Diagnosis: Ulcerative Colitis
Treatment Stelara 90 milligrams (mg) every 4 weeks
The health plan denied the Stelara 90 milligrams (mg) every 4 weeks.
The determination is overturned.

The patient has a history of ulcerative colitis (UC), severe atopic dermatitis and inflammatory arthritis. She has tried and failed numerous therapies, including infliximab, Entyvio and corticosteroids. She was started on Stelara at the standard dose, however, she continued to have active disease. Xeljanz was then added but was deemed ineffective and was stopped. She was then started on Rinvoq (upadacitinib) for her atopic dermatitis and arthritis and the Stelara was escalated to every 4 weeks. The requested service is continuation of Stelara at 90 milligrams (mg) every 4 weeks.
Continuation of the Stelara as requested is medically necessary.
Stelara is Food and Drug Administration (FDA) approved for the treatment of Crohn's disease and ulcerative colitis in adults. Despite the lack of FDA approval for pediatric patients, there are many peer reviewed publications supporting the efficacy and safety of Stelara in children with inflammatory bowel disease.
A report by Dayan JR et al, showed that ustekinumab (Stelara) is efficacious and safe in pediatric patients with inflammatory bowel disease.
According to Dhaliwal, Jasbir, et al: " Ustekinumab (UST) demonstrated efficacy in this paediatric cohort with otherwise treatment-refractory UC".
Therefore, the use of Stelara in treating refractory pediatric ulcerative colitis is appropriate. However, some patients do not respond adequately to the standard dose. Dose escalation is often required in biologics in order to achieve therapeutic levels and clinical remission. There are many peer reviewed literature reports showing that low Stelara levels were associated with poor clinical response. The requested dose of 90 mg every 4 weeks is proven to be effective in patients who fail the standard dose.
According to Dalal, R., et al: " UST dose escalation resulted in clinical remission in greater than (>) 50 percent (%) of UC patients and was more effective in those with loss of response compared to no/minimal response after induction. "
This patient has a history of refractory ulcerative colitis and has failed anti-tumor necrosis factor alpha, Entyvio, Xeljanz and conventional therapy. The patient also failed to respond to Stelara standard dose (90 mg every 8 weeks) and continued to have severe symptoms. She responded well to Stelara at 90 mg every 4 weeks. Discontinuation of Stelara at this time will put this child at risk of a colectomy. There are no suitable treatment alternatives for this child. Therefore, continuation of Stelara at 90 mg every 4 weeks is appropriate and medically necessary.