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Xolair (omalizumab) Prior Authorization Program Summary

Policy Number: PH-91171

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies. 

POLICY REVIEW CYCLE

              

Effective Date

Date of Origin   

07-01-2024           

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Xolair®

(omalizumab)

Injection for subcutaneous use

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

Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment

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

IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance

Limitations of use:

  • Not indicated for acute bronchospasms, or status asthmaticus
  • Not indicated for the emergency treatment of allergic reactions, including anaphylaxis
  • Not indicated for other allergic conditions, or other forms of urticaria

1

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Asthma

Asthma is a chronic inflammatory disorder of the airways.(2,3) It is characterized by variable and recurring clinical symptoms, airflow obstruction, bronchial hyperresponsiveness, and underlying inflammation.(2) Symptoms of asthma include wheezing, coughing, recurrent difficulty breathing, shortness of breath, and chest tightness. Generally, these symptoms will occur or worsen with exposure to allergens and irritants, infections, exercise, changes in weather, stress, or menstrual cycles. Guidelines recommend the use of detailed medical history, physical examination, and spirometry to make a diagnosis of asthma.(2,3)

The Global Initiative for Asthma (GINA) guidelines recommend a stepwise approach for managing asthma. Long-term goals for asthma management are to achieve good control of symptoms, maintain normal activity level, and to minimize the future risk of exacerbations, fixed airflow limitation, and side-effects.(3) IgE is the antibody responsible for activation of allergic reactions and is important to the pathogenesis of allergic asthma and the development and persistence of inflammation. GINA guidelines define moderate asthma as that which is well controlled with Step 3 or Step 4 treatment (e.g., low- or medium-dose inhaled corticosteroids (ICS) in combination with a long-acting beta agonist (LABA) in either treatment track). Severe asthma is defined as asthma that remains uncontrolled despite optimized treatment with high-dose ICS-LABA, or that requires high-dose ICS-LABA to prevent it from becoming uncontrolled. Severe asthma must be distinguished from asthma that is difficult to treat due to inadequate or inappropriate treatment, or persistent problems with adherence or comorbidities such as chronic rhinosinusitis or obesity, as they need very different treatment compared with if asthma is relatively refractory to high-dose ICS-LABA or even oral corticosteroids (OCS). Early initiation of low dose ICS in patients with asthma has led to greater improvement in lung function than initiation of ICS after symptoms have been present for more than 2 to 4 years. The 2023 GINA guidelines recommend every adult and adolescent with asthma should receive ICS-containing controller medication to reduce the risk of serious exacerbation, even in patients with infrequent symptoms.(3)

2023 GINA STEP recommendations for adults and adolescents (12 years of age and over) are intended to reduce the risk of serious exacerbations and are broken into two tracks based on reliever therapy.

Track 1 is the preferred approach recommended by GINA, because using low dose ICS-formoterol as reliever reduces the risk of exacerbations compared with regimens with short-acting β2-agonist (SABA) as reliever, and is a simpler regimen. Note ICS-formoterol should not be used as the reliever by patients taking any other (non-formoterol) ICS-LABA or ICS-LAMA:(3)

  • Step 1:
    • As-needed low dose ICS-formoterol
  • Step 2:
    • As-needed low dose ICS-formoterol
  • Step 3: address and treat modifiable risk factors (e.g., adherence, technique) before considering step up
    • Maintenance: low dose ICS-formoterol
    • Reliever: as-needed low dose ICS-formoterol
  • Step 4:
    • Maintenance: medium dose ICS-formoterol
    • Reliever: as-needed low dose ICS-formoterol
  • Step 5: patients with uncontrolled symptoms and/or exacerbations despite Step 4 treatment should be assessed for contributory factors, have their treatment optimized, and be referred for expert assessment including severe asthma phenotype, and potential add on treatment  
    • Maintenance: consider high dose ICS-formoterol 
    • Reliever: as-needed low dose ICS-formoterol
    • Add-on LAMA for patients greater than or equal to 18 years (greater than or equal to 6 years for tiotropium) in separate or combination inhalers
    • Refer for phenotypic assessment +/- biologic therapy
      • Add-on anti-IgE for severe allergic asthma
      • ​​​​​Subcutaneous (SC) omalizumab in patients greater than or equal to 6 years
      • Add-on anti-interleukin (IL)5 or anti-IL5R or anti-IL4R for severe eosinophilic/Type 2 asthma 
        • Anti-IL5: SC mepolizumab for patients greater than or equal to 6 years OR IV reslizumab for patients greater than or equal to 18 years of age
        • Anti-IL5R: SC benralizumab for patients greater than or equal to 12 years
        • Anti-IL4R: SC dupilumab for patients greater than or equal to 6 years
      • Add-on anti-thymic stromal lymphopoietin (TSLP) for severe asthma
        • SC tezepelumab for patients greater than or equal to 12 years
    • Add-on azithromycin three days/week reduces exacerbations, but increases antibiotic resistance
    • Maintenance oral corticosteroids (OCS) should be used only as last resort, because short-term and long-term systemic side-effects are common and serious

