Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Ulcerative Colitis
Treatment: Stelara (at a dose of 90 milligrams every 4 weeks)
The insurer denied: Stelara (at a dose of 90 milligrams every 4 weeks)
The denial is overturned.

The patient is an adult female with moderate to severe ulcerative colitis treated with Stelara 90 milligrams (mg) every 8 weeks. Colonoscopy from last month revealed severe active rectal disease. Serum Stelara level was low at 4. The physician (MD) is requesting to increase Stelara to 90 milligrams (mg) every 4 weeks. Stelara was denied, as the dose is higher than the Food and Drug Administration (FDA) approved dose of 90 milligrams every 8 weeks.

Stelara 90 milligrams every 4 weeks is medically necessary.

Medical literature supports dose intensification of biologics in patients who lose response to Food and Drug Administration (FDA) approved dosing. Stelara has been found to be safe and effective at doses as high as 90 milligrams every 4 weeks. Results from a retrospective cohort study of patients with Crohn's disease (CD) reported that among 122 patients on ustekinumab, 21 (17% [percent]) patients on every 8 week maintenance dosing required dose intensification (frequency increased to every 4 weeks [n(number)= (equal)11], every 6 weeks [n=5], or a combination of intravenous [IV] booster and frequency increase to every 6 weeks or every 4 
weeks [n=5]). A total of 11 patients (52%) had clinical response after dose escalation (2 [18%] were primary nonresponders to induction while 9 [82%] had poor initial clinical response). 
A multicenter, retrospective, open-label cohort study of adults with moderate to severe Crohn's disease (CD) was conducted to evaluate the long-term maintenance efficacy of ustekinumab 
therapy. During the maintenance therapy, dose escalation was required in 16.3% (17/104) patients and a combination strategy of reinduction and dose escalation was required in 6.7% (7/104) of patients. The most common escalated maintenance dosing was 90 milligrams subcutaneous (SC) every 4 or 6 weeks. Clinical response was regained in 52.9% (9/17) of patients who had dose escalation, and 57.1% (4/7) of patients who had combined reinduction and dose escalation. Results from a retrospective, multicenter, open-label study of patients with refractory Crohn's disease (CD) receiving ustekinumab, demonstrated that, among 11 patients who required a dosing interval reduction (includes 90 milligrams subcutaneous every 8 weeks to every 4 weeks [n=8], 90 milligrams subcutaneous every 8 weeks to every 6 weeks [n=1]), clinical improvement was seen in 73% (8/11) of patients.
Results from a retrospective, open-label, observational study of ustekinumab for the treatment of anti-tumor necrosis factor (anti-TNF) resistant Crohn's disease (CD) patients, demonstrated that, among patients who achieved clinical response at the last followup, dose escalation was required in 35% (7/20) of patients who received ustekinumab 90 milligrams subcutaneous every 8 weeks. Dose intensification of Stelara in patients with inflammatory bowel disease (IBD) has been found to be safe and effective at doses as high as 90 milligrams every 4 weeks. Medical literature supports dose intensification prior to changing to another agent, when there has been some response. This patent had some, but not a complete response to Stelara 90 milligrams every 8 weeks, with active disease on colonoscopy and low serum Stelara levels. Therefore, the requested Stelara 90 mg every 4 weeks is clinically appropriate, accepted standard of care and is medically necessary.