Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis. 
Treatment: Dupixent Syn 300, Pre-service. 

The insurer denied the Dupixent Syn 300, Pre-service. 
The denial is overturned. 

The patient is a male with severe atopic dermatitis affecting more than 15% body surface area that started years ago. He has tried and failed phototherapy, hydrocortisone 2.5% ointment, triamcinolone 0.1% ointment, Protopic 0.1% ointment and mometasone 0.1% cream. The request is for Dupixent injections. 

Yes, the proposed 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 body surface area (BSA) 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. 

Dupilumab is a monoclonal antibody that inhibits IL-4 and IL-13 (Interleukin 4 and Interleukin 13) signaling by blocking the shared IL-4Ra (Interleukin 4) and originally demonstrated efficacy in phase II clinical trials. It was approved by the US (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 milligrams (mg) and then every two weeks thereafter. 

Approval of dupilumab was based on clinical trials investigating dupilumab as monotherapy (Trials - SOLO 1 and SOLO 2) and in concomitant administration with topical corticosteroids (CHRONOS). Results from the SOLO 1 and SOLO 2 trials showed 36-38% of patients who received dupilumab had scores of zero or one (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 atopic dermatitis (AD). The patient has failed topical steroids and calcineurin inhibitors. 

Cyclosporine, azathioprine, methotrexate, and mycophenolate mofetil  are not Food and Drug Administration (FDA) 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. 

For the reasons above, Dupixent is medically necessary. 

Cyclosporine, azathioprine, methotrexate, and mycophenolate mofetil are not Food and Drug Administration (FDA) 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.