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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 |
4/1/2023 |
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FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Xolair® (omalizumab) Injection for subcutaneous use |
Moderate to severe persistent asthma in 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 Limitation of use: Omalizumab is not indicated for treatment of other allergic conditions, other forms of urticaria, relief of acute bronchospasms, or status asthmaticus.
Chronic idiopathic urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment
Add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids |
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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 low dose inhaled corticosteroids (ICS) in combination with a long-acting beta agonist (LABA). Severe asthma is defined as asthma that requires Step 4 or 5 treatment (e.g., with high dose ICS plus a LABA) to prevent it from becoming ‘uncontrolled’ or which remains uncontrolled despite this therapy. 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 2022 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)
2022 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 severe exacerbations compared with regimens with SABA as reliever, with similar symptom control:(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 risks of SABA-only treatment:(3)
2022 GINA STEP recommendations for children (6 to 11 years of age) are intended to reduce the risk of serious exacerbations:(3)
Moderate to Severe Allergic (IgE-mediated) Asthma Allergic asthma is triggered by inhalation of allergens triggering the production of IgE, the antibody responsible for activation of allergic reactions. IgE is important to the pathogenesis of allergic asthma and the development and persistence of inflammation.(3,4) Severe asthma is defined by GINA guidelines as asthma that is uncontrolled despite adherence with maximal optimized GINA Step 4 or Step 5 therapy (e.g., medium or high dose ICS with a second controller; maintenance OCS) and treatment of contributory factors (e.g., inhaler technique, smoking or comorbidities), or that worsens when high dose treatment is decreased. Roughly 3% to 10% of adults with asthma have severe asthma. Guidelines recommend use of omalizumab as add on therapy for patients who have failed to respond to standard therapy and have IgE-mediated allergic asthma.(3,4) 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) 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) 2022 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. 2022 GINA recommends the following step-down therapy process in patients responding well to targeted biologic therapy:(3)
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Chronic Idiopathic Urticaria (CIU) |
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)
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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)
First line therapy for CRSwNP consists of nasal saline irrigation in combination with intranasal corticosteroids.(8-10) The American Academy of Family Physicians notes that no one intranasal corticosteroid is superior to another or that increased dosing provides greater effectiveness. The American Academy of Otolaryngology recommends a short course of oral corticosteroids if no response is seen with intranasal corticosteroids after 3-months of appropriate use.(10) Short courses of oral corticosteroids (up to three weeks) can improve sinonasal symptoms and endoscopic findings. Surgical intervention may be required in patients in which medical therapy is ineffective.(8,9) |
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. July 2021. |
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. 2022. 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/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022; 77: 734– 766. doi:10.1111/all.15090 |
7 |
|
8 |
Stevens WW, Schleimer RP, and Kern RC. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016;4(4):565–572. |
9 |
Sedaghat AR. Chronic Rhinosinusitis. Am Fam Physician. 2017 Oct;96(8):500-506. |
10 |
Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical Practice Guideline (Update): Adult Sinusitis. Otolaryngol Head Neck Surg. 2015;152(2 suppl):S1-S39. Reaffirmed by American Academy of Family Physicians April 2020. |
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 |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Preferred Status |
Effective Date |
|
||||||
Xolair |
omalizumab subcutaneous soln prefilled syringe |
150 MG/ML ; 75 MG/0.5ML |
M ; N ; O ; Y |
N |
|
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CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Xolair |
omalizumab subcutaneous soln prefilled syringe |
150 MG/ML ; 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
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 Adbry (tralokinumab-ldrm) Actemra (tocilizumab) Arcalyst (rilonacept) Avsola (infliximab-axxq) Benlysta (belimumab) Cibinqo (abrocitinib) Cimzia (certolizumab) Cinqair (reslizumab) Cosentyx (secukinumab) Dupixent (dupilumab) Enbrel (etanercept) Entyvio (vedolizumab) Fasenra (benralizumab) Humira (adalimumab) Ilaris (canakinumab) Ilumya (tildrakizumab-asmn) Inflectra (infliximab-dyyb) Infliximab Kevzara (sarilumab) Kineret (anakinra) Nucala (mepolizumab) Olumiant (baricitinib) 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) Xeljanz (tofacitinib) Xeljanz XR (tofacitinib extended release) Xolair (omalizumab) Zeposia (ozanimod) |
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.
Commercial _ CS _ Xolair (omalizumab) Prior Authorization _ProgSum_ 4/1/2023