Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic dermatitis. 
Treatment: Dupixent 300 mg/2ml SC SOSY. 

The insurer denied coverage for Dupixent 300 mg/2ml SC SOSY. 

The denial is upheld. 

This is a male patient with atopic dermatitis (AD). The patient has failed treatment with Eucrisa, topical steroids, and Protopic. The provider is requesting Dupixent. 

According to Wong, et al., "Topical agents are the mainstay of treatment for mild-moderate AD and include 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." 

Per Johnson, et al., "MTX [Methotrexate] is recommended as a third-line option for the long-term treatment of children (8 years) and adults with moderate-to-severe AD based on two small, long-term RCTs. This treatment may be especially useful in patients who are not candidates for CsA. MMF or EC-MPS may be promising third-line agents in patients with moderate-to-severe AD who fail or are not candidates for the other off-label immunosuppressants. Larger, long-term RCTs are needed to make any further recommendations on dosing, monitoring, and long-term therapy for moderate-to-severe AD. Screening for UGT1A9 polymorphisms prior to the initiation of treatment could be considered to identify potential nonresponders to MMF. AZA is recommended as a third-line treatment for moderate-to-severe AD given its modest level of effectiveness as seen in a few small studies. AZA is usually reserved for patients who are not candidates for other third-line agents given its safety profile." 

Kolb, et al. states, "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 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." 

Dupixent is approved by the Food and Drug Administration for the treatment of moderate to severe atopic dermatitis in patients over the age of 6. 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. 

The patient has not tried and failed any systemic immunosuppressive medication. The patient is not immunosuppressed or immunocompromised. The patient does not have elevated liver function tests, liver disease, or uncontrolled hypertension. The patient has had efficacy with Dupixent utilizing the sample program, but there is no indication that the patient cannot have efficacy with preferred options or that he will experience adverse effects with a change in therapy. 
                                              
Dupixent was appropriately denied as the patient has not tried and failed systemic immunosuppressive medications.  The health plan acted reasonably with sound medical judgment in the best interest of the patient. 

The carrier's denial of coverage for Dupixent 300 mg/2ml SC SOSY is upheld. The medical necessity is not substantiated.