Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Nummular dermatitis
Treatment:  Dupixent 300 mg injection 

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

This patient is a female with a history of chronic kidney disease, anxiety, coronary artery disease, heart murmur, hyperlipidemia, hypothyroidism, irritable bowel syndrome, hypertension, gastroparesis, aortic stenosis with bicuspid aortic valve, status post aortic valve replacement, and dermatitis.  The office visit note states the patient was seen for follow up of nummular dermatitis.  The patient reported she had stopped using Zyrtec.  Prednisone and Zyrtec were ordered.  The patient reported significant improvement in symptoms while on Prednisone, but she began to flare again a week after she was off the medication.  Prednisone was restarted with a much longer taper, and Zyrtec was increased to 3-4 tablets daily.  The patient has continued complaints of flaring spongiotic dermatitis with intensely pruritic areas.  The patient has tried and failed topical medications including triamcinolone ointment, transabdominal lotion, desoximetasone cream, Sarna lotion, regular emollient application, and cetirizine tablets.  Dupixent was ordered.  Discontinuation or as needed usage of Omeprazole was discussed.

Per Howell, A. N., Ghamrawi, R. I., Strowd, L. C., & Feldman, S. R. (2020), "Cyclosporine, azathioprine, methotrexate, and mycophenolate mofetil are systemic agents available for the treatment of refractory AD; however, insufficient data exist to indicate the superiority of any one agent.  Dupilumab is a safe and efficacious injectable therapy in elderly patients."

Per Gerbens, L., Hamann, S., Brouwer, M., Roekevisch, E., Leeflang, M., & Spuls, P. I. (2018), "Based on this relatively small pragmatic study, MTX and AZA seem to be effective and safe as maintenance treatments in moderate-to-severe AD up to 5 years. Few patients in both groups survive on their originally allocated drug although some discontinued because of controlled AD."

The undated appeal letter noted the patient is not a candidate for cyclosporine secondary to an underlying history of essential hypertension.  Azathioprine is not FDA-approved for treatment of atopic dermatitis.  Dupixent is approved for the treatment of moderate to severe atopic dermatitis and achieves improvement not achieved by other comparably safe therapies. 

Up to Date in a review of dupilumab for treatment of severe atopic dermatitis states:

"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 [76]. Adverse effects of dupilumab include injection-site reactions, conjunctivitis, and headache [77].  Dupilumab has been shown to be associated with a reduced risk of skin infections, including eczema herpeticum [78]."

The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 
                                    
There is lack of current peer review literature to support the use of Dupixent over the available alternatives.  Furthermore, Up to Date supports the use of methotrexate and azathioprine. 

Based on the above, the medical necessity for Dupixent 300 mg injection is not substantiated.  The insurer's denial is upheld.