Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Eczema

Treatment: Dupixent

The insurer denied Dupixent.

The denial was overturned.

This is a female patient with severe eczema. It was also mentioned that the patient's father had severe eczema and was on Dupixent with great benefit. The patient had allergies that consisted of eggs, soy, cashews, as well as dairy. She had no medical allergies. It was noted that the patient had tried Aveeno, Aquaphor, Eucerin, and hydrocortisone steroid creams. The patient's then current medications included tacrolimus (Protopic) 0.1% treatment and dupilumab (Dupixent) 300 milligrams/2 milliliter syringe. An examination of the patient's face, neck, chest, abdomen, back, right upper and lower extremity, in addition to the left upper and lower extremity was significant for scattered erythematous scaly patches and excoriations covering a large portion of the patient's body. The patient has tried and failed conservative therapy. 

The provider indicated that the patient had severe atopic dermatitis with scattered erythematous scaly patches and excoriations covering her entire body, including face and hands, and affecting more than 50% of the body surface area. In addition, it was stated that the patient had already tried numerous treatments with no improvement, and her quality of life was significantly affected. The letter also stated that the patient tried and failed hydrocortisone 2.5%, Benadryl, Aveeno, Aquaphor, Eucerin, and tacrolimus 0.1% ointment.

According to Simpson, E.L., et al, (2019), "In this study, dupilumab significantly improved atopic dermatitis [AD] signs, symptoms, and quality of life in adolescents with moderate to severe AD, with an acceptable safety profile. Placebo-corrected efficacy and safety of dupilumab were similar in adolescents and adults."  

In a review of biologic treatment for atopic dermatitis in children, the authors note that traditional agents are not appropriate for long term use in the pediatric population due to risk of side effects. (Cline et al).  It must also be noted that there are no FDA approved agents for treatment of atopic dermatitis aside from dupilumab. Igelman et al in a multicenter study noted that dupilumab has been used in children with "treatment response and adverse events comparable to those seen in trials of adolescents and adult trials." 

Prezzano, J.C. & Beck, L.A., (2017) asserts, "Many patients with mild to moderate atopic dermatitis (AD) are managed by identifying and avoiding allergens and irritants, ensuring skin moisturization, and graded use of topical corticosteroids and/or calcineurin inhibitors. There is little consensus on the next step. Most systemic therapies are "off label" in the United States and include phototherapy, cyclosporine, mycophenolic acid precursors, azathioprine, and methotrexate."                                                       

The patient has severe eczema unresponsive to previous conservative therapy. The use of immunosuppressants could have adverse effects on bone marrow and solid organs leading to lifelong problems. Dupixent has been approved for treatment of atopic dermatitis in children as young as 6 years old as of May 26, 2020. As noted in the study by Paller et al, "Dupilumab biologic therapy targeting the shared receptor component for interleukin-4 and interleukin-13 improves outcomes in children with severe atopic dermatitis inadequately controlled with topical corticosteroids, including signs, symptoms, and quality-of-life, with an acceptable safety profile." 

Dupixent is considered medically necessary for this patient. The health care plan did not act reasonably or with sound medical judgment or in the best interest of the patient.

Based on the above, the medical necessity for Dupixent is substantiated.  The insurer's denial is overturned.