Xolair (omalizumab)

POLICY NUMBER

L.5.01.457

Xolair (omalizumab)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Immunoglobulin E (IgE) plays a central role in allergic inflammatory disorders. Xolair (omalizumab) is a monoclonal antibody that binds to IgE, inhibiting the binding of IgE to the receptors on the surface of mast cells, basophils, and dendritic cells. This lowers free IgE levels and causes subsequent down-regulation of IgE receptors.

Xolair (omalizumab) is indicated for the following:

• Use in adults and pediatric patients 6 years of age or older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids;

• Add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids;

• The reduction of allergic reactions (Type 1), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy;

• The treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.

Table 1:Subcutaneous XOLAIR Doses Every 2 or 4 Weeks* for Patients 12 Years of Age and Older with Asthma

Dosing frequency:

*Subcutaneous doses to be administered every 4 weeks**Subcutaneous doses to be administered every 2 weeks 

Table 2: Subcutaneous XOLAIR Doses every 2 or 4 Weeks* for Pediatric Patients with Asthma Who Begin XOLAIR Between the Ages of 6 to <12 Years

Dosing frequency:

* Subcutaneous doses to be administered every 4 weeks** Subcutaneous doses to be administered every 2 weeks

Table 3: Subcutaneous XOLAIR Doses every 2 or 4 Weeks* for Adult Patients with CRSwNP

Dosing frequency:

* Subcutaneous doses to be administered every 4 weeks** Subcutaneous doses to be administered every 2 weeks

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Initial Evaluation

Xolair (omalizumab) may be considered medically necessary when ALLof the following criteria are met:

1. ONE of the following:

   1. The

      individual

       has a confirmed diagnosis of

      chronic spontaneous urticaria (CSU)

      and ALL of the following:

      1. The 

         individual

         is ≥12 years of age;

      2. The 

         individual

         has 

         had

         hives 

         and itching

         for 

         over

         6 weeks

         ; AND

      3. ONE of the following:

         1. The individual

            has 

            had an inadequate response to regular use of a second-generation

            H1 antihistamine treatment (

            e.g

            , cetirizine, desloratadine, fexofenadine, levocetirizine, loratadine, etc.)

            after at least a 2-week duration of therapy at the maximally tolerated dose; OR

         2. The individual has an intolerance, hypersensitivity, or FDA-labeled contraindication to ALL second-generation H1 antihistamines;

      4. The requested dose does not exceed FDA-approved dosing for C

         S

         U 

         (

         150mg 

         or

          300mg every 4 weeks

         )

         ;

   2. The 

      individual

      has a confirmed diagnosis of 

      moderate-to-severe persistent

      asthma

      and ALL of the following:

      1. The 

         individual

         is ≥6 years of age

         and ONE of the following

         ;

         1. The individual is 6 to less than 12 years of age and BOTH of the following:

            1. The individual’s pretreatment IgE level is 30 IU/mL to 1300 IU/mL; AND

            2. The individual’s weight is 20 kg to 150 kg; OR

         2. The individual is 12 years of age or over and BOTH of the following:

            1. The individual’s pretreatment IgE level is 30 IU/mL to 700 IU/mL; AND

            2. The individual’s weight is 30 kg to 150 kg;

      2. The

         individual

          has a positive skin test or in vitro reactivity to a perennial aeroallergen;

      3. The individual has received BOTH of the following for at least 3 consecutive months and has been adherent for 90 days within the past 120 days:

         1. Maximally tolerated inhaled corticosteroid (ICS); AND

         2. At least ONE of the following:

            1. Inhaled long-acting beta-agonist (LABA);

            2. Inhaled long-acting muscarinic antagonist (LAMA);

            3. Leukotriene receptor antagonist (LTRA); OR

            4. Theophylline;

      4. The individual has uncontrolled asthma while on asthma control therapy as demonstrated by ONE of the following:

         1. Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months;

