Appeal type: Medical necessity
Decision: Upheld


Diagnosis: Atopic Dermatitis
Treatment: Pharmacy/Prescription Drugs (Dupixent)
The health plan denied the requested prescription Drug (Dupixent). 
The health plan's determination is upheld.

The patient is a female with atopic dermatitis (AD) (more than 30% body surface area involvement) with widespread excoriations and lichenification, as well as a history of secondary skin infections. Topical Mometasone, Triamcinolone, and Clobetasol, as well as oral Cetirizine have been tried and failed. The patient cannot sleep at night.
The medical necessity of Dupixent is under review for medical necessity.

The health plan's determination of medical necessity is upheld. 

The patient has failed to utilize and exhaust all appropriate topical therapies (in particular topical Tacrolimus, which is Food and Drug Administration (FDA) -approved for moderate to severe atopic dermatitis), as well as standard first-line oral therapies (such as Methotrexate, Cyclosporine, Mycophenolate Mofetil, and Azathioprine) and/or phototherapy. Dupixent is often insufficient to control severe atopic dermatitis, such that the aforementioned topical and systemic therapies are required in addition to Dupixent.
It should be emphasized that 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, [1-4] emolliation, mild soap, avoidance of irritants, and similar conservative treatments. Weather changes, physical illness, and even emotional stress can trigger atopic dermatitis. Topical steroids, topical Elidel and topical Tacrolimus are the mainstay of therapy for this condition. The patient has not failed topical therapies, in that more potent topical steroids, topical calcineurin inhibitors, and topical Eucrisa have not all been tried and failed. However, systemic therapies are often needed for more severe and/or treatment-resistant cases of atopic dermatitis [5-8] 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 [1-4, 6-8] and American Academy of Dermatology Clinical Guidelines in the treatment of atopic dermatitis [5] support use of phototherapy, Methotrexate, Azathioprine, or Mycophenolate Mofetil, and/or brief courses of systemic corticosteroids as potential and appropriate systemic therapies for more severe cases of atopic dermatitis. These treatments are both time-tested, standard of care, and supported by modern dermatology literature and larger studies/comparative trials.
While Dupixent is a promising new agent in the systemic treatment of atopic dermatitis, it is not confirmed to be significantly superior to these alternative, more cost-effective and time-tested oral and light therapies described above. To date, this patient has had no history of systemic therapies.
Accordingly, while systemic therapy is indicated for this patient, and Dupixent is one form of systemic therapy, Dupixent is being prescribed out of preference/convenience and not true medical necessity because other, more studied and cost-effective, alternatives have not yet been tried to date. The request for Dupixent is therefore not medically necessary for this patient's particular clinical scenario.