Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic dermatitis

Treatment: Dupixent (dupilumab) Injection for the treatment of atopic dermatitis

The insurer denied coverage for Dupixent (dupilumab) Injection for the treatment of atopic dermatitis.

The denial is upheld. 

This is a female patient who has atopic dermatitis affecting 10% body surface area (BSA). The patient has failed topical steroids, oral methotrexate, and Protopic. The request is for Dupixent. Dupixent is Food and Drug Administration (FDA) approved for the treatment of moderate to severe atopic dermatitis in patients above a certain age. Standard treatment options for patients with atopic dermatitis include a regimen of topical steroids as well as topical calcineurin inhibitors. After topical agents fail, standard practice is to pursue systemic therapy. The treating provider states the patient had nausea associated with methotrexate; however, methotrexate can be administered intramuscularly such that gastrointestinal side effects can then be avoided. The patient had no documented contraindication, intolerance, or failure to cyclosporine or any other systemic agent such as azathioprine or CellCept. The patient has not had an adequate trial and failure with systemic treatment according to the records submitted. There is no documentation that the patient is actively family planning. The patient does not have elevated liver function tests (LFTs) or liver disease or uncontrolled hypertension. The patient is not immunosuppressed or immunocompromised. A medical exception for Dupixent has not been established.

As outlined in the American Academy of Dermatology guidelines (2014), Systemic immunomodulator agents are indicated and recommended for the subset of adult and pediatric patients in whom optimized topical regimens using emollients, topical anti-inflammatory therapies, adjunctive methods, and/or phototherapy do not adequately control the signs and symptoms of disease. Phototherapy and systemic immunomodulating agents may also be used in patients whose medical, physical, and/or psychological states are greatly affected by their skin disease. Oral cyclosporine or corticosteroids are short term treatment options for moderate to severe dermatitis with rapid onset or bridging therapy. Oral cyclosporine is suggested over oral corticosteroid. Atopic dermatitis symptoms begin to resolve quickly with the use of cyclosporine within the first week and dramatic improvement can be seen in 8 weeks. Long term use of oral cyclosporine is limited by its side effects, mainly hypertension and kidney toxicity. Oral corticosteroids are recommended for patients who cannot use cyclosporine. Dose for corticosteroid recommended is 40 to 60 milligrams per day for one week then taper over the following two to three weeks. While patients are being tapered off, patients are transitioned to another immunosuppressive agent with better safety profile for long term use. Second-line systemic immunosuppressive agents include methotrexate, azathioprine, and mycophenolate mofetil. The maximum benefit of methotrexate may not be seen for several months after start of therapy. Azathioprine and mycophenolate mofetil benefits may be seen for 6 to 8 weeks.

Dupixent is not medically necessary as the patient has no documented contraindication, intolerance, failure to any conventional systemic treatment such as cyclosporine, azathioprine, CellCept, or intramuscular methotrexate which are considered standard treatment for this patient's diagnosis of atopic dermatitis. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient.                                         

The medical necessity for Dupixent (dupilumab) Injection for the treatment of atopic dermatitis is not substantiated. The insurer's denial is upheld.