Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease
Treatment: Stelara 90mg (milligrams) every 28 days, pre-service
The insurer denied the Stelara 90mg (milligrams) every 28 days, pre-service
The denial is overturned

This is a male patient with Crohn's disease. The patient has ileocolonic, stricturing, and perianal disease. The patient has tried and failed Remicade, Humira, Cimzia, and Entyvio. Stelara was started approximately three years ago and the dose was escalated to every four weeks approximately a year ago as computed tomography (CT) enterography showed inflammation in the distal colon and concern for a perianal fistula.

Yes, the proposed treatment with Stelara, 90 milligrams every 28 days, is medically necessary.

The denial reason was that the dose requested was not approvable.

The request is medically necessary as the patient failed standard dosing. 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. 

Dose escalation of Stelara may be required in some patients. In a retrospective multicenter cohort study performed on patients with Crohn's disease (CD), dose escalation was required in 17 patients (16.3%); response was recaptured in nine of 17 (52.9%) (Ma C et al, Inflamm Bowel Dis.). In another multicenter open-label study, dose escalation was effective in eight 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 Crohn's disease who received subcutaneous ustekinumab 90 milligrams every eight weeks at a single center was reviewed.  Data from 110 patients who initially received subcutaneous ustekinumab 90 milligrams every eight weeks and then had their interval shortened to every four 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 eight patients (7%). Following dose interval shortening, the patients' median Harvey Bradshaw Index decreased from 4.5 to three, the median level of C-reactive protein decreased from eight milligrams per liter (mg/L) to three milligrams per liter, and median level of fecal calprotectin decreased from 378 grams per gram (g/g) to 157 grams per gram). Among patients who had an Harvey Bradshaw Index greater than four, a level of C-reactive protein five milligrams per deciliter (mg/dL), a level of fecal calprotectin greater than 250 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 four), 22% had a normal level of C-reactive protein (less than five 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.

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.