Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Alopecia Areata. 
Treatment: Rinvoq Extended Release (ER). 

The insurer denied the request for Rinvoq ER. 
The health plan's determination is upheld. 

The patient is a male with alopecia areata. He also has lichen planopilaris and vitiligo. He has tried and failed Xeljanz. 

Rinvoq ER is not medically necessary for this member's alopecia areata. There are no medical and scientific literature and/or evidence based clinical practice guidelines that strongly support the administration of Rinvoq for this patient's condition as an accepted standard of practice in the U.S. prior to the generic alternatives. There is no documentation that the patient has exhausted all topical options, and that it would therefore be medically necessary to start systemic treatment with Rinvoq, which would carry a higher side effect profile.
There is no documentation provided that the patient has tried and failed topical immunotherapy, such as Diphenylcyclopropenone (DPCP). Chiang et al. writes their 2015 study findings: that for DPCP "treatment success, defined as 50 percent (%) terminal hair regrowth, was reached in 71% of alopecia totalis patients and in 56% of alopecia universalis patients" (1). Moreover, there is no documentation that the patient has tried and failed topical Squaric Acid. Topical Squaric Acid Dibutylester is a sensitizing agent which is also used for the treatment of alopecia areata and has been shown to be effective in several studies (2). Based on the documentation provided, the patient has not tried and failed all topical therapies available. These topical medications, which have been shown to be effective for the patient's condition, should be tried and failed prior to initiating Rinvoq. 

According to the dermatology literature, the generic medicines Methotrexate and oral corticosteroids covered by the patient's insurance plan are effective treatments for the management of alopecia universalis (3-5). Within the peer-reviewed literature, Anuset et al. 2016 writes "Methotrexate (MTX) combined with low- to moderate-dose oral corticosteroids (OC) may be an efficient and well-tolerated treatment for severe alopecia areata (AA)." Thus, methotrexate and corticosteroids are an effective first-line treatment for the management of severe alopecia (4). 

Additionally, according to Phan et al. "Methotrexate for alopecia areata: A systematic review and meta-analysis," published in the Journal of the American Academy of Dermatology early 2019, "Methotrexate has reasonable effectiveness in patients with severe AA...Combination treatment results in a higher complete response rate than Methotrexate stand-alone treatment...Methotrexate is an effective monotherapy or adjunct therapy in combi nation with corticosteroids in the treatment of severe AA" (5).
The evidence-based literature is consistent and in line with the patient's medical policy. The generic agents are appropriate agents for the treatment of the patient's alopecia. The formulary medications should be tried and failed prior to initiating Rinvoq. It is noted that the patient has tried and failed intralesional steroids. However, after review of the clinical documentation, there is no documentation provided that would justify the patient requiring treatment with Rinvoq prior to the generic alternatives such as Methotrexate in combination with oral corticosteroids, and the topical medications aforementioned.