Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic dermatitis. 
Treatment: Dupilumab (Dupixent) to Treat Atopic Dermatitis. 

The insurer denied coverage for Dupilumab (Dupixent) to Treat Atopic Dermatitis. 

The denial is upheld. 

This is a female patient with atopic dermatitis. The requested medication, Dupixent, is not considered medically necessary for this patient's condition. There is no medical and scientific literature and/or evidence-based clinical practice guidelines that strongly support the administration of Dupixent for this patient's condition as an accepted standard of practice in the United States over existing standard of care treatments. 

Dupixent is not medically necessary based on the standard of care, and there are no unique clinical circumstances to this particular patient that would make it medically necessary. It is noted that the patient has tried and failed topical steroids. However, the patient has no true contraindications to the conventional medications commonly used for atopic dermatitis, which have been, according to the American Academy of Dermatology Atopic Dermatitis Clinical Guidelines and dermatology literature, the conventional medications such as methotrexate that are effective treatments for the management of atopic dermatitis. [1, 2] 

Within the peer-reviewed literature, Gerbens et al. (2018) states that "[methotrexate (MTX)] and [azathioprine (AZA)] seem to be effective and safe as maintenance treatments in moderate to severe [atopic dermatitis (AD)] up to 5 years." Shah et al. (2018) states that "[methotrexate] is an effective treatment for moderate to severe atopic dermatitis with an acceptable safety profile...A low dose can be used to control the disease for prolonged periods without significant risk." There are several published studies that show that methotrexate is effective and safe for moderate-severe atopic dermatitis. [5-8]  

In a discussion of management of atopic dermatitis in Up to Date, they note that 
"Methotrexate is the author's preferred agent for long-term control of severe AD in adult and older adult patients. Methotrexate is usually administered in a single weekly dose of 7.5 to 25 mg [milligrams] in combination with daily supplementation with folic acid 1 mg to reduce the risk of several common methotrexate toxicities. (See "Major side effects of low-dose methotrexate".) The effect of methotrexate usually starts after a few weeks but may be delayed. The maximum benefit is often not seen for several months." 

With regard to Dupixent they note that "The efficacy of dupilumab is supported by several manufacturer-sponsored trials involving now more than 1300 patients [70,71] (see "Treatment of atopic dermatitis (eczema)", section on 'Dupilumab'). In one trial, at least a 75 percent improvement from baseline in the Eczema Area and Severity Index (EASI-75) was achieved by approximately 50 percent of patients taking dupilumab, compared with approximately 15 percent of those taking placebo [70]. 

However, the efficacy of dupilumab for the treatment of severe, recalcitrant eczema remains unclear. In fact, the trials included a large proportion (over 50 percent) of patients with moderate AD, and no preplanned or post-hoc subgroup analysis was performed to assess the efficacy of dupilumab in patients with severe disease [72]. Adverse effects of dupilumab include injection-site reactions, conjunctivitis, and headache [73]. Dupilumab has been shown to be associated with a reduced risk of skin infections, including eczema herpeticum [74]." 

The conventional medications, such as methotrexate, should be tried and failed prior to initiating Dupixent as they are standard of care in treatment of atopic dermatitis based on peer reviewed literature. The health plan acted reasonably with sound medical judgment, and in the best interest of the patient. 

The carrier's denial of coverage for Dupilumab (Dupixent) to Treat Atopic Dermatitis should be upheld. The medical necessity is not substantiated.