Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Alopecia universalis
Treatment: Xeljanz 10 milligram (mg)
The insurer denied coverage for Xeljanz 10 milligram (mg)

The denial is overturned 

This is a female, with a history of alopecia universalis treated with Xeljanz (oral tablet). She had an 80% regrowth of scalp hair and 100% regrowth of eyebrows and lashes. The plan considers this to be experimental in nature.

She has been on Xeljanz 10 milligram (mg) twice daily (BID) and was doing well. She has had a regrowth of hair of 80% to the scalp, and her eyebrows and eyelashes have regrown. Per the letter of medical necessity, the patient has used oral topical and intralesional steroids. Prior to the use of Xeljanz the patient lost all of her hair on her entire body.

Scientific evidence in peer-reviewed literature does support a result of improvement in health outcomes with Xeljanz and alopecia universalis. Multiple studies in respected journals have documented efficacy in the regrowth of hair in alopecia, including subtypes of areata and universalis.

"As such, the use of janus kinase (JAK) inhibitors for treatment of AA has emerged. JAK inhibitors block the T-cell (lymphocyte) mediated inflammatory response thought to be the driving factor behind AA pathogenesis, by inhibiting the janus kinase (JAK) signal transducer and activator of transcription (STAT) signaling pathway, leading to a reversal of hair loss in AA patients. Thus, in an effort to demonstrate the efficacy of JAK inhibitors in the treatment of AA, several studies have been published within recent years" (Dillion 2021).

Xeljanz 10 mg to treat alopecia areata/alopecia universalis does not have Food and Drug Administration (FDA) approval; it is used for off-label use.

The patient is a good candidate for Xeljanz 10 mg. As the patient has been on Xeljanz, the patient has demonstrated benefit and is a good candidate for the dose.

There are limited treatments. For this patient, Xeljanz is the best treatment at the time, as the documentation supports that Xeljanz has been successful in the treatment of this patient's alopecia. Further, studies show that once Xeljanz is used and then stopped, patients lose their hair again. Therefore, it would not be in the best interest to stop treatment for this patient.

"Expert opinion: The discovery of JAK inhibition represents a major breakthrough in the treatment of AA(Alopecia Areata). Positive results in early phase 1 and phase 2 clinical trials have enabled the commencement of phase 3 clinical trials and there is now a growing sense of optimism among patients with long-standing, treatment-refractory AA" (Ismail et al., 2020).

"As this is an off-label use of tofacitinib, this medication was obtained for most patients only after an extensive appeal process with insurance companies. Of the 20 patients treated, six experienced medication interruption due to adverse effects and two due to lapses in prescription insurance coverage. Durability among our population was shorter than the 10 to 12 weeks reported in other studies, with hair shedding occurring 4
to 5 weeks after discontinuation, suggesting that a short amount of time is needed for AA inflammatory pathways to re-establish themselves following discontinuation of medication" (Hogan et al., 2019). 

The medication has low side effects, so it is not an increased risk. 

The condition has limited treatment options and although off-label, Xeljanz is likely the best treatment for this patient and has demonstrated efficacy for her.

The carrier's denial of Xeljanz 10 mg to treat alopecia areata/alopecia universalis is overturned.