Omalizumab (Xolair®) is a recombinant DNA-derived humanized IgG1k murine monoclonal antibody that selectively binds to human immunoglobulin E (IgE). Omalizumab (Xolair) inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils, which limits the degree of release of mediators of the allergic response. Omalizumab (Xolair) is a healthcare administered subcutaneous (SC) injection that may be also be self-administered if the physician deems appropriate.
Omalizumab (Xolair) administration by a healthcare provider may be considered medically necessary for use in individuals who meet the following criteria for any ONE (1) of the indications listed below:
Asthma
Reauthorization of omalizumab (Xolair) may be considered medically necessary when the following criteria are met:
The use of omalizumab (Xolair) for any indication not listed on this policy is considered not medically necessary.
J2357 |
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Chronic
Rhinosinusitis with Nasal Polyps (CRSwNP)
Reauthorization of omalizumab (Xolair) may be considered medically necessary when the following criteria are met:
The use of omalizumab (Xolair) for any indication not listed on this policy is considered not medically necessary.
J2357 |
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Chronic Spontaneous Urticaria (CSU)
Reauthorization of omalizumab (Xolair) may be considered medically necessary when the following criteria are met:
The use of omalizumab (Xolair) for any indication not listed on this policy is considered not medically necessary.
J2357 |
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IgE Mediated Food Allergy
Reauthorization of omalizumab (Xolair) may be considered medically necessary when the following criteria are met:
The use of omalizumab (Xolair) for any indication not listed on this policy is considered not medically necessary.
J2357 |
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NOTE: The risk of anaphylaxis following administration of omalizumab (Xolair) necessitates the need for observation.
NOTE: 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.
Refer to Pharmacy Policy Bulletin J-19 regarding prior authorization information for leukotriene modifiers zafirlukast (Accolate), montelukast (Singulair).
Refer to Pharmacy Policy Bulletin J-1081 regarding prior authorization information for self-administered omalizumab (Xolair).
Refer to medical policy I-6 Approved Drugs and Biologicals for more information.
Covered Diagnosis Codes for J2357
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J33.0 |
J33.1 |
J33.8 |
J33.9 |
J44.0 |
J44.1 |
J44.9 |
J45.40 |
J45.41 |
J45.42 |
J45.50 |
J45.51 |
J45.52 |
J45.901 |
J45.902 |
J45.909 |
J45.990 |
J45.991 |
J45.998 |
L50.1 |
Z91.010 |
Z91.011 |
Z91.012 |
Z91.013 |
Z91.018 |
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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:
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:
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.
