Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Severe Alopecia
Treatment: Xeljanz 10 mg (milligrams), Pre-service
The insurer denied the Xeljanz 10 mg, pre-service.
The denial is overturned.

The patient is a male with severe alopecia areata (AA) for whom Xeljanz is requested. He has failed topical, intralesional and oral steroids. He suffers from severe eye irritation due to lack of eyelashes and eyebrows.

Yes, the health plan should cover the requested Xeljanz.

The current literature reflects Xeljanz as being more effective than other treatments.

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, 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 AA 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 AA. 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 AA (at least 40% [percent] scalp hair loss, alopecia totalis [AT], or alopecia universalis [AU]) who had stable or worsening disease for at least six months and received oral tofacitinib (5 to 10 mg [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% had a clinical response (at least 6% improvement in the Severity of Alopecia Tool [SALT] score) and 58% achieved greater than 50% improvement in the 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% (8 of 25 patients). No serious adverse effects occurred during treatment.

There is promising low-quality evidence regarding the effectiveness of JAK inhibitors in AA. Future large-sized randomized studies are required to confirm findings. However, of all the treatments reported to work in AA, JAK inhibitors have the most promising results to date. Although the long-term safety of JAK inhibitors in children is still unknown, tofacitinib is undergoing clinical trials for juvenile idiopathic arthritis in children aged 2 to 18 years (NCT02592434 and NCT01500551). Reports from the experience of authors suggest that tofacitinib may be a therapeutic option for children with severe AA who have failed conventional therapy. However, 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 AA based on the literature.

Therefore, given the above, Xeljanz is the best treatment option for this patient at this time.

Yes, the requested Xeljanz is more beneficial.