Anthem Blue Cross California Monoclonal Antibodies to Interleukin-5 Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of monoclonal antibodies against interleukin-5 (IL-5) in the treatment of individuals with eosinophilic conditions, including severe uncontrolled eosinophilic asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome. The agents approved by the Food and Drug Administration (FDA) include: • Cinqair (reslizumab), a monoclonal anti-IL-5 antibody • • Nucala (mepolizumab), a monoclonal anti-IL-5 antibody Fasenra (benralizumab), a monoclonal anti-IL-5 receptor alpha antibody Eosinophilic Asthma Researchers have discovered that eosinophils play a pivotal role in immune development and asthma. Eosinophils are a type of white blood cell whose natural role is to defend the body against disease and environmental substances. Eosinophils accumulate wherever allergic reactions take place, including those in allergic asthma. In individuals with eosinophilic asthma, white blood cells accumulate and release chemicals that may damage the lining of the lungs. Studies examining individuals with mild asthma have shown that airway inflammation due to eosinophils is a typical characteristic, and eosinophilic airway inflammation appears to be closely related to the risk of severe asthma exacerbations. Although the role eosinophils play in the pathophysiology of asthma is unclear, they represent a biomarker for predicting whether individuals will respond to corticosteroids, predicting which persons are at risk of exacerbation and for guiding steroid therapy in these events. Cinqair, Fasenra and Nucala are approved by the FDA to treat severe eosinophilic asthma. In 2013, the European Respiratory Society/American Thoracic Society (ERS/ATS) released guidance for defining, evaluating and treating severe asthma. The guidelines recommend to start by confirming the asthma diagnosis, including a spirometry assessment, and then differentiating severe asthma from milder asthma. The guidelines define severe asthma as asthma which has required treatment with high dose inhaled corticosteroids and a long-acting beta agonist, leukotriene modifier or theophylline for the previous year in order to prevent asthma symptoms from becoming uncontrolled. Alternatively, severe asthma can be defined as asthma that has required systemic corticosteroid treatment for over 50% of the previous year. ERS/ATS guidance defines uncontrolled asthma as meeting one of the following: • Poor symptom control: Asthma Control Questionnaire (ACQ) consistently >1.5, Asthma Control Test (ACT) <20 • • History of serious exacerbation: at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous Frequent severe exacerbations: two or more bursts of systemic corticosteroids in the previous year year • Airflow limitation: after appropriate bronchodilator withhold FEV 1 <80% predicted Cinqair is approved by the FDA for add-on maintenance treatment of individuals 18 years of age and older with severe asthma with an eosinophilic phenotype. Cinqair is administered monthly by intravenous infusion. The safety and efficacy of Cinqair was evaluated in two multicenter, randomized, double-blind, placebo-controlled trials in individuals with severe eosinophilic asthma confirmed by blood eosinophils ≥ 400 cells/microliter. Participants received background treatment consisting of medium-to-high dose inhaled corticosteroids 1 +/- long-acting beta agonist (LABA) +/- oral corticosteroids. Study data confirms the efficacy of Cinqair in reducing asthma exacerbations and improving asthma control and quality of life measures. Cinqair has a black box warning for anaphylaxis. Anaphylaxis occurred with Cinqair infusion in 0.3% of participants in placebo- controlled studies. Individuals should be observed after Cinqair administration for an appropriate period of time by a healthcare professional prepared to manage anaphylaxis that can be life-threatening. Discontinue Cinqair immediately if the patient experiences signs or symptoms of anaphylaxis. Fasenra is approved by the FDA for add-on maintenance treatment of individuals 12 years of age and older with severe asthma with an eosinophilic phenotype. Fasenra is administered every 8 weeks by subcutaneous injection. The safety and efficacy of Fasenra was evaluated in three multicenter, randomized, double-blind placebo-controlled trials (CALIMA, SIROCCO, ZONDA) in individuals with severe eosinophilic asthma confirmed by blood eosinophils ≥ 300 cells/microliter. The steroid-sparing study (ZONDA) enrolled participants with blood eosinophils ≥ 150 cells/microliter. Participants