Category Filter
- Advanced Imaging
- Autism Spectrum Mandate
- Behavioral Health
- Blue Advantage Policies
- Chronic Condition Management
- Genetic Testing
- HealthSmartRx Smart RxAssist Program
- Hemophilia Drugs
- Medical Policies
- Pre-Service Review (Predetermination/Precertification)
- Provider-Administered Drug Policies
- Radiation Therapy
- Self-Administered Drug Policies
- Transgender Services
Asset Publisher
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 |
|
10-01-2024 |
|
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:
|
|
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. 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 the reliever reduces the risk of exacerbations compared with regimens with short-acting β2-agonist (SABA) as the reliever, and is a simpler regimen:(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.(2,12) The ERS/ATS definition uncontrolled asthma for adult and pediatric patients 6 years of age and over:(17)
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. 2023 GINA recommends the biologics below based on patient eligibility factors:(3)
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)
|
|
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 Polyps |
Chronic rhinosinusitis with nasal polyps (CRSwNP) is an inflammatory condition affecting the paranasal sinuses.(9) The exact cause of CRSwNP is unknown, but biopsies of nasal polyps have shown elevated levels of eosinophils. Sinus computed tomography (CT) and/or nasal endoscopy are needed to determine the presence of sinonasal inflammation and nasal polyps.(8) The International Consensus Statement on Allergy and Rhinology: Rhinosinusitis (ICAR-RS) indicates that the diagnostic criteria for CRSwNP consist of ALL the following:(11)
Topical saline irrigation and intranasal corticosteroids (INCS) are recommended in the guidelines as initial treatment for CRSwNP.(7,9,11) Nasal saline irrigation used as adjunct treatment with other therapies improves symptoms and quality of life (QoL) outcomes and is considered an important aspect of management of CRSwNP. Saline irrigation can improve nasal mucosa function through the mechanical clearance of thick mucus and inflammatory mediators, including eosinophilic mucin.(7,11) INCS can have a positive impact on the disease and improve symptoms, reduce nasal polyp size, and improve sense of smell.(7,11) The ICAR-RS strongly recommends INCS before or after sinus surgery.(11) INCS are well tolerated and long term treatment is effective and safe. Many different INCS have been used in the treatment of CRSwNP, including triamcinolone, mometasone, fluticasone, and budesonide, but no differences were shown to recommend a specific formulation.(7) For patients using INCS for at least 4 weeks and who continue to have high disease burden, biologics may be considered and preferred over other medical treatment choices.(9) Oral systemic corticosteroids (OCS), used as a short course, can result in a significant reduction in symptoms and nasal polyps for up to three months after the start of treatment. Up to 2 courses per year, taken in addition to INCS, can be useful for patients with partially or uncontrolled disease.(7) The ICAR-RS strongly recommends the use of OCS in the short term management of CRSwNP, but does not recommend longer term use due to the increased risk of adverse effects.(11) Endoscopic sinus surgery (ESS) is aimed at improving symptoms and creating better conditions for local treatment. Sinus surgery should be considered when disease is refractory and remains symptomatic despite trial of primary medical therapy (e.g., nasal sinus irrigation, INCS, oral corticosteroids). Based on current evidence, delaying surgical intervention can be detrimental to symptom improvement and outcomes.(7,11) After surgery, patients need to continue other treatments due to the chronic nature of the disease and nasal polyps potentially reoccurring despite surgery.(7,8) INCS can help to prevent nasal polyp recurrence.(7,11) Biologics can be considered in patients where their disease remains uncontrolled despite appropriate medical treatment and sinus surgery. (9,10) Biologics vary in their magnitude of benefits and harms and certainty of evidence across outcomes. Dupilumab and omalizumab are the most beneficial for most patient important outcomes when comparing with other biologics, followed by mepolizumab.(9) |
|
IgE-Mediated Food Allergy |
Food allergies have been increasing in prevalence in the past few decades affecting about 3-10% of children and up to 10% of adults. Food allergies can be classified based on the underlying mechanism as follows: IgE-mediated (type I hypersensitivity), non-IgE mediated (type III or type IV hypersensitivity), or mixed IgE and non-IgE mediated (combination of IgE and cellular mechanisms). The European Academy of Allergy and Clinical Immunology (EAACI) defines IgE-mediated food allergy as both of the following:(14)
Symptoms of IgE-mediated food allergy can be cutaneous, gastrointestinal, ocular, respiratory, cardiovascular, and/or neurological related. Signs and symptoms may clinically manifest in an isolated or concomitant manner, with the same timing or differing. Reactions can range from being mild and localized to being systemic and fatal, including anaphylaxis.(15) Diagnosing IgE-mediated food allergy typically involves a detailed allergy-focused clinical history as a first step. In patients with a history of suspected IgE-mediated food allergy, the EAACI strongly recommends IgE sensitizations tests, such as a skin prick test (SPT) and/or a serum specific IgE test, as first line to support the diagnosis. If the results are contradictory or equivocal with the clinical history, additional tests may need to be performed, including an oral food challenge (OFC). The EAACI strongly recommends a supervised OFC as the reference diagnostic procedure to confirm or exclude food allergy in patients with an unclear diagnosis despite IgE sensitization tests.