Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Alopecia Universalis
Treatment: Xeljanz
The insurer denied Xeljanz.
The determination is overturned.

This is a male patient with alopecia universalis. He has tried and failed topical steroids, topical tofacitinib, and topical minoxidil. The prescriber is a dermatologist. The medication under review is Xeljanz 5 milligrams (mg) tablet.

The proposed health service or treatment Xeljanz 5 mg tablet is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. The patient has already tried and failed the standard of care treatments such as topical tofacitinib and topical minoxidil. There are no further standard treatments for this patient's conditions.
Based on the current peer-reviewed literature and accepted standards in the specialty's medical community, the treatment with Xeljanz considered medically necessary for this particular individual. The patient has failed all the conventional therapies.
In support of the use of Xeljanz for alopecia, Liu et al writes "Ninety patients met inclusion criteria. Of 65 potential responders to therapy, defined as those with alopecia totalis or alopecia universalis with duration of current episode of disease of 10 years or less or alopecia areata, 77 percent (%) achieved a clinical response, with 58% of patients achieving greater than 50% change in Severity of Alopecia Tool (SALT) score over 4 to 18 months of treatment. Patients with alopecia areata (AA) experienced a higher percent change in SALT score than did patients with alopecia totalis or alopecia universalis (81.9% versus 59.0%). Tofacitinib was well tolerated, and there were no serious adverse events" [1].
Jabbari et al writes in "An Open-Label Pilot Study to Evaluate the Efficacy of Tofacitinib in Moderate to Severe Patch-Type Alopecia Areata, Totalis, and Universalis" that "In our tofacitinib trial in 12 patients with moderate to severe AA, 11 patients completed a full course of treatment with minimal adverse events. Following limited response to the initial dose (5 mg twice a day [b.i.d.]), the dose was escalated (10 mg b.i.d.) for nonresponding subjects. Eight of 12 patients demonstrated 50% hair regrowth, while three patients demonstrated less than (<) 50% hair regrowth, as measured by Severity in Alopecia Tool scoring. One patient demonstrated no regrowth. Gene expression profiles and Alopecia Areata Disease Activity Index scores correlated with clinical response. Our open-label studies of ruxolitinib and tofacitinib have shown dramatic clinical responses in moderate to severe AA, providing strong rationale for larger clinical trials using janus kinase (JAK) inhibitors in AA" [2].
Phan et al writes in "JAK inhibitors for alopecia areata: a systematic review and meta-analysis" that "To determine the expected response of AA to JAK inhibitor therapy and factors which influence response and recurrence rates. A systematic review and meta-analysis was performed according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. From 30 studies and 289 cases, there were 72.4% responders, good responders 45.7% and partial responders 21.4%. Mean time to initial hair growth was 2.2 plus/minus () 6.7 months, and time to complete hair regrowth was 6.7  2.2 months. All 37 recurrences occurred when treatment was ceased after 2.7 months. Oral route was significantly associated with response to treatment compared to topical therapy. No difference was found between paediatric and adult cases in proportion of responses. There is promising low-quality evidence regarding the effectiveness of JAK inhibitors in AA" (3). Therefore, Xeljanz is effective for alopecia universalis. Given this patient's failure with conventional therapies, Xeljanz is warranted.