Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Alopecia areata.
Treatment: Xeljanz 10mg (one tablet twice daily) Pre-service.
The insurer denied the Xeljanz 10mg (one tablet twice daily) Pre-service.
The denial is overturned.

The patient is a male with severe alopecia areata, with over 60% loss of hair on the scalp and beard. He has failed topical, intralesional, and oral steroids. The condition severely affects his personal life and he has become isolated and depressed because of it. The request is for Xeljanz.

Yes, the proposed Xeljanz 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 JAK 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 JAK 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 (five to ten 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 ten years or less, 77 percent had a clinical response (at least six percent improvement in the Severity of Alopecia Tool [SALT] score) and 58 percent achieved greater than 50 percent improvement in the SALT score over four to 18 months of treatment. Patients with a disease episode longer than ten years appeared less likely to respond to treatment; the clinical response rate in this population was 32 percent (eight of 25 patients). No serious adverse effects occurred during treatment.

There is promising low-quality evidence regarding the effectiveness of JAK 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, JAK inhibitors have the most promising results to date. Because of the potential for serious adverse effects with JAK 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, Xeljanz is the best treatment option for this patient at this time.

The current literature reflects Xeljanz as being more effective than other treatments. Even though it is not a Food and Drug Administration (FDA) approved indication, it is commonly used in clinical practice.