Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis. 
Treatment: Dupixent 300MG/2ML SC SOPN. 

The insurer denied the Dupixent 300MG/2ML SC SOPN. 
The denial is overturned. 

The patient is a female with atopic dermatitis. She has been treated with multiple topical steroids, topical calcineurin inhibitors Tacrolimus and Pimecrolimus, and Eucrisa. The patient is unable to do phototherapy due to time constraints.  She has 80-90% BSA (body surface area).  Her provider is requesting Dupixent. 

Yes, the requested Dupixent is medically necessary. 

The health plan denied the request due to requirement for use of systemic immunosuppressants. 

Dupilumab is United States Food and Drug Administration indicated for treatment of recalcitrant atopic dermatitis. Two trials, SOLO-1 and SOLO-2, demonstrated that patients treated with Dupilumab experienced significant, clinically meaningful improvements in their atopic dermatitis at week 16 as measured by the EASI score (Eczema Area and Severity Index). Dupilumab was well tolerated with the most commonly reported side effects including injection site reactions and conjunctivitis. Dupilumab is a novel interleukin-4 and interleukin-13 blocker, which inhibits the arm of the immune system responsible for atopic dermatitis. In clinical trials, after 12 weeks of monotherapy with dupilumab, 85% of patients had a greater than 50% reduction in eczema severity and pruritus scores decreased by 57.1%. In phase III clinical trials, dupilumab led to a 75% improvement in eczema severity, when compared to placebo, and decreased symptoms of anxiety and depression. It also led to a significantly decreased use of topical corticosteroids. The safety and efficacy were supported in a recent meta-analysis of all published dupilumab paper. 

Approximately two years ago, the FDA (United States Food and Drug Administration) also approved dupilumab for the treatment of patients aged 6 years and older with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. This approval followed a phase 3, randomized, double blinded placebo controlled trial that enrolled 367 patients to evaluate the safety and efficacy of dupilumab in children (ages 6-11 years) for treatment of atopic dermatitis. Significantly and clinically meaningful improvements in patients signs and symptoms of atopic dermatitis as well as quality of life were reported. As seen in adults, treatment in pediatric population was reportedly well tolerated with the most commonly reported side effects including injection site reactions and conjunctivitis. 

According to the multidisciplinary review (Gresham et al), vaccine efficacy may be reduced in patients receiving systemic immune-targeting therapies because of the impaired immune response in these patients. There is a trend toward a decreased immune response and vaccine immunogenicity in patients on systemic immunotherapies, particularly patients receiving azathioprine, cyclosporine, methotrexate, mycophenolate mofetil, or JAK (janus kinase) inhibitors. Therefore, it would not be advisable to use a systemic therapy in this patient, as it can decrease vaccine efficacy (should she become eligible for the vaccine) and place this patient at higher risk of covid-19 complications, when a safer alternative is available. 

In addition, per the review by Ungar et al, patients on dupilumab experienced less severe COVID-19 manifestations and lesser symptoms compared with patients on other systemics and on limited/no treatment. These results suggest that Th2 (T helper-2) modulation with dupilumab may have a protective effect on anti-viral immune response in patients with AD (atopic dermatitis). Therefore Dupixent is medically necessary. 

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.