received background treatment consisting of medium-to-high dose inhaled corticosteroids + LABA +/- oral corticosteroids. Study data confirms the efficacy of Fasenra in reducing exacerbations that require hospitalization or emergency department visits, improving asthma control and providing a steroid-sparing benefit. Nucala is approved by the FDA as add-on maintenance treatment of individuals 6 years of age and older with severe asthma with an eosinophilic phenotype. Nucala is administered monthly by subcutaneous injection. The safety and effectiveness of Nucala was established in three multicenter, double-blind, randomized, placebo-controlled trials (DREAM, SIRIUS, MENSA) in individuals with severe eosinophilic asthma confirmed by blood eosinophils ≥ 150 cells/microliter at initiation of treatment or blood eosinophils ≥ 300 cells/microliter in the past 12 months. Participants received background treatment consisting of high dose inhaled corticosteroids + controller therapy +/- oral corticosteroids. Study data confirms the efficacy of Nucala in reducing exacerbations that require hospitalization or emergency department visits, improving asthma control and quality of life measures and providing a steroid-sparing benefit. The 2022 Global Initiative for Asthma (GINA) guidelines include Cinqair, Fasenra and Nucala as treatment options in Step 5 of their asthma management algorithm. Add-on targeted biologic therapy should be considered for individuals with exacerbations or poor symptom control despite taking at least high-dose inhaled corticosteroid/long acting beta 2 –agonists and who have allergic or eosinophilic biomarkers or need maintenance oral corticosteroids. The 2020 European Respiratory Society/American Thoracic Society (ERS/ATS) guideline on management of severe asthma makes a similar recommendation, suggesting an anti-IL-5 agent as add-on therapy for adults with severe uncontrolled asthma with an eosinophilic phenotype. Comparative Dodses for Inhaled Corticosteroids (Adults and Adolescents) (Wenzel 2021) Drug Beclomethasone 40 or 80 mcg/actuation Budesonide 90 or 180 mcg/actuation Ciclesonide 80 or 160 mcg/actuation Fluticasone propionate MDI: 44, 110 or 220 mcg/actuation DPI: 50, 100 or 250 mcg/dose Fluticasone furoate 50, 100 or 200 mcg/dose Mometasone MDI: 50, 100 or 200 mcg/actuation DPI: 110 or 220 mcg/actuation Low Daily Dose Medium Daily Dose High Daily Dose 80-160 mcg >160-320 mcg >320-640 mcg 180-360 mcg >360–720 mcg >720-1440 mcg 160 mcg 320 mcg 640 mcg 176–220 mcg 100-250 mcg >220–440 mcg >250–500 mcg >440-1760 mcg >500-2000 mcg 50 mcg 200 mcg 220 mcg 100 mcg 200 mcg >200-400 mcg >220-440 mcg >400-800 mcg >440-880 mcg DPI = dry powder inhaler, MDI = metered dose inhaler Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Nucala is approved by the FDA as add-on maintenance treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP). FDA approval was based on the results of a randomized, double-blind, placebo-controlled trial where nasal polyp score (NPS) and nasal obstruction visual analog scale (VAS) score were the principal outcome. The trial enrolled individuals with recurrent and symptomatic nasal polyps with an inadequate response to at least 8 weeks of nasal corticosteroids as well as at least one surgery for polyp removal within the previous 10 years. Participants received Nucala or placebo in addition to background nasal corticosteroid therapy. The Nucala group had a statistically significant greater improvement at week 52 in NPS and nasal obstruction VAS score compared to the placebo group. 2 In 2014, the Joint Task Force on Practice Parameters (JTFPP) representing the American Academy of Allergy, Asthma & Immunology (AAAAI), the American College of Allergy, Asthma & Immunology (ACAAI) and the Joint Council of Allergy, Asthma & Immunology published a practice parameter on the diagnosis and management of rhinosinusitis. In 2015, the American Academy of Otolaryngology- Head and Neck Surgery Foundation (AAO-HNS) published a clinical practice guideline on adult sinusitis. Both publications recommend confirming a clinical diagnosis of nasal polyps with imaging using anterior rhinoscopy, nasal endoscopy or computed tomography (CT). Intranasal corticosteroids are recommended for long-term treatment of nasal polyps. A short course of oral corticosteroids is included as a reasonable option to decrease polyp size and alleviate symptoms. Sinonasal surgery is another treatment option. The AAAAI/ACAAI guidance predates Nucala receiving FDA approval for nasal polyps but states Nucala has shown benefit in treatment of CRSwNP. In 