Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease
Treatment: Stelara 90mg (milligrams) every 4 weeks
The insurer denied: Stelara 90mg (milligrams) every 4 weeks
The denial is overturned

The patient is an adult male with moderate to severe Crohn's disease. He has failed budesonide, and had some, but not a complete response to Stelara 90 mg (milligrams) every 8 weeks. His provider is requesting to increase Stelara to 90 mg (milligrams) every 4 weeks.

The requested Stelara every 4 weeks is medically necessary.

Medical literature supports dose intensification of biologics in patients who lose response to the Food and Drug Administration (FDA) approved dosing. Stelara has been found to be safe and effective at doses as high as 90 milligrams every four weeks.

Results from a retrospective cohort study of patients with Crohn's disease (CD) reported that among 122 patients on ustekinumab, 21 (17%[percent]) patients on every eight-week maintenance dosing required dose intensification (frequency increased to every four weeks [n=(equal)11], every six weeks [n=5], or a combination of intravenous (IV) booster and frequency increase to every six weeks or every four weeks [n=5]). (Young et al., 2018).

A multicenter, retrospective, open-label cohort study of adults with moderate to severe CD (Crohn's disease) was conducted to evaluate the long-term maintenance efficacy of ustekinumab therapy. During the maintenance therapy, dose escalation was required in 16.3% of patients and a combination strategy of reinduction and dose escalation was required in 6.7% of patients. The most common escalated maintenance dosing was 90 milligrams subcutaneously (SC) every four or six weeks. Clinical response was regained in 52.9% of patients who had dose escalation, and 57.1% of patients who had combined reinduction and dose escalation (Ma et al., 2017).

Per Ollech et al. (2020), "We obtained data from 110 patients who initially received subcutaneous ustekinumab 90 mg every 8 weeks and then had their interval shortened to every 4 weeks. 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 eight (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 mg/L (milligrams per liter) to 3 mg/L (milligrams per liter) (P = .031), and median level of fecal calprotectin decreased from 378 ug/g (micrograms per gram) to 157 ug/g (micrograms per gram) (P = .57). Among patients who had an HBI (Harvey Bradshaw Index) >(greater then)4, a level of CRP (Creactive protein) greater than or equal to 5 mg/dL (milligrams per deciliter), a level of fecal calprotectin >250 ug/g (micrograms per 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 less than or equal to 4), 22% had a normal level of CRP (C-reactive protein), 50% had reduced levels of fecal calprotectin, and 36% achieved endoscopic remission. Shortening the ustekinumab 90 mg (milligrams) dose interval to 4 weeks for patients with CD (Crohn's disease) who did not respond to doses every 8 weeks improved clinical and biological indices of disease activity. Patients who lose response to the standard dose of ustekinumab might benefit from dose interval shortening, which was effective and safe."

Medical literature supports dose intensification prior to changing to another agent when there has been some response. This patient had some response, but recently had recurrent symptoms and evidence of active disease on Stelara 90 milligrams every eight weeks. Therefore, the requested Stelara 90 milligrams every four weeks is clinically appropriate, an accepted standard of medical care, and medically necessary.