Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Severe Alopecia Areata
Treatment: Xeljanz 10mg Tablet
The insurer denied: Xeljanz 10mg Tablet
The denial is overturned.

The patient is an adult female with severe alopecia areata affecting over 90% 9percent) of her body surface area (BSA) that has failed psoralen plus ultraviolet A (PUVA) therapy, as well as topical, intralesional and systemic steroids. The submitted note states that the patient started Xeljanz 10 milligrams (MG) by mouth (PO) twice a day (BID) six months earlier and experienced full regrowth of her hair all over the body. In addition to hair growth, her depression resolved with successful treatment. The request is for Xeljanz 10 milligrams twice a day.

The proposed treatment is medically necessary.

The current literature reflects Xeljanz as being more effective than other treatments. Alopecia areata (AA) is a relatively common disease, but no satisfactory treatment has yet been developed. Recently, research progress has been made in the pathogenesis of alopecia areata, revealing that autoreactive cytotoxic T cells are important and that the Janus kinase (JAK) pathway is involved. Therefore, the potential of Janus kinase inhibitors as therapeutic agents for alopecia areata is attracting attention. There have been a number of case reports and small clinical trials reporting promising outcomes of Janus kinase inhibitors tofacitinib, ruxolitinib and baricitinib for alopecia areata. The majority of the literature to date is based on small volume data, with a lack of definitive evidence or guidelines. A retrospective study of 90 adults with severe alopecia areata (at least 40 percent scalp hair loss, alopecia totalis, or alopecia universalis) who had stable or worsening disease for at least six months and received oral tofacitinib (5 to 10 milligrams twice daily) for at least four months (with or without adjuvant prednisone) supports benefit. Of the 65 patients with a duration of the current disease episode of 10 years or less, 77 percent had a clinical response (at least 6 percent improvement in the Severity of Alopecia Tool [SALT] score) and 58 percent achieved greater than 50 percent improvement in the Severity of Alopecia Tool (SALT) score over 4 to 18 months of treatment. Patients with a disease episode longer than 10 years appeared less likely to respond to treatment; the clinical response rate in this population was 32 percent (8 of 25 patients). No serious adverse effects occurred during treatment. There is promising low-quality evidence regarding the effectiveness of Janus kinase inhibitors in 
alopecia areata. Future large-sized randomized studies are required to confirm findings. However, of all the treatments reported to work in alopecia areata, Janus kinase inhibitors have the most promising results to date. Because of the potential for serious adverse effects with Janus kinase inhibitors, including infection and malignancy, a thorough discussion of risks and benefits is necessary before the initiation of treatment. This is an accepted off label use and dose for the treatment of alopecia areata based on the literature. Therefore, given the above, and in consideration of the full regrowth of hair the patient has experienced since on the drug, Xeljanz is the best treatment option for this patient at this time.