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. 

The patient is an adult female, diagnosed with alopecia univeralis. She has tried and failed topical, oral and intralesional therapy. The patient was started on Xeljanz 10 milligrams (mg) twice daily (BID) and has since seen 80% regrowth of hair. The provider requested continuation of treatment with Xeljanz, and it was denied. 

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. There are several peer-reviewed literature citing's showing the safety and efficacy of JAK (Janus kinase) inhibitors such as Xeljanz for the treatment of alopecia areata/universalis.

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

Xeljanz 10 mg to treat alopecia areata/alopecia universalis does not need/have final approval from the appropriate regulatory bodies for this diagnosis. To date, Xeljanz has not had Food and Drug Administration (FDA) approval for treatment of alopecia areata. However, many if not most of our treatments for various dermatologic conditions are with off-label uses of medications. Currently there are no FDA-approved medications for this patient's medical disease.

"Alopecia areata (AA), a prevalent inflammatory cause of hair loss, lacks FDA-approved therapeutics for extensive cases, which are associated with very poor rates of spontaneous hair regrowth and major psychological distress" (Renert-Yuval, Y., & Guttman-Yassky, E. 2017).

This patient is a good candidate for Xeljanz 10 mg to treat alopecia areata/alopecia universalis. The patient has tried and failed the conventional, "off-label" treatments for her disease and after starting Xeljanz, has demonstrated a positive clinical response.

Xeljanz 10 mg to treat alopecia areata/alopecia universalis is the best available treatment for this patient at this time. The patient has tried and failed the conventional, "off-label" treatments for her disease and after starting Xeljanz, has demonstrated a positive clinical response.

Adverse risks are not increased over standard treatment/services. All treatment options for alopecia universalis come with risks and the use of Xeljanz is at no higher risk and the patient has seen extensive hair growth since starting treatment with Xeljanz. 

"We reviewed 35 AA patients treated with tofacitinib in a specialty hair disease clinic between January 2013 and July 2019 for outcomes, adverse events, and feasibility of treatment. No serious adverse events were experienced. 83.9% of patients experienced clinically significant scalp regrowth, and 32.3% experienced near total/total regrowth. Though this study was confined to retrospective analysis, the results showed that tofacitinib was safe, effective, and practical for this cohort of 35 AA patients" (Benton, S., et al., 2022).

Continuation of treatment with Xeljanz 10 mg BID is more beneficial to treat this patient's medical disease of alopecia areata than the standard treatments. As indicated in the clinical notes and appeal documents submitted, this patient has already tried and failed several conventional treatments for this disease. There are no FDA-approved treatment options and current medical literature demonstrates that continued treatment with JAK inhibitors such as Xeljanz is an effective treatment for this autoimmune disease. The patient has shown a positive clinical response with Xeljanz and therefore continuation of care is the best way to maintain stability of the disease.

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