Appeal type: Medical necessity
Decision: Overturned

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

The patient is a male with Crohn's disease, having fistulizing disease with abscess formation, diagnosed approximately three years ago. He has failed treatment with Remicade and prednisone. Stelara was started approximately 9 months ago. Due to ongoing disease activity, the dose was escalated to every 6 weeks approximately six months ago. Since then, the patient has ongoing symptoms and elevated inflammatory markers  CRP (C-reactive protein) of 38 and calprotectin of 2190. The Stelara level was 4.5.

Yes, the requested Stelara every 4 weeks is medically necessary.
Dose escalation of Stelara may be required in some patients. In a retrospective multicenter cohort study that was performed on patients with CD (Crohn's disease), dose escalation was required in 17 patients (16.3%); response was recaptured in 9 of 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 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] 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 4), 22% had a normal level of CRP (C-reactive protein) (< [less 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).

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
While the plan has initially covered Stelara every 4 weeks for 6 months, its determination was to reduce dosing frequency. This is not in accordance with the standard of care.

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.