Diagnosis: Crohn's Disease.

Treatment: Stelara to treat Crohn's disease.

The insurer denied coverage for Stelara to treat Crohn's disease.

The denial is overturned.

This is a female patient who has Crohn's Disease. She had been treated with Stelara every 8 weeks. A colonoscopy showed active colitis. Her doctor advised decreasing the Stelara interval to every 4 weeks. The physician has provided an article that was submitted to the Congress of the European Crohn's and Colitis Organization in March 2019 titled "Optimization helps patients with Crohn's recapture Stelara response." The study looked at patients with active Crohn's disease on Stelara every 8 weeks. The dose was escalated to every 4 weeks and 57% of patients had a successful clinical response.

Clinical Gastroenterology and Hepatology 2021 Jan 19(1): 104-110 has an article titled "Effectiveness of Ustekinumab Dose Escalation in Patients with Crohn's Disease." The conclusion was that shortening the ustekinumab 90 milligrams (mg) dose to 4 weeks in patients with Crohn's disease, who did not respond to doses every 8 weeks, improved clinical and biological indices of disease activity. Patients who love response to the standard dose of ustekinumab might benefit from dose interval shortening which was effectiveness and safe.

The medical literature supports the use of Stelara at 4 week intervals. It is a medically necessary treatment. The healthcare plan did not act reasonably or in the best interest of the patient.

The insurer's denial of coverage for Stelara to treat Crohn's disease is overturned. Medical necessity is substantiated.