FASENRA (benralizumab) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Medical Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. O1045.docx Page 1 of 9
FASENRA (benralizumab) Description: FASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for the add-on maintenance treatment of individuals aged 12 years and older with severe asthma with an eosinophilic phenotype. Asthma is a complex disorder characterized by variable and recurring clinical symptoms, airflow obstruction, bronchial hyperresponsiveness and underlying inflammation. Inflammation is an important component in the pathogenesis of asthma. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes and cytokines) are involved in inflammation. It is estimated that about half of individuals with severe asthma exhibit the eosinophilic phenotype with elevated eosinophil levels (a marker of inflammation) in both the blood and airways. Activated eosinophils can increase airway smooth muscle contraction and mucous secretion. Interleukin-5 (IL-5) is an important cellular signal in eosinophilic inflammation. About 10% of asthma individuals have severe asthma which may be uncontrolled despite high doses of standard-of-care asthma controller medicines and can require the use of chronic oral corticosteroids (OCS). Severe, uncontrolled asthma is debilitating and potentially fatal with individuals experiencing frequent exacerbations and significant limitations on lung function and quality of life. Inhaled corticosteroids (ICS) are the most effective long term therapy for control and management of asthma. Asthma is said to be well controlled when asthma symptoms are twice a week or less; use of rescue bronchodilator medication is twice a week or less; there is no nocturnal or early morning awaking due to asthma symptoms; there are no limitations of work, school, or exercise; and the Forced Expiratory Volume (FEV1) is normal or at the individual s personal best. On the other hand, indicators of asthma that is not adequately controlled include limitation of normal activities, poor lung function with FEV1 of < 80% predicted, at least 2 episodes per year of asthma exacerbations requiring oral systemic corticosteroids. More frequent and intense exacerbations requiring urgent, unscheduled care, hospitalization, or ICU admission points toward worse disease control. O1045.docx Page 2 of 9 Classification of Asthma Control (12 years of age and older) Well Controlled Not Well Controlled Very Poorly Controlled Symptoms < 2 days/week > 2 days/week Throughout the day Nighttime awakenings < 2 days/month 1-3x/week > 4x/week Interference with normal activities None Some limitation Extremely limited SABA use to control symptoms (not for EIB prevention < 2 days/week > 2 days/week Several times/day FEV1 or peak flow > 80% predicted or personal best 60-80% predicted or personal best Asthma Control Test > 20 16-19 < 15 < 60% predicted or personal best
Criteria: Fasenra for the add-on maintenance treatment of individuals aged 12 years and older with severe asthma with an eosinophilic phenotype is considered medically necessary with documentation of ALL of the following: 1. Provider is an allergist, immunologist or pulmonologist 2. Individual has been compliant with maximally-dosed inhaled corticosteroid and long acting inhaled beta-2 agonist and another asthma controlling medication (such as LTRA, LAMA, or theophylline) with or without daily oral corticosteroid for at least the last three months 3. Individual has poor control of severe asthma or has recurrent exacerbations requiring additional medication treatment with documentation of ALL of the following: Frequent (two or more) severe asthma exacerbations requiring courses of systemic corticosteroids (steroid burst) within the past 12 months One or more serious asthma exacerbations requiring visit to emergency room or urgent care, or requiring hospitalization or mechanical ventilation within the past 12 months Controlled asthma that worsens when the dose of inhaled or systemic corticosteroid is tapered Baseline forced expiratory volume (FEV1) is less than 80% predicted or has FEV1/FVC < 0.8 4. Blood eosinophil count is > 150 cells/microliter in the past 3 months or > 300 cells/microliter in the past 12 months 5. Individual s underlying conditions or triggers for asthma or pulmonary disease are being maximally managed 6. Will not be used for the relief of acute bronchospasm or status asthmaticus 7. Will not be used for the treatment of other eosinophilic conditions 8. Will not be used concurrently with Xolair (omalizumab), Nucala (mepolizumab), Cinqair (reslizumab), Dupixent (dupilumab) 9. Absence of ALL of the following contraindications: Known hypersensitivity to benralizumab or any of its excipients O1045.docx Page 3 of 9
