Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Alopecia Universalis. 
Treatment: Xeljanz 10 milligrams (mg). 

The insurer denied coverage for Xeljanz 10 milligrams (mg). 

The denial is overturned. 

According to the medical records, the patient is diagnosed with alopecia universalis, has been treated with Xeljanz 10 milligrams (mg) two times a day (BID) and has had positive results with 80% regrowth of scalp hair. The start date is unknown but submitted medical records show that the patient was on this medication and had been doing well. The treating provider is requesting continuation of Xeljanz 10mg, but the request was denied by the plan. The provider is appealing the denial. 

The plan did not act reasonably and with sound judgement and did not act in the best interest of the patient. The patient has a medical condition of the immune system and has been stabilized with the requested medication Xeljanz. At this time, there are no Food and Drug Administration (FDA) approved medications for this disease and therefore Xeljanz is often prescribed as an off-label option for advanced or resistant cases and has many peer-reviewed studies showing its safety and efficacy. To deny the patient access to a medication that has stabilized the medical condition is not acting in the best interest of the patient. Standard of care would be to continue the current medication that is effective and has not given the patient any adverse events. 

Per Ibrahim O. et al (2017), Janus kinase (JAK) inhibitors have been shown to attenuate the inflammatory cascade associated with Alopecia Areata (AA). Our results indicate that tofacitinib is efficacious in the treatment of AA. Although small, our cohort achieved greater median improvement in Severity of Alopecia Tool (SALT) scores than reported in previously published studies (50.5% vs (versus) 21%). This outcome may be related to our higher doses, longer duration of therapy, and patients' shorter duration of current disease episode. In addition, our results demonstrate lack of durability of effect after the discontinuation of therapy, a finding similar to that in other studies. 

Hogan, S. et al. (2019) concludes "The majority of patients experienced hair regrowth, ranging from less than 5 percent to 100 percent regrowth during the study. This is consistent with other studies, suggesting disease duration might not predict patient response, but rather a pathophysiological mechanism might be involved. Our study is limited by its small sample size, precluding detailed subgroup analyses. Larger, randomized, controlled trials are needed to explore such variations in regrowth. Nevertheless, our results suggest JAK inhibition might serve as an effective treatment modality for AA." 

"AA is a common, inflammatory, nonscarring type of hair loss. Significant variations in the clinical presentation of AA have been observed, ranging from small, well-circumscribed patches of hair loss to a complete absence of body and scalp hair. Patients affected by AA encompass all age groups, sexes, and ethnicities, and may experience frustration with the unpredictable nature of their disease for which there is currently no definitive treatment. The cause of AA remains incompletely understood, though it is believed to result-at least in part-from a loss of immune privilege in the hair follicle, autoimmune-mediated hair follicle destruction, and the upregulation of inflammatory pathways. Patients with AA frequently experience marked impairment in psychological well-being, self-esteem, and may be more likely to suffer from psychiatric comorbidities" (Strazzulla, L. C. et al. 2018). 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Xeljanz 10 milligrams (mg) is substantiated.