Track 2 is an alternative approach if Track 1 is not possible or is not preferred by a patient with no exacerbations on their current therapy. Before considering a regimen with SABA reliever, the clinician should consider whether the patient is likely to be adherent with their controller therapy; if not, they will be exposed to the higher risk of exacerbations with SABA-only treatment:(3)

  • Step 1:
    • Take ICS whenever SABA taken
    • Reliever: as-needed ICS-SABA or as needed SABA
  • Step 2:
    • Preferred maintenance: low dose  ICS
    • Preferred reliever: as-needed ICS-SABA or as-needed SABA
    • Alternative options with limited indications, or less evidence for efficacy and/or safety:
      • Low dose ICS whenever SABA taken
      • Daily LTRA. These are less effective than daily ICS, particularly for preventing exacerbations and there is a US FDA boxed warning about the risk of serious mental health effects with montelukast
    • Daily low-dose ICS-LABA as initial therapy leads to faster improvement in symptoms and FEV1 than ICS alone but is costlier, and the reduction in exacerbations compared with SABA is similar to that with ICS
    • For adults with rhinitis who are allergic to house dust mite and have FEV1 > 70% predicted, consider adding sublingual immunotherapy (SLIT)
  • Step 3: address and treat modifiable risk factors (e.g., adherence, technique) before considering step up
    • Preferred maintenance: low dose ICS-LABA
    • Preferred reliever: as-needed ICS-SABA or as-needed SABA
    • Alternative options:
      • Medium dose ICS 
      • Low-dose ICS plus LTRA but review US FDA boxed warning
      • For adults with rhinitis who are allergic to house dust mite and have FEV1 > 70% predicted, consider adding SLIT
  • Step 4:
    • Preferred maintenance: medium/high dose ICS-LABA
    • Preferred reliever: as-needed ICS-SABA or as-needed SABA
    • Alternative options:
      • Add-on LAMA for patients greater than or equal to 18 years (greater than or equal to 6 years for tiotropium my mist inhaler)
        • Before considering add-on LAMA for patients with exacerbations, increase ICS dose to at least medium
      • For adults with rhinitis who are allergic to house dust mite and have FEV1 > 70% predicted, consider adding sublingual immunotherapy (SLIT)
  • Step 5: patients with uncontrolled symptoms and/or exacerbations despite Step 4 treatment should be assessed for contributory factors, have their treatment optimized, and be referred for expert assessment including severe asthma phenotype, and potential add on treatment
    • Maintenance: medium/high dose ICS-LABA
    • Reliever: as-needed ICS-SABA or as-needed SABA
    • Add-on LAMA for patients greater than or equal to 18 years (greater than or equal to 6 years for tiotropium) in separate or combination inhalers
    • Refer for phenotypic assessment +/- biologic therapy
      • Add-on anti-IgE for severe allergic asthma
        • ​​​​​SC omalizumab in patients greater than or equal to 6 years
      • Add-on anti-interleukin (IL)5 or anti-IL5R or anti-IL4R for severe eosinophilic/Type 2 asthma 
        • Anti-IL5: SC mepolizumab for patients greater than or equal to 6 years OR IV reslizumab for patients greater than or equal to 18 years of age
        • Anti-IL5R: SC benralizumab for patients greater than or equal to 12 years
        • Anti-IL4R: SC dupilumab for patients greater than or equal to 6 years
      • Add-on anti-thymic stromal lymphopoietin (TSLP) for severe asthma
        • SC tezepelumab for patients greater than or equal to 12 years
    • Add-on azithromycin three days/week reduces exacerbations, but increases antibiotic resistance
    • Maintenance OCS should  only be used as last resort, because short-term and long-term systemic side-effects are common and serious

2023 GINA STEP recommendations for children (6 to 11 years of age) are intended to reduce the risk of serious exacerbations:(3)

  • Step 1:
    • Low dose ICS taken whenever SABA taken
    • Reliever: as needed SABA
  • Step 2
    • Preferred: daily low dose ICS
    • Preferred reliever: as needed SABA 
    • Alternative options:
      • Low-dose ICS whenever SABA is taken using separate inhalers
      • Daily LTRA are less effective for exacerbation reduction. Advise parents about US FDA warning on montelukast
  • Step 3: after checking inhaler technique and adherence, and treating modifiable risk factors (any of the following):
    • Medium-dose ICS  maintenance plus as-needed SABA
    • Low-dose ICS-LABA maintenance plus as-needed SABA 
    • Maintenance and reliever therapy (MART) with a very low dose of budesonide-formoterol DPI
  • Step 4: Individual children's responses vary, so each of the Step 3 options may be tried before considering a step-up to Step 4. Refer for expert advice  
    • Preferred: medium dose ICS-LABA plus as-needed SABA
    • Preferred: low dose ICS-formoterol MART plus as-needed low-dose ICS-formoterol 
    • Alternative options:
      • Add-on tiotropium
      • Add-on LTRA
  • Step 5:
    • Refer for phenotypic assessment with or without higher dose ICS-LABA
    • Reliever: as needed SABA (or ICS-formoterol reliever for MART)
    • Add on therapy with anti-IgE or anti-IL4R, anti-IL5
    • As a last resort consider add on low dose OCS but consider side effects

