Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Alopecia Areata. 
Treatment: Xeljanz 10 milligram (mg) tablet, 60 tablets, 30 day supply by mouth. 
The insurer denied coverage for Xeljanz 10 milligram (mg) tablet, 60 tablets, 30 day supply by mouth. 
The denial is overturned. 

The treating provider has diagnosed the patient with alopecia universalis, with rapidly progressive hair loss, involving the scalp, eyebrows, eyelashes, and beard area. The patient has tried and failed topical, intralesional and oral steroids. The patient also suffers from Crohn's disease (CD). The treating provider is requesting therapy with Xeljanz 10 milligrams (mg), twice daily. 

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. Current medical literature supports the use of janus tyrosine kinase (JAK) inhibitors such as Xeljanz for the treatment of the autoimmune disease of alopecia universalis. 

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 (United States ) US Food and Drug Administration has accepted clinical studies with JAK (janus kinase) inhibitors for alopecia areata by the so-called investigational new drug process, which implies a favorable 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.1 Our results indicate that tofacitinib is efficacious in the treatment of AA. Although small, our cohort achieved greater median improvement in SALT scores than reported in previously published studies (50.5% vs 21%).3 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." 

Xeljanz 10 mg tablet, 60 tablets, 30 day supply by mouth does not have final approval from the appropriate regulatory bodies for this diagnosis. Xeljanz is not approved by the  Food and Drug Administration (FDA) for alopecia. 

This patient is a good candidate for Xeljanz 10 mg tablet, 60 tablets, 30 day supply by mouth. There is only one FDA approved medication for this disease, which is Olumiant, which is in the same class of medication as Xeljanz. The patient is a good candidate as the patient has tried and failed conventional therapy, all of which are non-FDA approved options as well. 

Xeljanz 10 mg tablet, 60 tablets, 30 day supply by mouth is the best available treatment for this patient at this time. The treating provider has expressed that this is the appropriate treatment for this patient. The treating provider's place of work has conducted most of the current research for the use of Xeljanz for Alopecia, which has shown to be effective, as well as other studies. 

The adverse risks are not increased over standard treatment/services. Every treatment for every condition has a risk versus benefit ratio. The patient has failed standard treatment, which also come with certain risks, and were found to be ineffective. Xeljanz also has risks but offers a greater chance for success. The clinical studies of this medication for treatment of alopecia areata/universalis have shown that this is a safe and very effective treatment option. 

Alopecia universalis is a disease of the immune system, and JAK inhibitors, such as Xeljanz are the current, break-through methods of treating this devastating condition, as there have been no previous satisfactory treatment options available. The use of Xeljanz is appropriate for treating this patient's medical disease.

Xeljanz is likely to be more beneficial than any of the standard treatments for this patient. The carrier's denial of Xeljanz 10 mg tablet, 60 tablets, 30 day supply by mouth should be overturned.