Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease
Treatment: Stelara 90 mg/ml syringe every 6 weeks
The insurer denied the Stelara 90 mg/ml syringe every 6 weeks.
The denial is overturned.

The patient is a female with moderate-to-severe Crohn's. She is status post resection, and has failed Remicade, Tysabri and Entyvio. She started Stelara 90 mg (milligrams) every 8 weeks, and had a partial response, but was unable to come off steroids until methotrexate was added. Per provider is requesting to increase Stelara to 90 mg (milligrams) every 6 weeks.

Yes, the health plan should cover the Stelara every 6 weeks.
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) 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.

Therefore, as 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, and as this patient has failed but had some response to Stelara 90 mg (milligrams) every 8 weeks, the health plan should cover the requested Stelara 90 mg (milligrams) every 6 weeks.

Yes, the Stelara every 6 weeks is more beneficial.
The patient has already had side effects or did not respond to anti-TNFs (tumor necrosis factors) and Entyvio, and has had a partial response to Stelara 90 mg (milligrams) every 8 weeks. As per rationale to question 1, dose intensification to Stelara 90 mg (milligrams) every 6 weeks is more beneficial than any standard treatment for Crohn's that she has failed.