Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Alopecia 
Treatment: Xeljanz
The insurer is denied coverage for Xeljanz.
The denial is upheld.
This is a male patient with a history of alopecia areata (AA) and atopic dermatitis. The patient consulted a dermatologist with complaints of alopecia; his eyebrows had fallen out but had regrown without treatment and his eyelashes remained intact. The office visit note stated that the patient had prior treatment with topical steroids. A current examination revealed that the patient's eyebrows and eyelashes were intact. A few sub centimeter patches of alopecia with some pigtail hairs were noted. It was also noted that the patient was noted to have had significant regrowth with topical tofacitinib and has had no problems with treatment. Tofacitinib was to be continued. 

According to Phan & Sabaratnam (2019)'s systematic review and meta-analysis of JAK Inhibitors for Alopecia Areata (AA), oral route was significantly associated with response to treatment compared to topical therapy. No difference was found between pediatric and adult cases in proportion of responses. Though there is promising low-quality evidence regarding the effectiveness of JAK inhibitors in AA, future large-sized randomized studies are required to confirm these findings. These findings were based on number of case reports and small clinical trials. As per Putterman & Castelo-Soccio (2018), "limited results suggest that topical tofacitinib might be a reasonable adjunct or second-line therapy for pediatric patients with AAfor whom systemic therapies are not desired"
and "controlled studies with larger cohorts are needed to determine efficacy and identify factors associated with favorable outcomes."

As per Putterman & Castelo-Soccio (2018), the "mainstays of treatment are topical or intralesionalste roids and irritant therapy" for pediatric patients with alopecia areata (AA). Some patients are also trialed on systemtic therapies, including oral corticosteroids or off-label use of immunosuppressive drugs, such as methotrexate, cyclosporine A, mycophenolate mofetil, or azathioprine. In this study, topical tofacitinib was only trialed on patients who have failed on topical steroids as well as systemic
therapies such as oral prednisone or methotrexate. In this case, this patient has trialed topical steroids but have not trialed intralesional steroid in the past. There is no documentation that this patient has tried and failed on irritant therapy and/or systemic therapy.

To date, the literature support for topical Xeljanz (tofacitinib) for treatment of pediatric alopecia areata is lacking in terms of its efficacy and safety. The literature that suggests its possible use in this pediatric cohort was limited to pediatric cases that have tried and failed mainstay treatments as well as systemic therapy, such as oral steroid. This was not the case for this patient. Thus, topical Xeljanz (tofacitinib) is not considered medically necessary for this patient.

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.

Based on the above, the medical necessity for Xeljanz compound is not substantiated. The insurer's denial should be upheld.