Appeal type: Step Therapy
Decision: Overturned

Diagnosis: Skin Disorders/Dermatitis
Treatment: Pharmacy/Prescription Drugs-Dupixent
The health plan denied the medication as not medically necessary. The reviewer has overturned the health plan determination in whole.

The patient has atopic dermatitis associated with fissures and pustules of the palms and soles. The patient has tried and failed topical clobetasol, tacrolimus, and halobetasol. Methotrexate was utilized but the patient developed alopecia (hair loss). Otezla was also tried and failed for several months. The flares of this patient's eczema causes the inability to walk or handle objects.

The patient has utilized both topical and oral medications for atopic dermatitis for a significant length of time (over a year), and has significant functional impairment of the hands and feet to require an alternative form of systemic therapy, consistent with current medical literature and standards of care. Further use of either topical agents or systemic agents carries a very likely outcome of incomplete disease control and/or adverse side effects for this particular patient.

Atopic dermatitis (AD) is a common chronic inflammatory skin disease that predominantly affects children. However, it can persist in adulthood and/or start at older ages. Due to its chronic nature and frequently occurring relapses, AD has a substantial effect on patients' quality of life, often requiring long-term systemic treatment, especially in adult patients, who are more frequently refractory to adequate topical treatment with mid- to high-potent corticosteroids and/or calcineurin inhibitors. Therefore, treatment with systemic therapies is often needed to take control of the disease, prevent exacerbations, and improve quality of life.
Many AD patients respond satisfactorily to topical or systemic treatments, but for those patients who do not respond or have contraindications, new biologic agents appear to be promising therapies.

Topical tacrolimus has not been noted to be more efficacious than high-potency topical steroids or oral Methotrexate as per current medical literature [1-4]. 

a)  Other alternative oral or topical agents are of no greater benefit than those previously used for this patient's hand/foot atopic dermatitis, and after the side effect of alopecia for this patient using methotrexate, the risk of adverse reactions to other oral agents (azathioprine, mycophenolate mofetil) are a considerable likelihood of occurrence. Further use of tacrolimus or oral agents are not recommended, both because of insufficient response to more potent topical agents (clobetasol and halobetasol) and oral agents (Methotrexate). Topical tacrolimus has not been noted to be more efficacious than high-potency topical steroids or oral Methotrexate as per current medical literature [1-4]. 
b)  Other alternative oral or topical agents are of no greater benefit than those previously used for this patient's hand/foot atopic dermatitis, and formulary alternatives not yet used are as likely to be ineffective as those previously used.
c)  The patient has tried and failed all reasonable step therapy oral and topical alternatives, and further use of other alternatives on formulary would likely be ineffective as well.
d)  No, the patient is neither stable nor controlled on a prescription drug selected by the provider, with respect to functional impairment of the hands and feet.
e)  The required prescription drugs are not in the best interest of the patient. Further use of current or alternative topical and oral medications without Dupixent are, more likely than not, to lead to further or worsening functional impairment and potential significant side effects that require discontinuation.