Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis
Treatment: Dupixent 300MG/2ML (milligrams per milliliter) SC (subcutaneous) SOPN (Solution Pen-Injector)
The insurer denied: Dupixent 300MG/2ML SC SOPN
The denial is overturned.

The patient is an adult female with a medical history of atopic dermatitis and alopecia areata. The patient has tried and failed intramuscular Kenalog and triamcinolone. She has been stable on Dupixent. This request for coverage is under review.

The proposed treatment is medically necessary.
At this time, the patient has been on Dupixent for two years with excellent disease control on the same. For the sake of treatment continuum, remaining on this drug is safer given that any new medication poses new possible health risks. This patient has had no adverse reactions to Dupixent and if it were to be discontinued in lieu of a plan covered medication, that medication may have side effects or even fail to resolve atopic dermatitis. Dupixent would be unlikely to be as effective moving forward if restarted after cessation. Therefore, this request is medically necessary for continuation of therapy.

Dupixent has demonstrated efficacy and safety per Thomson et al, "740 patients were included in the trial: 319 were randomly assigned to dupilumab qw, 106 to dupilumab q2w and 315 to the placebo arm. At week-16, more patients in the dupilumab groups achieved the co-primary endpoints: IGA 0/1 (39% [125 patients] qw dosing, 39% [41 patients] q2w dosing vs 12% [39 patients] receiving placebo; p<0.0001) and EASI-75 (64% [204] and 69% [73] vs 23% [73]; p<0.0001). Whilst no new safety signals were identified, adverse effects (AEs) were noted in 261 (83%) in those receiving dupilumab qw plus TCS, 97 (88%) dupilumab q2w plus TCS and 266 (84%) for placebo plus TCS." (Thomson et al., 2017).

Furthermore, per Fleming (2018) "Eight randomized controlled trials in 4 publications with 2706 participants were included, with follow-up time ranging from 4 to 52 weeks. Meta-analysis including all dosing schedules and follow-up times showed a RR of skin infection of 0.54 (95% CI, 0.42-0.70) and an odds ratio of eczema herpeticum of 0.34 (95% CI, 0.14-0.84) for dupilumab compared with placebo. No significant association was found for dupilumab with overall herpesvirus infections (RR, 1.16; 95% CI, 0.78-1.74) and overall infections (RR, 0.98; 95% CI, 0.83-1.16) ...Dupilumab is associated with a decreased incidence of skin infections and eczema herpeticum in adults with moderate-to-severe AD. The mechanism underlying this association is uncertain but is likely related to improvement in AD severity. Dupilumab, a monoclonal antibody targeting interleukin 4 and interleukin 13, appears to significantly decrease the risk for skin infections and eczema herpeticum in adults with moderate-to-severe AD."

Finally, per Vangipuram et al. (2017) "In clinical trials, it has demonstrated efficacy by reducing clinical activity and symptoms, and showed improvement in the AD genomic phenotype, including a significant reduction in Th2 chemokines and reversal of key epidermal markers of AD. It also has a favorable safety profile. This review discusses the role of dupilumab in treating Th2 related inflammation, and its efficacy and safety, as demonstrated in clinical trials. Dupilumab (Dupixent) recently gained US FDA approval for patients with moderate-to-severe AD, and is poised to revolutionize the management of this chronic, relapsing condition."