Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Crohn's Disease.
Treatment: Stelara 90mg every 4 weeks, Pre-service.
The insurer denied the Stelara 90mg every 4 weeks, Pre-service.
The denial is overturned.

The patient is a female with Crohn's disease. She has failed Remicade, Humira, and methotrexate.  She is on Stelara for over a year.  On Stelara, the patient has five bowel movements per day.  She continues to have fistula drainage. Three months ago, CT (computed tomography) scan showed a complex perirectal fistula and stable wall thickening and mucosal enhancement involving a loop of terminal ileum.  The request is for Stelara every 4 weeks.

Yes, the heatlh plan should cover the Stelara every 4 weeks.
Dose escalation of Stelara may be required in some patients. The patient has ongoing evidence of increased disease activity and requires dose escalation for better control of disease.

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 (Kopylov 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 per liter) to 3 mg/L (milligrams per liter), and median level of fecal calprotectin decreased from 378 g/g (micrograms per gram) to 157 g/g (micrograms per gram). Among patients who had an HBI (Harvey Bradshaw Index) >4, a level of CRP (C-reactive protein) 5mg/dL (milligrams per deciliter), a level of fecal calprotectin >250 g/g (micrograms per gram), or endoscopic evidence for disease activity before dose interval shortening, after the dose interval was shortened, 28% achieved clinical remission (an HBI [Harvey Bradshaw Index] score 4), 22% had a normal level of CRP (C-reactive protein) (<5 mg/dL [milligrams per deciliter]), 50% had reduced levels of fecal calprotectin, and 36% achieved endoscopic remission (Ollech JE et al, Clin Gastroenterol Hepatol.).

Therefore, given the above, the health plan should cover the Stelara every 4 weeks.

Yes, Stelara every 4 weeks is likely to be more beneficial.
The standard would be continue with the current dose, which the patient is failing.