Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease
Treatment: Prescription drug, Stelara at a dose of 90 milligrams every 4 weeks for a diagnosis of Crohn's Disease
The insurer denied coverage for the prescription drug, Stelara at a dose of 90 milligrams every 4 weeks for a diagnosis of Crohn's Disease.
The denial is overturned. 

This is a male patient with a past medical history of Crohn's Disease, Crohn's Ileocolitis, anemia, and gastroesophageal reflux disease. He was placed on a tapering dose of prednisone at an office visit, as he was having abdominal pain. He was on 5 milligrams of prednisone daily. He was only having 2 bowel movements per day.  

The patient had started utilizing Stelara 90 milligrams. The patient had been on Remicade in the past but developed antibodies to this. He was then placed on Cimzia but this was stopped because of progressive disease. He had been on Entyvio but this had to be stopped because he had low drug levels despite being on Entyvio every 4 weeks. The patient was status post right hemicolectomy with resection of the terminal ileum and temporary ileostomy. The patient had a colonoscopy revealing localized erythema in the distal neoterminal ileum. The magnetic resonance (MR) enterography showed acute inflammation involving multiple loops of the proximal small bowel. Acute and chronic inflammation was identified. The treatment plan included continuation of Stelara 90 milligrams every 8 weeks and to decrease the interval if the drug levels were low. Laboratory results noted the drug level was low. The patient underwent a computed tomography (CT) scan of the abdomen revealing active Crohn's Disease of the small bowel. There was circumferential mural thickening along a segment of the small bowel. He had multiple prominent mesenteric lymph nodes. The patient's provider recommended the interval of Stelara injections be decreased to every 4 weeks in hopes of putting him into remission and maintaining remission; indicating this in turn could decrease future hospital admissions and the potential need for repeat surgery.

Scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes. The prescription drug, Stelara at a dose of 90 milligrams every 4 weeks for a diagnosis of Crohn's Disease does not have final approval from the appropriate regulatory bodies for this diagnosis at this dosing. However, this patient is a good candidate for the prescription drug, Stelara at a dose of 90 milligrams every 4 weeks for a diagnosis of Crohn's Disease. The prescription drug, Stelara at a dose of 90 milligrams every 4 weeks for a diagnosis of Crohn's Disease is the best available treatment for this patient at this time.

The patient has complicated Crohn's Disease requiring surgery and is currently uncontrolled. He has failed other biologic agents and Stelara levels at the Food and Drug Administration (FDA) approved dose are very low. According to the guidelines, the next step is to increase the dose of Stelara before considering switching to another medication. 

The carrier's denial of the prescription drug, Stelara at a dose of 90 milligrams every 4 weeks for a diagnosis of Crohn's Disease should be overturned, as the requested dose interval is likely to be more beneficial than any other standard treatment.