XOLAIR (omalizumab)

XOLAIR (omalizumab)

Prefilled Syringe and Auto-injector: Self-Administration – injectable

Vial for reconstitution: Medical Administration – injectable

Diagnosis considered for coverage: 

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

• Indicated for chronic rhinosinusitis with nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment

• Indicated for chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment 

• Indicated for the reduction of allergic reactions (Type I), 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 

• Limitations of Use:

  • Not indicated for acute bronchospasm or status asthmaticus

  • Not indicated for other allergic conditions or other forms of urticaria

  • Not indicated for the emergency treatment of allergic reactions, including anaphylaxis

Coverage Criteria:

For diagnosis of allergic asthma: 

• Dose does not exceed 375 mg every 2 weeks (dose is based on serum total IgE level measure before the start of treatment and by body weight); AND

• Documented diagnosis of moderate to severe persistent allergic asthma; AND

• Prescribed by or in consultation with a pulmonologist or allergist/immunologist; AND

• Positive skin test or in vitro reactivity to a perennial aeroallergen; AND

• One of the following (a or b):

  1. Both of the following:

     1. Patient is 12 years of age or older

     2. Pre-treatment serum immunoglobulin (Ig)E level between 30-700 IU/mL; OR

  2. Both of the following:

     1. Patient is 6 years to less than 12 years of age

     2. Pre-treatment serum immunoglobulin (Ig)E level between 30-1300 IU/mL; AND

• Patient has paid claims or is currently being treated with ONE of the following, unless there is a contraindication or intolerance to these medications (a or b):

  1. Both of the following:

     1. High-dose inhaled corticosteroids (ICS) (e.g., greater than 500 mcg fluticasone propionate equivalent/day)

     2. Additional asthma controller medication (e.g., leukotriene receptor antagonist, long-acting beta-2 agonist [LABA],tiotropium); OR

  2. One maximally-dosed combination ICS/LABA product (e.g., Advair [fluticasone propionate/salmeterol], Symbicort [budesonide/formoterol], Breo Ellipta [fluticasone/vilanterol]); AND

• Will not be used in combination with other biologic medications for severe asthma (e.g., Cinqair (reslizumab), Fasenra (benralizumab), Dupixent (dupilumab), or Nucala (mepolizumab))

For diagnosis of chronic idiopathic urticaria (CIU):

• Dose does not exceed 300 mg every 4 weeks; AND

• Diagnosis of chronic idiopathic urticaria; AND

• Patient is 12 years of age or older; AND

• Prescribed by or in consultation with an allergist/immunologist or dermatologist; AND

• Persistent symptoms (itching and hives) for at least 4 consecutive weeks despite titrating to an optimal dose with a second-generation H1 antihistamine (e.g., cetirizine, fexofenadine), unless there is a contraindication or intolerance to H1 antihistamines; AND

• Used concurrently with an H1 antihistamine, unless there is a contraindication or intolerance to H1 antihistamines; AND

• Patient has tried and had an inadequate response or intolerance to at least TWO of the following additional therapies:

  1. Doxepin

  2. H1 antihistamine

  3. H2 antagonist (e.g., famotidine, cimetidine)

  4. Hydroxyzine

  5. Leukotriene receptor antagonist (e.g., montelukast); AND

• Will not be used in combination with Cinqair, Fasenra, Dupixent, or Nucala

For diagnosis of nasal polyps:  

• Dose does not exceed 600 mg every 4 weeks (dose is based on serum total IgE level measure before the start of treatment and by body weight); AND

• Diagnosis of nasal polyps; AND

• Patient is 18 years of age or older; AND

• Prescribed by or in consultation with an allergist/immunologist, otolaryngologist, or pulmonologist; AND

• Unless contraindicated, the patient has had an inadequate response to 2 months of treatment with an intranasal corticosteroid (e.g., fluticasone, mometasone); AND

• Used in combination with another agent for nasal polyps (e.g., intranasal corticosteroid); AND 

• Will not be used in combination with Cinqair, Fasenra, Dupixent, or Nucala

For diagnosis of IgE-mediated food allergy:

