Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease
Treatment:  Stelara 90mg every 4 weeks
The insurer denied the  Stelara 90mg every 4 weeks.
The denial is overturned.

The patient is a male with Crohn's disease of the colon who has failed mesalamine and Humira.  The patient started Stelara and has done well on standard therapy until recently.  Since earlier this year the patient developed increasing symptoms of active disease with worsening diarrhea and abdominal pain.  He was placed on steroid therapy with improvement in symptoms.  Colonoscopy confirmed active disease.  The request is for Stelara 90 mg (milligrams) every 4 weeks.

The health plan denied the request on the basis that the requested dose is not FDA (United States Food and Drug Administration) or compendia supported.

The patient's physician is appealing the denial on the basis that the patient has failed standard dosing.

Yes, the health plan should cover the Stelara every 4 weeks.
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, data from 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 ug/g (micrograms per gram) to 157 ug/g (micrograms per gram). Among patients who had an HBI (Harvey Bradshaw Index) > (greater than) 4, a level of CRP (C-reactive protein) 5mg/dL (milligrams per deciliter), a level of fecal calprotectin > (greater than) 250ug/g, 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) (< (greater than) 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.).

Yes, the requested Stelara every 4 weeks is more beneficial.
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 CD (Crohn's disease).