Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Atopic Dermatitis
 
Treatment: Duxipent

The insurer denied the Duxipent. The denial was upheld.   

This is a patient who is being treated for Atopic Dermatitis. The patient was re-evaluated by her doctor after being prescribed Prednisone 40 mg for one week with tapering dosage. It was reported that the patient had failed topical steroid treatment. The provider requested Dupixent.

Dupixent is Food and Drug Administration (FDA) approved for the treatment of moderate to severe atopic dermatitis in patients over the age of 12. 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. 

According to Wong et al. (2017), "Topical agents are the mainstay of treatment for mild-moderate AD and include topical corticosteroids [TCS] and topical calcineurin inhibitors (TCI). TCS are effective agents in addressing the pruritus and inflammation of AD and work by inducing inhibitory proteins that decrease inflammatory mediator activity. For patients with moderate-to-severe disease refractory to topical therapy, consideration should be given to the use of phototherapy or systemic immunomodulatory agents. Narrow-band UVB (wavelength = 311 nm) is the most commonly used type of phototherapy for AD and is typically administered 2 to 3 times per week. Narrow-band UVB 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."

Boguniewicz, et al. (2018), "Before stepping up therapy, the patient should be assessed for nonadherence, potential comorbidities, and other factors that might negatively affect response to therapy. Confirmation is needed that the increased level of symptoms is due to AD. When nonpharmacologic interventions alone are not enough to manage the patient's symptoms, a step-up to maintenance therapy with a topical prescription medication (e.g., topical corticosteroid [TCS], topical calcineurin inhibitor [TCI], or crisaborole ointment) should be tried. Most patients with moderate AD show long-term clinical improvement with moisturizers, avoidance of triggers, and use of prescription anti-inflammatory agents, (e.g., TCS, TCI, crisaborole). Patients who do not achieve complete or almost complete resolution of their signs and symptoms might require a step-up. Treatment options for patients with moderate to severe AD have largely been limited to phototherapy and/or systemic immunosuppressive agents, with the specific step-up determined according to patient need, availability of and access to treatment."

Lastly, as per Up to Date, both cyclosporine and methotrexate are recommended prior to use of Dupixent. Moreover they state "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."

Based on the above, the insurer's denial of Formulary Exception for Dupixent is upheld.