Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Frontal fibrosing alopecia
Treatment: Xeljanz 10 milligrams (mg) tablet
The insurer denied coverage for the Xeljanz 10 mg tablet.
The denial is overturned.

This is an adult with frontal fibrosing alopecia (FFA). The patient has failed therapy with ultrapotent topical steroids, finasteride, and diphenhydramine. Xeljanz is recommended by the treating physician.

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. 

Xeljanz 10 milligrams (mg) daily is not Food and Drug Administration (FDA) approved for frontal fibrosing alopecia or lichen planopilaris.

The patient has failed standard first line therapies for frontal fibrosing alopecia including ultrapotent topical steroids and finasteride. The use of Xeljanz off-label would be supported as a standard therapy and the patient appears to be a good candidate as the medication is prescribed by a board-certified Dermatologist.

Xeljanz is used for a more common alopecia, alopecia areata for about a decade. It has been shown to be safe and effective. While FFA/ lichen planopilaris (LPP) is rarer, there continues to be sufficient literature showing safe and effective use. Lastly a similar medication, baricitinib, was approved for use in alopecia areata this past year and further supports that Janus kinase (JAK) inhibitors are safe in humans.

The use of Xeljanz in this patient with frontal fibrosing alopecia, who has failed topical steroid and oral finasteride, is more likely to be beneficial than any other standard treatment.

Frontal Fibrosing Alopecia (FFA) is a rare, scarring alopecia. It is a variant of lichen planopilaris (LPP), which is a form of lichen planus (LP). There are currently no FDA approved therapies for FFA, and this is likely because of the rarity of this disease. There is extensive literature supporting the use of apremilast as a treatment for LP and LPP (and therefore FFA). There have been multiple controlled trials showing benefit of apremilast in LP and LPP.

The manuscripts provided for review are not the appropriate literature as these are for alopecia areata and related disease. This is not the condition in this patient. Cited in this review are multiple case studies and case reports showing benefit of tofacitinib in frontal fibrosing alopecia and/or lichen planopilaris. For example, in Batra, et al, the authors report that despite frontal fibrosing alopecia being considered a "scarring" alopecia, there can be hair regrowth with tofacitinib. There are many additional citations at pubmed.gov that have not been cited.

Xeljanz was recently shown to be safe and effective in alopecia areata per the medical literature. The FDA approved a similar drug baricitinib for alopecia areata. The use, which is supported by many case reports and case studies in frontal fibrosing alopecia would be considered an appropriate off-label use of Xeljanz. 

In summary, the denial of Xeljanz 10 milligrams (mg) tablet and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.