Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis
Treatment: Dupixent Syn (syringe) 300
The insurer denied the Dupixent Syn (syringe) 300
The denial is overturned

The patient is a man with severe atopic dermatitis since childhood affecting 40% of body surface area. His EASI score is 36 (Eczema Area and Severity Index) and IGA (Investigator's Global Assessment) 4. It is causing debilitating pain, itching and scratching. He has tried and failed high potency topical steroids, betamethasone, hydrocortisone 2.5% and Opzelura. The disease interferes with daily activities and sleep.

Yes, the requested 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 (Interleukin)-4 and IL (Interleukin)-13 signaling by blocking the shared IL (Interleukin)-4Ra and originally demonstrated efficacy in phase 2 clinical trials. 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.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
The patient has severe a topic dermatitis affecting 40% body surface area. Topical treatment is insufficient to control his disease. Therefore, Dupixent is medically necessary.