Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Moderate to severe atopic dermatitis. 
Treatment: Dupixent 300 milligrams (mg)/ 200 milliliters (ml) injection to treat atopic dermatitis. 

The insurer denied coverage for Dupixent 300 mg/ 200 ml injection to treat atopic dermatitis. 

The denial is overturned. 

This is a female patient with a history of moderate to severe atopic dermatitis. The patient has a body surface area (BSA) affected of greater than 10%. The patient has tried and failed topical tacrolimus, triamcinolone, Eucrisa, prednisone, and antihistamines. The treating provider is requesting treatment with Dupixent (dupilumab). 

The Telemedicine Visit with the dermatologist indicates the patient had atopic dermatitis on greater than 10% of her BSA. The patient was not responding well to Tacrolimus. The physician recommended administering 600 milligrams (mg) of subcutaneous (SC) Dupixent (dupilumab) at first and then administering 300 mg of SC Dupixent (dupilumab) every two weeks. 

Dupixent (dupilumab) is indicated for moderate to severe atopic dermatitis (AD) in patients that have failed topical therapy. The policy criteria requires in addition to the topical medications that the patient has tried, an eight week trial of teratogenic medication, which would be ill-advised for a young female of reproductive age when a safer treatment option is available (Menter et al). As atopic dermatitis is a chronic disease, an eight week trial of any medication is not expected to have a major effect on the outcome of her disease. In general, a longer treatment course is to be expected. Additionally, the other treatment options are potentially more toxic to the patient. This patient has had a reasonable trial and failure of topical and systemic alternatives and has had inadequate control. Thus, Dupixent (dupilumab) is medically necessary and in accordance with generally accepted practice guidelines. 

"In clinical trials dupilumab consistently showed robust efficacy and acceptable safety in adults with moderate-to-severe AD" (Guttman-Yassky, et al., 2018). 

Dupixent (dupilumab) 300mg/200ml [milliliters] is medically necessary for the treatment of this patient of reproductive age who has failed topical therapy. The patient has a BSA affected of greater than 10%. The patient has tried and failed topical tacrolimus, triamcinolone, Eucrisa, prednisone, and antihistamines. Multiple studies have demonstrated the safety and efficacy of long term therapy with Dupixent (dupilumab). This medication is a safer option for long term treatment over the conventional systemic medications methotrexate, azathioprine, mycophenolate and cyclosporine. 

"The favorable benefit-risk profile in this study supports the long-term role of dupilumab treatment for patients with moderate to severe AD and shows that blocking interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling can achieve sustained control of AD signs and symptoms with an acceptable safety profile in patients with significant disease burden and for whom conventional topical treatments are inadequate" (Deleuran, et al., 2019). 

"A biologic drug such as dupilumab, which has recently received the Unites States (US) Food and Drug Administration (FDA) breakthrough therapy designation for AD, presents as the most efficacious and safe systemic treatment for adult AD patients" (Megna, et al., 2017). 

The health plan did not act reasonably with sound medical judgment in the best interest of the patient.       

The insurer's denial of coverage for Dupixent 300 mg/ 200 ml injection to treat atopic dermatitis is overturned. Medical necessity is substantiated.