Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease
Treatment: Stelara 90mg (milligrams) /ml (milliliter) Syringe (every 4 weeks)
The insurer denied the Stelara 90mg (milligrams) / ml (milliliter) Syringe (every 4 weeks)
The denial is overturned.

The patient is a male with Crohn's disease, status post ileocectomy with sigmoid segmental resection, and fistula takedown / ileocolonic resection with ileo - ascending anastomosis and sigmoid colectomy. The patient has failed Pentasa, Remicade, Humira.

Stelara was started approximately four years ago, and increased approximately one year ago, due to active disease. Colonoscopy showed mild stricturing and fissuring of the anal canal with loss of tissue compliance. There were serpiginous ulcers in the neo-terminal ileum, which could not be intubated. There were a few ulcers in the rectum < [less than] 1 cm (centimeter) in size. The patient has had clinical improvement on the every-4-weeks dosing.

Yes, the health plan should cover the Stelara every 4 weeks.
Stelara was started approximately four years ago and increased approximately one year ago due to active disease. The active disease was evidenced by colonoscopy. Colonoscopy showed mild stricturing and fissuring of the anal canal with loss of tissue compliance. There were serpiginous ulcers in the neo-terminal ileum which could not be intubated. There were a few ulcers in the rectum < [less than] 1 cm (centimeters) in size.

There has been clinical improvement on Stelara every 4 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.).

In another multicenter open-label study, dose escalation was effective in 8 of 11 (73%) patients (Khorrami S et al. Inflamm Bowel Dis.).

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.).

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 mg (milligrams) every 8 weeks at a single center was reviewed. Data from 110 patients who initially received subcutaneous ustekinumab 90 mg (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, the median level of CRP (C-reactive protein) decreased from 8 mg/L (milligrams/liter) to 3 mg/L (milligrams/liter), and median level of fecal calprotectin decreased from 378 ug/g (micrograms/gram) to 157 ug/g (micrograms/gram). Among patients who had an HBI (Harvey Bradshaw Index) > [greater4, a level of CRP (C-reactive protein) 5mg/dL, a level of fecal calprotectin > [greater than] 250ug/g (micrograms/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) (< [less than] 5 milligrams/deciliter), 50% had reduced levels of fecal calprotectin, and 36% achieved endoscopic remission (Ollech JE et al, Clin Gastroenterol Hepatol. 2021).

Yes, the requested Stelara every 4 weeks is more beneficial.
De-escalation would not be appropriate for this patient, as this could lead to destabilization of disease. Fully utilizing the benefit of Stelara would be indicated prior to changing to another biologic agent, since there are few biologic agents that may be used in the treatment of Crohn's disease.