CurrentAlaska MedicaidPolicy N/A

Prior authorization and coverage criteria for Zulresso (brexanolone) infusion

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Coverage and prior authorization criteria for Zulresso (brexanolone) infusion for treatment of postpartum depression for Alaska Medicaid members and the requirements providers must meet to obtain approval.

Policy Summary

PayerAlaska Medicaid

PolicyZulresso (brexanolone) prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation including age, DSM-5 diagnosis, HAM-D ≥20, prior antidepressant trials or contraindications, psychiatrist prescriber/consultation, REMS-certified administration setting confirmation, and patient weight.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥20minimum HAM-D score

≤6 months

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CurrentAlaska MedicaidPolicy N/A

Prior authorization and coverage criteria for Zulresso (brexanolone) infusion

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Know when Alaska Medicaid releases new policies or updates existing guidance.

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Policy Summary

PayerAlaska Medicaid

PolicyZulresso (brexanolone) prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥20minimum HAM-D score

≤6 months

Coverage Criteria for Zulresso (brexanolone)

Initial Therapy Approval

Covered when ALL of the following are met:

Zulresso approval criteria: 1) Patient is 18 years of age or older; 2) Diagnosis of major depressive episode defined by DSM-5 criteria; 3) Hamilton Rating Scale for Depression (HAM-D) score >= 20; 4) Prescribed by or in consultation with a psychiatrist; 5) Patient is <= 6 months postpartum; 6) Onset of symptoms in the third trimester or within 4 weeks of delivery; 7) Patient has tried and failed at least one adequate oral antidepressant (e.g., SSRI, SNRI, TCA) at maximally indicated dose for at least 6-8 weeks OR has a contraindication or intolerance to at least two antidepressants from two different classes; 8) Medication will be administered in a REMS-certified healthcare setting; 9) Patient weight is submitted.

Initial approval: one 60-hour infusion; weight-based dosing limited to a single 60-hour infusion.

Patients with active psychosis are excluded from authorization for brexanolone (Zulresso).

Treatment is not authorized for patients who are lactating or actively breastfeeding upon initiation and during treatment, unless there is a documented agreement to temporarily stop breastfeeding during the course of therapy.

Coding and Assessment Thresholds

Covered HCPCS CodesHCPCSCovered

J1632

Brexanolone injection (Zulresso) - HCPCS code listed in policy

HAM-D threshold — required score

Required HAM-D scoreHAM-D ≥ 20 is required for approval

Scale referencedHamilton Rating Scale for Depression (HAM-D)

Context of useScore used as objective severity threshold within approval criteria

Provider Responsibilities and Prior Authorization Requirements

Prior Authorization

Prior authorization required for Zulresso (brexanolone)

Prior authorization is required for brexanolone (Zulresso). Approval is granted only when all listed approval criteria are met, and initial approval is limited to a single 60-hour infusion billed with HCPCS J1632.

Patient must be ≥ 18 years of age.
DSM-5 diagnosis of major depressive episode.
HAM-D score ≥ 20.
Prescribed by or in consultation with a psychiatrist.
Patient ≤ 6 months postpartum with symptom onset in the third trimester or within 4 weeks of delivery.
Medication administered in a REMS-certified healthcare setting.
Patient weight must be submitted.
Initial approval: one 60-hour infusion (weight-based dosing not to exceed a 60-hour infusion).
Bill using HCPCS J1632.

Key Definitions

Postpartum depression (PPD) definition — DSM-5 onset timing

PPD definition (DSM-5 onset timing)Major depressive episode meeting DSM-5 criteria with symptom onset in the third trimester or within 4 weeks of delivery

IndicationPolicy applies to postpartum depression (PPD) in adults

Age contextPatient must be 18 years of age or older to qualify

HAM-D — definition and threshold usage

DefinitionHAM-D refers to the Hamilton Rating Scale for Depression

Threshold for approvalA HAM-D score of 20 or greater (HAM-D ≥ 20) is required

Role in criteria

Setting and Safety Requirements

Infusion in REMS-certified healthcare setting

Medication must be administered in a REMS-certified healthcare setting with required monitoring:

Admin setting requirement: Medication must be administered in a REMS-certified healthcare setting with monitoring for excessive sedation, sudden loss of consciousness, and hypoxia (pulse oximetry).

Use caution in patients with end-stage renal disease; monitor for suicidal thoughts and behaviors.

Treatment Modalities and Administration

Brexanolone (Zulresso) infusion

Zulresso safety monitoring: Brexanolone (Zulresso) is administered as an intravenous infusion and requires continuous monitoring for excessive sedation, sudden loss of consciousness, and hypoxia (pulse oximetry). Monitor for suicidal thoughts and behaviors and use caution in end-stage renal disease.one 60-hour infusion (initial approval)

Dose and duration are weight-based; initial approval is limited to a single 60-hour infusion.

Visit and Quantity Limits

Zulresso infusion — one 60-hour infusion (initial approval duration)

Initial approval durationOne 60‑hour infusion (initial approval)

Visit limitWeight‑based dosing limited to a single 60‑hour infusion

Administration settingMust be administered in a REMS‑certified healthcare setting per policy

Background

Brexanolone (Zulresso) is a neuroactive steroid and GABA-A receptor positive modulator indicated for the treatment of postpartum depression in adults. The medication is administered as a single, weight‑based continuous intravenous infusion and requires monitoring in a REMS‑certified healthcare setting due to risks including excessive sedation, sudden loss of consciousness, and hypoxia. Policy approval requires objective severity (a HAM‑D score ≥ 20), timing related to childbirth (onset in the third trimester or within 4 weeks postpartum and treatment initiation at ≤ 6 months postpartum), and documentation of prior pharmacotherapy trials or contraindications; initial authorization is for one 60‑hour infusion billed with HCPCS J1632.