Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis
Treatment: Dupixent 300MG (milligrams)/2ML (milliliters) Pen
The insurer denied Dupixent 300MG/2ML Pen.
The denial is overturned.

The patient is an adult female with a past medical history of asthma, hypertension, hyperlipidemia, depression, and severe refractory atopic dermatitis for many years. She presents with erythematous scaly papules and plaques on the face, arms, and scalp. The lesions are itchy, and tender and interfere with her quality of life. She has tried and failed multiple including topical and systemic steroids, namely, prednisone, triamcinolone, hydrocortisone, Opzelura, betamethasone, mometasone as well as numerous systemic antihistamines, emollients, and oral antibiotics due to extensive infection from excessive scratching. She has also tried and failed topical pimecrolimus. These have not adequately controlled the symptoms.

The requested 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.

Dupixent (dupilumab) is a monoclonal antibody that inhibits IL (interleukin)-4 and IL-13 signaling by blocking the shared IL-4Ra (interleukin 4 receptor) and originally demonstrated efficacy in phase 2 clinical trials. In March 2017, 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 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 (n=[equal]671) and SOLO 2 (n=708) trials showed 36-38% (percent) 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%) (P < [less than] .001). 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 (P < .001). 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 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.