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Prior Authorization Criteria for Brexanolone (Zulresso) Effective July 1, 2020

Last updated on 6/12/2020

Information posted June 12, 2020

Note:   Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to eligible clients. Administrative procedures such as prior authorization, pre-certification, referrals, and claims/encounter data filing may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the client's specific MCO for details.

Effective for dates of service on or after July 1, 2020, prior authorization will be required for brexanolone (Zulresso) (procedure code C9055) for Texas Medicaid.

Brexanolone (Zulresso) is a benefit for female clients who are 18 years of age and older, and is indicated for the treatment of postpartum depression in adults. Brexanolone (Zulresso) must be prescribed by, or in consultation with, a psychiatrist or obstetrician/gynecologist.

Brexanolone (Zulresso) is not a benefit for clients with active psychosis or history of bipolar disorder or schizophrenia.

Risk Evaluation and Mitigation Strategy Program

Brexanolone (Zulresso) is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of excessive sedation or sudden loss of consciousness.

Health-care facilities must enroll in the brexanolone (Zulresso) REMS program.

Prior to brexanolone (Zulresso) treatment, clients must also be enrolled in the brexanolone (Zulresso) REMS program. Certified facilities must ensure that brexanolone (Zulresso) is only administered to clients who are enrolled in the brexanolone (Zulresso) REMS program.

Pharmacies must be certified in the brexanolone (Zulresso) REMS program and must only dispense to health-care facilities certified to administer brexanolone (Zulresso).

Prior Authorization Requirements

Prior authorization requests for procedure code C9055 must be submitted with a Special Medical Prior Authorization (SMPA) Request Form, and may be approved for one continuous 60-hour intravenous infusion per pregnancy or postpartum period.

Documentation of the client’s dosage, administration schedule, number of doses to be administered during the prior authorization period, the requested units per dose, and the dosage calculation must be submitted in Section C of the Special Medical Prior Authorization (SMPA) Request Form under Statement of Medical Necessity.

The Special Medical Prior Authorization (SMPA) Request Form must be completed, signed, and dated by the prescribing provider. The Special Medical Prior Authorization (SMPA) Form will not be accepted beyond 90 days from the date of the prescribing provider’s signature.

The completed Special Medical Prior Authorization (SMPA) Request Form must be maintained by the prescribing provider in the client's medical record and is subject to retrospective review.

For treatment of postpartum depression with brexanolone (Zulresso) therapy, all of the following criteria must be met:

  • The client has a diagnosis of postpartum depression (diagnosis code F530) with a HAM-D total score of at least 20, or as scored by an alternative comparable rating scale that measures depressive symptoms.
  • The onset of the major depressive episode is within the third trimester and no later than the first four weeks postpartum.
  • The client is six months or less postpartum at screening.
  • The client does not have active psychosis or history of bipolar disorder or schizophrenia.
  • The client has not received treatment with brexanolone (Zulresso) for the current postpartum depressive episode.
  • The client must have continuous pulse oximetry monitoring during the infusion period due to risk of serious harm, and must be accompanied when interacting with their children as the drug can cause loss of consciousness.
  • A health-care provider must be available on site for continuous monitoring of the client for the duration of the infusion.

For more information, call the TMHP Contact Center at 800-925-9126.