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Xolair (omalizumab) Prior Authorization Program Summary
Policy Number: PH-1171
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:
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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)
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)
2023 GINA STEP recommendations for children (6 to 11 years of age) are intended to reduce the risk of serious exacerbations:(3)
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)
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)
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:
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)
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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)
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)
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)
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 Immunol. 2009 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:
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:
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