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 patient is a female who has atopic dermatitis.  The patient has failed phototherapy and prednisone.  The treating provider requests Dupixent.  The office note states the patient has itching and eczematous patches for two years.  She has tried and failed steroid creams, Zyrtec, prednisone, and phototherapy. 

According to Wong, et al. (2017), "Topical agents are the mainstay of treatment for mild-moderate AD and include TCS [topical corticosteroids] 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."

Comparison clinical studies involving available systemic therapies for AD (cyclosporine, methotrexate, azathioprine, montelukast, and Dupixent) have shown the strongest evidence for cyclosporine and Dupixent.  In clinical study data, cyclosporine was associated with a 56 percent improvement in SCORing Atopic Dermatitis (SCORAD) scores, and Dupixent is associated with a higher 66 percent improvement in SCORAD scores. 

Dupixent is Food and Drug Administration (FDA) approved 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.  The patient does not have any known history of elevated liver function tests (LFTs) or liver disease or uncontrolled hypertension.  The patient is not immunosuppressed or immunocompromised.  While this class of systemic immunomodulating drugs are not specifically FDA approved for atopic dermatitis, their use is considered standard of care for patients, who have failed topical conventional therapies.  In comparison, Dupixent lacks the long-term data of this class of drugs used in many dermatologic and rheumatologic indications.  The patient has no documented contraindication, intolerance or failure to systemic immunomodulating DMARDs.  A medical exception for Dupixent has not been established.  Therefore, Dupixent 300 mg/2ml SC SOSY is not considered medically necessary for this patient.

The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient.     

Dupixent 300 mg/2ml SC SOSY is not considered medically necessary for this patient.

Based on the above, the medical necessity for Dupixent 300 mg/2ml SC SOSY is not substantiated.  The insurer's denial is upheld.