Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis. 
Treatment: Dupixent. 

The insurer denied the Dupixent (Pre-service). 
The denial is overturned. 

The patient is a man with atopic dermatitis affecting his trunk and extremities, but especially severe on the hands and feet, for whom Dupixent is requested. He has tried and failed topical steroids, including clobetasol. He has diabetes and hypertension. 

Yes, the treatment with Dupixent is medically necessary. 
The patient has severe atopic dermatitis affecting multiple areas of the body. He is a candidate for systemic therapy, as the BSA (body surface area) is too large for reasonable control with topical medications. Topical therapies are not appropriate therapy for severe, widespread atopic dermatitis, affecting sensitive areas, which should be treated with systemic therapy. 

Dupixent (Dupilumab) is a monoclonal antibody that inhibits IL-4 (interleukin 4) and IL-13 (interleukin 13) signaling by blocking the shared IL-4Ra (interleukin 4 receptor) and originally demonstrated efficacy in phase 2 clinical trials. It was approved by the United States Food and Drug Administration (FDA) for adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It is a subcutaneous injection administered initially at a dose of 600 mg (milligrams) and then every two weeks thereafter. 

Approval of dupilumab was based on clinical trials investigating dupilumab as monotherapy (SOLO 1 [Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis] and SOLO 2 [Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis]) and in concomitant administration with topical corticosteroids (CHRONOS [Study to Assess the Efficacy and Long-term Safety of Dupilumab in Adult Participants With Moderate-to-Severe Atopic Dermatitis]). Results from the SOLO 1 (Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis) and SOLO 2 (Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis) trials showed 36-38% of patients who received dupilumab had scores of 0 or 1 (clear or almost clear) on the Investigator's Global Assessment scale compared with placebo (8-10%). Additionally, improvement from baseline to week 16 of at least 75% on the Eczema Area and Severity Index (EASI) was reported in significantly more patients who received each regimen of dupilumab than in patients who received placebo. 

Given its unprecedented efficacy, dupilumab is now a first-line therapeutic for moderate-to-severe AD (atopic dermatitis). The patient has failed topical steroids and calcineurin inhibitors. 

Cyclosporine, azathioprine, methotrexate, and mycophenolate mofetil are not FDA (United States Food and Drug Administration)-approved for use in atopic dermatitis (Insufficient data exists to firmly recommend optimal dosing, duration of therapy, and precise monitoring protocols for any systemic immunomodulating medication. Strength of Recommendation: B Level of Evidence: I or II, depending on agent), while Dupixent is. 

Systemic steroids and cyclosporine are not a reasonable long-term treatment for moderate to severe atopic dermatitis due to their severe side effect profile. 

Therefore, for the reasons above, Dupixent is medically necessary. 

Severe disease refractory to topical steroids affecting multiple areas of the body should be treated with systemic medication. The use of topical medications is impractical and unlikely to suffice, especially tacrolimus/pimecrolimus/crisaborole, all inferior efficacy compared to potent topical steroids, which the patient has already failed. Also, they are not indicated for severe disease.