Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic dermatitis

Treatment: Dupixent Syn 300

The insurer denied coverage for Dupixent Syn 300. The denial is overturned.

This patient is a female with a history of arthritis, asthma, hypertension, lupus, and eczema. She was seen by the treating provider. According to the office visit notes, the patient presented with complaints of itching of the face and hands, which has been present for years. She is currently using Eucrisa, Mometasone and other medications with steroids. In addition she has tried and failed many topical medications with no relief. A recent patch test and bloodwork were negative. The office visit note documents an impression of eczema of the left central malar cheek, right inferior malar cheek, second web space on her left hand, and right radial dorsal hand. Pimecrolimus topical cream was ordered. Additional recommendations were to discontinue Eucrisa, continue Mometasone for two weeks, and consistent use of antihistamines. The patient returned to the office and reported she did not get the Pimecrolimus. A biopsy by shave method was performed. The office visit notes an impression of atopic dermatitis. Dupixent was recommended.

According to Del Rosso, J. Q. (2019), "Atopic dermatitis (AD) is a chronic disorder that requires thorough patient education and a therapeutic management strategy designed to control flares, decrease recurrences, and reduce pruritus. In cases that cannot be controlled by proper skin care and barrier repair, topical therapy, and avoidance of triggers, systemic therapy is often required to control flares and maintain remission. It is important for clinicians to avoid becoming overly dependent on the intermittent use of systemic corticosteroid therapy to control flares, without incorporating other treatment options that might more optimally control AD over time..."

Per Kovalenko, P. et al. (2016), "An exploratory population pharmacokinetic model for functional dupilumab was developed. Data from healthy volunteers and patients with atopic dermatitis (AD) receiving intravenous or subcutaneous doses were integrated. The data included 197 participants (2,518 measurements of dupilumab in serum) from six phase I and II studies. The data were analyzed using stochastic approximation expectation-maximization and importance sampling methods. The best structural model was a two-compartment model with parallel linear and Michaelis-Menten elimination from the central compartment... The model adequately described dupilumab pharmacokinetics for intravenous and subcutaneous routes of administration."

Finally, Prezzano, J.C. & Beck, L.A. (2017) asserts, "Many patients with mild to moderate atopic dermatitis (AD) are managed by identifying and avoiding allergens and irritants, ensuring skin moisturization, and graded use of topical corticosteroids and/or calcineurin inhibitors. There is little consensus on the next step. Most systemic therapies are "off label" in the United States and include phototherapy, cyclosporine, mycophenolic acid precursors, azathioprine, and methotrexate. The decision to use these therapies should be based on efficacy and safety readouts from well designed, long-term trials."

The health plan did not act reasonably and with sound medical judgement and in the best interest of the patient. Dupixent Syn 300 is considered medically necessary for this patient. The patient had significant atopic dermatitis that has been poorly responsive to topical corticosteroids.

The carrier's denial of coverage for Dupixent Syn 300 is substantiated. The insurer's denial is overturned.