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.

This is an adult female with Crohn's disease. Stelara was started and the patient was able to taper off budesonide and mesalamine. Colonoscopy showed quiescent Crohn's disease. However, the patient has increasing symptoms of loose stools and abdominal discomfort prior to upcoming Stelara injections. The request is for Stelara every 6 weeks. 

The health plan should cover the proposed treatment. 

The patient has increasing symptoms of loose stools and abdominal discomfort prior to upcoming Stelara injections. The request is for Stelara every 6 weeks. Inadequate treatment of Crohn's disease may lead 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 milligram every 8 weeks at a single center was reviewed. Data from 110 patients who initially received subcutaneous ustekinumab 90 milligram 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 g/g (gram per gram) to 157 g/g (gram per gram) (P = .57). Among patients who had an Harvey Bradshaw Index>4, a level of CRP (C-reactive protein) 5 milligrams/per deciliter, a level of fecal calprotectin > (greater than) 250g/g (gram per gram), or endoscopic evidence for disease activity before dose (Harvey Bradshaw Index score 4), 22% had a normal level of C-reactive protein (< [less than} 5 milligrams/per deciliter).), 50% had reduced levels of fecal calprotectin, and 36% achieved endoscopic remission (Ollech JE et al, Clin Gastroenterol Hepatol. 2021).