Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic Dermatitis
Treatment: Dupixent 300 milligram/2 milliliters SC SOSY
The insurer denied Dupixent 300 milligram/2 milliliters SC SOSY.
The denial was upheld.

This is a male patient who presented to a dermatologist with complaints of eczema for many years.  The patient's history included hyperlipidemia.  It was stated also that the patient failed oral steroids, protopic, and betamethasone.  The patient also complained about severe itching that interfered with daily activities, and also caused trouble sleeping.  It was documented that the patient was using Atarax 10 milligrams every night.  The physical exam indicated eczematous patches and papules on chest/arms/ankles; body surface area 10%.  The visit diagnosis included atopic dermatitis. The dermatologist requested Dupixent for this patient. This request was denied by the insurer. He explained that the patient used the insurer's suggested alternative tacrolimus ointment and his symptoms were not relieved.  His appeal letter stated that topical therapy was only indicated for mild disease and the patient's dermatitis was past the use of topical, oral, or phototherapy treatment as it was too severe.  

"Before stepping up therapy, the patient should be assessed for nonadherence, potential comorbidities, and other factors that might negatively affect response to therapy (Table 3). Confirmation is needed that the increased level of symptoms is due to AD.  When nonpharmacologic interventions alone are not enough to manage the patient's symptoms, a step-up to maintenance therapy with a topical prescription medication (eg, topical corticosteroid [TCS], topical calcineurin inhibitor [TCI], or crisaborole ointment) should be tried (Fig 4).9,  53,  64,  65,  66,  67 Treatment options for patients with moderate to severe AD have largely been limited to phototherapy and/or systemic immunosuppressive agents, with the specific step-up determined according to patient need, availability of and access to treatment, and cost.9,  57,  80 A new therapeutic approach became available in 2017 with FDA approval of the targeted biological therapy, dupilumab, for patients with moderate to severe AD who have an inadequate response to, or cannot use, topical therapy (Fig 4).65,  81,  82" (Boguniewicz et al 2018).

Gooderham, et al. (2017) discusses several DMARD options for atopic dermatitis: "Cyclosporine is recommended as first-line treatment for short-term use, azathioprine is second line, and methotrexate third-line.5" Similar evidence has been stated by Dias-Polak et al. (2019),

Up to Date states that "Dupilumab is also an option for patients who are not candidates for or failed previous treatment with conventional immunosuppressive agents, such as cyclosporine, methotrexate, mycophenolate mofetil, or azathioprine."

The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. Standard of care therapy includes the use of systemic agents (cyclosporine, azathioprine, methotrexate, and mycophenolate), and UVB or UVA therapy.  Also, use of calcineurin inhibitors such as tacrolimus and pimecrolimus.  Therefore, the treating provider's argument that the systemic agents and phototherapy are not recommended for atopic dermatitis would be inaccurate. There is no indication that the patient has tried and failed topical calcineurin inhibitors, systemic agents (cyclosporine, azathioprine, methotrexate, mycophenolate, and UVB or UVA therapy).  

The carrier's denial of coverage for Dupixent 300 milligram/2 milliliters SC SOSY is upheld.  Medical necessity is not substantiated.