         2. Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or visit to the emergency room or urgent care within the past 12 months;

         3. Controlled asthma that worsens when the doses of inhaled and/or systemic corticosteroids are tapered; OR

         4. The individual has baseline (prior to therapy with the requested agent) Forced Expiratory Volume (FEV1) that is less than 80% of predicated;

      5. The individual will continue asthma control therapy (i.e., ICS, ICS/LABA, LTRA, LAMA, theophylline) in combination with the requested agent; AND

      6. The individual's

         weight and baseline IgE levels correspond to the dosing charts in description

         and prescribing information; OR

   3. The individual has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) and ALL of the following:

      1. The individual is ≥18 years of age and BOTH of the following:

         1. The individual’s pretreatment IgE level is 30 IU/mL to 1500 IU/mL; AND

         2. The individual’s weight is 30kg to 150kg;

      2. The individual’s diagnosis was confirmed by ONE of the following:

         1. Anterior rhinoscopy or endoscopy; OR

         2. Computed tomography (CT) of the sinuses;

      3. The individual has at least TWO of the following symptoms consistent with chronic rhinosinusitis:

         1. Nasal discharge (rhinorrhea or post-nasal discharge);

         2. Nasal obstruction or congestion;

         3. Loss or decreased sense of smell (hyposmia); OR

         4. Facial pressure or pain;

      4. The individual has had symptoms consistent with chronic rhinosinusitis for at least 12 consecutive weeks;

      5. ONE of the following:

         1. The individual has tried and had an inadequate response to at least ONE intranasal corticosteroid therapy (e.g., fluticasone nasal spray, mometasone nasal spray) after at least a 4-week duration of therapy; OR

         2. The individual has an intolerance, hypersensitivity, or FDA-labeled contraindication to ALL intranasal corticosteroids; AND

      6. The individual’s weight and baseline IgE levels correspond to the dosing charts in description and prescribing information;

2. The prescriber is a specialist in the area of the individual's diagnosis or has consulted with a specialist in the area of the individual's diagnosis (e.g., dermatologist, pulmonologist, allergist, immunologist);

3. The individual does not have an FDA labeled contraindication to therapy with the requested agent;

4. The individual is not currently being treated with another immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, JAK inhibitor);

5. If the request is for Xolair vials to be administered by a healthcare professional, the individual has tried unsuccessfully to utilize self-administered Xolair or is clinically unable to do so; AND

6. The prescribed dosage is within the program quantity limit based on FDA approved labeled dosage.

Length of Approval: 6 months

Renewal Evaluation

Xolair (omalizumab) may be approved for RENEWAL when ALL of the following criteria are met:

1. The

   individual

   has been previously approved for the requested agent through the BCBSMS PA process;

2. ONE of the following:

   1. The individual has a diagnosis of chronic spontaneous urticaria (CSU) and has had clinical benefit with the requested agent (i.e., improved symptoms, decrease in weekly urticaria activity score [UAS7]);

   2. The individual has a diagnosis of moderate to severe persistent asthma and ALL of the following:

      1. The individual has had improvements or stabilization with the requested agent (i.e., increase in FEV1, decrease in the required dose of inhaled corticosteroid, decrease in need for systemic corticosteroid treatment for asthma exacerbation, decrease in number of hospitalizations or urgent care visits due to asthma exacerbations); AND

      2. The individual is currently treated within the past 90 days and is compliant with standard asthma therapy (i.e., inhaled corticosteroids, long-acting beta-2 agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist, theophylline); OR

   3. The individual has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) and ALL of the following:

      1. The individual has had clinical benefit with the requested agent (e.g., reduction in nasal congestion, nasal polyp size, rhinorrhea, sinonasal inflammation, improved sense of smell); AND

      2. The individual will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids) in combination with the requested agent;

3. The prescriber is a specialist in the area of the individual’s diagnosis (e.g., dermatologist, allergist, immunologist, pulmonologist) or has consulted with a specialist in the area of the individual’s diagnosis;

4. The individual does not have an FDA labeled contraindication to therapy with the requested agent;

5. The individual is not currently being treated with another immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, JAK inhibitor);

6. If the request is for Xolair vials to be administered by a healthcare professional, the individual has tried unsuccessfully to utilize self-administered Xolair or is clinically unable to do so; AND

7. The prescribed dosage is within the program quantity limit based on FDA approved labeled dosage and the individual’s pretreatment serum IgE level and body weight.