Severe Asthma Phenotype and Eosinophilic Asthma Subphenotype

Roughly 3% to 10% of adults with asthma have severe asthma as defined by the GINA 2023 guidelines.(3) The European Respiratory Society (ERS)/American Thoracic Society (ATS) guidelines (2014; updated 2020) and the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group mirror the GINA definition of severe asthma, and defined uncontrolled asthma for adult and pediatric patients 5 years of age and over:(2,12)

  • Frequent severe exacerbations (i.e., two or more bursts of systemic corticosteroids within the past 12 months)
  • Serious exacerbations (i.e., at least one hospitalization, intensive care unit stay, or mechanical ventilation in the past 12 months)
  • Airflow limitation (i.e., FEV1 less than 80% predicted)
  • Asthma that worsens upon tapering of high-dose ICS or systemic corticosteroids

A specialist, preferably in a multidisciplinary severe asthma clinic (if available) performs further assessment, which includes the patient’s inflammatory phenotype (i.e., Type 2 or non-Type 2).(3)

Type 2 inflammation is characterized by the presence of cytokines such as interleukin (IL)-4, IL-5, and IL-13, which are often produced by the adaptive immune system on recognition of allergens. It is also characterized by eosinophilia or increased fraction of exhaled nitric oxide (FeNO) and may be accompanied by atopy. In many patients with asthma, Type 2 inflammation rapidly improves when ICS are taken regularly and correctly; this is classified as mild or moderate asthma. In severe asthma, Type 2 inflammation may be relatively refractory to high dose ICS. Type 2 inflammation is considered refractory if any of the following are found while the patient is taking high dose ICS or daily OCS:(3)

  • Blood eosinophils greater than or equal to 150 cells/microliter
  • FeNO greater than or equal to 20 ppb
  • Sputum eosinophils greater than or equal to 2%
  • Asthma is clinically allergen-driven

Biologic agents should be considered as add-on therapy for patients with refractory Type 2 inflammation with exacerbations or poor symptom control despite taking at least high dose ICS/LABA, and who have allergic or eosinophilic biomarkers or need maintenance OCS.(3) 2023 GINA recommends the biologics below based on patient eligibility factors:

  • Anti-IgE (omalizumab):
    • Sensitization on skin prick testing or specific IgE
    • Total serum IgE and weight within dosage range
    • Exacerbations in the last year
  • Anti-IL5/Anti-IL5R (benralizumab, mepolizumab, reslizumab):
    • Exacerbations in the last year
    • Blood eosinophils greater than or equal to 150 cells/microliter (for benralizumab and mepolizumab) or greater than or equal to 300 cells/microliter (for reslizumab)
  • Anti-IL4R (dupilumab):
    • Exacerbations in the last year
    • Blood eosinophil greater than or equal to 150 cells/microliter but less than or equal to 1500 cells/microliter, or FeNO greater than or equal to 25 ppb, or taking maintenance OCS
  • Anti-TSLP (tezepelumab):
    • Exacerbations in the last year

Patient response should be evaluated 4 months after initiating therapy and follow up should occur every 3 to 6 months thereafter. 2023 GINA recommends the following step-down therapy process in patients responding well to targeted biologic therapy:(3)

  • Reevaluate the need for each asthma medication every 3 to 6 months, but inhaled therapy should not be completely stopped
  • Oral treatments: gradually decreased starting with OCS due to significant adverse effects.
  • Inhaled treatments: consider reducing ICS dose after 3 to 6 months, but do not completely stop inhaled therapy. Continue at least medium dose ICS and remind patients of the importance of continued inhaled controller therapy
  • Biologic treatments: trial withdrawal after 12 months of treatment and only if patient’s asthma remains well controlled on medium dose ICS, and for allergic asthma, there is no further exposure to a previous allergic trigger

Chronic Spontaneous Urticaria (CSU)

Chronic spontaneous urticaria (CSU) can be a debilitating condition that can significantly affect a patient's quality of life. Routine diagnostic work-up for CSU is limited to blood tests for complete blood count and inflammatory markers, such as C-reactive protein and/or erythrocyte sedimentation rate, mostly to rule out other potential diseases. Skin prick testing, typically used to identify specific allergens, is not useful for CSU as the condition is rarely caused by type 1 allergy. CSU is also referred to as chronic urticaria (CU) or chronic idopathic urticaria (CIU).(13)

Urticaria is characterized by the development of wheals (hives), angioedema, or both. Chronic urticaria is defined by the presence of urticaria that has been continuously or intermittently present for more than 6 weeks.(5,6) Treatment goals for CIU involves symptom control and improvement in quality of life that is acceptable to the patient.(6) 

