Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Immunologic Disorders/Alopecia. 
Treatment: Pharmacy/Prescription Drugs. 

The health plan denied the requested medication Xeljanz as not medically necessary. 
The health plan's determination is overturned. 

The patient is a female with alopecia universalis, treated with oral, topical and intralesional steroids. The provider is requesting Xeljanz. The patient has lost all hair on her body and is experiencing eye irritation. 

At issue is the medical necessity of the health service/treatment with Xeljanz. 

The health plan's determination is overturned, in whole. 

Yes. medical necessity is defined as: 
1) clinically appropriate for the symptoms, diagnosis, treatment of a condition.
2) given for the diagnosis or direct care of the condition. 
3) condition would be adversely affected if services were not provided. 
4) within standards of good medical practice. 
5) not mainly for the convenience of the patient or provider. 
6) not more costly than an alternative service at least as likely to produce equivalent results. 
7) the most appropriate level of service that can be safely given. 
Alopecia universalis is a severe form of alopecia areata (AA) involving total body hair loss - including eyelashes, groin, etc. Regrowth of hair rarely occurs. Treatment studies for any form of alopecia areata are difficult to perform because the disease has an unpredictable course, and much investigation is still needed. 
A wide range of treatments have been used for the management of alopecia areata, most of which are not highly effective. Treatments include topical or intralesional corticosteroids, topical Minoxidil (2%[percent] or 5%), topical Anthralin, systemic corticosteroids, Cyclosporine, and other immunosuppressants. A dependable and safe treatment for extensive disease (totalis or universalis) has yet to be found. Given the rarity of the disease, large randomized controlled trials are extremely difficult. 

Alopecia areata and its variants is an extremely distressing disease. With further case reports of "off-label" uses of medications such as Xeljanz, more treatment options can become available. Xeljanz is currently Food and Drug Adminsistration (FDA) approved for Rheumatoid arthritis and undergoing approval trials for psoriasis and psoriatic arthritis. It is known to be safe and effective in the conditions for which it is FDA approved. Biologic medications as a whole have many off label uses, leading to better outcomes in rare diseases for which large, randomized trials are not readily available. The 2019 systematic review performed a literature search to identify clinical trials and case reports and concluded that several clinical studies have shown very promising results in the treatment of alopecia areata (AA) with oral formulas of JAKs (kinase inhibitors). These agents do need chronic administration to maintain response. Topical formulations did not show satisfactory responses. The safety profile of these agents appears to be favorable. 
Therefore, given the support in current literature and lack of effective therapies for alopecia areata, and this patient's favorable response to therapy, Xeljanz is medically necessary.