Appeal type: Medical necessity
Decision: Upheld

Skin Disorders. 
Pharmacy/Prescription Drugs. 

Diagnosis: Alopecia. 
Treatment: Xeljanz. 
The insurer denied Xeljanz. The health plan's determination is upheld. 

The patient is a female with diffuse alopecia areata and vitiligo for many years, and has been seen by her current dermatologist. For her alopecia areata and vitiligo, the patient has failed topical and injected steroids, topical immunomdulators, topical drithocreme, and long courses of phototherapy. However, the patient's conditions have not responded to all treatments. The patient has required the daily use of a hairpiece, and her vitiligo covers nearly 50% of her body surface area. Emotional and physical stress are reported.

Xeljanz is not medically necessary for this patient. 
While understandable to consider Xeljanz for this patient's conditions, the requested medication is not indicated at this time, and merits further study before being presumed acceptable for widespread clinical use. At this time, the long-term safety of this medication is not as confirmed as short-term efficacy in the use of Xeljanz for these conditions. 

Alopecia areata and vitiligo are notoriously difficult and unpredictable to treat, as well as unpredictable in their response to treatment. Oral immunosuppressants, light therapy, contact allergen treatment and related therapies have all resulted in variable and unsatisfactory outcomes, and self-resolution is often the only choice a patient has (along with hairpieces and camouflage) for severe cases. 

However, while Xeljanz has some promising preliminary results in open-label studies for alopecia areata, and there are some case reports for vitiligo, the overall literature and reviews on alopecia areata mention Xeljanz only as investigational. Xeljanz was denied Food and Drug Administration (FDA) approval for use in psoriasis, in large part for safety reasons, and is not without a significant risk of side effects that preclude an acceptable risk for use outside of the investigational setting for the condition of alopecia areata. 
At this time, Xeljanz is only FDA-approved for rheumatoid arthritis patients who have failed methotrexate, and for psoriatic arthritis, and for ulcerative colitis--all three conditions have indications whereby the safety risks of not using treatment are significantly greater than treatment itself. Xeljanz has recently been recommended to be used with lower dosing in rheumatoid arthritis patients. 

The same cannot be said for Xeljanz in the treatment of alopecia areata or vitiligo, where physical/functional impairment and overall health impacts are minimal to nonexistent--despite the social/psychological impacts that can occur in some patients. The proper dosing, anticipated side effects and long-term outcomes are not known at this time for Xeljanz in the treatment of alopecia areata or vitiligo, as well as short-term and long-term safety risks of relevance to this patient's overall health. There are no large, randomized, controlled, prospective trials demonstrating and proving the safe and effective treatment of alopecia areata (or vitiligo) with a specific dosing of Xeljanz. 
Therefore, as per the evidence-based literature, Xeljanz is not medically necessary for this patient's conditions of alopecia areata and vitiligo.