The 2021 EAACI/GA LEN/EDF/WAO guidelines, endorsed by the American Academy of Allergy, Asthma, and Immunology, American Academy of Dermatology, American College of Asthma, and Allergy, and Immunology, recommend the following for the treatment of CIU:(6)

  • Recommend discontinuing medications suspected to worsen CIU (e.g., NSAIDs)
  • First line treatment: second-generation H-1 antihistamine (cetirizine, levocetirizine, fexofenadine, loratadine, desloratadine) dosed daily
  • Second-line treatment: Increase the dose up to 4 times the FDA max if inadequate control after 2-4 weeks of therapy at the FDA max
  • Third-line treatment: addition of omalizumab

First-line treatment with second generation H-1 antihistamines is consistent in other guidelines but recommend omalizumab as second-line treatment and ciclosporin (off-label use) as third-line treatment.(13)

Chronic Rhinosinusitis with Nasal Polyposis

Chronic rhinosinusitis with nasal polyposis (CRSwNP) is an inflammatory condition affecting the paranasal sinuses. The International Consensus Statement on allergy and rhinology: Rhinosinusitis indicates that the diagnostic criteria for chronic rhinosinusitis (CRS) consist of ALL the following:(11)

  • Symptoms greater than or equal to 12 weeks
  • Two of the following symptoms:
    • Nasal discharge (rhinorrhea or post-nasal drainage)
    • Nasal obstruction or congestion
    • Hyposmia (loss or decreased sense of smell)
    • Facial pressure or pain
  • One or more of the following findings:
    • Evidence of inflammation on nasal endoscopy or computed tomography
    • Evidence of purulence coming from paranasal sinuses or ostiomeatal complex

Sinus computed tomography (CT) and/or nasal endoscopy are needed to determine the presence of sinonasal inflammation and nasal polyps. The exact cause of CRSwNP is unknown, but biopsies of nasal polyps have shown elevated levels of eosinophils.(8)

Intranasal corticosteroids (INCS) are recommended in the guidelines for CRSwNP. There are several formulations of INCS and it is recommended that clinicians must help each patient arrive at management decision consistent with that patient's values and preferences as no formulation is recommended over another. For patients using INCS for at least 4 weeks and who continue to have high disease burden, biologics are preferred over other medical treatment choices. Biologics vary in their magnitude of benefits and harms and certainty of evidence across outcomes. For outcomes most important to patient care, dupilumab and omalizumab are the most beneficial, followed by mepolizumab. Other management options for CRSwNP that patients and their caregivers could consider include saline rinse, surgery, antibiotics, and for people with aspirin (non-steroidal anti-inflammatory)-exacerbated respiratory disease consider using aspirin therapy after desensitization.(9) 

Efficacy

Asthma(1)

The safety and efficacy of Xolair in adult and adolescent patients 12 years of age and older were evaluated in three randomized, double-blind, placebo-controlled, multicenter trials. In all three trials an exacerbation was defined as a worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline inhaled corticosteroid dose. In two of these trials patients had a forced expiratory volume in 1 second (FEV1) between 40 and 80% predicted. All patients had a FEV1 improvement of at least 12% following beta-2-agonist administration. All patient were required to have a baseline IgE between 30 and 700 IU/mL and a body weight not more than 150 kg. Dosing information includes weights of at least 30 kg. In both of these trials the number of exacerbations per patient was reduced in patients treated with Xolair compared with placebo. In the third trial there was no restriction on screening FEV1. The number of exacerbations in patients treated with Xolair was similar to that in the placebo-treated patients. The absence of an observed treatment effect may be related to differences in the patient population compared with the other two trials. In all three trials, a reduction of asthma exacerbations was not observed in the Xolair treated patients who had an FEV1 > 80% at the time of randomization. Reductions in exacerbations were not seen in patients who required oral steroids as maintenance therapy.

The safety and efficacy of Xolair in pediatric patients 6 to less than 12 years of age with moderate to severe asthma is based on one randomized, double-blind, placebo controlled, multicenter trial and an additional supportive study. The primary efficacy variable was the rate of asthma exacerbations during the 24-week, fixed steroid treatment phase. An asthma exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose for at least 3 days and/or treatment with rescue systemic (oral or IV) corticosteroids for at least 3 days. At 24 weeks, the Xolair group had a statistically significantly lower rate of asthma exacerbations (0.45 vs 0.64) with an estimated rate ratio of 0.69 (95% CI). Dosing for pediatric patients between the ages of 6 to less than 12 years is based on weight and IgE level with dosing available for weights less than or equal to 150 kg and IgE levels between 30 and 1300 IU/mL.

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)(1)

The safety and efficacy of Xolair was evaluated in two, randomized, multicenter, double-blind, placebo-controlled clinical trials that enrolled patients with CRSwNP with inadequate response to nasal corticosteroids. The co-primary endpoints in both trials were nasal polyp score (NPS) and average daily nasal congestion score (NCS) at Week 24. In both trials, patients who received Xolair has statistically significant greater improvement from baseline at Week 24 in NPS and weekly average NCS, than patients who received placebo.