2022, the JTFPP published guidelines for the medical management of CRSwNP. The guidelines focus on select interventions for treatment of CRSwNP including intranasal corticosteroids, biologics and aspirin therapy after desensitization. The guidelines recommend intranasal corticosteroids over no intranasal corticosteroids in individuals with CRSwNP. The guidelines also recommend biologics over no biologics but note it is a conditional recommendation as other treatment options should be considered or used together with biologics (including inhaled corticosteroids and surgery. Eosinophilic Granulomatosis with Polyangiitis Eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome, is a multisystem disorder characterized by chronic rhinosinusitis, asthma and prominent peripheral blood eosinophilia. EGPA is classified as a vasculitis of the small to medium-sized arteries although the vasculitis is often not apparent in the initial phases of the disease. This blood vessel inflammation affects organ systems including the lungs, gastrointestinal tract, skin, heart and nervous system. Nucala is approved by the FDA for the treatment of adults with EGPA. The safety and efficacy of Nucala for the treatment of EGPA was evaluated in a multicenter, parallel-group, double-blind, phase 3 trial of 136 adults with a diagnosis of relapsing or refractory EGPA for at least six months who had received at least 4 weeks of a stable prednisolone or prednisone therapy. The clinical trial inclusion criteria defined EGPA as a history or presence of asthma, a blood eosinophil level of greater than or equal to 10% of leukocytes or an absolute eosinophil count of greater than 1000 cells per mm3 and the presence of two or more features associated with EGPA. Participants were randomized to receive Nucala or placebo in addition to standard care (glucocorticoid treatment with or without immunosuppressive therapy). The two primary endpoints in the clinical trial were the accrued weeks of disease remission over a 52-week period and the proportion of participants in remission at both week 36 and week 48 of treatment. Remission was defined as Birmingham Vasculitis Activity Score (BVAS) = 0 [no active vasculitis] and the receipt of prednisolone or prednisone at a dose of 4 mg or less per day. Participants receiving Nucala achieved a significantly greater accrued time in remission compared to placebo (28% vs. 3% of participants had ≥ 24 weeks of accrued remission; odds ratio, 5.91; 95% CI, 2.68 to 13.03; p<0.001) and a significantly higher proportion of participants in remission at both week 36 and week 48 compared to placebo (32% vs. 3%; odds ratio, 16.74; 95% CI, 3.61 to 77.56; p<0.001). In 2021, the American College of Rheumatology/Vasculitis Foundation (ACR/VF) published guidelines for the management of vasculitis. The guidelines discuss the role of Nucala in non-severe relapsing disease. For individuals with active, non-severe EGPA, ACR/VF conditionally recommends initiating treatment with Nucala and glucocorticoids over methotrexate, azathioprine or mycophenolate mofetil and glucocorticoids. For individuals with EGPA who have experienced relapse with non-severe disease manifestations (asthma and/or sinonasal disease) while receiving methotrexate, azathioprine or mycophenolate mofetil, ACR/VF conditionally recommends adding Nucala over switching to another agent. For patients with EGPA who have experienced relapse with non-severe disease manifestations (asthma and/or sinonasal disease) while receiving low-dose glucocorticoids and no other therapy, ACR/VF conditionally recommends adding Nucala over adding methotrexate, azathioprine or mycophenolate mofetil. Hypereosinophilic Syndrome Hypereosinophilic syndromes (HES) are a group of rare disorders marked by increased levels of eosinophils in blood and tissues. Eosinophils can infiltrate many organ systems and lead to dermatological, pulmonary, gastrointestinal, neurologic and cardiovascular manifestations. HES diagnosis can be confirmed by blood eosinophil counts greater than or equal to 1,500 cells/microliter on two or more occasions and/or tissue eosinophilia. The goal of treatment is to reduce eosinophil levels and prevent organ damage. Systemic corticosteroids are the backbone of HES therapy. Immunosuppressive and cytotoxic agents are also utilized in treatment of HES. Nucala is approved by the FDA for the treatment of individuals age 12 years and older with HES for ≥6 months without an identifiable non-hematologic secondary cause. The safety and efficacy of Nucala for the treatment of HES was evaluated in a