Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis. 
Treatment: Dupixent Pen 300mg/2ml PEN INJCTR, Pre-service. 

The insurer denied the Dupixent Pen 300mg/2ml PEN INJCTR. 
The denial is overturned. 

The patient is a woman with severe atopic dermatitis affecting more than 10% body surface area, including her hands, feet, arms, and legs.  She has an IgA (Immunoglobulin A) score of 3.  Her previously-tried and failed medications include tacrolimus, pimecrolimus, betamethasone, prednisone, and triamcinolone.  All of those therapies have been ineffective for the patient.  This is a request for approval of Dupixent injections. 

Yes, the requested treatment with Dupixent is medically necessary. 

The patient has severe atopic dermatitis affecting multiple areas of the body. She 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. 

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), with originally demonstrated efficacy in phase 2 clinical trials. In March 2017, it was approved by the US 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 2 weeks thereafter. 

Approval of dupilumab was based on clinical trials investigating dupilumab as monotherapy (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 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 for this patient.