Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Crohn's Disease
Treatment: Stelara 90mg/ml SC SOSY every 4 weeks
The insurer denied the Stelara 90mg/ml SC SOSY every 4 weeks
The denial is upheld. 

The patient is a female with moderate to severe Crohn's, status post resection. She has failed azathioprine, Remicade, Entyvio, Cimzia and Humira, and started Stelara 90 mg (milligrams) every 8 weeks. She had some, but not a complete response, and serum Stelara level was low at 1.6. Her provider is requesting to increase Stelara to 90 mg (milligrams) every 4 weeks.

No, the requested Stelara every 4 weeks is not medically necessary for this patient at this time.
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 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 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 mg [milligrams] every 8 weeks to every 4 weeks, 90 mg [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 [tumor necrosis factor]) 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. This patient has failed Stelara 90 mg (milligrams) every 8 weeks, but there is no documentation that she has failed every 6 week dosing. Therefore, there is no documentation that Stelara 90 mg (milligrams) every 6 weeks, would likely result in serious risk of harm to the patient, as compared to the Stelara 90 mg (milligrams) every 4 weeks. While dose intensification of Stelara has been shown to be safe and effective at doses as high as 90 mg (milligrams) every 4 weeks, the standard of care would be a trial of the drug at every 6 weeks before every 4 weeks is attempted. This patient has only tried a dosing schedule of every 8 weeks. A move to every 4 weeks would not be standard of care for this patient at this time.