HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-213-006
Topic:
Brexanolone (Zulresso)
Section:
Injections
Effective Date:
October 9, 2023
Issued Date:
October 9, 2023
Last Revision Date:
July 2023
Annual Review:
July 2023
 
 

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.

Policy Position

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 not medically necessary and, therefore, non-covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.

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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. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.


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 0 to 52, with the score corresponding to the following classifications:

  •   0-7: 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 0 to 3 that reflect the patient’s experience over the past week. The total score ranges from 0 to 30. An EPDS ≥13 is an acceptable cut-point for identifying women at risk for major depression in clinical settings.


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Place of Service: Inpatient/Outpatient

Brexanolone (Zulresso) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.



The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.