Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Brexanolone (Zulresso) may be considered medically necessary for the treatment of individuals 15 years of age and older when ALL of the following criteria are met:
- Prescribed by or in consultation with a physician, nurse practitioner or physician’s assistant specializing in psychiatry and trained in the proper diagnosis and management of postpartum major depression; and
- Individual meets the Diagnostic and Statistical Manual of Mental Disroders-5 (DSM-5) criteria for a major depressive episode by a structured clinical interview for DSM-5 disorders; and
- Individual has a diagnosis of moderate to severe postpartum depression based on either of the following:
- Hamilton Rating Scale for Depression (HAM-D) score equal to or greater than 20; or
- Edinburgh Postnatal Depression Scale (EPDS) score equal to or greater than 13; and
- Symptom onset occurred within the third trimester or within four (4) weeks of delivery; and
- Individual is less than or equal to six (6) months postpartum; and
- Individual does not have active psychosis; and
- Individual does not have a history or bipolar disorder, schizophrenia, and/or schizoaffective disorder; and
- Facility will be certified by the Zulresso REMS program; and
- Facility will ensure individual receiving medication is enrolled in the Zulresso REMS program; and
- Individual will be continuously monitored for the entire duration of infusion by an appropriately trained healthcare provider (this must include continuous pulse oximetry monitoring and interventions as necessary for any excessive sedation or sudden loss of consciousness).
More than one (1) infusion per pregnancy/childbirth of brexanolone (Zulresso) is considered experimental/investigational and, therefore, non-covered. The safety and efficacy of more than one infusion per pregnancy/childbirth has not been established in peer-reviewed published literature.
Brexanolone (Zulresso) for the treatment of any other indication is considered experimental/investigational and, therefore, non-covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.