Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic dermatitis
Treatment: Dupixent Syn 300
The insurer denied the Dupixent Syn 300. 
The denial is overturned.

Yes, the treatment with Dupixent Syn 300 is medically necessary.

The patient is a female with a history of moderate to severe atopic dermatitis (AD) since adolescence. She has failed topical therapy. She has severe fissuring of the hands and ears. Her EASI (Eczema Area and Severity Index) score is 18.7, and IGA (Investigator's Global Assessment) is four. The medical chart note documents that she was not treated for 1.5 years and is currently looking for a new job, so cannot do phototherapy. She drinks alcohol and has a family history of hypertension. At that visit, she was prescribed tacrolimus, Eucrisa, halobetasol and Dupixent.

The patient has severe atopic dermatitis affecting multiple areas of the body, including the hands and ears. She is a candidate for systemic therapy, as the BSA (body surface area) is too large for reasonable control with topical medications. Topical calcineurin inhibitors (tacrolimus) and topical steroids 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 signaling by blocking the shared IL-4Ra and 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 and then every two 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=671) and SOLO 2 (n=708) 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%) (P< .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 emerging as a first-line therapeutic for moderate-to-severe AD. The patient has failed topical steroids, calcineurin inhibitors, and systemic steroids. Additionally, topical calcineurin inhibitors are not indicated for severe disease.

Phototherapy is not appropriate for sensitive areas and impossible to obtain during the COVID-19 pandemic. Cyclosporine, azathioprine, methotrexate, 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. The patient is not a candidate for conventional systemic therapy (methotrexate, azathioprine, mycophenolate) due to her gender and childbearing age. Systemic steroids and cyclosporine are not a reasonable long-term treatment for moderate to severe atopic dermatitis due to their severe side effect profile.