Appeal type: Medical necessity
Decision: Upheld

Skin Disorder
Pharmacy/Prescription Drug

Diagnosis: Atopic Dermatitis
Treatment Xeljanz
The insurer denied the Xeljanz
The determination is upheld.

The patient has severe atopic dermatitis (AD) affecting more than 30% of her body surface area, involving erythema of the face and with plaques of the torso and extremities. The patient has tried and failed topical steroids such as triamcinolone, hydrocortisone, and clobetasol, as well as topical tacrolimus. The patient has also tried and failed oral Prednisone, Methylprednisolone, Fluconazole, Xyzal, and Cyclosporine. Dupixent was not tolerated because of it causing red face syndrome.
The medical necessity of Xeljanz is under review for medical necessity.
 The Xeljanz is not medically necessary. The patient has severe atopic dermatitis, and requires systemic therapy to restore her quality of life. The topical and oral medications, as well as Dupixent she has taken either have not worked for this patient, and/or have toxicities that prevent long-term use. However, as per all modern dermatology literature reviews (1-5), Xeljanz is either not mentioned or is barely mentioned as as a medication that has not been proven to be safe for long-term use in the treatment of atopic dermatitis. Oral janus kinase inhibitors such as Xeljanz do likely have some promise for this patient's indication, but a have unresolved safety/efficacy and outcomes questions at this time. Although FDA-approved for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, Xeljanz was held off for approval in the treatment of psoriasis, in large part because of safety concerns such as infections and tumor formation. Despite general dermatologic interest in treating challenging diagnoses such as moderate to severe atopic with a new mechanism of action (janus kinase inhibition), the role of treating atopic dermatitis using this mechanism of action is uncertain at this time.
The dosage, safety/efficacy questions, and the long-term outcomes of Xeljanz are unknown for the indication of atopic dermatitis, and therefore, Xeljanz is ideally not indicated for any use outside of any closely-monitored investigational trial. Second-generation janus kinase inhibitors (such as Rinvoq) are undergoing clinical trials for confirmed safe and effective use for the treatment of atopic dermatitis, but questions about short-term and long-term safety and efficacy for these agents still remain unanswered.
Accordingly, with the lack of proper data for use of Xeljanz, treatments used in combination (for example, topical agents, low-dose prednisone, and/or phototherapy with Mycophenolate Mofetil used concurrently) are the appropriate, safe, and standard of care for severe atopic dermatitis at this time.
Per Megna M, et al Atopic dermatitis (AD) is a common chronic inflammatory skin disease that predominantly affects children. However, it can persist in adulthood and/or start at older ages. Due to its chronic nature and frequently occurring relapses, AD has a substantial effect on patients' quality of life, often requiring long-term systemic treatment, especially in adult patients, who are more frequently refractory to adequate topical treatment with mid- to high-potent corticosteroids and/or calcineurin inhibitors. Therefore, treatment with systemic therapies is often needed to take control of the disease, prevent exacerbations and improve quality of life. However, data regarding systemic treatment effectiveness and long-term safety in adult patients with AD are insufficient. Indeed, standardized international guidelines are lacking, and the treatment approach widely differs among diverse countries. This review focuses on the use of systemic treatments in adult AD patients analyzing published literature.