Xolair (omalizumab)
Indications for Prior Authorization
Xolair (omalizumab)
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For diagnosis of Allergic Asthma
Indicated for adults and pediatric patients 6 years of age and 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.Limitations of Use: Xolair is not indicated for treatment of other allergic conditions. Xolair is not indicated for the relief of acute bronchospasm or status asthmaticus.
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For diagnosis of Chronic Spontaneous Urticaria (CSU)
Indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.Limitations of Use: Xolair is not indicated for treatment of other forms of urticaria.
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For diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Indicated for 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. -
For diagnosis of IgE-Mediated Food Allergy
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. XOLAIR is to be used in conjunction with food allergen avoidance. Limitations of Use: XOLAIR is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
Criteria
Xolair
Prior Authorization (Initial Authorization)
Length of Approval: 6 months [B]
For diagnosis of Allergic Asthma
- Diagnosis of moderate to severe persistent allergic asthma [1, 2] AND
- Positive skin test or in vitro reactivity to a perennial aeroallergen [1, D] AND
- One of the following:
- All of the following:
- Patient is 6 years of age or older but less than 12 years of age AND
- Pre-treatment serum immunoglobulin (Ig)E level between 30 to 1300 IU/mL AND
- Patient is currently being treated with one of the following unless there is a contraindication or intolerance to these medications [3]:
- Both of the following:
- Medium-dose inhaled corticosteroid (e.g., greater than 100 – 200 mcg fluticasone propionate equivalent/day)
- Additional asthma controller medication (e.g., leukotriene receptor antagonist [LTRA] [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium])
- One medium dosed combination ICS/LABA product (e.g., Advair Diskus [fluticasone propionate 100mcg/ salmeterol 50mcg], Symbicort [budesonide 80mcg/ formoterol 4.5mcg] Breo Ellipta [fluticasone furoate 50 mcg/ vilanterol 25 mcg])
- All of the following:
- Patient is 12 years of age or older AND
- Pre-treatment serum immunoglobulin (Ig)E level between 30 to 700 IU/mL AND
- Patient is currently being treated with one of the following unless there is a contraindication or intolerance to these medications [3]:
- Both of the following:
- High-dose inhaled corticosteroid (ICS) (e.g., greater than 500 mcg fluticasone propionate equivalent/day)
- Additional asthma controller medication (e.g., leukotriene receptor antagonist [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium])
- One maximally-dosed combination ICS/LABA product (e.g., Advair [fluticasone propionate 500mcg/ salmeterol 50mcg], Symbicort [budesonide 160mcg/ formoterol 4.5mcg], Breo Ellipta [fluticasone 200mcg/ vilanterol 25mcg])
- Prescribed by or in consultation with one of the following: [G]
- Pulmonologist
- Allergist/Immunologist
Xolair
Prior Authorization (Reauthorization)
Length of Approval: 12 months
For diagnosis of Allergic Asthma
- Patient demonstrates 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 [LTRA] [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium]) unless there is a contraindication or intolerance to these medications [3] AND
- Prescribed by or in consultation with one of the following: [G]
- Pulmonologist
- Allergist/immunologist
Xolair
Prior Authorization (Initial Authorization)
Length of Approval: 3 months [E]
For diagnosis of Chronic Spontaneous Urticaria (CSU)
- Diagnosis of chronic spontaneous urticaria [1] AND
- Patient is 12 years of age or older 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 at least TWO of the following additional therapies: [6, 7]
- Doxepin
- H1 antihistamine
- H2 antagonist (e.g., famotidine, cimetidine)
- Hydroxyzine
- Leukotriene receptor antagonist (e.g., montelukast)
- Prescribed by or in consultation with one of the following:
- Allergist/immunologist
- Dermatologist
Xolair
Prior Authorization (Reauthorization)
Length of Approval: 6 months [B]
For diagnosis of Chronic Spontaneous Urticaria (CSU)
- 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:
- Reduction in itching severity from baseline
- Reduction in the number of hives from baseline
Xolair
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
- Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) AND
- Patient is 18 years of age or older AND
- Unless contraindicated, the patient has had an inadequate response to 2 months of treatment with an intranasal corticosteroid (e.g., fluticasone, mometasone) [8, 9] AND
- Used in combination with another agent for chronic rhinosinusitis with nasal polyps (CRSwNP) [H] AND
- Prescribed by or in consultation with one of the following:
- Allergist/Immunologist
- Otolaryngologist
- Pulmonologist
Xolair
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
- Patient demonstrates 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 chronic rhinosinusitis with nasal polyps (CRSwNP) [H] AND
- Prescribed by or in consultation with one of the following:
- Allergist/Immunologist
- Otolaryngologist
- Pulmonologist
Xolair
Prior Authorization (Initial Authorization)
Length of Approval: 20 Week(s)
For diagnosis of IgE-Mediated Food Allergy
- 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
- Patient is 1 year of age or older AND
- Used in conjunction with food allergen avoidance AND
- Both of the following:
- 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
- Dosing is according to serum total IgE levels and body weight
- Prescribed by or in consultation with one of the following:
- Allergist
- Immunologist
Xolair
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of IgE-Mediated Food Allergy
- 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 AND
- Dosing will continue to be based on body weight and pretreatment total IgE serum levels AND
- Prescribed by or in consultation with one of the following:
- Allergist
- Immunologist
P & T Revisions
2024-10-01, 2024-05-13, 2024-04-05, 2023-10-04, 2023-04-24, 2022-05-04, 2022-03-03, 2021-11-09, 2021-06-07, 2021-05-26, 2021-05-25, 2021-03-12, 2021-02-04, 2020-02-07, 2019-10-29
References
- Xolair Prescribing Information. Genentech, Inc. South San Francisco, CA. March 2024.