Chronic Spontaneous Urticaria (CSU)(1)

The safety and efficacy of Xolair for the treatment of CSU, previously referred to as chronic idiopathic urticaria (CIU) was assessed in two placebo-controlled, multiple-dose clinical trials of 24 and 12 weeks duration. Disease severity was measured by a weekly urticaria activity score (UAS7), which is a composite of the weekly itch severity score and the weekly hive count score. All patients were required to have a UAS7 of greater than or equal to 16 and a weekly itch severity score greater than or equal to 8 for the 7 days prior to randomization, despite having used an H1 antihistamine for at least 2 weeks. In both trials patients who received Xolair 150 mg and 300 mg had greater decreases from baseline in weekly itch severity score and weekly hive count scores than placebo at week 12.

Safety

Omalizumab has a boxed warning due to risk of anaphylaxis. Because of the risk of anaphylaxis, therapy should be initiated in a healthcare setting. Selection of patients for self-administration should be based on criteria to mitigate risk from anaphylaxis. 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
  • Patient should receive at least 3 doses of Xolair under the guidance of a healthcare provider with no hypersensitivity reactions
  • Patient or caregiver is able to recognize symptoms of anaphylaxis
  • Patient or caregiver is able to treat anaphylaxis appropriately
  • Patient or caregiver is able to perform SC injections with Xolair prefilled syringe with proper technique according to the prescribed dosing regimen and Instructions for Use

Omalizumab is contraindicated in patients with history of hypersensitivity to omalizumab or any ingredients of omalizumab.(1)

REFERENCES

Number

Reference

1

Xolair prescribing information. Genentech, Inc. February 2024.

2

International European Respiratory Society (ERS)/American Thoracic Society (ATS) Guidelines on Management of Severe Asthma. Eur Resp J. 2020;55:1900588. Available at https://erj.ersjournals.com/content/55/1/1900588.

3

Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2023. Available at www.ginasthma.org

4

Lanier B, Bridges T, Kulus M, et al. Omalizumab for the Treatment of Exacerbations in Children with Inadequately Controlled Allergic (IgE-mediated) Asthma. J Allergy Clin Immunol2009 Dec;124(6):1210-1216.

5

Bernstein J, Lang D, Khan D, et al. The Diagnosis and Management of Acute and Chronic Urticaria: 2014 Update. J Allergy Clin Immunol. 2014;133(5):1270-1277.

6

Zuberbier, T, Abdul Latiff, AH, Abuzakouk, M, et al. The international EAACI/GA^2LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022; 77: 734– 766. doi:10.1111/all.15090

7

Reference no longer used

8

Stevens WW, Schleimer RP, and Kern RC. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016;4(4):565–572.

9

Rank MA, Chu DK, Bognanni A, Oykhman P, Bernstein JA, Ellis AK, Golden DBK, Greenhawt M, Horner CC, Ledford DK, Lieberman J, Luong AU, Orlandi RR, Samant SA, Shaker MS, Soler ZM, Stevens WW, Stukus DR, Wang J, Peters AT. The Joint Task Force on Practice Parameters GRADE guidelines for the medical management of chronic rhinosinusitis with nasal polyposis. J Allergy Clin Immunol. 2023 Feb;151(2):386-398. doi: 10.1016/j.jaci.2022.10.026. Epub 2022 Nov 9. PMID: 36370881.

10

Reference no longer used

11

Orlandi, RR, Kingdom, TT, Smith, TL, et al. International consensus statement on rhinology and allergy: rhinosinusitis. Int Forum Allergy  Rhinol. 2021; 11: 213– 739. https://doi.org/10.1002/alr.22741

12

National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. 2020 Focused updates to the asthma management guidelines. National Heart, Lung, and Blood Institute, 2007. Available at: https://www.nhlbi.nih.gov/health-topics/all-publications-and-resources/2020-focused-updates-asthma-management-guidelines

13

Guideline for Diagnosis and Management of Chronic Spontaneous Urticaria. Physician's Weekly. April 2021.

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Xolair

omalizumab subcutaneous soln auto-injector

150 MG/ML ; 300 MG/2ML ; 75 MG/0.5ML

M ; N ; O ; Y

N

Xolair

omalizumab subcutaneous soln prefilled syringe

150 MG/ML ; 300 MG/2ML ; 75 MG/0.5ML

M ; N ; O ; Y

N

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Xolair

omalizumab subcutaneous soln auto-injector

150 MG/ML ; 300 MG/2ML ; 75 MG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Xolair

omalizumab subcutaneous soln prefilled syringe

150 MG/ML ; 300 MG/2ML ; 75 MG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. ONE of the following:
    1. The requested agent is eligible for continuation of therapy AND ONE of the following:

Agents Eligible for Continuation of Therapy

All Target Agents are eligible for continuation of therapy

      1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
      2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
    1. BOTH of the following:
      1. ONE of the following:
        1. The patient has a diagnosis of moderate to severe persistent asthma AND ALL of the following:
          1. ONE of the following:
            1. The patient is 6 to less than 12 years of age AND BOTH of the following:
              1. The pretreatment IgE level is 30 IU/mL to 1300 IU/mL AND
              2. The patient’s weight is 20 kg to 150 kg OR
            2. The patient is 12 years of age or over AND BOTH of the following:
              1. The pretreatment IgE level is 30 IU/mL to 700 IU/mL AND
              2. The patient’s weight is 30 kg to 150 kg AND
          2. Allergic asthma has been confirmed by a positive skin test or in vitro reactivity test (RAST) to a perennial aeroallergen AND
          3. The patient has documented ongoing symptoms of moderate to severe persistent asthma as indicated by ONE of the following:
            1. Moderate persistent asthma as indicated by at least ONE of the following:
              1. Daily symptoms
              2. Nighttime awakenings > 1x/week but not nightly
              3. SABA use for symptom control occurs daily
              4. Some limitation to normal activities
              5. Lung function (percent predicted FEV1) >60%, but <80%
              6. Exacerbations requiring oral system corticosteroids are generally more frequent and intense relative to mild asthma OR
            2. Severe persistent asthma as indicated by at least ONE of the following:
              1. Symptoms throughout the day
              2. Nighttime awakenings, often 7x/week
              3. SABA use for symptom control occurs several times daily
              4. Extremely limited in normal activities
              5. Lung function (percent predicted FEV1) <60%
              6. Exacerbations requiring oral system corticosteroids are generally more frequent and intense relative to moderate asthma AND
          4. The prescriber has assessed baseline disease severity as indicated by at least ONE of the following:
            1. Use of inhaled rescue medication
            2. Use of inhaled or systemic corticosteroids
            3. Reported disease severity symptoms (e.g., number of hospitalizations, ER visits, unscheduled visits to healthcare provider due to condition, asthma attacks, chest tightness or heaviness, coughing or clearing throat, difficulty taking deep breath or difficulty breathing out, shortness of breath, sleep disturbance, night wakening, or symptoms upon awakening, tiredness, wheezing/heavy breathing/fighting for air, etc.)
            4. Forced expiratory volume in 1 second (FEV1)  OR
        2. The patient has a diagnosis of chronic spontaneous urticaria (CSU) (otherwise known as chronic idiopathic urticaria [CIU]) AND ALL of the following:
          1. The underlying cause of the patient’s condition is NOT considered to be any other allergic condition(s) or other form(s) of urticaria AND
          2. The patient has had over 6 weeks of hives and itching AND
          3. If the patient is currently being treated with medications known to cause or worsen urticaria, then ONE of the following:
            1. The prescriber has reduced the dose or discontinued any medications known to cause or worsen urticaria (e.g., NSAIDs) OR
            2. A reduced dose or discontinuation of any medications known to cause or worsen urticaria is not appropriate AND
          4. The prescriber has provided a baseline score from an objective clinical evaluation tool, such as: Urticaria Activity Score (UAS7), Angioedema Activity Score (AAS), Dermatology Life Quality Index (DLQI), Angioedema Quality of Life (AE-QoL), urticaria control test (UCT), angioedema control test (AECT), or Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) AND
          5. ONE of the following:
            1. The patient has tried and had an inadequate response to the FDA labeled maximum dose of a second-generation H-1 antihistamine (e.g., cetirizine, levocetirizine, fexofenadine, loratadine, desloratadine) after at least a 1-month trial OR
            2. The patient has an intolerance or hypersensitivity to second-generation H-1 antihistamine therapy OR
            3. The patient has an FDA labeled contraindication to ALL second-generation H-1 antihistamines AND
          6. ONE of the following:
            1. The patient has tried and had an inadequate response after at least a 1-month trial to at least ONE of the following:
              1. A dose above the FDA labeled maximum dose (e.g., up to 4 times the FDA labeled maximum dose) of a second-generation H-1 antihistamine OR     
              2. A leukotriene receptor antagonist (LTRA) OR
              3. Another H-1 antihistamine OR
              4. An H-2 antagonist (e.g. ranitidine, etc.) OR
              5. Cyclosporine OR
            2. The patient has an intolerance or hypersensitivity to therapy with second-generation H-1 antihistamines, leukotriene receptor antagonists (LTRA), H-2 antagonists, or cyclosporine OR
            3. The patient has an FDA labeled contraindication to ALL second-generation H-1 antihistamines, leukotriene receptor antagonists (LTRA), H-2 antagonists, AND cyclosporine OR
        3. The patient has a diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) AND ALL of the following:
          1. The patient has bilateral symptomatic sino-nasal polyposis with symptoms lasting at least 8 weeks AND
          2. The patient has at least TWO of the following symptoms consistent with chronic rhinosinusitis (CRS):
            1. Nasal discharge (rhinorrhea or post-nasal drainage)