 Length of Approval: 12 months

 Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

1. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

2. appropriate with regard to standards of good medical practice; and

3. not solely for the convenience of the Member, his or her Provider; and

4. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

Medication Failure

Medication failure is defined as disease progression at generally accepted doses (for >3 months use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.

BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

7/15/2003: Approved by the Pharmacy & Therapeutics (P & T) Committee

9/24/2004: Code Reference section updated, HCPCS S0107 added, note added HCPCS J3490

3/21/2005: Preferred provider changed from Nova Factor to Accredo, # 2 "The patient has been compliant with traditional asthma therapy adequate for moderate to severe persistent asthma for a minimum period of six months and has had an inadequate response to this therapy, including inhaled corticosteroids, long acting b-agonist, and a leukotriene modifier or theophylline." changed to "The patient has been compliant with traditional asthma therapy adequate for moderate to severe persistent asthma for a minimum period of six months and has had an inadequate response to this therapy, including inhaled corticosteroids and a long acting b-agonist or a leukotriene modifier or theophylline." Table 1: Administration Every 4 Weeks ** See Table 2 added, Table 2: Administration Every 2 Weeks changes * See Table 1 and x Do Not Dose added

3/22/2005: Code Reference section updated, HCPCS J3490 deleted, HCPCS J2357 with effective date of 1/1/2005 added, HCPCS S0107 effective date of 1/1/2004 and deletion date of 3/31/2005 added.

10/28/2005: Description section updated. Policy section updated to add Xolair® and change the Accredo telephone # from 1-866-839-2162 to 1-866-240-3373. Policy Guidelines section updated to remove Omalizumab information. Sources updated; Xolair added.

11/3/2005: Code Reference section updated, IDC9 diagnosis codes 493.00, 493.10, 493.11, 493.12, 493.20, 493.90 deleted.

11/2005: Approved by Pharmacy & Therapeutics (P & T) Committee.

8/8/2008: Off labeled indications removed from description section.

01/01/2009: Accredo preferred provider information removed. BCBSMS information added.

02/19/2014: The policy statement was revised to add the following requirement: The patient has a positive skin test or in vitro reactivity to a perennial aeroallergen.

05/08/2014: Policy description updated to add chronic idiopathic urticaria in adults and adolescents as an indication. Policy statement revised to state that Omalizumab (Xolair®) is considered medically necessary for chronic idiopathic urticaria (CIU) under the following condition: The patient is 12 years of age or older with a diagnosis of chronic idiopathic urticaria by an allergist or immunologist who remain symptomatic despite H1 antihistamine treatment. For CIU, Xolair is administered 150 or 300mg every 4 weeks. Added statement that Omalizumab (Xolair®) is considered medically necessary for asthma under certain conditions. Policy statement revised to replace "allergic asthma" with "persistent asthma" and add "and symptoms that are inadequately controlled with inhaled corticosteroids." It previously stated: The patient is 12 years of age or older with moderate to severe allergic asthma (has a strong IgE mediated component) for a minimum of one year. Replaced bullet points with numbers.

06/25/2014: Policy statement revised to remove "a diagnosis of" and state that Omalizumab (Xolair®) is considered medically necessary for chronic idiopathic urticaria (CIU) under the following condition: The patient is 12 years of age or older with chronic idiopathic urticaria defined by the presence of hives on most days of the week for a period of six weeks or longer, diagnosed by an allergist or immunologist, who remain symptomatic despite H1 antihistamine treatment. For CIU, Xolair is administered 150 or 300mg every 4 weeks.