- 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.
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (2022 update). 2022 www.ginasthma.org. Accessed April 2023.
- Per clinical consult with asthma specialist, January 6, 2011.
- 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.
- 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.
- DRUGDEX System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically. Accessed March 11, 2021.
- 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.
- 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.
- 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.
End Notes
- National treatment guidelines recommend the combination of an inhaled glucocorticosteroid and a long-acting beta2-agonist for the treatment of moderate persistent or severe persistent asthma. [2-5]
- The Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention update recommends that patients with asthma should be reviewed regularly to monitor their symptom control, risk factors and occurrence of exacerbations, as well as to document the response to any treatment changes. Ideally, response to Type 2-targeted therapy should be re-evaluated every 3-6 months, including re-evaluation of the need for ongoing biologic therapy for patients with good response to Type 2 targeted therapy. Clinical studies for allergic asthma evaluated an initial 16-week steroid stable phase in which subjects received omalizumab with a constant dose of inhaled steroids. This 16-week period may not be sufficient amount of time to show reduction in exacerbations. For allergic asthma, initial authorization duration increased from 16 weeks to 6 months. [3, 4]
- Asthma treatment can often be reduced, once good asthma control has been achieved and maintained for three months and lung function has hit a plateau. However the approach to stepping down will depend on patient specific factors (e.g., current medications, risk factors). At this time evidence for optimal timing, sequence and magnitude of treatment reductions is limited. It is feasible and safe for most patients to reduce the ICS dose by 25-50% at three month intervals, but complete cessation of ICS is associated with a significant risk of exacerbations [3].
- Sensitization to a perennial allergen (e.g., mite, cat, dog) should be required. [4] Xolair is indicated for children and adults (6 years of age and above) 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. [1]
- For chronic idiopathic urticaria, response observed at 12 weeks (one 24-week trial with data reported at 12 weeks, and one 12-week trial) [1]
- Per clinical consult, April 2024.
- Referral to an asthma specialist for consultation or comanagement is recommended if Xolair is being considered. [2]
- Other agents used for nasal polyps include intranasal corticosteroids and nasal saline.
Revision History
- 2024-10-01: Added age criterion for CRSwNP.
- 2024-05-13: 2024 annual review. Background changes. Updated criteria language and formatting for asthma indication to align with other drugs within the class, including merging the age criterion, IgE pre-treatment levels and prior treatment requirements, to allow for differences in optimal treatment.
- 2024-04-05: Updated guideline to include criteria for the new FDA approved indication 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.
- 2023-10-04: Program update to standard reauthorization language. No changes to clinical intent
- 2023-04-24: 2023 UM Annual Review. Updated indications to align with PI. Update chronic idiopathic urticaria to be chronic spontaneous urticaria and update nasal polyps to be Chronic rhinosinusitis with nasal polyps (CRSwNP) in criteria to align with updated indications. No changes to clinical intent. Background updates
- 2022-05-04: Annual review no changes to criteria.
- 2022-03-03: Updated criteria/examples to align all asthma mABs class criteria. Updated reauth criteria to req an ICS only.
- 2021-11-09: Updated criteria for nasal polyp indication
- 2021-06-07: update formulary to reflect specialty, no changes to criteria
- 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
- 2021-03-12: Annual review; updated criteria and references
- 2021-02-04: Updated guideline to add criteria for the new FDA approved indication for add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids
- 2020-02-07: Annual review; updated criteria
- 2019-10-29: Updated guideline to add examples of therapy.
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