Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Skin Disorders.
Treatment: Pharmacy/Prescription Drugs.
The insurer denied: Xeljanz.
The denial is: Upheld in whole.

The patient is a male with alopecia areata/alopecia universalis. According to a letter from the provider they are seeking coverage for Xeljanz. The patient has previously failed topical, intralesional, and oral steroids.
The subject under review is the medical necessity for Xeljanz.

The health plan's determination is upheld in whole.

No, Xeljanz is not medically necessary for this patient.
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 dibutyl ester (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 inhibitors, which includes Tofacitinib and Ruxolitinib, are effective in alopecia areata, including AU. However, JAK inhibitors have not yet been approved by the Food and Drug Administration (FDA) for use in skin conditions."
Furthermore, according to Kassira et al., "Management of alopecia totalis (AT) 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, tumor necrosis factor alpha (TNFa) 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 dibutyl ester, 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."
Per Ibrahim et al., "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, Salman et al., "Janus kinase inhibitors are emerging treatment alternatives in various immune-mediated diseases including alopecia universalis. Herein, we report a patient with psoriasis and alopecia universalis in whom treatment with tofacitinib led to remission of psoriasis without improvement in 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. 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 summary, it is not known which the best patient type is to respond to 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, medical necessity for Xeljanz has not been established.