randomized, double-blind, placebo-controlled, multicenter, 32-week trial in 108 individuals aged 12 and older with HES for at least six months. Participants in the trial had experienced 3 at least two HES flares within the past 12 months and had a blood eosinophil count greater than or equal to 1,000 cells/microliter at screening. Individuals with non-hematologic secondary HES (including drug hypersensitivity, parasitic helminth infection, HIV infection, non-hematologic malignancy) or FIP1L1-PDGFRα kinase-positive HES were excluded from the trial. Participants were randomized to receive Nucala or placebo in addition to background HES therapy consisting of chronic or episodic oral corticosteroids, immunosuppressive and/or cytotoxic therapy. The primary endpoint in the clinical trial was the number of HES flares. HES flare was defined as worsening of clinical signs and symptoms of HES or increasing eosinophils resulting in the need to escalate background HES therapy by increasing the oral corticosteroid dose or increasing/adding cytotoxic or immunosuppressive therapy. Over the 32-week treatment period, the incidence of HES flares was 28% for the Nucala group compared to 56% for the placebo group. Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Cinqair (reslizumab) Initial requests for Cinqair (reslizumab) for severe eosinophilic asthma may be approved if the following criteria are met: I. II. III. IV. V. VI. Individual is 18 years of age or older; AND Individual has a diagnosis of severe eosinophilic asthma; AND Evidence of asthma is demonstrated by the following (NAEPP, 2008): A. B. A pretreatment forced expiratory volume in 1 second (FEV1) less than 80% predicted; AND FEV1 reversibility of at least 12% and 200 ml after albuterol administration; AND Documentation is provided that individual has had a 3 month trial and inadequate response or intolerance to combination controller therapy (high dose inhaled corticosteroids plus long acting beta2 –agonists, leukotriene modifiers, long-acting muscarinic antagonists or oral corticosteroids) (GINA 2022); AND Individual has experienced two or more asthma exacerbations in the prior 12 months requiring use of a systemic corticosteroid or temporary increase in the individual’s usual maintenance dosage of oral corticosteroids (ERS/ATS, 2013); AND Documentation is provided that individual has a blood eosinophil count (in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection) greater than or equal to 400 cells/microliter (400 cells/mm3) at initiation of therapy. Continuation requests for Cinqair (reslizumab) for severe eosinophilic asthma may be approved if the following criteria are met: I. Treatment with Cinqair has resulted in clinical improvement in one or more of the following: A. Decreased utilization of rescue medications; OR B. Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in inhaled C. corticosteroid dose or treatment with systemic corticosteroids); OR Increase in percent predicted FEV1 from pretreatment baseline; OR Reduction in reported asthma-related symptoms, such as asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing. Cinqair (reslizumab) may not be approved for the following: I. II. In combination with Dupixent, Fasenra, Nucala, Tezspire or Xolair; OR May not be approved when the above criteria are not met and for all other indications. Approval Duration Initial Requests: 6 months Continuation Requests: 12 months Fasenra (benralizumab) Initial requests for Fasenra (benralizumab) for severe eosinophilic asthma may be approved if the following criteria are met: I. II. Individual is 12 years of age or older; AND Individual has a diagnosis of severe eosinophilic asthma; AND 4 III. Evidence of asthma is demonstrated by the following (NAEPP, 2008): A. A pretreatment forced expiratory volume in 1 second (FEV1) less than 80% predicted; AND B. FEV1 reversibility of at least 12% and 200 milliliters after albuterol administration; AND IV. V. VI. Documentation is provided that individual has had a 3 month trial and inadequate response or intolerance to combination controller therapy (high dose inhaled corticosteroids plus long acting beta2 –agonists, leukotriene modifiers, long-acting muscarinic antagonists or oral corticosteroids) (GINA 2022); AND Individual has experienced two or more asthma exacerbations in the prior 12 months requiring use of a systemic corticosteroid or temporary increase in the individual’s usual maintenance dosage of oral corticosteroids (ERS/ATS, 2013); AND Documentation is provided that individual has a blood eosinophil count (in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection) greater than or equal to 300 cells/microliter (300 cells/mm3) at initiation of therapy. Continuation requests for Fasenra (benralizumab) for severe eosinophilic asthma may be approved if the following criteria are met: I. Treatment with Fasenra has resulted in clinical improvement in one or more of the following: A. Decreased utilization of rescue medications; OR B. Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in inhaled corticosteroid dose or treatment with systemic corticosteroids); OR Increase in percent predicted FEV1 from pretreatment baseline; OR C. D. Reduction in reported asthma-related symptoms, such as asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing. Fasenra (benralizumab) may not be approved for the following: I. II. In combination with Cinqair, Dupixent, Nucala, Tezspire or Xolair; OR May not be approved when the above criteria are not met and for all other indications. Approval Duration Initial Requests: 6 months Continuation Requests: 12 months Nucala (mepolizumab) Initial requests for Nucala (mepolizumab) for severe eosinophilic asthma may be approved if the following criteria are met: I. II. III. IV. V. VI. Individual is 6 years of age or older; AND Individual has a diagnosis of severe eosinophilic asthma; AND Evidence of asthma is demonstrated by the following (NAEPP, 2008): A. A pretreatment forced expiratory volume in 1 second (FEV1) less than 80% predicted; AND B. FEV1 reversibility of at least 12% and 200 milliliters after albuterol administration; AND Documentation is provided that individual has had a 3 month trial and inadequate response or intolerance to combination controller therapy (high dose inhaled corticosteroids plus long acting beta2 –agonists, leukotriene modifiers, long-acting muscarinic antagonists or oral corticosteroids) (GINA 2022); AND Individual has experienced two or more asthma exacerbations in the prior 12 months requiring use of a systemic corticosteroid or temporary increase in the individual’s usual maintenance dosage of oral corticosteroids (ERS/ATS, 2013); AND Documentation is provided that individual has one of the following blood eosinophil counts (in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease and known or suspected parasitic infection): A. Greater than or equal to 150 cells/microliter (150 cells/mm3) at initiation of therapy; OR B. Greater than or equal to 300 cells/microliter (300 cells/mm3) in the prior 12 months. Continuation requests for Nucala (mepolizumab) for severe eosinophilic asthma may be approved if the following criteria are met: I. Treatment with Nucala has resulted in clinical improvement in one or more of the following: A. Decreased utilization of rescue medications; OR B. Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in inhaled corticosteroid dose or treatment with systemic corticosteroids); OR Increase in percent predicted FEV1 from pretreatment baseline; OR C. D. Reduction in reported asthma-related symptoms, such as asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing. 5 Initial requests for Nucala (mepolizumab) for eosinophilic granulomatosis with polyangiitis may be approved if the following criteria are met: I. II. Individual is 18 years of age or older; AND Individual has been diagnosed with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA) defined as (Wechsler, 2017): A. A history or presence of asthma; AND B. A blood eosinophil level of greater than or equal to 10% of leukocytes or an absolute eosinophil count of greater than 1000 cells per mm3 (in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease and known or suspected parasitic infection), and documentation is provided; AND C. The presence of two or more features of eosinophilic granulomatosis with polyangiitis (such as, a biopsy showing histopathological evidence of eosinophilic vasculitis, perivascular eosinophilic infiltration, or eosinophil-rich granulomatosis inflammation; neuropathy, mono or poly [motor deficit or nerve conduction abnormality]; pulmonary infiltrates, non-fixed; sinonasal abnormality; cardiomyopathy; glomerulonephritis; alveolar hemorrhage; palpable purpura; antineutrophil cytoplasmic antibody [ANCA] positive status); AND III. Individual is using in combination with oral corticosteroid therapy (Wechsler, 2017). Continuation requests for Nucala (mepolizumab) for eosinophilic granulomatosis with polyangiitis may be approved if the following criteria are met: I. Treatment with Nucala has resulted in the achievement of remission at some point during treatment defined as (Wechsler, 2017): A. Birmingham Vasculitis