Cinqair
Drug - Cinqair® (reslizumab) [Teva]
January 2018
Therapeutic area - Asthma
Initial approval criteria
- Patient must be 18 years of age or older AND
- Has a diagnosis of asthma with an eosinophilic phenotype indicated by blood eosinophil of ≥400 cells/mcL within 3 to 4 weeks of dosing (documentation of lab results must be submitted at time of request) AND
- Must be used for add-on maintenance treatment in patients with 6 months of claims history showing adherence with BOTH of the following:
- High-dose inhaled corticosteroids
- An additional controller medication (e.g., long-acting beta agonist, etc.) AND
- Has evidence of severe disease indicated by ALL of the following:
- Asthmatic symptoms occurring throughout the day
- Frequent nighttime awakenings of 7 times per week
- Multiple doses of short-acting beta agonist (SABA) required daily for symptom control
- Extreme limitation of normal activities due to asthma symptoms
- Lung function (percent predicted FEV1) <60%
- More frequent and intense asthma exacerbations requiring oral systemic corticosteroids relative to mild or moderate asthma AND
- Has uncontrolled disease documented by ONE of the following:
- At least one exacerbation in the previous year resulting in hospitalization or emergency department visits OR
- Patient requires daily oral corticosteroids in addition to regular maintenance therapy AND
- At time of request, provide baseline FEV1 and frequency of asthma exacerbation per month
- Initial approval will be for 6 months in duration
Renewal approval criteria
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following:
- Parasitic (helminth) infection
- Herpes zoster infection
- Headache
- Injection site reaction
- Back pain
- Fatigue
- Treatment has resulted in clinical improvement as documented by at least ONE of the following:
- Decreased frequency of exacerbations (defined as improvement of asthma as demonstrated by decreased use of oral/systemic corticosteroids and/or less frequent hospitalizations and/or reduced frequency of ER visits) OR
- Improvement in lung function, measured in FEV1
- Renewal approval will be for 12 months in duration
Quantity limits:
One infusion (3 mg/kg) per 28 days
Denial criteria
Concurrent use with Xolair or Nucala
Billing of Cinqair
Cinqair is not covered through the MHCP fee-for-service pharmacy benefit and must be submitted as a medical claim. Cinqair should be administered by a healthcare professional in a healthcare setting. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended by the manufacturer.
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411