• Patient is 1 year of age or older; AND

• Prescribed by or in conjunction with an allergist/immunologist; AND

• One of the following:

  • Both of the following:

    • Diagnosis of IgE Mediated Food Allergy as evidenced by one of the following:

      • Positive skin prick test (defined as greater than or equal to 4 mm wheal greater than saline control) to food 

      • Positive food specific IgE (greater than or equal to 6 kUA/L) 

      • Positive oral food challenge, defined as experiencing dose-limiting symptoms at a single dose of less than or equal to 300 mg of food protein 

    • Clinical history of IgE Mediated Food Allergy

  • Provider attestation that patient has a history of severe allergic response, including anaphylaxis, following exposure to one or more foods; AND

• Baseline (pre-Xolair treatment) serum total IgE level is greater than or equal to 30 IU/mL and less than or equal to 1850 IU/mL; AND

• Dosing is according to serum total IgE levels and body weight 

Reauthorization Criteria:

For diagnosis of allergic asthma: 

• Dose does not exceed 375 mg every 2 weeks; AND

• Prescribed by or in consultation with a pulmonologist or allergist/immunologist; AND

• Documentation of positive clinical response to therapy (e.g., reduction in exacerbations, improvement in forced expiratory volume in 1 second [FEV1], decreased use of rescue medications); AND

• Patient continues to be treated with an inhaled corticosteroid (ICS) (e.g., fluticasone, budesonide) with or without additional asthma controller medication (e.g., leukotriene receptor antagonist [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], tiotropium) unless there is a contraindication or intolerance to these medications; AND

• Will not be used in combination with other biologic medications for severe asthma (e.g., Cinqair (reslizumab), Fasenra (benralizumab), Dupixent (dupilumab), or Nucala (mepolizumab))

For diagnosis of chronic idiopathic urticaria:

• Dose does not exceed 300 mg every 4 weeks; AND 

• Prescribed by or in consultation with an allergist/immunologist or dermatologist; AND

• Patient’s disease status has been re-evaluated  since the last authorization to confirm the patient’s condition warrants continued treatment; AND

• Patient has experienced at least one of the following:

  1. Reduction in itching severity from baseline, OR

  2. Reduction in number of hives from baseline; AND

• Will not be used in combination with Cinqair, Fasenra, Dupixent, or Nucala

For diagnosis of nasal polyps:

• Dose does not exceed 600 mg every 4 weeks; AND

• Prescribed by or in consultation with an allergist/immunologist, otolaryngologist, or pulmonologist; AND

• Documentation of a positive clinical response to therapy (e.g., reduction in nasal polyps score [NPS; 0-8 scale], improvement in nasal congestion/obstruction score [NCS; 0-3 scale]); AND

• Used in combination with another agent for nasal polyps (e.g., intranasal corticosteroid); AND

• Will not be used in combination with Cinqair, Fasenra, Dupixent, or Nucala

For diagnosis of IgE-mediated food allergy:

• Dosing will continue to be based on body weight and pretreatment total IgE serum levels; AND

• Prescribed by or in conjunction with an allergist/immunologist; AND

• Patient demonstrates positive clinical response to therapy (e.g., reduction of type 1 allergic reactions, including anaphylaxis, following accidental exposure to one or more foods); AND

• Used in conjunction with food allergen avoidance

Coverage Duration:

For diagnosis of allergic asthma:

• Initial: 6 months

• Reauthorization: 1 year

For diagnosis of chronic idiopathic urticaria:

• Initial: 3 months

• Reauthorization:  6 months

For diagnosis of nasal polyps:

• Initial: 1 year

• Reauthorization:  1 year

For diagnosis of IgE-mediated food allergy:

• Initial: 6 months

• Reauthorization: 1 year

Dosing:

For diagnosis of allergic asthma:

• 75 to 375 mg subcutaneous every 2 to 4 weeks

• Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).  Refer to dose determination charts.

For diagnosis of chronic idiopathic urticaria:

• 150 or 300 mg subcutaneous every 4 weeks

• Dosing is not dependent on serum IgE level or bodyweight

For diagnosis of nasal polyps:

• 75 to 600 mg subcutaneous every 2 to 4 weeks

• Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). 

