Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Severe Alopecia
Treatment: Xeljanz 10 mg (milligrams), Pre-service
The insurer denied the Xeljanz 10 mg, pre-service.
The denial is upheld.

The patient is a male with a medical history of alopecia areata. He has tried and failed topical/oral/intralesional steroids. The provider is appealing the denial of Xeljanz citing research supporting the use of Xeljanz for treating alopecia.

No, the health plan should not cover the requested Xeljanz.

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 (FDA) approval for treating alopecia, therefore it is considered experimental/investigational in nature and should not be covered. Additionally, there are other medications that this patient has yet to fail.

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 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. However, JAK inhibitors have not yet been approved by the FDA for use in skin conditions."

Furthermore, according to Kassira, et al, "Management of AT [alopecia totalis] and AU 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 and AU. The PubMed database was searched for clinical trials, retrospective studies, and case reports of treatments for AT and AU. A total of 40 studies were retrieved and analyzed. Therapies studied for AT/AU included: topical immunotherapy, steroids, photodynamic therapy, immunosuppressive agents, TNF [tumor necrosis factor] 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. 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. Based on recent developments in the understanding of the pathomechanism of AA, JAK inhibitors appear to be a therapeutic option; however, their efficacy for the treatment of AA has not been systematically examined."

No, the requested Xeljanz cannot be stated to be more beneficial.

Some promising therapies include: diphenylcyclopropenone (DPCP), squaric acid dibutylester (SADBE), photodynamic therapy, steroids, cyclosporine in combination with methylprednisolone (a steroid).