Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Alopecia universalis.

Treatment: Xeljanz 10 milligrams (mg) tablet.

The insurer denied coverage for Xeljanz 10 mg tablet. 

The denial is upheld. 

This is a female patient with alopecia universalis. The patient has failed topical and intralesional steroids. The request is for Xeljanz.

According to the United States (U.S.) 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). 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. (2017), "Management of AT [alopecia totalis] and AU can be challenging, and although multiple treatment modalities have been explored, no therapy is currently FDA-approved..."

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). To truly assess efficacy, therapeutic trials should continue in the clinical setting for a minimum of 4 months and potentially up to 1 year. Patients should be informed of the lack of durability of effects after the treatment is discontinued. Future 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."

In addition, according to Salman et al. (2017), "Janus kinase inhibitors are emerging treatment alternatives in various immune-mediated diseases including alopecia universalis ...Despite 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 King et al, 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 ...It has been well documented in the medical literature of the inability of Xeljanz to maintain long-term efficacy. 

The use of Xeljanz is considered experimental and investigational as there is not a clinical consensus the treatment results in an improvement in health outcome. Xeljanz is not FDA approved for the treatment of alopecia universalis nor is there medical compendia support. As the use of Xeljanz is considered experimental and investigational, it cannot be concluded that the patient would be a suitable candidate for treatment. 

Xeljanz is not likely to be more beneficial than any other existing standard health service.                                                

The carrier's denial of coverage for Xeljanz 10 milligrams (mg) tablet should be upheld.