Criteria: (cont.) Continuation of Fasenra is considered medically necessary with documentation of ALL of the following: 1. ONE of the following: Decrease dose of inhaled corticosteroids (ICS) Decrease need for systemic corticosteroids Decreased utilization of rescue medications Increase in predicted FEV1 from baseline Decrease in hospitalizations/emergency room visits Decreased exacerbations 2. Must be using and is adherent with ICS-containing asthma controller medication(s) 3. NOT used for the treatment of other eosinophilic conditions 4. NOT used for the relief of acute bronchospasm or status asthmaticus 5. NOT used with Cinqair (reslizumab), Nucala (mepolizumab), Xolair (omalizumab) or Dupixent (dupilumab) Fasenra for all other indications not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Lack of final approval from the Food and Drug Administration, and 2. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 3. Insufficient evidence to support improvement of the net health outcome, and 4. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 5. Insufficient evidence to support improvement outside the investigational setting. These indications include, but are not limited to: Treatment with dosing or frequency outside the FDA-approved dosing and frequency O1045.docx Page 4 of 9
Resources: Literature reviewed 02/06/18. We do not include marketing materials, poster boards and nonpublished literature in our review. 1. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2016. Accessed 01/24/2018. Available at www.ginasthma.org. Fasenra Package Insert: - FDA-approved indication and dosage: Indication For the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Recommended Dose Administer by subcutaneous injection. Recommended dose is 30 mg every 4 weeks for the first 3 doses, followed by once every 8 weeks thereafter. Limitations of Use: Not for treatment of other eosinophilic conditions. Not for relief of acute bronchospasm or status asthmaticus. Initial Approval Duration: 3 months Renewal Approval Duration: 12 months O1045.docx Page 5 of 9
Resources: (cont.) Bronchodilators Short-acting beta-agonists (SABA) Long-acting beta-agonists (LABA) Short-acting antimuscarinics (SAMA) Long-acting antimuscarinics (LAMA) Inhaled corticosteroids (ICS) Combination products Antimuscarinics/beta agonist ICS/LABA Other Leukotriene Receptor Antagonists (LRTA) Xanthine derivatives albuterol (ProAir HFA, ProAir RespiClick, Proventil HFA, Ventolin HFA) levalbuterol (Xopnenx HFA) formoterol (Foradil aerolizer) indacaterol (Arcapta Neohaler) olodaterol (Striverdi Respimat) salmeterol (Serevent Diskus) ipratropium (Atrovent HFA) aclidinium (Tudorza Pressair) glycopyrrolate (Seebri Neohaler) tiotropium (Spiriva, HandiHaler, Spiriva Respimat) umeclidinium (Incruse Ellipta) beclomethasone (Qvar) budesonide (Pulmicort Flexhaler) ciclesonide (Alvesco) flunisolide (Aerospan) fluticasone (Arnuity Ellipta, Flovent Diskus, Flovent HFA) mometasone (Asmanex, Asmanex HFA) ipratropium/albuterol (Combivent Respimat) glycopyrrolate/formoterol (Bevespi Aerosphere) glycopyrrolate/indacaterol (Utibron) tiotropium/olodaterol (Stiolto Respimat) umeclidinium/vilanterol (Anoro Ellipta) budesonide/formoterol (Symbicort) fluticasone/salmeterol (Advair HFA, Advair Diskus) fluticasone/vilanterol (Breo Ellipta) mometasone/formoterol (Dulera) montelukast (Singulair) zafirlukast (Accolate) zileuton (Zyflo, Zyflo CR) theophylline available as nebulized product: albuterol, levalbuterol, Brovana (arformoterol), Perforomist (formoterol), ipratropium, ipratropium/albuterol, Pulmicort Respules (budesonide) O1045.docx Page 6 of 9
Resources: (cont.) 2016 GINA Guidelines on Stepwise Approach to Treatment of Asthma Coding: HCPCS: C9399, J3590 Coding Updates: O1045.docx Page 7 of 9
Non-Discrimination Statement: Blue Cross Blue Shield of Arizona (BCBSAZ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability or sex. BCBSAZ provides appropriate free aids and services, such as qualified interpreters and written information in other formats, to people with disabilities to communicate effectively with us. BCBSAZ also provides free language services to people whose primary language is not English, such as qualified interpreters and information written in other languages. If you need these services, call (602) 864-4884 for Spanish and (877) 475-4799 for all other languages and other aids and services. If you believe that BCBSAZ has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability or sex, you can file a grievance with: BCBSAZ s Civil Rights Coordinator, Attn: Civil Rights Coordinator, Blue Cross Blue Shield of Arizona, P.O. Box 13466, Phoenix, AZ 85002-3466, (602) 864-2288, TTY/TDD (602) 864-4823, crc@azblue.com. You can file a grievance in person or by mail or email. If you need help filing a grievance BCBSAZ s Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 509F, HHH Building, Washington, DC 20201, 1 800 368 1019, 800 537 7697 (TDD). Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html Multi-Language Interpreter Services: O1045.docx Page 8 of 9
Multi-Language Interpreter Services: (cont.) O1045.docx Page 9 of 9