Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Stelara 90MG (milligrams)/ML (milliliters) Syringe (every 6 weeks).
The insurer denied: Stelara 90MG (milligrams)/ML (milliliters) Syringe (every 6 weeks).
The denial is overturned.

The patient is an adult female with moderate to severe Crohn's. She has failed Pentasa and budsonide, and started Stelara 90 milligram every 8 weeks. She had some initial response, and colonoscopy revealed improvement. Recently she has increased diarrhea and abdominal pain, as well as increased psoriasis before her next injection. Her physician is requesting to increase Stelara to 90 milligram every 6 weeks.

The health plan should cover the proposed treatment. 

Medical literature supports dose intensification of biologics in patients who lose response to FDA (Food Drug Administration) approved dosing. Stelara has been found to be safe and effective at doses as high as 90 milligram 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 [n=11], every 6 weeks [n=5], or a combination of IV (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 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 milligram SC (subcutaneous) 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 milligram SC (subcutaneous) every 8 weeks to every 4 weeks [n=8], 90 milligram SC (subcutaneous) 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 milligram SC (subcutaneous) 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 milligram every 4 weeks. As the patient has failed Stelara 90 milligram every 8 weeks, medical literature supports dose intensification prior to changing to another agent, and therefore, the health plan should cover the requested Stelara 90 milligram every 6 weeks.