Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Immunologic Disorders/Alopecia
Treatment: Prescription Drugs/Xeljanz
The health plan denied the prescription drug as not medically necessary. 
The reviewer has upheld the health plan determination.

The patient is diagnosed with Alopecia Areata that is extensive and throughout the scalp and bearded area. The patient has tried and failed Topical Minoxidil and Clobetasol, Clodan shampoo, Ketoconazole, and Oral Minoxidil and Dexamethasone.

Xeljanz has a significant potential to be an efficacious treatment for Alopecia Areata and other skin diseases. However, this medication also has a significant potential to cause blood clotting, malignancies, and immunosuppression leading to severe infections. The data to determine Xeljanz's benefits versus the risks, as well as outcomes data, is lacking and the Food and Drug Administration approval of Xeljanz for this condition is therefore also lacking.

Xeljanz is not medically necessary for this patient.

While understandable to consider Xeljanz for this patient's condition, the requested medication 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 this condition.

Alopecia Areata is notoriously difficult and unpredictable to treat, as well as unpredictable in its 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) for severe cases.

However, while Xeljanz has some promising preliminary results in open-label studies, the overall literature and reviews on Alopecia Areata mention Xeljanz only as investigational. Xeljanz was denied 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, 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, 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 with a specific dosing of Xeljanz. As per the evidence-based literature, Xeljanz is not medically necessary.