Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Alopecia universalis

Treatment: Xeljanz extended release (XR) 22 milligrams (mg), for a quantity of 30 every 30 days

The insurer denied coverage for Xeljanz XR 22 mg, for a quantity of 30 every 30 days

The denial is upheld. 

The patient is a female with alopecia universalis. She has lost all of the hair on her head and body. She has failed topical, intralesional, and oral steroids. The medication under review is Xeljanz XR 22 mg, for a quantity of 30 every 30 days.

Xeljanz XR 22 mg for a quantity of 30 every 30 days is not considered medically necessary for this patient. There are no medical and scientific literature and/or evidence based clinical practice guidelines that strongly support the administration of Xeljanz for this patient's condition, as an accepted standard of practice in the United States prior to the conventional alternatives. 

There is no documentation the patient has exhausted all topical options, and so it would therefore not be medically necessary to start systemic treatment with Xeljanz, which would carry a higher side effect profile.

For example, there is no documentation provided that the patient has tried and failed topical immunotherapy, such as diphenylcyclopropenone (DPCP). 

Chiang et al. (2015) writes of 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." 

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. (Hill, N. D. et al. 2015)

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 Xeljanz. Therefore, Xeljanz is not medically necessary for this patient.

Moreover, according to the dermatology literature, the preferred medicines methotrexate (MTX) and oral corticosteroids covered by the patient's insurance plan are effective treatments for the management of alopecia universalis.
  
Within the peer-reviewed literature, Anuset et al. (2016) writes "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.

Additionally, according to Phan et al. (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 combination with corticosteroids in the treatment of severe AA."

Finally, as per Up to Date "Janus kinase (JAK) inhibitors appear to induce hair growth in alopecia areata; however, further study is necessary prior to conclusions about efficacy and safety. JAK inhibitors appear to be targeted therapy for alopecia areata." Also, King et al published 2 trials of a different JAK inhibitor concluding that "In two phase 3 trials involving patients with severe alopecia areata, oral baricitinib was superior to placebo with respect to hair regrowth at 36 weeks. Longer trials are required to assess the efficacy and safety of baricitinib for alopecia areata."

The preferred agents are appropriate agents for the treatment of the patient's alopecia. The formulary medications could be tried prior to initiating Xeljanz.  

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

The insurer's denial of coverage for Xeljanz XR 22 mg, for a quantity of 30 every 30 days is upheld. Medical Necessity is not substantiated.