Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Stelara (dosed every 6 weeks).
The insurer denied the Stelara (dosed every 6 weeks).
The denial is overturned.

The patient is a male with Crohn's disease and primary sclerosing cholangitis diagnosed when he was younger. He has failed Remicade, Humira, Cimzia, Entyvio, and Imuran. Stelara was started approximately two years ago. Trough level of Stelara showed a level of 2.6. The patient has increased frequency of bowel movements, urgency, and rectal bleeding. He had re-induction of Stelara and then was lost to follow up. The request is for Stelara every 6 weeks.

Yes, the Stelara every 6 weeks is medically necessary.

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, 506 patients with CD (Crohn's disease) who received subcutaneous ustekinumab 90 mg every 8 weeks at a single center was reviewed. Data from 110 patients who initially received subcutaneous ustekinumab 90 mg 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 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.).

Therefore, given the above, the requested Stelara every 6 weeks is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
Dose escalation of therapy by increasing the frequency of administration or by increasing the dose is conducted in clinical practice if a patient exhibits signs of increased disease activity.