Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Alopecia areata

Treatment: Xeljanz 10 milligrams (mg), 10 mg PO (by mouth) two times a day (BID) for one year

The insurer denied coverage for Xeljanz 10 milligrams (mg), 10 mg PO two times a day (BID) for one year

The denial is overturned

The patient is a female who has a two-year history of alopecia areata with a loss of 40% (percent) of her hair. She has attempted topical, oral, and intralesional steroids without improvement. Her dermatologist notes that her hair loss causes her social dysfunction and psychological distress. Her dermatologist plans to treat with Xeljanz 10mg twice daily.

The scientific evidence supports improved patient outcomes with the use of Xeljanz for alopecia areata. Xeljanz should be considered effective for alopecia areata. There have been four well-designed trials as well as retrospective studies that clearly demonstrate the safety and efficacy of this treatment published in the major journals in the field of dermatology [Bokhari] [Kennedy] [Jabbari] [Almutairi]. These studies suggest that excellent clinical effect [Severity of Alopecia Tool (SALT)] Reduction > 50% can be seen in 58.8 to 66% of patients even with longstanding and widespread alopecia areata/totalis/universalis and at least 20% of patients see complete response. The use of tofacitinib (Xeljanz) for alopecia areata is supported by the most influential pharmacology textbook in dermatology: Wolverton's Comprehensive Dermatologic Drug Therapy [Wolverton]. Importantly, there are no available treatment options for widespread alopecia areata that are considered generally effective and none that are FDA (food and drug administration) approved. The safety profile of Xeljanz is well studied in the population of patients with rheumatoid arthritis and psoriatic arthritis and appears well-tolerated [Wolverton].

The use of Xeljanz is not FDA approved for the treatment of alopecia areata.

The patient is a good candidate for treatment with Xeljanz for her alopecia areata. She has widespread hair loss, psychological distress, and has been refractory to usual first-line therapies. The patient has tried and failed alternative therapies, and no other logical next line of therapy exists. While it is worth noting that tofacitinib is not FDA or American Hospital Formulary Service Drug Information (AHFS DI) approved for the condition, no other treatment is, and tofacitinib is undergoing phase three clinical trials which are expected to lead to its approval for the indication of alopecia areata. At the present, its use is supported by several, both prospective and retrospective, non-phase three studies which is more evidence than exists for any alternative therapeutic modality.

The use of Xeljanz is the most likely therapy to lead to clinical improvement for the patient of the potential therapeutic options available to the patient. There have been four well-designed trials as well as retrospective studies that clearly demonstrate the safety and efficacy of this treatment published in the major journals in the field of dermatology [Bokhari] [Kennedy] [Jabbari] [Almutairi]. These studies suggest that excellent clinical effect [SALT Reduction > 50%] can be seen in 58.8 to 66% of patients even with longstanding and widespread alopecia areata/totalis/universalis and at least 20% of patients see complete response.

The use of Xeljanz is more likely to be beneficial to the patient than any alternative therapy available to this patient. Meta-analyses demonstrate that Xeljanz is more likely to be effective than any alternative therapeutic option.

The carrier's denial of Xeljanz 10 milligrams (mg), 10 mg by mouth (PO) two times a day (BID) for one year to treat alopecia areata should be overturned.