Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Alopecia areata

Treatment: Compounded tofacitinib cream

The insurer denied coverage for compounded tofacitinib cream.

The denial is upheld. 

This is a male patient with alopecia areata. The patient has used topical steroids, tacrolimus, and topical anthralin. The provider requests tofacitinib compounded 2% cream for this patient's treatment.

According to Kassira et al. (2017), "Management of [alopecia totalis (AT)] and [alopecia universalis (AU)] can be challenging, and although multiple treatment modalities have been explored, no therapy is currently [Food and Drug Administration (FDA)]-approved. This review focuses on the evidence for current treatment options for AT and AU. The PubMed database was searched ...for clinical trials, retrospective studies, and case reports of treatments for AT and AU. A total of 40 studies were retrieved and analyzed. Therapies studied for AT/AU included: topical immunotherapy, steroids, photodynamic therapy, immunosuppressive agents, [tumor necrosis factor (TNF)-a] inhibitors, and other therapies, such as sulfasalazine, bexarotene, [Janus kinase (JAK)] inhibitors, and simvastatin/ezetimibe. Although certain treatments showed significant hair regrowth, no treatment was completely effective. The most promising therapies with the highest quality data include diphenylcyclopropenone, squaric acid dibutylester, photodynamic therapy, steroids, and cyclosporine in combination with methylprednisolone. High-quality randomized-controlled trials with large sample sizes are lacking. Unified outcome guidelines are encouraged to facilitate the comparison of future studies."

As per the National Institutes of Health (NIH) and the Genetic and Rare Diseases Information Center (GARD), "No therapy has been found to work for everyone who has alopecia universalis (AU) which makes managing AU challenging. Although multiple treatments have been explored, no therapy is currently approved by the United States Food and Drug Administration (FDA). Some promising therapies include: diphenylcyclopropenone (DPCP); squaric acid dibutylester (SADBE); photodynamic therapy; steroids; cyclosporine in combination with methylprednisolone (a steroid). There are several recent studies showing that a class of medication known as [Janus kinase (JAK)] inhibitors, which includes tofacitinib and ruxolitinib, are effective in alopecia areata, including AU. However, JAK inhibitors have not yet been approved by the FDA for use in skin conditions" (NIH/GARD, 2017).                                                         

Based on the review of the medical record and literature, the compounded tofacitinib cream is not considered medically necessary for this patient. A search using PubMed revealed anecdotal data for use in patients of a certain age group and failed to reveal any research based data in this age group. A medical exception to facilitate the use of compounded tofacitinib cream has not been established.

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.

Based on the above, the medical necessity for compounded tofacitinib cream is not substantiated.  The insurer's denial should be upheld.