Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic dermatitis

Treatment: Dupixent 

The insurer denied coverage for Dupixent.

The denial is upheld.

This is a female child with atopic dermatitis (AD). Standard treatment options for patients with atopic dermatitis include a regimen of topical steroids as well as topical calcineurin inhibitors. The patient has failed topical steroids, Protopic, and Eucrisa. After topical agents fail, standard practice is to pursue systemic therapy such as phototherapy. The provider requested Dupixent. 

"Careful environmental history and education are part of the management of all AD patients including education on the pathophysiology of AD, identification of patient-specific allergens, and avoidance of or reduced exposure to relevant allergens (where possible) as this often improves AD. Topical corticosteroids (TCSs) are the first-line treatment for an acute flare of AD as they provide more rapid effects that lead to decreased inflammation and pruritus. Topical calcineurin inhibitors (TCIs), including tacrolimus 0.1% ointment, tacrolimus 0.03% ointment, and pimecro-limus 1% cream, are considered second-line agents for the management of AD flares...pimecrolimus 1% cream is approved for patients with mild-to-moderate AD [in this patient's age group]" (Johnson et al 2019).

"The four major components of treatment include trigger avoidance, daily skin care, anti-inflammatory therapy, and other complementary modalities. Daily skin care includes the application of emollients twice daily, with the application within three minutes of exiting lukewarm shower or bath to prevent skin drying. Ointments are the most occlusive but may be more greasy. Topical steroids, which should be applied before emollients to "lock-in" their effect, are first-line agents for acute flares. The potency should be strong enough to control a flare quickly, and consideration should be given for tapering every other day and for maintenance therapy twice weekly (e.g., weekends) in the usual areas of involvement. Reversible side effects of steroid use include skin atrophy and telangiectasia. When atopic dermatitis is not controlled with topical agents, systemic agents include phototherapy, cyclosporine, azathioprine, mycophenolate mofetil, and methotrexate...Other complementary therapies include bleach baths one to two times weekly, low allergen maternal diets during breastfeeding, and probiotic and prebiotic use in pregnant mothers and at-risk infants which has shown 50% decreased frequency of atopic dermatitis [in this patient's age group]. Recently crisaborole [Eucrisa] topical ointment was approved for mild to moderate AD. The drug is a phosphodiesterase inhibitor and shown to improve skin symptoms. Some patients may benefit from probiotics; it is believed that the bacterial products may enhance the immune system and prevent the development of allergic Immunoglobulin E (IgE) antibody response. Numerous studies show that bleach baths may help relieve the symptoms of AD by lowering the risk of superinfection with bacteria" (Kolb, et al. 2020).                                                         

The patient is not old enough to receive Dupixent. Dupixent is not Food and Drug Administration (FDA) approved for the treatment of moderate to severe atopic dermatitis in this patient's age group. There is no medical compendia support for the use of this medication in this patient's age group. There is potential efficacy of Dupixent in this pediatric population; however, there is no clinical consensus with regards to optimal dosing and frequency of injection in this age population. A medical exception for Dupixent has not been established. 

The health plan acted reasonably with sound medical judgment in the best interest of the patient. 

The carrier's denial of coverage for Dupixent is upheld. The medical necessity is not substantiated.