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202302-159295

2023

Oxford

PPO

Skin Disorders

Pharmacy/ Prescription Drugs

Medical necessity

Overturned

Case Summary

Diagnosis: Atopic Dermatitis
Treatment: Dupixent
The insurer denied Dupixent.
The denial is overturned.

The patient is an adult male with atopic dermatitis, treated with triamcinolone and dexamethasone. The patient has eczematous plaques to the extremities and trunk, with 30% (percent) BSA (body surface area) affected. The patient's provider is requesting Dupixent. The health plan denied coverage of the request, as it requires a trial and failure to a topical calcineurin inhibitor or Eucrisa. The denial is being appealed. The provider states that further topicals are not effective for the severe disease.

The requested Dupixent is medically necessary.

While topical calcineurin inhibitors can be used in atopic dermatitis, they are not indicated for severe disease. This patient has 30% BSA (body surface area). Dupixent (Dupilumab) is United States Food and Drug Administration indicated for treatment of recalcitrant atopic dermatitis, approved in 2017. Two trials SOLO-1 and SOLO-2 demonstrated that patients treated with Dupilumab experienced significant, clinically meaningful improvements in their atopic dermatitis at week 16 as measured by the EASI score (Eczema Area and Severity Index). Dupilumab was well tolerated with the most commonly reported side effects including injection site reactions and conjunctivitis. Dupilumab is a novel interleukin-4 and interleukin-13 blocker, which inhibits the arm of the immune system responsible for atopic dermatitis. In clinical trials, after 12 weeks of monotherapy with dupilumab, 85% of patients had a greater than 50% reduction in eczema severity and pruritus scores decreased by 57.1%. In phase III clinical trials, dupilumab led to a 75% improvement in eczema severity, when compared to placebo, and decreased symptoms of anxiety and depression. It also led to a significantly decreased use of topical corticosteroids. The safety and efficacy were supported in a recent meta-analysis of all published dupilumab paper. (Han, et al)

Therefore, given the above, the requested Dupixent is medically necessary at this time.

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