Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Alopecia Universalis.
Treatment: Xeljanz 10mg Tablet.

The insurer denied the Xeljanz 10mg Tablet.  The denial is overturned.

The patient is a male who has alopecia universalis that has failed treatment with topical, intralesional, and systemic steroids. He has also failed topical Opzelura to eyebrows. The patient has severe eye inflammation and irritation due to a lack of eyebrows and eyelashes which makes him unable to participate in activities of daily living or exercise. This is a request for the approval of Xeljanz 10 mg (milligrams) tablets.

Yes, the health plan should cover the requested Xeljanz.
The current literature reflects Xeljanz as being more effective than other treatments.

Alopecia areata (AA), of which alopecia universalis is the most severe form, 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 [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 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 and dose for the treatment of AA (alopecia areata) based on the literature.

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

Yes, the Xeljanz is more beneficial.  The current literature reflects tofacitinib (Xeljanz) as being more effective than other treatments.

Alopecia areata (AA) is a complex autoimmune disease with a multi-factorial etiology that has a severe negative impact on a patient's psychoemotional well-being as well as their quality of life, and accounts for a significant global disease burden. With greater knowledge and a better understanding into the pathomechanism of AA (alopecia areata), the emergence of JAK (Janus kinase) inhibitor use for AA (alopecia areata) treatment is in fact very promising and serves as an effective and viable strategy in treating this debilitating disease. Oral and topical formulation of JAK (Janus kinase) inhibitors tofacitinib, ruxolitinib and baricitinib, were studied in the treatment of AA (alopecia areata) and its variants. A growing body of scientific publications, mostly in the form of case reports, has demonstrated exceptional efficacy of oral formulations of JAK (Janus kinase) inhibitors, particularly with tofacitinib and ruxolitinib in treating moderate to severe, as well as refractory or recalcitrant cases of AA (alopecia areata). Moreover, it was demonstrated that these patients would need to maintain JAK (Janus kinase) inhibitor treatment in order to maintain hair regrowth. In addition to these, reports also identified adverse effects that were not severe, but mostly mild and transient.