            2. Nasal obstruction or congestion
            3. Loss or decreased sense of smell (hyposmia)
            4. Facial pressure or pain AND
          3. The patient has at least THREE of the following indicators for biologic treatment:
            1. The patient has evidence of type 2 inflammation (e.g., tissue eosinophils greater than or equal to 10/hpf, blood eosinophils greater than or equal to 150 cells/microL, or total IgE greater than or equal to 100 IU/mL)
            2. The patient has required greater than or equal to two courses of systemic corticosteroids per year or greater than 3 months of low dose corticosteroids, unless contraindicated
            3. Disease significantly impairs the patient’s quality of life
            4. The patient has experienced significant loss of smell
            5. The patient has a comorbid diagnosis of asthma AND
          4. The patient does NOT have any of the following:
            1. Antrochoanal polyps
            2. Nasal septal deviation that would occlude at least one nostril
            3. Disease with lack of signs of type 2 inflammation
            4. Cystic fibrosis
            5. Mucoceles AND
          5. The prescriber has ruled out other causes of nasal congestion/obstruction (e.g., acute sinusitis, nasal infection or upper respiratory infection, rhinitis medicamentosa, tumors, infections, granulomatosis, etc.) AND
          6. The prescriber has assessed baseline disease severity utilizing an objective measure/tool AND
          7. ONE of the following:
            1. The patient has tried and had an inadequate response to intranasal corticosteroids (e.g., fluticasone, Sinuva) used for at least a 4-week trial OR
            2. The patient has an intolerance or hypersensitivity to therapy with intranasal corticosteroids (e.g., fluticasone, Sinuva) OR
            3. The patient has an FDA labeled contraindication to ALL intranasal corticosteroids OR
        4. The patient has another FDA approved indication for the requested agent AND the requested dose is within FDA labeled dosing for the requested indication OR
      2. If the patient has an FDA labeled indication, then ONE of the following:
        1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
        2. There is support for using the requested agent for the patient’s age for the requested indication AND
    2. The patient has another indication that is supported in compendia for the requested agent AND
  1. If the patient has a diagnosis of moderate to severe persistent asthma, ALL of the following:
    1. ONE of the following:
      1. The patient is NOT currently being treated with the requested agent AND is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months OR
      2. The patient is currently being treated with the requested agent AND ONE of the following:
        1. Is currently treated with an inhaled corticosteroid for at least 3 months that is adequately dosed to control symptoms OR
        2. Is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months OR
      3. The patient has an intolerance or hypersensitivity to inhaled corticosteroid therapy OR
      4. The patient has an FDA labeled contraindication to ALL inhaled corticosteroids AND
    2. ONE of the following:
      1. The patient is currently being treated for at least 3 months with ONE of the following:
        1. A long-acting beta-2 agonist (LABA) OR
        2. A Leukotriene receptor antagonist (LTRA) OR
        3. Long-acting muscarinic antagonist (LAMA) OR
        4. Theophylline OR
      2. The patient has an intolerance or hypersensitivity to therapy with long-acting beta-2 agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline OR
      3. The patient has an FDA labeled contraindication to ALL long-acting beta-2 agonists (LABA) AND long-acting muscarinic antagonists (LAMA) AND
    3. The patient will continue asthma control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline) in combination with the requested agent AND
    4. The requested dose is based on the patient’s pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 375 mg every 2 weeks AND
  2. If the patient has a diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP), ALL of the following:
    1. The patient is currently treated with standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids) AND
    2. The patient will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids) in combination with the requested agent AND
    3. The requested dose is based on the patient’s pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 600 mg every 2 weeks AND
  3. ​​​​​If the patient has a diagnosis of chronic spontaneous urticaria (CSU) (otherwise known as chronic idiopathic urticaria [CIU]), the requested dose is within FDA labeled dosing for the requested indication AND does NOT exceed 300 mg every 4 weeks AND
  4. If the patient has another FDA labeled indication for the requested agent, the requested dose is within FDA labeled dosing for the requested indication AND
  5. If the patient has another indication that is supported in compendia for the requested agent, the requested dose is supported in compendia for the requested indication AND
  6. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
  7. ONE of the following (Please refer to “Agents NOT to be used Concomitantly” table): 
    1. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors, IgG2 lambda monoclonal antibody agents) OR
    2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
      1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND
      2. There is support for the use of combination therapy (copy of support required, e.g., clinical trials, phase III studies, guidelines) AND
  8. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use

