Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic Dermatitis
Treatment: Dupixent (dupilumab)
The insurer denied Dupixent.
The determination is upheld.

This is a male patient with moderate to severe atopic dermatitis (up to 40 percent (%) body surface area involvement) with lichenified patches on the arms, legs, and back. The condition has lasted for years, and has been associated with redness, itching, and bleeding. The patient has tried and failed 2.5 percent (%) hydrocortisone cream, 0.1% triamcinolone ointment, and oral hydroxyzine syrup. Dupixent, as per the clinic notes, was added. Dupixent is under review for medical necessity.

The Dupixent is not medically necessary. First-line topical therapies, as well as systemic therapies, that are medically appropriate and time-tested have not been utilized to control this patient's condition.  Atopic dermatitis is an ongoing inflammatory disease affecting the skin, with the need to control any immune/inflammatory hypersensitivity being for some patients intermittent, and for some patients to be controlled on a chronic and ongoing basis. The usual treatment is with topical steroids and topical immunomodulators (1, 2, 4), emolliation, mild soap, avoidance of irritants, and similar conservative treatments. Weather changes, physical illness, and even emotional stress can trigger atopic dermatitis. Topical steroids, as well as nonsteroidal topical agents are the mainstay of therapy for this condition. The patient has not failed topical therapies, however, in that the topical calcineurin inhibitor tacrolimus (brand name Protopic), which is the only nonsteroidal topical agent that is Food and Drug Administration (FDA)-approved for moderate to severe atopic dermatitis, has not been tried and failed. It should be noted that topical calcineurin inhibitors continue to show no significantly higher incidence of malignancies or adverse effects in repeated studies, and are therefore appropriate for this patient to use long-term as a steroid-sparing medication.
However, systemic therapies are often needed for more severe and/or treatment-resistant cases of atopic dermatitis (1-7), and such appears to be the case with this patient.

Dupixent is only truly medically necessary when other similar, reasonable, and standard treatments have been tried and failed, but such is not the case at this time. If topical therapies cannot control this patient's atopic dermatitis, then systemic therapies become standard of care in order to achieve proper disease control, physical functioning and quality of life.

Modern dermatology literature reviews (1-6) and American Academy of Dermatology Clinical Guidelines in the treatment of atopic dermatitis (7) support use of phototherapy, and/or oral agents such as Methotrexate, Cyclosporine, or Azathioprine, and/or brief courses of systemic corticosteroids as potential and appropriate systemic therapies for more severe cases of atopic dermatitis. These treatments are all time-tested, standard of care, and supported by modern dermatology literature and larger studies/comparative trials, and even for young patients such as this individual. While Dupixent is a vital part of the dermatologic armamentarium for the systemic treatment of atopic dermatitis, it is not confirmed to be significantly superior than these alternative, more time-tested oral and light therapies described above. To date, this patient has had no past history of systemic therapies.

Accordingly, while systemic therapy is indicated for this patient, and Dupixent is one form of systemic therapy, other, more studied alternatives have not yet been tried to date. The request for Dupixent is therefore not medically necessary for this patient's particular clinical scenario.