Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Asthma.
Treatment: Dupixent 300 mg/2ml syringe.
The insurer denied the Dupixent 300 mg/2ml syringe.
The denial is overturned. 

The patient is a female with severe allergic asthma. She has tried and failed ICS/LABA (inhaled corticosteroids/long-acting b2-agonist) and Singulair with frequent asthma exacerbations requiring systemic steroids. The patient is prescribed Dupixent. 

The clinical documentations provided reports that patient has been compliant with ICS/LABA as well as other asthma maintenance medications, but she continues to have difficult-to-treat asthma. The patient has had recent asthma exacerbation requiring steroids, and she has had multiple cycles of prednisone use in the past 12 months. 

Dupilumab has been shown to increase lung function and reduced severe exacerbations in patients with uncontrolled persistent asthma irrespective of baseline eosinophil count. Thus, in addition to inhaled corticosteroids plus long-acting 2-agonist therapy could improve the lives of patients with uncontrolled persistent asthma compared with standard therapy alone. To date, there is the strong need to compare the efficacy across the monoclonal antibodies (mAbs) approved to treat severe asthma. All the investigated mAbs were more effective than placebo in reducing the risk of exacerbation and improving lung function. Dupilumab showed a general superiority compared to the other mAbs, as it significantly reduced the risk of exacerbation vs. omalizumab, and significantly improved FEV1 (forced expiratory volume 1 second) when compared to omalizumab, mepolizumab, and benralizumab. The addition of Dupixent is medically necessary. 

Yes, the treatment with Dupixent is medically necessary.

The clinical documentations provided reports that patient has been compliant with ICS/LABA (inhaled corticosteroids/long-acting b2-agonist) as well as other asthma maintenance medications, but she continues to have difficult-to-treat asthma. The patient has had recent asthma exacerbation requiring steroids, and she has had multiple cycles of prednisone use in the past 12 months. The addition of Dupixent is likely to improve patient's asthma symptoms significantly and improve quality of life.

Dupilumab has been shown to increase lung function and reduced severe exacerbations in patients with uncontrolled persistent asthma irrespective of baseline eosinophil count. Thus, addition to inhaled corticosteroids plus long-acting 2-agonist therapy could improve the lives of patients with uncontrolled persistent asthma compared with standard therapy alone. To date, there is the strong need to compare the efficacy across the monoclonal antibodies (mAbs) approved to treat severe asthma. All the investigated mAbs were more effective than placebo in reducing the risk of exacerbation and improving lung function. Dupilumab showed a general superiority compared to the other mAbs, as it significantly reduced the risk of exacerbation vs. omalizumab, and significantly improved FEV1 (forced expiratory volume 1 second) when compared to omalizumab, mepolizumab, and benralizumab. The addition of Dupixent is medically necessary.