Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Ileocolitis. 
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 Crohn's. She has failed Remicade and Humira and is status post ileocecectomy. Two years ago, she started Stelara 90 milligrams every 8 weeks, and had some improvement, but last year, she developed increased symptoms, active disease with an elevated fecal calprotectin. Serum Stelara level 2 months ago was 0. The medical doctor is requesting to increase Stelara to 90 milligrams every 4 weeks. Stelara was denied, as the dose is higher than 90 milligrams every 8 weeks. 

The health plan should cover Stelara 90 milligrams every 4 weeks. 

Medical literature supports dose intensification of biologics in patients who lose response to FDA (Food Drug Administration) 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 CD (Crohn's Disease) reported that among 122 patients on ustekinumab, 21 (17%) patients on every 8-week maintenance dosing required dose intensification (frequency increased to every 4 weeks [n=11], every 6 weeks [n=5], or a combination of IV (intravenous) 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 CD (Crohn's Disease) 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 SC (subcutaneous) 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 CD (Crohn's Disease) receiving ustekinumab, demonstrated that, among 11 patients who required a dosing interval reduction (includes 90 milligrams SC (subcutaneous) every 8 weeks to every 4 weeks [n=8], 90 milligram SC (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 CD (Crohn's Disease) patients, demonstrated that, among patients who achieved clinical response at the last follow up, dose escalation was required in 35% (7/20) of patients who received ustekinumab 90 milligrams SC (subcutaneous) every 8 weeks. Dose intensification of Stelara in patients with IBD (inflammatory bowel disease) 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 patient had an initial, then lost response to Stelara 90 milligrams every 8 weeks. She has also failed Humira and Remicade. Therefore, the requested Stelara 90 milligrams every 4 weeks is clinically appropriate, accepted standard of care and is medically appropriate and should be covered by the health plan.