Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Stelara (dosed every 4 weeks), Pre-service.
The insurer denied the Stelara (dosed every 4 weeks), Pre-service.
The denial is overturned.

The patient is a male with moderate to severe Crohn's. He had an infusion reaction with Remicade, and failed Humira. He has had some, but not a complete response with Stelara 90 mg (milligrams) every 8 weeks, with ongoing loose stools with mucus. A recent colonoscopy revealed active disease in the terminal ileum. His provider is requesting to increase Stelara to 90 mg (milligrams) every 4 weeks.

Yes, the requested Stelara 90 mg (milligrams) 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 mg (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, every 6 weeks, or a combination of intravenous booster and frequency increase to every 6 weeks or every 4 weeks). 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 mg (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 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 every 8 weeks to every 4 weeks, 90 milligrams every 8 weeks to every 6 weeks), 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 followup, dose escalation was required in 35% (7/20) of patients who received ustekinumab 90 mg (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 mg (milligrams) every 4 weeks. As the patient has had some improvement with Stelara 90 mg (milligrams) every 8 weeks, with ongoing active disease, and has failed Humira and Remicade, medical literature supports dose intensification prior to changing to another agent, and therefore, increasing the patient's dose/frequency (beyond FDA [United States Food and Drug Administration] labeling) is recommended by clinical practice guidelines over switching to other guideline-supported options, and the requested Stelara 90 mg (milligrams) every 4 weeks is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
As it is medically necessary, the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient by denying Stelara every 4 weeks.