(14) Due to patient and physician fears of severe reactions and logistic considerations, OFC should be reserved for cases that cannot be clarified with IgE sensitization tests.(14,15) Strict avoidance of trigger foods and training in the use of rescue medication for allergic reactions have been the main approach to manage food allergies. Strict avoidance of trigger foods can lead to reduced diet diversity, social restrictions impacting quality of life, potential risk of nutritional deficiencies, and anxiety over the possible accidental random exposure of the trigger food.(15) The Global Allergy and Asthma Excellence Network (GA2LEN) 2022 food allergy guidelines suggest that people with a documented food allergy avoid the offending food unless their individual circumstances and risks allow for some consumption, as advised by their healthcare professional.(16) When severe reactions occur, prompt administration of epinephrine should be used, which is the drug of choice for anaphylaxis. Allergen immunotherapy is an option for some food allergies as a disease-modifying therapy. Allergen immunotherapy uses sequential doses of increased amounts of the allergen in an attempt to desensitize the patient to the allergen.(15) The GA2LEN guidelines show that allergen immunotherapy can be a treatment option for some specific food allergies (i.e., peanut, hen’s egg, cow’s milk) for select children with substantial risk of severe reactions and/or substantially impaired quality of life. However, no recommendation was made for using allergen immunotherapy in adults, even though it may be useful for select adults if potential benefits outweigh the risks.(16) |
|
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. IgE-Mediated Food Allergy(1) The safety and efficacy of Xolair was evaluated in a multi-center, randomized, double-blind, placebo-controlled Food Allergy (FA) trial (NCT03881696) in adult and pediatric patients 1 year of age to less than 56 years who were allergic to peanut and at least two other foods, including mild, egg, wheat, cashew, hazelnut, or walnut (i.e., studied foods). The FA trial enrolled patients who experienced dose-limiting symptoms (e.g., moderate to severe skin, respiratory, or gastrointestinal symptoms) to a single dose of less than or equal to 100 mg of peanut protein and less than or equal to 300 mg protein for each of the other two foods during the screening double-blind placebo-controlled food challenge (DBPCFC). Patients with a history of severe anaphylaxis (defined as neurological compromise or requiring intubation) were excluded from the study. Patients were randomized 2:1 to receive a subcutaneous dosage of Xolair (based on serum IgE level measured before the start of treatment and body weight) or placebo every 2 to 4 weeks for 16 to 20 weeks. After 16 to 20 weeks of treatment, each patient completed a DBPCFC consisting of placebo and each of their 3 studied foods. Efficacy of Xolair was based on 165 pediatric patients who were included in the efficacy analyses. The efficacy of Xolair in adults is supported by the adequate and well-controlled trial of Xolair in pediatric patients, disease similarity in pediatric and adult patients, and pharmacokinetic (PK) similarity. The primary efficacy endpoint was the percentage of patients who were able to consume a single dose of greater than or equal to 600 mg of peanut protein without dose-limiting symptoms (e.g., moderate to severe skin, respiratory, or gastrointestinal symptoms) during DBPCFC. Xolair treatment led to a statistically higher response rate (68%) than placebo (5%). The secondary efficacy endpoints were the percentage of patients who were able to consume a single dose of greater than or equal to 10000 mg of cashew, milk, or egg protein without dose-limiting symptoms during DBPCFC. The study met secondary endpoints and demonstrated that Xolair treatment led to statistically higher response rates than placebo for all three foods. |
|
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 |
Holguín F, Cardet JC, Chung KF, et al. Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline. The European Respiratory Journal. 2020;55(1):1900588. doi:10.1183/13993003.00588-2019 |
|
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 |
Fokkens W, Lund VJ, Mullol J, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020;0(0):1-464. doi:10.4193/rhin20.600 |
|
8 |
Stevens WW, Schleimer RP, Kern RC. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016;4(4):565-572. doi:10.1016/j.jaip.2016.04.012 |
|
9 |
Rank MA, Chu DK, Bognanni A, et al. The Joint Task Force on Practice Parameters GRADE guidelines for the medical management of chronic rhinosinusitis with nasal polyposis. J Allergy Clin Immunol. 2023;151(2):386-398. doi:10.1016/j.jaci.2022.10.026 |
|
10 |
Fokkens WJ, Viskens A, Backer V, et al. EPOS/EUFOREA update on indication and evaluation of Biologics in Chronic Rhinosinusitis with Nasal Polyps 2023. Rhinology. 2023;0(0):194-202. doi:10.4193/rhin22.489 |
|
11 |
Orlandi RR, Kingdom TT, Smith TL, et al. International consensus statement on allergy and rhinology: rhinosinusitis 2021. International Forum of Allergy & Rhinology. 2021;11(3):213-739. doi: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. |
|
14 |
Santos AF, Riggioni C, Agache I, et al. EAACI guidelines on the diagnosis of IgE‐mediated food allergy. Allergy. 2023;78(12):3057-3076. doi:10.1111/all.15902 |
|
15 |
Cafarotti A, Giovannini M, Bégin P, Brough HA, Arasi S. Management of IgE‐mediated food allergy in the 21st century. Clinical & Experimental Allergy. 2022;53(1):25-38. doi:10.1111/cea.14241 |
|
16 |
Muraro A, De Silva D, Halken S, et al. Managing food allergy: GA2LEN guideline 2022. World Allergy Organization Journal. 2022;15(9):100687. doi:10.1016/j.waojou.2022.100687 |
|
17 |
Chung KF, Wenzel SE, Brożek J, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. The European Respiratory Journal. 2014;43(2):343-373. doi:10.1183/09031936.00202013 |
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_ 10-01-2024 _
© Copyright Prime Therapeutics LLC. July 2024 All Rights Reserved