Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Stelara Injection 90mg (milligrams)/mL (milliliter) every 4 weeks.

The insurer denied: Stelara Injection 90mg (milligrams)/mL (milliliter) every 4 weeks.  The denial is overturned.

The patient is an adult female with moderate to severe Crohn's disease. She has failed Entyvio and steroids. She has had some, but not a complete, response to Stelara 90 milligrams every 8 weeks, with improvement in small bowel disease, but ongoing elevated calprotectin and colonic disease. Her provider is requesting to increase Stelara to 90 milligrams every 4 weeks.

The requested Stelara 90 mg every 4 weeks is medically necessary.

Medical literature supports dose intensification of biologics in patients who lose response to FDA (United States Food and 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% [percent]) 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 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 non-responders 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 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 re-induction 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 every 8 weeks to every 4 weeks [n=8], 90 milligrams 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 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 some, but not a complete response to Stelara 90 milligrams every 8 weeks, with ongoing active colonic inflammation. She has failed Entyvio. Therefore, increasing Stelara to 90 milligrams every 4 weeks prior to a trial of Skyrizi is clinically appropriate, accepted standard of care and is medically necessary.