Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease. 
Treatment: Stelara 90mg/ml every 4 weeks. 

The insurer denied the Stelara 90mg/ml every 4 weeks. 
The denial is overturned. 

The patient is a male with ileo-colonic perianal Crohn's disease. He has failed 6-MP (mercaptopurine) and methotrexate, and did well with Remicade, however developed skin abscesses. Earlier this year he was started on Stelara 90 mg (milligrams) every 8 weeks. He had a good response, but began having increased symptoms at 6 weeks, and Stelara was increased to 90 mg (milligrams) every 4 weeks. He has done well since that time, with improvement in symptoms. Fecal calprotectin is decreased from 3000 to 300. His provider is requesting continuation of Stelara 90 mg (milligrams) every 4 weeks. 

Yes, the requested Stelara every 4 weeks is medically necessary. 

Medical literature supports dose intensification of biologics in patients who lose response to FDA (United State 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 had some but not a complete response to Stelara 90 mg (milligrams) every 8 weeks, with increased symptoms at 6 weeks. He has improved on 90 mg (milligrams) every 4 weeks, and as he does still have an elevated fecal calprotectin of 300, he likely still has mucosal disease, and would be likely to flare with dose de-escalation. Therefore, the requested continuation of Stelara 90 mg (milligrams) every 4 weeks is clinically appropriate, accepted standard of care and medically necessary.