Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Moderate to Severe Persistent Asthma

Treatment: Dupixent 300 mg/2ml (milligram per milliliter) pen injector

The insurer denied coverage for Dupixent 300 mg/2ml (milligram per milliliter) pen injector

The denial is upheld

The request is for Dupixent for allergic rhinitis, food allergies, eosinophilic esophagitis, and asthma. He has required prednisone for asthma. The patient is adherent with high dose inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA). The use of Dupixent is supported by scientific evidence in peer-reviewed literature for asthma. However, there are no head-to-head studies which have shown that Dupixent is more effective than the available alternatives for this patient's clinical scenario.

Castro M, et al."The annualized rate of severe asthma exacerbations was 0.46 (95% [percent] confidence interval [CI], 0.39 to 0.53) among patients assigned to 200 mg [milligram] of dupilumab every 2 weeks and 0.87 (95% CI, 0.72 to 1.05) among those assigned to a matched placebo, for a 47.7% lower rate with dupilumab than with placebo (P<0.001); similar results were seen with the dupilumab dose of 300 mg every 2 weeks. At week 12, the forced expiratory volume (FEV1) had increased by 0.32 liters in patients assigned to the lower dose of dupilumab (difference vs. matched placebo, 0.14 liters; P<0.001); similar results were seen with the higher dose. Among patients with a blood eosinophil count of 300 or more per cubic millimeter, the annualized rate of severe asthma exacerbations was 0.37 (95% CI, 0.29 to 0.48) among those receiving lower dose dupilumab and 1.08 (95% CI, 0.85 to 1.38) among those receiving a matched placebo (65.8% lower rate with dupilumab than with placebo; 95% CI, 52.0 to 75.6); similar results were observed with the higher dose. Blood eosinophilia occurred after the start of the intervention in 52 patients (4.1%) who received dupilumab as compared with 4 patients (0.6%) who received placebo."      

However as summarized in Up to Date: "The biologic agents for severe asthma have not been compared in head-to-head trials, but certain patient and medication features help to guide selection. As described, only patients with an IgE [immunoglobin E] level >20 IU/mL [international unit per milliliter] with clinical and testing evidence of atopy are candidates for omalizumab; only patients with an elevated eosinophil count are candidates for mepolizumab and other anti-interleukin (IL) agents; some agents are not approved for use under a certain age; and some agents require more or less frequent dosing.

This patient is not a good candidate for Dupixent 300 mg/2ml (milligram per milliliter) pen injector. There are effective, safe alternatives that have not been trialed. This patient has not failed or have a contraindication to the available alternatives. Dupixent is not Food and Drug Administration (FDA) approved for the other diagnoses that this patient has.     In this case, the patient has not failed the available alternatives. Dupixent is not FDA approved for the other diagnoses that this patient has.    There are not adverse risks increased over standard treatment/services.     

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.                                                    

The carrier's denial of Dupixent 300 mg/2ml (milligram per milliliter) pen injector should be upheld.