Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease
Treatment: Stelara 90mg (every 4 weeks)
The insurer denied the Stelara 90mg (every 4 weeks).
The denial is overturned.

The patient is a female with moderate to severe Crohn's disease (CD). She had been on Stelara 90 mg (milligrams) every 8 weeks, and colonoscopy revealed active disease. Stelara was increased to 90 mg (milligrams) every 4 weeks with good results. Her provider is requesting to continue Stelara at 90 mg (milligrams) every 4 weeks.

Yes, the Stelara every 4 weeks is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient.

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% [percent]) patients on every 8 week maintenance dosing required dose intensification (frequency increased to every 4 weeks, every 6 weeks, or a combination of IV [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 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 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) of 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 receiving ustekinumab demonstrated that, among 11 patients who required a dosing interval reduction (includes 90 mg every 8 weeks to every 4 weeks, 90 mg 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 resistant CD 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 mg 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 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 mg every 8 weeks, with active disease on colonoscopy, and is doing well on Stelara 90 mg every 4 weeks. Therefore, the requested Stelara 90 mg every 4 weeks is clinically appropriate, accepted standard of care, and medically necessary. The health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient by denying it. Stelara should be approved at 90 mg every 4 weeks for 12 months.