Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Alopecia Areata.
Treatment: Tofacitinib compound.

The insurer denied Tofacitinib compound.  The denial was overturned.

This is a patient that has a diagnosis of alopecia areata.  The patient consulted a dermatologist with complaints of hair loss located to right anterior scalp that was reportedly getting worse.  There was a negative pull test.  An intralesional injection was performed.  Intralesional injections were performed for alopecia located to left anterior scalp.

The consulting provided reported that the patient's progressive alopecia has resulted in several bald patches that are located on the patient's anterior scalp, are very visible to others, cannot be covered up with surrounding hair, and have now been present for over a year.  The patient has been treated with several courses of intralesional Kenalog without effectiveness.  The treating provider states that peer-reviewed scientific literature demonstrates the prescribed compound as clinically safe and effective and provided numerous articles for review.  The patient has tried and failed topical and injectable corticosteroids for alopecia areata.  Systemic and topical Xeljanz (Tofacitinib) has been found to be safe, effective, and durable in the treatment of alopecia areata.  Since the patient has tried and failed conservative therapy, the request for Tofacitinib compound is medically necessary.

Per Liu, L. Y., & King, B. A. "Alopecia areata (AA) is an autoimmune disease affecting people of all ages.  There is currently no cure for AA, and a highly efficacious therapy for severe AA has been elusive.  Recently, scientific advances have identified the Janus kinase pathway as a target for treatment.  Both Janus kinase inhibitors approved by the US Food and Drug Administration, tofacitinib and ruxolitinib, have shown promise in open-label clinical trials."

Per Kennedy Crispin, M., Ko, J. M., Craiglow, B. G., Li, S., Shankar, G., Urban, J. R.,  King, B. A., "Of 66 subjects treated, 32% experienced 50% or greater improvement in SALT score.  AA and ophiasis subtypes were more responsive than AT and AU subtypes.  Shorter duration of disease and histological peribulbar inflammation on pretreatment scalp biopsies were associated with improvement in SALT score.  Drug cessation resulted in disease relapse in 8.5 weeks.  Adverse events were limited to grade I and II infections.  An AA responsiveness to JAK/STAT inhibitors score was developed to segregate responders and nonresponders, and the previously developed AA disease activity index score tracked response to treatment."

Per Renert-Yuval, Y., & Guttman-Yassky, E., "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.  Current treatments for severe cases include broad immune-suppressants, which are associated with significant adverse effects, precluding long-term use, with rapid hair loss following treatment termination.  As a result of the extent of the disease in severe cases, topical contact sensitizers and intralesional treatments are of limited use.  The pathogenesis of AA is not yet fully understood, but recent investigations of the immune activation in AA skin reveal Th1/IFN-, as well as Th2, PDE4, IL-23, and IL-9 upregulations.  Tissue analyses of both animal models and human lesions following broad-acting and cytokine-specific therapeutics (such as JAK inhibitors and ustekinumab, respectively) provide another opportunity for important insights into the pathogenesis of AA".

The health plan did not act reasonably with sound medical judgment in the best interest of the patient.                                        

The carrier's denial of coverage for Tofacitinib compound is overturned.  The medical necessity is substantiated.