that a trial of an oral antidepressant is not appropriate (e.g., severity of depression).

Quantity Limits for Zurzuvae

Quantity limit — Zurzuvae 20 mg and 25 mg

Drug formulationZurzuvae 20 mg and 25 mg

Quantity limit28 tablets per 14 days

Limit period14 days

Quantity limit — Zurzuvae 30 mg

Drug formulationZurzuvae 30 mg

Quantity limit14 tablets per 14 days

Limit period14 days

Definitions

Postpartum depression diagnosis for adults

DefinitionPostpartum depression — depressive episode occurring in the postpartum period in adults

Age requirementApplies to adults (age ≥18 years)

Documentation requiredDate of delivery must be documented to confirm member is <12 months postpartum

Background

Zurzuvae (zuranolone) is indicated for the treatment of postpartum depression in adults. This policy applies to pharmacy benefit coverage for Zurzuvae and defines prior authorization requirements, step-therapy expectations, documentation needed to confirm postpartum status, and applicable quantity limits.

Key policy scope points: prescribers must document that the member has a diagnosis of postpartum depression, is 18 years of age or older, and is less than 12 months postpartum with the delivery date recorded. Prior authorization is required and the policy outlines initial and continuation criteria, required trials or clinical rationale regarding oral antidepressants, and short-duration authorizations consistent with the drug's labeled use.