Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Alopecia Universalis.
Treatment: Xeljanz 10mg Tablet.

The insurer denied the Xeljanz 10mg Tablet.  The denial is upheld.

The patient is a male. The request is for coverage of Xeljanz for the treatment of alopecia areata.

No, the health plan should not cover the requested Xeljanz.
Xeljanz does not have FDA (United States Food and Drug Administration) approval for treating alopecia and is therefore considered experimental/investigational.

No, the requested Xeljanz is not more beneficial.
The use of Xeljanz is not considered standard of care for treating alopecia nor medically appropriate for this patient. The requested agent lacks Food and Drug Administration approval for treating alopecia, therefore it is considered experimental/investigational in nature and should not be covered.

According to the U.S. Department of Health & Human Services, National Institutes of Health (NIH) and Genetic & Rare Diseases Information Center (GARD), "No therapy has been found to work for everyone who has alopecia universalis (AU) which makes managing AU [alopecia universalis] challenging. Although multiple treatments have been explored, no therapy is currently approved by the United States Food and Drug Administration (FDA). Some promising therapies include: diphenylcyclopropenone (DPCP), squaric acid dibutylester (SADBE), photodynamic therapy, steroids, cyclosporine in combination with methylprednisolone (a steroid). There 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 [alopecia universalis]. However, JAK (janus kinase) inhibitors have not yet been approved by the FDA (United States Food and Drug Administration) for use in skin conditions."

Furthermore according to Kassira et al., "Management of AT [alopecia totalis] and AU [alopecia universalis] can be challenging, and although multiple treatment modalities have been explored, no therapy is currently FDA-approved. This review focuses on the evidence for current treatment options for AT [alopecia totalis] and AU [alopecia universalis]. The PubMed database was searched for clinical trials, retrospective studies, and case reports of treatments for AT [alopecia totalis] and AU [alopecia universalis]. A total of 40 studies were retrieved and analyzed. Therapies studied for AT [alopecia totalis]/AU [alopecia universalis] included: topical immunotherapy, steroids, photodynamic therapy, immunosuppressive agents, TNF [tumor necrosis factor] inhibitors, and other therapies, such as sulfasalazine, bexarotene, JAK [janus kinase] inhibitors, and simvastatin/ezetimibe. Although certain treatments showed significant hair regrowth, no treatment was completely effective. The most promising therapies with the highest quality data include diphenylcyclopropenone, squaric acid dibutylester, photodynamic therapy, steroids, and cyclosporine in combination with methylprednisolone. High-quality randomized-controlled trials with large sample sizes are lacking. Unified outcome guidelines are encouraged to facilitate the comparison of future studies."

As per Crispin et al., "Alopecia areata (AA) is an autoimmune disease characterized by hair loss mediated by CD8+ [cluster of differentiation 8] T cells. There are no reliably effective therapies for AA [alopecia areata]. Based on recent developments in the understanding of the pathomechanism of AA [alopecia areata], JAK [janus kinase] inhibitors appear to be a therapeutic option; however, their efficacy for the treatment of AA [alopecia areata] has not been systematically examined. "