Brexanolone (Zulresso)

Policy ID: I-213-007

Section: Injections

Effective Date: August 01, 2019

Revised Date: September 03, 2024

Revision Effective Date: November 01, 2024

Last Reviewed: September 17, 2024

Applies To: Commercial and Medicaid Expansion

Description

Brexanolone (Zulresso ^TM ) 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.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

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.

The use of brexanolone (Zulresso) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J1632

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Code

F53.0

Professional Statements and Societal Positions Guidelines

Hamilton Rating Scale for Depression (HAM-D)

HAM-D is a 17-item rating scale to determine the severity level of depression in a patient before, during, and after treatment. The total score ranges from zero (0) to 52, with the score corresponding to the following classifications:

zero (0) - seven (7) : No depression (normal)
8-16: Mild depression
17-23: Moderate depression
greater than or equal to 24: Severe depression

Edinburgh Postnatal Depression Scale (EPDS)

EPDS is a self-report instrument containing 10 items that are ranked from zero (0) to three (3) that reflect the individual's experience over the past week. The total score ranges from zero (0) to 30. An EPDS greater than or equal to 13 is an acceptable cut-point for identifying women at risk for major depression in clinical settings.

ND Committee Review

Internal Medical Policy Committee 7-16-2019 Adopted new policy

Internal Medical Policy Committee 1-22-2020 Coding update

Added new code, C9055

Internal Medical Policy Committee 9-21-2020 Coding update

Added new code, J1632,
Removed C9055

Internal Medical Policy Committee 3-17-2021 Revision

Updated criteria, and
Added Professional Statements and Societal Positions Guidelines

Internal Medical Policy Committee 3-23-2022 Annual Review-no changes in criteria

Internal Medical Policy Committee 9-28-2022 Revision

Updated indicated age to 15 years of age and older, was previously 18 years of age and older,
Updated experimental/investigational statement

Internal Medical Policy Committee 9-12-2023 Annual review, no clinical content change

Internal Medical Policy Committee 9-17-2024 Effective November 01, 2024

Annual review no clinical content change

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-213-006

Section: Injections

Effective Date: August 01, 2019

Revised Date: September 07, 2022

Revision Effective Date: November 01, 2022

Last Reviewed: September 12, 2023

Archived Date: October 31, 2024

Applies To: Commercial and Medicaid Expansion

Description

Brexanolone (Zulresso^TM) 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.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

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).

Procedure Code

J1632

Diagnosis Code

F53.0

Professional Statements and Societal Positions Guidelines

Hamilton Rating Scale for Depression (HAM-D)

zero (0) - seven (7): No depression (normal)
8-16: Mild depression
17-23: Moderate depression
≥24: Severe depression

Edinburgh Postnatal Depression Scale (EPDS)

EPDS is a self-report instrument containing 10 items that are ranked from zero (0) to three (3) that reflect the individual’s experience over the past week. The total score ranges from zero (0) to 30. An EPDS ≥13 is an acceptable cut-point for identifying women at risk for major depression in clinical settings.

ND Committee Review

Internal Medical Policy Committee 7-16-2019 Adopted new policy

Internal Medical Policy Committee 1-22-2020 Coding update

Added new code, C9055

Internal Medical Policy Committee 9-21-2020 Coding update

Added new code, J1632,
Removed C9055

Internal Medical Policy Committee 3-17-2021 Revision

Updated criteria, and
Added Professional Statements and Societal Positions Guidelines

Internal Medical Policy Committee 3-23-2022 Annual Review-no changes in criteria

Internal Medical Policy Committee 9-28-2022 Revision

Updated indicated age to 15 years of age and older, was previously 18 years of age and older,
Updated experimental/investigational statement

Internal Medical Policy Committee 9-12-2023 Annual review, no clinical content change

Links

References (PDF)

Disclaimer

Our Partners in Health:
Members
Employers
Producers

Fargo (Headquarters)
4510 13th Ave. S.
Fargo, N.D., 58121

Medical Policies Quick Search