MEDICAL COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 07/05/18 SECTION: DRUGS LAST REVIEW DATE: LAST CRITERIA REVISION DATE: ARCHIVE DATE:

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1 CINQAIR (reslizumab) 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. O990.3.docx Page 1 of 9

2 CINQAIR (reslizumab) Description: Cinqair (reslizumab) is an interleukin-5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance in the treatment of severe asthma with an eosinophilic phenotype. It is administered by a healthcare provider. Definitions: Recurrent Exacerbations: 2 or more acute exacerbations in a 12-month period Severe Asthma: Asthma that does not respond to repeated courses of treatment with beta2-agonist medications. Adult: Age 18 years and older Criteria: See Resources section for FDA-approved dosage and 2016 GINA Guidelines on Stepwise Approach to Treatment of Asthma, Classification of Asthma Control, Asthma Control Test, and Bronchodilators. Cinqair is considered medically necessary for add-on maintenance treatment of individuals aged 18 years and older, with severe asthma with an eosinophilic phenotype 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 ANY 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 < Blood eosinophil count is > 400 cells/microliter within the last 3-4 weeks of dosing O990.3.docx Page 2 of 9

3 Criteria: (cont.) Cinqair is considered medically necessary for add-on maintenance treatment of individuals with severe asthma 18 years of age and older, and with an eosinophilic phenotype with documentation of ALL of the following: (cont.) 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 Fasenra (benralizumab), Nucala (mepolizumab), Xolair (omalizumab), or Dupixent (dupilumab) 9. Absence of ALL of the following contraindications: Hypersensitivity to reslizumab or any of its excipients Continuation of Cinqair 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 Fasenra (benralizumab), Nucala (mepolizumab), Xolair (omalizumab), or Dupixent (dupilumab) O990.3.docx Page 3 of 9

4 Criteria: (cont.) Cinqair for all other indications not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome, and 3. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives. These indications include, but are not limited to: Acute bronchospasm Other eosinophilic conditions Status asthmaticus Treatment with dosing or frequency outside the FDA-approved dosing and frequency Resources: Literature reviewed 07/05/18. 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, Accessed 01/24/2018. Available at 2. UpToDate. An overview of asthma management. 10/05/2017. Cinqair Package Insert. 03/23/2016: - FDA-approved indication and dosage: Indication As add-on maintenance treatment in individuals with severe asthma 18 years and older and with an eosinophilic phenotype Recommended Dose 3 mg/kg intravenous every 4 weeks. Initial Approval Duration: 3 months Renewal Approval Duration: 12 months O990.3.docx Page 4 of 9

5 Resources: (cont.) 2016 GINA Guidelines on Stepwise Approach to Treatment of Asthma Coding: HCPCS: C9399, C9481, J2786, J3490, J3590 Coding Updates: 12/19/16 Added: HCPCS code J /05/16 Added: HCPCS code C9481 O990.3.docx Page 5 of 9

6 Resources: (cont.) 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 > < 15 < 60% predicted or personal best Asthma Control Test 1. In the past 4 weeks, how much of the time did your asthma keep you from getting as much done at work, school or at home? All of the time [1] Most of the time [2] Some of the time [3] A little of the time [4] None of the time [5] 2. During the past 4 weeks, how often have you had shortness of breath? More than once a day [1] Once a day [2] 3 to 6 times a week [3] Once or twice a week [4] Not at all [5] 3. During the past 4 weeks, how often did your asthma symptoms (wheezing, coughing, shortness of breath, chest tightness or pain) wake you up at night or earlier than usual in the morning? 4 or more nights a week [1] 2 to 3 nights a week [2] Once a week [3] Once or twice [4] Not at all [5] 4. During the past 4 weeks, how often have you used your rescue inhaler or nebulizer medication (such as albuterol)? 3 or more times per day [1] 1 to 2 times per day [2] 2 or 3 times per week [3] Once a week or less [4] Not at all [5] 5. How would you rate your asthma control during the past 4 weeks? Not Controlled at all [1] Poorly controlled [2] Somewhat controlled [3] Well controlled [4] Completely controlled [5] Score: O990.3.docx Page 6 of 9

7 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 O990.3.docx Page 7 of 9

8 CINQAIR (reslizumab) 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) for Spanish and (877) 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 , (602) , TTY/TDD (602) , crc@azblue.com. You can file a grievance in person or by mail or . 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 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, , (TDD). Complaint forms are available at Multi-Language Interpreter Services: O990.3.docx Page 8 of 9

9 CINQAIR (reslizumab) Multi-Language Interpreter Services: (cont.) O990.3.docx Page 9 of 9

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