Activity Score (BVAS), version 3, of 0 (on a scale from 0 to 63), and documentation is provided; AND B. Receipt of prednisolone or prednisone at a dose of 4 mg or less per day. Initial requests for Nucala (mepolizumab) for hypereosinophilic syndrome (HES) may be approved if the following criteria are met: I. II. III. IV. V. Individual is 12 years of age or older; AND Individual has been diagnosed with hypereosinophilic syndrome (HES) for at least six months; AND Individual has had a trial and inadequate response to oral corticosteroids (WHO 2022); AND Documentation is provide that individual has experienced two or more HES flares within the past 12 months requiring escalation in therapy (increase in oral corticosteroid dose or increase/addition of immunosuppressive or cytotoxic therapy); AND Documentation is provided that individual has a blood eosinophil count greater than or equal to 1,000 cells/microliter. Continuation requests for Nucala (mepolizumab) for hypereosinophilic syndrome (HES) may be approved if the following criteria are met: I. Treatment with Nucala has resulted in clinically significant improvement or stabilization in clinical signs and symptoms of disease (including but not limited to decrease or absence of HES flares, improvement in fatigue). Nucala (mepolizumab) for hypereosinophilic syndrome (HES) may not be approved for the following: I. II. Individuals with non-hematologic secondary HES (including but not limited to drug hypersensitivity, parasitic helminth infection, HIV infection, non-hematologic malignancy); OR Individuals with FIP1L1-PDGFRα kinase-positive HES. Initial requests for Nucala (mepolizumab) for chronic rhinosinusitis with nasal polyps (CRSwNP) may be if approved if the following criteria are met: I. II. III. Individual is 18 years of age or older; AND Individual has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP); AND Documentation is provided that there is presence of bilateral nasal polyps demonstrated on one of the following (AAO- HNS 2015): A. Anterior rhinoscopy; OR B. Nasal endoscopy; OR C. Computed tomography (CT); AND IV. V. Individual has had a trial and inadequate response to maintenance intranasal corticosteroids; AND Individual is refractory to or is ineligible or intolerant to the following (AAAAI/ACAAI 2014, JTFPP 2022): A. Systemic corticosteroids; OR 6 VI. Individual is requesting Nucala as add-on therapy to maintenance intranasal corticosteroids. B. Sinonasal surgery; AND Continuation requests for Nucala (mepolizumab) for chronic rhinosinusitis with nasal polyps (CRSwNP) may be if approved if the following criteria are met: I. II. Treatment with Nucala has resulted in clinically significant improvement in clinical signs and symptoms of disease (including but not limited to improvement in nasal congestion or reduced nasal polyp size); AND Individual continues to use Nucala in combination with maintenance intranasal corticosteroids. Nucala (mepolizumab) may not be approved for the following: I. II. In combination with Cinqair, Dupixent, Fasenra, Tezspire or Xolair; OR May not be approved when the above criteria are not met and for all other indications. Approval Duration Initial Requests: 6 months Continuation Requests: 12 months Quantity Limits Selected Monoclonal Antibodies to Interleukin-5 Quantity Limits Drug Cinqair (reslizumab) 100 mg vial Fasenra (benralizumab) 30 mg prefilled syringe/autoinjector Nucala (mepolizumab) 40 mg/0.4 mL prefilled syringe Nucala (mepolizumab) 100 mg vial, 100 mg/ml prefilled syringe/autoinjector Limit 3 mg/kg every 4 weeks 30 mg (1 syringe/autoinjector) every 8 weeks 40 mg (1 syringe) every 4 weeks 100 mg (1 vial/syringe/autoinjector) every 4 weeks Override Criteria For Fasenra, may approve 1 additional 30 mg prefilled syringe/autoinjector at week 4. The total allowed quantity for initiation of therapy is 30 mg once every 4 weeks for the first 3 doses. For Nucala, may approve up to 300 mg (3 vials/syringes/autoinjectors) every 4 weeks if individual is using for eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome (HES). Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS J0517 J2182 J2182 J2786 ICD-10 Diagnosis J32.0-J32.8 J33.9 J45.20-J45.998 J82.81-J82.89 M30.1 Injection, benralizumab, 1 mg [Fasenra] Injection, mepolizumab, 1 mg [Nucala] [Nucala] (mepolizumab) 40 mg/0.4 mL prefilled syringe) Injection, reslizumab, 1 mg [Cinqair] Chronic sinusitis Nasal Polyp Asthma Pulmonary eosinophilia, not elsewhere classified Polyarteritis with lung involvement (Churg-Strauss) [mepolizumab (Nucala) only] 7 Doc Document History Revised: 2/24/2023