Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Alopecia Areata.
Treatment: Xeljanz, Pre-service.
The insurer denied the Xeljanz, Pre-service.
The denial is overturned.

The patient is a female with severe alopecia areata affecting over 80% of the scalp. She has failed topical, intralesional, and oral steroids. Her dermatologist is requesting approval for Xeljanz.

Yes, the requested 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 AA (alopecia areata), revealing that autoreactive cytotoxic T cells are important and that the Janus kinase (JAK) pathway is involved. Therefore, the potential of JAK (Janus kinase) inhibitors as therapeutic agents for AA (alopecia areata) is attracting attention. There have been a number of case reports and small clinical trials reporting promising outcomes of JAK (Janus kinase) inhibitors tofacitinib, ruxolitinib and baricitinib for AA (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 mg 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 SALT (Severity of Alopecia Tool) 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 JAK (Janus kinase) inhibitors in AA (alopecia areata). Future large-sized randomized studies are required to confirm findings. However, of all the treatments reported to work in alopecia areata, JAK (Janus kinase) inhibitors have the most promising results to date. Because of the potential for serious adverse effects with JAK (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 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.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
The patient has severe disease that has failed topical, intralesional, and oral steroids. She has respiratory disease for which oral JAK (Janus kinase) inhibitor's are excepted as label treatment.