Appeal type: Medical necessity
Decision: Upheld

The patient is a male with atopic dermatitis. He has tried tacrolimus. Symptoms are interfering with sleep. He has tried clobetasol and possibly mometasone. The subject under review is the medical necessity of Dupixent.

The health plan's determination is upheld.

No, the request is not medically necessary. First line treatments for atopic dermatitis include systemic medications such as azathioprine or cyclosporine per practice guidelines which the patient has not tried and failed.
Dupixent is indicated for treatment of moderate to severe atopic dermatitis not adequately controlled with topical prescription therapies, in ages 18 and older. 
The safety and efficacy of Dupixent was established in three randomized, double-blind, placebo controlled pivotal studies. The populations in these trials included adults that had atopic dermatitis for at least 3 years and had involvement of 10% of the body surface area. The study entrants were also previously uncontrolled by topical therapies. SOLO-1 (number [n]=671) and SOLO-2 (n=708) evaluated Dupixent as monotherapy, while CHRONOS (n=740) evaluated Dupixent as combination therapy. In all studies, the primary endpoint was a score of 0 (clear) or 1 (almost clear) on the Investigator's Global Assessment (IGA) and a reduction of  2 points from baseline to week 16. In SOLO-1, the primary endpoint was met in 38% of subjects in the Dupixent group versus 10% of subjects in the placebo group (probability [P] less than [<] 0.001). In SOLO-2, the primary endpoint was achieved in 36% of subjects in the Dupixent group versus 18% in the placebo group (P< 0.001). In week 16 of the CHRONOS trial, 38.7% of Dupixent subjects met the primary endpoint versus 10% of those treated with placebo (P< 0.001). At week 52, similar results were reported for the CHRONOS trial.
The usual treatment for first line therapies for atopic dermatitis is with topical steroids and topical immunomodulators. Topical steroids, such as: topical Elidel and topical tacrolimus, are the mainstay of therapy for this condition.
However, systemic therapies are often needed for more severe and/or treatment-resistant cases of atopic dermatitis, and such appears to be the case with this patient. Dupixent is only truly medically necessary when other similar, reasonable, and standard treatments have tried and failed, but such is not the case at this time.  
Dermatology literature reviews and American Academy of Dermatology Clinical Guidelines in the treatment of atopic dermatitis support use of phototherapy, methotrexate, azathioprine, or mycophenolate mofetil, and/or brief courses of systemic corticosteroids, as potential and appropriate systemic therapies for more severe cases of atopic dermatitis. These treatments are both time-tested, standard of care, and supported by modern dermatology literature and larger studies/comparative trials. In particular, prolonged and/or recurrent (as needed) courses of prednisone, phototherapy, and/or oral immunosuppressants are the best first-line options for this patient's treatment.
While Dupixent  is a promising new agent in the systemic treatment of atopic dermatitis, it is not confirmed to be superior than these alternative, and time-tested therapies described above.  
Accordingly, while systemic therapy is indicated for this patient, and Dupixent is one form of systemic therapy, Dupixent is being prescribed out of preference/convenience and not true medical necessity. Other, more studied alternatives have not yet been tried to date, such as azathioprine or cyclosporine. The request for Dupixent is therefore not medically necessary for this patient's particular clinical scenario.