Appeal type: Experimental/Investigational
Decision: Overturned

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

The patient is a female who is requesting coverage of Xeljanz for the treatment of alopecia areata (AA). She has tried and failed topical/intralesional (IL)/oral steroids. The provider is appealing the denial citing the need for Xeljanz.

No, the health plan should not cover the proposed treatment.

The use of Xeljanz is not considered standard of care for treating alopecia. The requested agent lacks Food and Drug Administration (FDA) approval for treating alopecia, therefore it is considered experimental/investigational in nature. 

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 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 alopecia universalis. However, JAK (Janus kinase) inhibitors have not yet been approved by the FDA (Food and Drug Administration) for use in skin conditions."

Furthermore according to Kassira, et al (2017), "Management of alopecia totalis and alopecia universalis can be challenging, and although multiple treatment modalities have been explored, no therapy is currently FDA-approved (Food and Drug Administration). This review focuses on the evidence for current treatment options for alopecia totalis and alopecia universalis. The PubMed database was searched for clinical trials, retrospective studies, and case reports of treatments for alopecia totalis and alopecia
universalis. A total of 40 studies were retrieved and analyzed. Therapies studied for alopecia totalis and 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."

The patient has tried multiple conventional therapies listed above with minimal success. While the JAK inhibitors, such as Xeljanz, are promising, they are not yet FDA-approved for alopecia universalis. They are therefore considered experimental/investigational. Furthermore, there are other therapies listed above that have not been tried yet.

The requested health service or treatment is not more beneficial than any standard treatment for the insured's condition or disease.