Xeljanz denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Xeljanz. Common therapies for lichen sclerosus include high-potency topical corticosteroids, such as clobetasol, systemic immunosuppressive agents, such as methotrexate, and retinoids, such as acitretin. Narrowband ultraviolet B (NB-UVB) is also an option for patients with widespread or treatment-resistant disease. For patients with refractory or severe cases of lichen sclerosus, particularly those who fail conventional treatments, emerging therapies, including Xeljanz, have shown potential in targeting the underlying immune dysregulation involved in the disease. Xeljanz works by inhibiting a pathway which plays a key role in the inflammatory process of various autoimmune and inflammatory skin diseases.

Nature of Statutory Criteria/Case Summary: An enrollee’s parent has requested authorization and coverage for (1) Xeljanz, or (2) in the alternative, Olumiant. Alopecia areata is a chronic autoimmune condition which leads to hair loss. If this persists over time without adequate treatment, permanent hair loss can ensue, leading to considerable psychosocial distress. In recent years there has been a wealth of evidence pointing to the efficacy of oral Janus kinase (JAK) inhibitors such as Xeljanz (generic name tofacitinib) and Olumiant (generic name baricitinib) in the treatment of this condition including cases of complete remission. King and colleagues report 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.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Xeljanz for treatment of the enrollee’s rheumatoid arthritis. Findings: The physician reviewer found that There is a lack of support in the literature for the use of Xeljanz (tofacitinib) in the treatment of rheumatoid arthritis (RA). The 2015 American College of Rheumatology (ACR) guideline, for the treatment of rheumatoid arthritis recommends methotrexate (MTX) with or without tumor necrosis factor inhibitor (TNFi) as the next treatment option in patients who have failed MTX alone. The guidelines noted, “there are potential longer-term safety concerns related to tofacitinib that need more study, partly related to the shorter experience using tofacitinib.” A second TNFi with or without MTX of non-TNF biologic with or without agent is recommended over Xeljanz.

Nature of Statutory Criteria/Case Summary: An enrollee has requested or Xeljanz for treatment of her atopic dermatitis. Findings: Three physician reviewers found that atopic dermatitis is a common itchy inflammatory skin disease characterized by immune activation, marked epidermal hyperplasia, and defective barrier function, reflecting underlying alterations in keratinocyte differentiation. The disease may be associated with significant morbidity, particularly when complicated by secondary infection. Frequent disruption of sleep is common, and emotional stress associated with the illness can have a significant impact on quality of life for patients and families. Much effort has recently been placed on the development of new treatment strategies for this increasingly common illness.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Xeljanz, then check the rights and deadlines that apply to your plan.