Diagnosis: Alopecia universalis.

Treatment: Xeljanz.

The insurer denied coverage for the medication Xeljanz for the treatment of alopecia universalis.

The denial is upheld.

This is a female patient with alopecia universalis. The patient is experiencing severe chronic eye inflammation and irritation due to a lack of eyebrows and eyelashes. The patient also has a history of Hashimoto's disease which is controlled with Synthroid. The patient has failed topical, intralesional and oral steroids for her diagnosis of alopecia universalis. The request is for Xeljanz (tofacitinib).

According to the United States Department of Health & Human Services, National Institutes of Health (NIH) and Genetic & Rare Diseases Information Center (GARD) (2017), "No therapy has been found to work for everyone who has alopecia universalis (AU) which makes managing AU challenging. Although multiple treatments have been explored, no therapy is currently approved by the United States Food and Drug Administration (FDA)...here are several recent studies showing that a class of medication known as JAK [Janus kinase] inhibitors, which includes Tofacitinib and Ruxolitinib, are effective in alopecia areata, including AU. However, JAK inhibitors have not yet been approved by the FDA for use in skin conditions."

Furthermore, according to Kassira et al. (2017), "Management of [alopecia totalis (AT)] and [alopecia universalis (AU)] can be challenging, and although multiple treatment modalities have been explored, no therapy is currently [Food and Drug (FDA)]-approved...herapies studied for AT/AU included: topical immunotherapy, steroids, photodynamic therapy, immunosuppressive agents, [tumor necrosis factor (TNF)-a] inhibitors, and other therapies, such as sulfasalazine, bexarotene, JAK inhibitors, and simvastatin/ezetimibe. Although certain treatments showed significant hair regrowth, no treatment was completely effective..."

As per Ibrahim et al. (2017), "Tofacitinib citrate is a Janus kinase 1/3 inhibitor approved for the treatment of rheumatoid arthritis, but it has recently been used to treat alopecia areata (AA)...uture studies, including those using other Janus kinase inhibitors, such as ruxolitinib phosphate, are needed and should continue to elucidate these medications' efficacy, safety, and durability in the treatment of AA."

As per Salman et al. (2017), "Janus kinase inhibitors are emerging treatment alternatives in various immune-mediated diseases including alopecia universalis...espite the promising potential in alopecia areata treatment, research evaluating the efficacy of different Janus kinase inhibitors and possible prognostic factors related with a more favorable response are warranted."

In a retrospective study of 90 patients by Liu et al. (2017), Xeljanz was studied and shown to have possible efficacy in treating patients with alopecia. However there is insufficient evidence by way of large randomized controlled cohort prospective trials showing the long-term safety and efficacy of Xeljanz in treating this patient population. As such, there are no clinical guidelines with regards to optimal dosing and duration of therapy. There is also a lack of consensus with regards to the optimal patient scenario. In other words it is not known which patient type is ideal for this treatment. Treatment response always depends on how long the patient has had alopecia and to what extent the hair loss entails. It has been well documented in the medical literature of the inability of Xeljanz to maintain long-term efficacy. Therefore at this time, a medical exception for Xeljanz has not been established.

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.

The medical necessity for the medication Xeljanz for the treatment of alopecia universalis is not substantiated. The insurer's denial should be upheld.