Brexanolone (ZulressoTM) is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator that is chemically identical to endogenous allopregnanolone. The mechanism of action of brexanolone (Zulresso) is not fully understood, but is thought to be related to its positive allosteric modulation of GABAA receptors.
Brexanolone (Zulresso) may cause excessive sedation or sudden loss of consciousness during administration. Due to the risk of serious harm, individuals must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Individuals must be accompanied during interactions with their child(ren). Due to these risks, brexanolone (Zulresso) is only available through a Risk Evaluation and Mitigation Strategy (REMS) program called the Zulresso REMS requiring the facility must be certified and the individual receiving treatment must be registered.
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 18 years of age and older when ALL of the following criteria are met:
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. There is a lack of scientific documentation supporting its use for any other indication.
NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.