HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-53-019
Topic:
Omalizumab (Xolair)
Section:
Injections
Effective Date:
August 27, 2018
Issued Date:
September 17, 2018
Last Revision Date:
August 2018
Annual Review:
August 2018
 
 

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.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

Omalizumab (Xolair) may be considered medically necessary for use in individuals with moderate to severe persistent asthma who meet ALL the following criteria:

  • Individuals must be compliant with current therapeutic regimen; and
  • Individual is greater than or equal to six (6) years of age; and
  • Have a positive skin test or in vitro reactivity to a perennial aeroallergen; and
  • Baseline IgE titer greater than or equal to 30 IU/mL; and
  • Symptoms are inadequately controlled despite a three month trial of the following:
    • A medium or high-dose inhaled corticosteroid; or
    • A systemic corticosteroid;
      AND
    • A long-acting beta-agonists; or
    • A leukotriene receptor antagonist 
J2357



Omalizumab (Xolair) may be considered medically necessary for the treatment of chronic idiopathic urticaria (CIU) when ALL of the following criteria are met:

 

  • Individual is greater than or equal to twelve (12) years of age; and
  • Documented failure, contraindication, or intolerance to a four-week trial of one second-generation non-sedating histamine receptor type 1 (H1) antihistamine at the maximum recommended doses (eg, cetirizine [Zyrtec®], fexofenadine [Allegra®], loratadine [Claritin®, Alavert®], desloratadine [Clarinex®], levocetirizine [Xyzal®]); and
  • Documented failure, contraindication, or intolerance to at least a two-week trial of ANY ONE of the following medications:
    • Leukotriene receptor antagonist (eg, zafirlukast [Accolate®], montelukast [Singulair®], zileuton [Zyflo®]) in addition to the non-sedating H1 antihistamine; or
    • Histamine H2-receptor antagonist (eg. cimetidine [Tagamet®], famotidine [Pepcid®], nizatidine [Axid®], ranitidine [Zantac®]) in addition to the non-sedating H1 antihistamine; or
    • First-generation (sedating) H1 antihistamine (eg, chlorpheniramine [Chlor-Trimeton®], cyproheptadine [Periactin®], diphenhydramine [Benadryl®]) in addition to the non-sedating H1 antihistamine; or
    • Substitution to a different second-generation non-sedating H1 antihistamine. 
J2357



The use of omalizumab (Xolair) for any indication not listed on this policy is considered experimental/investigational, and therefore, not covered. Scientific evidence does not support the use of omalizumab for any other indications not listed above.

J2357



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.


Related Policies

Refer to Pharmacy Policy Bulletin J-19 regarding prior authorization information for leukotriene modifiers zafirlukast (Accolate), montelukast (Singulair).

 


Diagnosis Codes Section

 

ICD-10 Diagnosis Codes

Covered Diagnosis Codes

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

 

 

 

 

 



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of Omalizumab (Xolair) 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


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.



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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.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.





    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.