Length of Approval:  6 months

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

 

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
  2. ONE of the following:
    1. The patient has a diagnosis of moderate to severe persistent asthma AND ALL of the following
      1. The patient has had improvements or stabilization with the requested agent from baseline (prior to therapy with the requested agent) as indicated by at least ONE of the following:
        1. Increase in percent predicted Forced Expiratory Volume (FEV1) OR
        2. Decrease in the dose of inhaled corticosteroid required to control the patient’s asthma OR
        3. Decrease in need for treatment with systemic corticosteroids due to exacerbations of asthma OR
        4. Decrease in the number of hospitalizations, need for mechanical ventilation, or visits to the emergency room or urgent care due to exacerbations of asthma AND
      2. The patient is currently treated and is compliant with standard therapy [i.e., inhaled corticosteroids (ICS), ICS/long acting beta-2 agonists (ICS/LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonist (LAMA), theophylline] AND
      3. The requested dose is based on the patient’s pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 375 mg every 2 weeks OR
    2. The patient has a diagnosis of chronic spontaenous urticaria (CSU) (otherwise known as chronic idiopathic urticaria [CIU]) AND ALL of the following:
      1. The patient has had clinical benefit with the requested agent as indicated by improvement from baseline using an objective clinical evaluation tool (i.e., urticaria activity score (UAS7), angioedema activity score (AAS), Dermatology Life Quality Index (DLQI), Angioedema Quality of Life (AE-QoL), urticaria control test (UCT), angioedema control test (AECT), or Chronic Urticaria Quality of Life Questionnaire(CU-Q2oL) AND
      2. The prescriber has recorded a current score from an objective clinical evaluation tool (i.e., UAS7, AAS, DLQI, AE-QoL, UCT, AECT, or CU-Q2oL) within the past 6 months AND
      3. The requested dose is within FDA labeled dosing for the requested indication AND does NOT exceed 300 mg every 4 weeks OR
    3. The patient has a diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) AND ALL of the following:
      1. The patient has had clinical benefit with the requested agent as indicated by improvement in signs and symptoms compared to baseline in at least ONE of the following:
        1. Reduction in nasal polyp size
        2. Reduction in need for systemic corticosteroids
        3. Improvement in quality of life
        4. Improvement in sense of smell
        5. Reduction of impact of comorbidities
        6. Improvement on a disease activity scoring tool (e.g., nasal polyposis score [NPS], nasal congestion [NC] symptom severity score, sino-nasal outcome test-22 [SNOT-22], etc.) AND
      2. The patient will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids) in combination with the requested agent
      3. The requested dose is based on the patient’s pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 600 mg every 2 weeks OR
    4. The patient has another FDA labeled indication for the requested agent AND BOTH of the following:
      1. The patient has had clinical benefit with the requested agent AND
      2. The requested dose is within FDA labeled dosing for the requested indication OR
    5. The patient has another indication that is supported in compendia for the requested agent AND BOTH of the following:
      1. The patient has had clinical benefit with the requested agent AND
      2. The requested dose is supported in compendia for the requested indication AND
  3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
  4. ONE of the following (Please refer to “Agents NOT to be used Concomitantly” table): 
    1. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
    2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
      1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND
      2. There is support for the use of combination therapy (copy of support required, e.g., clinical trials, phase III studies, guidelines) AND
  5. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use

Length of Approval:  6 months

CONTRAINDICATION AGENTS

Contraindicated as Concomitant Therapy

Agents NOT to be used Concomitantly

Abrilada (adalimumab-afzb)

Actemra (tocilizumab)

Adalimumab

Adbry (tralokinumab-ldrm)

Amjevita (adalimumab-atto)

Arcalyst (rilonacept)

Avsola (infliximab-axxq)

Benlysta (belimumab)

Bimzelx (bimekizumab-bkzx)

Cibinqo (abrocitinib)

Cimzia (certolizumab)

Cinqair (reslizumab)

Cosentyx (secukinumab)

Cyltezo (adalimumab-adbm)

Dupixent (dupilumab)

Enbrel (etanercept)

Entyvio (vedolizumab)

Fasenra (benralizumab)

Hadlima (adalimumab-bwwd)

Hulio (adalimumab-fkjp)

Humira (adalimumab)

Hyrimoz (adalimumab-adaz)

Idacio (adalimumab-aacf)

Ilaris (canakinumab)

Ilumya (tildrakizumab-asmn)

Inflectra (infliximab-dyyb)

Infliximab

Kevzara (sarilumab)

Kineret (anakinra)

Litfulo (ritlecitinib)

Nucala (mepolizumab)

Olumiant (baricitinib)

Omvoh (mirikizumab-mrkz)

Opzelura (ruxolitinib)

Orencia (abatacept)

Otezla (apremilast)

Remicade (infliximab)

Renflexis (infliximab-abda)

Riabni (rituximab-arrx)

Rinvoq (upadacitinib)

Rituxan (rituximab)

Rituxan Hycela (rituximab/hyaluronidase human)

Ruxience (rituximab-pvvr)

Siliq (brodalumab)

Simponi (golimumab)

Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Sotyktu (deucravacitinib) 

Stelara (ustekinumab)

Taltz (ixekizumab)

Tezspire (tezepelumab-ekko)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Tysabri (natalizumab)

Velsipity (etrasimod)

Wezlana (ustekinumab-auub)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Xolair (omalizumab)

Yuflyma (adalimumab-aaty)

Yusimry (adalimumab-aqvh)

Zeposia (ozanimod)

Zymfentra (infliximab-dyyb)

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.  

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

ALBP _  Commercial _ CS _ Xolair_omalizumab__PA _ProgSum_ 07-01-2024  _© Copyright Prime Therapeutics LLC. May 2024 All Rights Reserved