Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Stelara (ustekinumab). 
The denial is overturned.

This is a male patient, who has severe structuring Crohn's disease and has had a prior bowel obstruction. He has tried and failed two anti-tumor necrosis factor (TNF) agents (infliximab and adalimumab). He has had recent hospitalizations for flare of his Crohn's disease that required steroids. Imaging studies showed stricture and abscesses. Because of his prior exposure to anti-TNF agents the attending provider would like to start him on Stelara to treat his severe Crohn's disease since it has a different mechanism of action.
At issue is the medical necessity of Stelara (ustekinumab).

The health plan's determination of medical necessity is overturned in whole.

The requested health service/treatment of Stelara (ustekinumab) is medically necessary for this patient.
Since this patient has been treated with two anti TNF agents (infliximab and adalimumab) in the past, it is appropriate to start him on a biological agent with a different mechanism of action. Crohn's disease results from a pathological immune response to luminal antigens in genetically predisposed individuals. Since the causes of Crohn's disease are complex and only partially understood, treatment is based on the empiric use of anti-inflammatory drugs. Although multiple therapies for Crohn's disease currently exist, a substantial proportion of patients are unresponsive to conventional agents. Approximately a third of patients fail treatment with TNF antagonists, and up to 40 percent (%) of patients who initially benefit subsequently lose response. Ustekinumab, has emerged as a promising new treatment for both psoriasis and Crohn's disease. Clinical efficacy of ustekinumab in Crohn's disease was evaluated for the treatment of moderate to severe Crohn's disease in a randomized, placebo-controlled trial that included 104 patients. In this study, ustekinumab was given subcutaneously (90 milligrams [mg]) or intravenously (IV) (4 or 5 mg/kilogram [kg]). There were 2 Crohn's disease populations: the first comprised patients who had previously received conventional or biologic therapy (population 1), and the second comprised patients who did not respond to infliximab (population 2). In the first population, compared with placebo, ustekinumab groups showed a higher rate of clinical response at week 4 as evaluated by the Crohn's Disease Activity Index. The authors concluded that the ustekinumab response was more evident in patients who had previously received infliximab. Another trial evaluated the clinical efficacy of ustekinumab in patients with Crohn's Disease resistant to TNF-alpha inhibitors. Maintenance therapy resulted in a significantly increased rate of clinical remission and response in the ustekinumab group compared with placebo. These results demonstrated the clinical efficacy of ustekinumab as induction therapy in Crohn's disease resistant to TNF-alpha inhibitors. Furthermore, patients who initially responded to ustekinumab also had significantly increased rates of response to this treatment when given as maintenance therapy. Ustekinumab offers a treatment option to Crohn's disease patients who have never responded to infliximab, primary non-responders, as well as patients who have attenuated anti-TNF response or become intolerant to anti-TNF therapy. One third of anti-TNF naive patients are primary non responders. Approximately one third of initial anti-TNF responders lose response or become intolerant over time, secondary non-responders, requiring dose escalation or switching to another anti-TNF agent. Typically, response rates among anti-TNF naive patients are higher than response rates among secondary nonresponders who switch within the anti-TNF class.
Therefore, Stelara (ustekinumab) is medically necessary to treat this patient's Crohn's disease.