Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Ileocolitis. 
Treatment: Stelara (at a dose of 90 milligrams every 4 weeks). 

The insurer denied: Stelara (at a dose of 90 milligrams every 4 weeks). 
The denial is overturned. 

This is an adult female with Crohn's ileocolitis. The patient has tried and failed infliximab. She underwent ileocecectomy over 10 years ago. The patient has tried and failed adalimumab. Stelara was started 2 years ago. Stelara level was 0 two months ago. The patient had worsening frequency of bowel movements and urgency. The patient has nocturnal diarrhea. 

The health plan should cover Stelara 90 milligrams every 4 weeks. 

Stelara was started 2 years ago. Stelara level was 0 two months ago. The patient had worsening frequency of bowel movements and urgency. The patient has nocturnal diarrhea. Inadequate treatment of Crohn's disease may lead to complications of Crohn's disease, which include malnutrition (B12 deficiency, increased risk for osteoporosis), bowel obstruction secondary to bowel inflammation and strictures, fistulas and abscesses, increased risk for colon cancer, and extra-intestinal manifestations. Dose escalation of Stelara may be required in some patients. In a retrospective multicenter cohort study was performed on patients with CD (Crohn's disease), dose escalation was required in 17 patients (16.3%); response was recaptured in 9/17 (52.9%) (Ma C et al, Inflamm Bowel Dis. 2017.). 

In another multicenter open-label study, dose escalation was effective in 8 of 11 (73%) patients (Khorrami S et al. Inflamm Bowel Dis. 2016.). 
In a single center retrospective open-label observational study, dose escalation was required in 47.7% of the patients and was successful in 61.1% of them (Kapylov et al. J Crohns Colitis. 2014.). 

In a retrospective study to determine the effectiveness of ustekinumab dose interval shortening, 506 patients with CD (Crohn's disease), who received subcutaneous ustekinumab 90 milligrams every 8 weeks at a single center was reviewed. Data from 110 patients who initially received subcutaneous ustekinumab 90 milligrams every 8 weeks and then had their interval shortened to every 4 weeks was studied. Harvey Bradshaw Index (HBI) scores before and after the dose interval shortening was available for 78 patients in the cohort (71%), levels of C-reactive protein (CRP) for 60 patients (55%), and levels of fecal calprotectin for 8 patients (7%). Following dose interval shortening, the patients' median HBI (Harvey Bradshaw Index) decreased from 4.5 to 3 (P = .002), the median level of CRP (C-reactive protein) decreased from 8 milligrams per liter to 3 milligrams per liter (P = .031), and median level of fecal calprotectin decreased from 378 gram per gram to 157 gram per gram (P = .57). Among patients who had a Harvey Bradshaw Index >4, a level of CRP (C-reactive protein) 5 milligrams per liter, a level of fecal calprotectin >250 microgram/gram, or endoscopic evidence for disease activity before dose interval shortening, after the dose interval was shortened, 28% achieved clinical remission (a Harvey Bradshaw 
Index score 4), 22% had a normal level of CRP (C-reactive protein) (<5 milligrams (mg) per deciliter), 50% had reduced levels of fecal calprotectin, and 36% achieved endoscopic remission (Ollech JE et al, Clin Gastroenterol Hepatol. 2021).