Diagnosis: Crohn's disease
Treatment: Rinvoq
The insurer denied Rinvoq.
The determination is upheld.

This is a male patient with a history of Crohn's disease. He has tried and failed many therapies, including infliximab and corticosteroids. The requested service is Rinvoq. At issue is whether the Rinvoq is medically necessary for this patient.

The medical necessity of Rinvoq cannot be established. Rinvoq is a selective janus kinase (JAK) inhibitor that is being used in several immune-mediated inflammatory disease. Rinvoq is Food and Drug Administration (FDA) approved for the treatment of ulcerative colitis in adults. The safety and efficacy of Rinvoq are well established in adult ulcerative colitis patients. According to Sandborn, William J., et al: "8 weeks of treatment with upadacitinib was more effective than placebo for inducing remission in patients with moderately to severely active UC."
However, there is no evidence supporting the use of Rinvoq in treating pediatric Crohn's disease. The safety and efficacy of this treatment are not well supported by the current literature. There are more suitable therapies that have not been tried in this case. Therefore, the requested treatment is not consistent with the generally accepted practices and is unproven and not medically necessary. Medical necessity is not established due to lack of supportive literature of using Rinvoq in pediatric Crohn's disease.