Diagnosis: Ulcerative colitis
Treatment: Stelara 90 mg every 4 weeks
The insurer denied Stelara 90 mg every 4 weeks.
The determination is overturned.


This is a patient with ulcerative colitis (rectosigmoiditis). She has failed oral and rectal corticosteroids, oral and rectal 5-aminosalicylates, and high-dose Entyvio. She started Stelara and has been using tacrolimus suppositories. A flexible sigmoidoscopy showed mild-moderate proctitis. Stelara was increased to 90 milligrams (mg) every 4 weeks. She had intermittent hematochezia and dyschezia while on Stelara 90 mg every 4 weeks. At issue is the medical necessity of Stelara 90 mg every 4 weeks.

The request for Stelara 90 mg every 4 weeks is medically necessary.
The patient has failed multiple therapies, both conventional and biologic; she then had improvement on Stelara [1-3]. Stelara has shown efficacy for the treatment of Ulcerative Colitis in a Phase III trial, UNIFI [1,4]. This trial demonstrated that a single intravenous dose of Stelara induced clinical remission in a significantly greater proportion of patients than placebo did, as measured by both clinical response and endoscopic response; this result was attained in a patient population which was 50 percent (%) biologic-refractory. Recent studies have demonstrated that Stelara 90 milligrams (mg) every 4 weeks is safe and well-tolerated for the treatment of inflammatory bowel disease, with recovery of effectiveness in patients with active disease [5-7]. A recent study showed that 43% of ulcerative colitis patients on Stelara required dose escalation, and over 50% of those with dose escalation achieved corticosteroid-free remission, and long-term improvement in endoscopic inflammation [8].
In this case, the patient has ulcerative colitis, and has failed alternatives, with active disease symptoms after initial response to Stelara. As the patient had initial improvement on Stelara with subsequent loss of response and then improvement on Stelara every 4 weeks, continuation of Stelara 90 mg every 4 weeks is supported. Decrease of the dose to 90 mg every 8 weeks, or a discontinuation of Stelara (even if an alternative is immediately attempted), may result in disease flare and complications such as toxic megacolon, dysplasia leading to colorectal cancer, hospitalization, or need for surgery. For all of these reasons, the request to continue Stelara 90 mg every 4 weeks is supported as medically necessary for the treatment of this patient's ulcerative colitis.