Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Alopecia universalis.

Treatment: Xeljanz 10 milligrams (mg) tablet.

The insurer denied coverage for Xeljanz 10 mg tablet.

The denial is overturned. 

This is a female patient who has been diagnosed with alopecia universalis and has been treated with oral, topical and intralesional steroids. The provider has prescribed Xeljanz which was denied by the insurance. 

Scientific evidence in peer-reviewed literature supports Xeljanz to treat alopecia areata and it's more severe form alopecia universalis. Alopecia universalis is a medical disease of the immune system. There are several literature reports demonstrating the efficacy of Xeljanz in treating this condition.      

The use of Xeljanz does not need or have to have final approval. Many medications are used outside their Food and Drug Administration (FDA) approved diagnoses to treat other medical conditions. There are no FDA approved medications for alopecia areata, yet medications; particularly immunosuppressants have been used to treat it. It is standard of care to treat many dermatologic conditions with off-label uses of conventional medications. Medications such as the requested Xeljanz offer more effective treatment options with less potential side effects.     

This patient is a good candidate for treatment with Xeljanz. This is the best available treatment for this patient. There are no FDA approved medications for this condition but current peer-reviewed literature reports the efficacy and safety in treating alopecia universalis patients with this medication. Current medical literature suggests that using Xeljanz is safe and effective. There are no FDA approved medications for this chronic condition and there are no long-term conventional treatment options where risks do not outweigh benefits.

Liu, L. et al. (2017) write "The successful reversal of the distortion of appearance that characterizes alopecia areata (AA) leads to improvement in psychosocial functioning. In the broader context of appropriate and essential medical care, the treatment of AA satisfies the definition of medical necessity and is merited, by objective measures, in the same way that treatment of other chronic dermatoses, such as atopic dermatitis and psoriasis, is merited."

As stated in Gilhar, A. et al. (2019), "the US [United States] Food and Drug Administration has accepted clinical studies with Janus kinase (JAK) inhibitors for alopecia areata by the so-called investigational new drug process, which implies a favourable risk benefit ratio assessment."

Strazzulla, Lauren C. et al. (2017) write "The Janus kinase/signal transducers and activators of transcription pathway is upregulated in alopecia areata but not in normal hair follicles."

Per Ibrahim O. et al (2017), "Janus kinase inhibitors have been shown to attenuate the inflammatory cascade associated with AA. Our results indicate that tofacitinib is efficacious in the treatment of AA...

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."     

There are no reports of adverse risks over standard treatments. Xeljanz is likely to be more beneficial than any other existing standard health service.                                                    

The carrier's denial of coverage for Xeljanz 10 mg tablet should be overturned.