Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic dermatitis.
Treatment: Dupixent Syn 300 mg.

The insurer denied coverage for Dupixent Syn 300 mg.
The denial is upheld. 

This is a female patient with atopic dermatitis affecting 40% body surface area (BSA). The patient has failed topical steroids, and Protopic. The request is for Dupixent.
According to Wong et al. (2017), "Topical agents are the mainstay of treatment for mild-moderate [atopic dermatitis (AD)] and include [topical corticosteroids (TCS)] and topical calcineurin inhibitors (TCI)...arrow-band UVB [ultraviolet B] is a safe option that can provide relief from the signs and symptoms of AD Cyclosporine A is a calcineurin inhibitor that controls T-cell mediated inflammation by preventing the transcription of inflammatory cytokines. Cyclosporine A has been found to be effective in the management of severe and refractory AD in adults and children. Methotrexate, azathioprine and mycophenolate mofetil are antimetabolite medications that work as a folate antagonist, purine analog and purine synthesis inhibitor, respectively. These medications have been shown to be variably effective in treatment-resistant AD." In this case, the patient has no documented contraindication to a second medium or high potency topical steroid that is on the formulary. 

The American Academy of Dermatology (AAD) guidelines suggest application of moisturizers should be an integral part of the treatment of patients with atopic dermatitis (AD) as there is strong evidence that their use reduces disease severity and need for pharmacologic intervention. The AAD recommends TCS for patients who fail to respond to good skin care and regular use of emollients alone. Topical calcineurin inhibitors (TCIs) (e.g., pimecrolimus, tacrolimus) are recommended by the AAD and are effective for acute and chronic treatment. Phototherapy is recommended as a treatment for both acute and chronic AD in children and adults, after failure of the mentioned above. 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. Oral cyclosporine or corticosteroids are short term treatment options for moderate to severe dermatitis with rapid onset or bridging therapy. 

As per Kolb and Ferrer-Bruker (2020), "Sensitive areas (including the intertriginous areas of the axilla and groin, in addition to the face) may require topical nonsteroidal agents including calcineurin inhibitors such as tacrolimus and pimecrolimus. Newer non-steroidal agents include crisaborole, which exerts its effect by blocking [phosphodiesterase type 4 (PDE-4)]. When atopic dermatitis is not controlled with topical agents, systemic agents include phototherapy (ultraviolet (UV) A, UVB, and narrow-band UVB), cyclosporine, azathioprine, mycophenolate mofetil, and methotrexate." 

Based on review of the medical record and literature, Dupixent is not considered medically necessary for this patient. 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 such as phototherapy. In this case, the patient has failed triamcinolone, but no other medium to high potency topical steroid was trialed six months prior to that. There is no exception for Dupixent use. 

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.                                                         

The carrier's denial of coverage for Dupixent Syn 300 mg [milligrams] should be upheld. The medical necessity is not substantiated.