Diagnosis: Inflammatory Bowel Disease
Treatment: Stelara
The insurer denied Stelara.
The determination is overturned.

The patient has a history of very early onset inflammatory bowel disease, likely ulcerative colitis (UC). She has tried and failed infliximab and conventional therapy. The requested service is Stelara, which is under review for medical necessity.

Yes, Stelara is medically necessary in this case.
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.
Per Dhaliwal, Jasbir, et al: " Ustekinumab demonstrated efficacy in this paediatric cohort with otherwise treatment-refractory UC".
This patient has a history of refractory inflammatory bowel disease, which failed anti- tumor necrosis factor alpha (infliximab) and conventional therapy. Humira is unlikely to be effective as it has a similar mechanism of action to infliximab. There are no other suitable treatment alternatives beside Stelara. Therefore, Stelara is medically necessary in this case.