Appeal type: Medical necessity
Decision: Overturned

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

The patient is an adult male with moderate to severe Crohn's disease. He had an initial response to Stelara 90 mg (milligrams) every 8 weeks and has lost response. His serum Stelara level is low at 1. His provider is requesting to increase Stelera to 90 mg (milligrams) every 4 weeks. Stelara was denied coverage by the health plan, as the dose is higher than the FDA (United States Food and Drug Administration)-approved dose of 90 mg (milligrams) every 8 weeks. The denial is being appealed.

The requested Stelara 90 milligrams every four weeks is clinically appropriate, an accepted standard of medical care, and 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 [%]) of patients on every eight-week maintenance dosing required dose intensification (frequency increased to every four weeks [n=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]). A total of 11 patients (52%) had clinical response after dose escalation (two [18%] were primary non-responders to induction while nine [82%] had poor initial clinical response) (Young et al., 2018).
Per Ollech et al. (2020), "We obtained data from 110 patients who initially received subcutaneous ustekinumab 90 mg every eight weeks and then had their interval shortened to every four 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 eight mg/L [milligrams per liter] to three 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 [microgams per gram] (P = .57). Among patients who had an HBI [Harvey Bradshaw Index] of more than four, a level of CRP [greater than or equal to] five mg/dL [milligrams per deciliter], a level of fecal calprotectin more than 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 (an HBI [Harvey Bradshaw Index] score [less than or equal to] four), 22% had a normal level of CRP [C-reactive protein] (less than five mg/dL [micrograms per deciliter]), 50% had reduced levels of fecal calprotectin, and 36% achieved endoscopic remission. Shortening the Ustekinumab 90 mg [milligram] dose interval to four weeks for patients with CD [Crohn's disease] who did not respond to doses every eight 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 lost response to Stelara 90 milligrams every eight weeks with increased symptoms and has a low serum Stelara level. Therefore, the requested Stelara 90 milligrams every four weeks is clinically appropriate, an accepted standard of medical care, and medically necessary.