Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Alopecia Areata. 
Treatment: Xeljanz 10 milligram (mg) tablet, 60 tablets, 30 day supply by mouth. 
The insurer denied coverage for Xeljanz 10 milligram (mg) tablet, 60 tablets, 30 day supply by mouth. 
The denial is upheld. 

The treating provider has diagnosed the patient with a history of alopecia universalis with over 50% (percent) hair loss. The patient has failed topical, intralesional, and oral steroids. The treating provider is requesting therapy with Xeljanz 10 milligram (mg) tablets, twice daily. 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. There are several case series demonstrating the efficacy of Xeljanz for alopecia universalis, but there are no long-term studies nor clinical trials to assess a larger sample size and evaluate its long-term safety. Xeljanz 10 mg (milligrams) tablet, 60 tablets, 30 day supply by mouth does not have final approval from the appropriate regulatory bodies for this diagnosis. It is not approved by the Food and Drug administration (FDA) for alopecia. 

This patient is not a good candidate for Xeljanz 10 mg tablet, 60 tablets, 30 day supply by mouth. Given the uncertainty of the long-term effects of Xeljanz, and the other numerous treatment options for alopecia that this patient has not tried yet, the patient is not a good candidate at this time. 

Xeljanz 10 mg tablet, 60 tablets, 30 day supply by mouth is not the best available treatment for this patient at this time. Although Xeljanz has shown promising results in patients with alopecia areata, it is not yet FDA-approved for this condition. This patient has not tried other standard treatments, immune sensitization with dinitrochlorobenzene (DNCB), squaric acid, cyclosporine, or pulsed prednisone therapy. The patient is also a candidate for Olumiant, which is a similar JAK (janus kinase) inhibitor that is approved by the FDA for alopecia. 

The adverse risks are increased over standard treatment/services. Compared to other methods of treatment, Xeljanz can have increased risks of elevated liver function tests (LFTs), and therefore needs routine blood monitoring.  Xeljanz is not likely to be more beneficial than any of the standard treatments/procedures for this patient. This patient would more likely benefit from Olumiant, which has been more extensively studied, and is FDA-approved for alopecia. 

Per King, B., et al., (2021), "These results support the efficacy and safety of baricitinib in patients with 50% scalp hair loss." 

Per Zheng, C., & Tosti, A. (2021), "Alopecia areata (AA) is a chronic, relapsing, autoimmune disorder characterized by patchy non-scaring hair loss. Although the pathogenesis of alopecia areata is not yet completely elucidated, loss of immune privilege in anagen stage hair follicles is widely accepted to play a key role. Several cytokines that depend on Janus kinase signaling have been identified to be involved in AA, including interleukin (IL)-2, IL-7, IL-15, IL-21, and interferon-, making Janus kinase inhibitors an attractive therapeutic target." 

Per King, B., et al., (2022), "In two phase 3 trials involving patients with severe alopecia areata, oral baricitinib was superior to placebo with respect to hair regrowth at 36 weeks." 

The carrier's denial of Xeljanz 10 mg tablet, 60 tablets, 30-day supply by mouth should be upheld. Xeljanz is not likely to be more beneficial than any of the other standard treatments for this patient.