Background

Cinqair is an interleukin-5 (IL-5) antagonist monoclonal antibody indicated for add on maintenance treatment of patients with severe asthma aged 18 years of age and older with an eosinophilic phenotype. IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Cinqair binds to IL-5 and blocks it from binding to the IL-5 receptor complex on eosinophil surfaces. Inflammation is a large component of asthma and there are multiple cell types and mediators involved. Cinqair reduces the production and survival of eosinophils, however its mechanism of action in asthma has not been definitively established. Cinqair is provided in 100 mg/10 mL (10 mg/mL) single use vials. The recommended dosage regimen is 3 mg/kg once every 4 weeks by intravenous infusion over 20–50 minutes.

Asthma

Asthma is a respiratory disorder characterized by increased responsiveness of the trachea and bronchi to various stimuli resulting in the narrowing of the airways, along with mucous secretion. Symptoms vary in severity and intensity and include wheezing, cough and dyspnea. Attacks can be triggered by exercise, allergens, irritants and viral infections. Based on symptoms, the four levels of asthma severity are:

• Mild intermittent (comes and goes)—you have episodes of asthma symptoms twice a week or less, and you are bothered by symptoms at night twice a month or less; between episodes, however, you have no symptoms and your lung function is normal.
• Mild persistent asthma—you have asthma symptoms more than twice a week, but no more than once in a single day. You are bothered by symptoms at night more than twice a month. You may have asthma attacks that affect your activity.
• Moderate persistent asthma—you have asthma symptoms every day, and you are bothered by nighttime symptoms more than once a week. Asthma attacks may affect your activity.
• Severe persistent asthma—you have symptoms throughout the day on most days, and you are bothered by nighttime symptoms often. In severe asthma, your physical activity is likely to be limited.

Treatment of asthma is based on a step up and step down approach based on the asthma severity and symptoms. Medications include short acting beta agonists for fast relief. Long term treatment centers around the use of ICSs and possible addition of medications such as LABAs, LTRAs, inhaled LAMAs, or theophylline.

Policy (Criteria)

Coverage is provided when the criteria below are met and there has been a trial and failure of preferred therapy (if applicable). 

Cinqair (Reslizumab) is considered MEDICALLY NECESSARY for individuals with moderate to severe persistent asthma who meet all of the following criteria:

• 18 years of age or older
• Symptoms are inadequately controlled after a combination controller therapy (high doses of inhaled corticosteroids plus long-acting beta₂-agonists, long-acting muscarinic antagonists or leukotriene modifiers) or cannot tolerate the medications
• A  baseline (pre-treatment) peripheral blood eosinophil level greater than or equal to 150 cells per microliter
• One of the following:
  • At least 2 or more asthma exacerbations requiring systemic corticosteroids (e.g., prednisone) within the past 12 months
  • Prior asthma-related hospitalizations within the past 12 months
• Prescribed by or in consultation with a pulmonologist or allergist/immunologist

Continued treatment with Reslizumab beyond 6 months is considered MEDICALLY NECESSARY when the following criteria are met:

• Treatment with reslizumab has resulted in clinical improvement as documented by one or more of the following:
  • Decreased utilization of rescue medications
  • Decreased frequency of exacerbations (defined as worsening of asthma that requires increase in inhaled corticosteroid dose or treatment with systemic corticosteroids)
  • Increase in percent predicted FEV₁from pretreatment baseline
  • Reduction in reported asthma-related symptoms, such as, but not limited to, wheezing, shortness of breath, coughing, fatigue, sleep disturbance or asthmatic symptoms upon awakening
• Patient is currently being treated with the following unless there is a contraindication or intolerance to these medications:
  • Inhaled corticosteroid (ICS) (e.g., fluticasone, budesonide) with or without

Additional asthma controller medication (e.g., leukotriene receptor antagonist, long-acting beta-2 agonist [LABA], theophylline)

• Prescribed by or in consultation with a pulmonologist or allergist/immunologist

References

1. Cinqair [package insert]. Teva Respiratory, LLC. Frazer, Pennsylvania. Updated 2016.
2. Cinqair Prior Authorization. Express Scripts. Updated 3/30/2016.
3. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (EPR-3). National Heart, Lung, and Blood Institute. www.nhlbi.nih.gov/guidelines/asthma

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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