Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Alopecia areata. 
Treatment: Xeljanz XR 5mg. 
The insurer denied coverage for Xeljanz XR 5mg. 
The denial is overturned. 

This is a female patient with a history of alopecia areata. An office visit noted that the patient presented for evaluation of alopecia areata, which started many years prior and has been moderate and persistent since then. The patient's previous treatments included clobetasol solution, Rogaine and ILK injections weekly. The patient's scalp had few relatively alopecic patches, and her eyebrows/ eyelashes were within normal limits. The office visit document noted an impression of mild and persistent alopecia areata. The treatment with Xeljanz (tofacitinib) was discussed. 

According to Renert-Yuval et al. (2017), "Alopecia areata (AA), a prevalent inflammatory cause of hair loss, lacks FDA-approved therapeutics for extensive cases, which are associated with very poor rates of spontaneous hair regrowth and major psychological distress. Current treatments for severe cases include broad immune-suppressants, which are associated with significant adverse effects, precluding long-term use, with rapid hair loss following treatment termination. As a result of the extent of the disease in severe cases, topical contact sensitizers and intralesional treatments are of limited use. The pathogenesis of AA is not yet fully understood, but recent investigations of the immune activation in AA skin reveal Th1/IFN-, as well as Th2, PDE4, IL-23, and IL-9 upregulations. Tissue analyses of both animal models and human lesions following broad-acting and cytokine-specific therapeutics (such as JAK inhibitors and ustekinumab, respectively) provide another opportunity for important insights into the pathogenesis of AA."  As per Liu et al. (2018), though "[there is currently no cure for AA, and highly efficacious therapy for severe AA has been elusive...recently, scientific advances have identified the Janus kinase pathway as a target for treatment." Liu et al. (2018) state that "both Janus kinase inhibitors approved by the US Food and Drug Administration, tofacitinib and ruxolitinib, have shown promise in open-label clinical trials." 

Based on the review of the medical record and literature, the request for Xeljanz XR 5mg is considered medically necessary for this patient. There is no Food and Drug Administration (FDA) approved therapies for alopecia areata totalis, and there is no plan approved therapies for alopecia areata. The patient has tried and failed conservative therapy with Clobetasol solution, Rogaine, and ILK injections weekly. According to literature, Xeljanz has been found to be safe, effective, and durable in the treatment of alopecia areata, and the patient has had a positive response with this treatment. Since this patient started Xeljanz treatment, it was noted that her disease has remitted. The patient had been successfully treated with Xeljanz. Therefore, the continuation of Xeljanz XR 5 mg is considered medically necessary for this patient. 

The health plan did not act reasonably with sound medical judgment and in the best interest of the patient. 

Based on the above, the medical necessity for Xeljanz XR 5mg is substantiated. The insurer's denial should be overturned.