12/31/2014: Added the following new 2015 HCPCS code to the Code Reference section: J9301.

08/26/2015: Medical policy revised to add ICD-10 codes. Removed HCPCS code J9301 from the Code Reference section.

05/31/2016: Policy number L.5.01.457 added. Policy Guidelines updated to add medically necessary definition.

11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

11/14/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

11/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy title updated with minor change: "Omalizumab (Xolair®)" changed to "Xolair (omalizumab)." Policy section updated to add that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Policy statement regarding the use of Omalizumab (Xolair®) for asthma updated to change the patient age from "12 years of age" to "6 years of age." Added administration table for pediatric patients.

07/23/2019: Policy Exceptions updated to state that for State Health Plan members, Omalizumab (Xolair) does not require prior authorization. However, it will be reviewed for medical necessity based on medical policy guidelines. Effective 04/01/2019.

09/24/2019: Code Reference section updated to revise code description for ICD-10 diagnosis code J44.0, effective 10/01/2019.

10/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added statement to perform a formulary drug search on the patient's member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member's benefit plan. Policy description updated to revise the adolescent age from "12" to "6." Policy section updated to revise medically necessary criteria for chronic idiopathic urticaria and asthma. Length of approval for initial evaluation is 6 months. For renewal evaluation, the length of approval is 12 months. Sources updated.

06/30/2020: Policy section updated to remove criteria that the patient has been compliant with traditional asthma therapy adequate for moderate to severe persistent asthma for a minimum period of six months and has had an inadequate response to this therapy, including inhaled corticosteroids and a long acting β-agonist or a leukotriene modifier or theophylline. Policy Guidelines updated to state that BCBSMS determines patient medication trials and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

02/18/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy updated to move tables regarding dosing information from the Policy section to the Policy Description. Medically necessary criteria updated regarding chronic idiopathic urticaria and asthma. Revised renewal evaluation criteria. Added statement that services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary. Policy Exceptions updated. Policy Guidelines updated regarding BCBSMS request for medical records and to define investigative and medication failure. Sources updated. Code Reference section updated to add ICD-10 diagnosis code L50.1.

01/23/2023: Table 1 in policy description updated to make the following correction: "150" should be "300."

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

07/01/2023 Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.

06/03/2025: Policy reviewed by Pharmacy & Therapeutics (P&T) Committee; no changes.

08/01/2025: Policy effective 10/01/2025 - Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Xolair (omalizumab) and to add table for subcutaneous Xolair doses for adult patients with CRSwNP. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Initial and renewal criteria updated regarding chronic spontaneous urticaria, moderate-to-severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), prescriber requirements, FDA labeled contraindications, immunomodulatory agents, Xolair administration, and dose requirement. Sources updated. Policy update effective 10/01/2025.

SOURCE(S)

1. Berger, William E. MD, MBA. Monoclonal anti-IgE antibody: a novel therapy for allergic airways disease. American College of Allergy, Asthma, and Immunology. Feb 2002; 88(2): 152-161.

2. Johansson, S.G.O. MD, PhD; Haahtela, Tari MD, PhD; O’Byrne, Paul M. MD. Omalizumab and the immune system: an overview of preclinical and clinical data. American College of Allergy, Asthma, and Immunology. Aug 2002; 89(8): 132-138.

3. National Heart, Lung, and Blood Institute. Guidelines for the Diagnosis and Management of Asthma: Expert Panel Report 2. July 1997.

4. National Heart, Lung, and Blood Institute. Global Strategy for Asthma Management and Prevention. 2002.

5. Xolair prescribing information. Genentech, Inc. November 2024. Last accessed March 2025.

6. Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022; 77: 734–766. doi: 10.1111/all.15090

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document. 

Covered Codes

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