For diagnosis of IgE-mediated food allergy:

• 75 to 600 mg every 2 to 4 weeks

• Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg)

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Administration:

  • Initiate Xolair therapy in healthcare setting, closely observe patients for an appropriate period of time after administration and be prepared to manage anaphylaxis

  • Xolair prefilled syringe

    • Pediatric Patients 6 to 11 years of age: Xolair prefilled syringe should be administered by a caregiver

    • Adolescents 12 years of age and older: Xolair prefilled syringe may be self-administered under adult supervision.

  • Xolair Autoinjector

    • Pediatric Patients 1 to 11 years of age: Xolair autoinjectors (all doses) are not intended for use in pediatric patients under 12 years of age

    • Adolescents 12 years of age and older: Xolair autoinjector may be self-administered under adult supervision. The Xolair autoinjectors (all doses) are intended for use only in adults and adolescents aged 12 years and older.

• The selection of patients for self-administration of Xolair should be based on criteria to mitigate risk from anaphylaxis. 

  • Healthcare providers should consider known risk factors for anaphylaxis to Xolair and mitigation strategies when selecting patients for self-administration. Patient-specific factors including the following criteria should be considered:

    1. Patient should have no prior history of anaphylaxis, including to Xolair or other agents, such as foods, drugs, biologics, etc.

    2. Patient should receive at least 3 doses of Xolair under the guidance of a healthcare provider with no hypersensitivity reactions

    3. Patient or caregiver is able to recognize symptoms of anaphylaxis

    4. Patient or caregiver is able to treat anaphylaxis appropriately

    5. Patient or caregiver is able to perform subcutaneous injections with Xolair prefilled syringe with proper technique according to the prescribed dosing regimen and Instructions for Use

Policy Updates:

• 9/1/2014 – Last reviewed

• 2/2022 – Updated Xolair policy to include new indication and adding PA

• 6/1/2023 – Criteria updated as a part of a class review for severe asthma medications

• 9/1/2024 – Addition of Xolair autoinjector and new indication of IgE-mediated food allergy (P&T 08/20/2024) (P&T Meeting August)

References:

1. Xolair Prescribing Information. Genentech, Inc. South San Francisco, CA. December 2020.
2. National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. National Institutes of Health Publication No.08-5846. Bethesda, MD, 2007. Available at: https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma. Accessed January 9, 2020.
3. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (2020 update). 2020 www.ginasthma.org. Accessed March 2021.
4. Per clinical consult with asthma specialist, January 6, 2011.
5. National Institute for Health and Care Excellence (NICE). Omalizumab for treating severe persistent allergic asthma (review of technology appraisal guidance 133 and 201). London (UK): National Institute for Health and Care Excellence (NICE); 2013 Apr. 64 p. (Technology appraisal guidance; no. 278). Available at https://www.nice.org.uk/guidance/ta278/resources/omalizumab-for-treating-severe-persistent-allergic-asthma-pdf-82600619176645. Accessed January 9, 2020.
6. Bernstein JA, Lang DM, Khan DA, et al. The diagnosis and management of acute and chronic urticaria: 2014 update. J Allergy Clin Immunol. 2014;133(5):1270-7.
7. DRUGDEX System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically. Accessed March 11, 2021.
8. Peters AT, Spector S, Hsu J, et al. Diagnosis and management of rhinosinusitis: a practice parameter update. Ann Allergy Asthma Immunol. 2014;113(4):347-85.
9. Orlandi RR, Kingdom TT, Hwang PH, et al. International consensus statement on allergy and rhinology: rhinosinusitis. Int Forum Allergy Rhinol. 2016 Feb; Suppl 1:S22-209.
10. A, Boyce J, Ass’ad A, Burks Wesley, A et al. Guidelines for the Diagnosis and Management of Food Allergy in the United States: Report of the NIAID-Sponsored Expert Panel. Journal of Allergy and Clinical Immunology. 2010; 126(6): 1079-1378.