Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Atopic dermatitis

Treatment:  Dupixent (dupilumab) 

The insurer denied coverage for Dupixent (dupilumab).  The denial was reversed.

This patient is a male who a history of atopic dermatitis, erythema, and scaling distributed on the left and right hands.  The treatment plan was to continue Halobetasol and Eucrisa twice daily.  A note mentioned that the patient received counselling on Dupixent.  It was noted the patient had ultraviolet-B (UVB) treatment in the past with minimal effect.  In the earliest office note, thepatient had atopic dermatitis on the left lateral superior chest, right lateral superior chest, right ulnar dorsal hand, right antecubital skin, and left antecubital skin.  At that time, he was started on Halobetasol cream twice daily for 2 weeks, then once daily if improved, then tapered off.  It was indicated that the patient's condition was worsening and more than 10 % of his body, chest, arms, fingers, and hands, was affected.  The patient tried fluticasone propionate 0.05% topical cream, which worsened his condition.  He also tried tacrolimus 0.1% topical ointment with no effect.  Also noted was the presence of kidney disease that was a contraindication for several treatments.

According to Vangipuram, R., & Tyring, S. K. (2017), "Atopic dermatitis (AD) is the most common chronic inflammatory disease affecting 2-10% of adults and up to 15-30% of children.  Despite a rising prevalence, effective and safe therapeutics for patients with moderate-to-severe AD are limited due to toxicity and side effects.  Dupilumab, an interleukin (IL)-4 and IL-13 antagonist that limits type 2 T helper (Th2) driven inflammatory activity, is a promising therapeutic option...".

Gooderham, M. J., et al. (2018) states, "Atopic dermatitis (AD) is a chronic, pruritic immune-mediated inflammatory dermatosis characterized by a T helper 2 (Th2) immune response phenotype and may be associated with systemic inflammation.  Dupilumab is an interleukin 4 (IL-4) receptor-antagonist that inhibits IL-4 and IL-13 signaling through blockade of the shared IL-4 subunit.  Blockade of IL-4/13 is effective in reducing Th2 response.  Dupilumab has recently been approved in the United States and Europe for the treatment of adult patients with moderate-to-severe AD.  Clinical trials have shown that adults with moderate-to-severe AD who receive weekly or biweekly dupilumab injections have significantly improved clinical and patient-reported outcomes...".

According to Beck, L.A., et al. (2014), "Patients treated with dupilumab had marked and rapid improvement in all the evaluated measures of atopic dermatitis disease activity."     

The patient has a history of atopic dermatitis involving at least 10% body surface area, with involvement of the hands intertriginous areas and other associated areas.  He has tried and failed Eucrisa, halobetasol, prednisone, tacrolimus, and fluticasone. Phototherapy has been tried and failed in the past.  In addition, phototherapy would be contraindicated due to sensitive areas of involvement such as the intertriginous areas.  The use of cyclosporine, azathioprine, methotrexate, and mycophenolate mofetil would be contraindicated in an individual with pre-existing renal disease.  Therefore, Dupixent should be approved and is medically necessary in this case.
	
The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

Based on the above, the medical necessity for Dupixent (dupilumab) is substantiated.  The insurer's denial is reversed.