Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease 
Treatment: Stelara 
The insurer denied Stelara. 
The denial is overturned. 

This is a female patient who has severe Crohn's disease and has had a prior bowel resection. She has tried and failed two anti-tumor necrosis factor (TNF) agents (adalimumab and infliximab). She had a recent hospitalization due to a flare of her Crohn's disease. Because of prior exposure to two anti-TNF agents, the attending provider would like to start her on Stelara to treat her severe Crohn's disease since it has different mechanism of action. 

At issue is the medical necessity of Stelara. 

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

The requested health service/treatment of Stelara is medically necessary for this patient.

Since this patient has been treated with two anti-TNF agents in the past, it is appropriate to start her on a biological agent with a different mechanism of action. Therefore, Stelara is medically necessary to treat this patient's Crohn's disease. According to current guidelines, in adult outpatients with moderate to severe Chron's disease (CD) who never responded to anti-TNF (primary nonresponse), the American Gastroenterological Association (AGA) recommends the use of ustekinumab (Stelara) and suggests the use of vedolizumab over no treatment for the induction of remission. Multiple studies have shown that ustekinumab is superior to vedolizumab in patients who have failed anti-TNF therapy. Manlay and colleagues showed that ustekinumab was more effective to achieve early and long-term effectiveness than vedolizumab in Crohn's disease patients who previously failed response to anti-TNF agents. Biemans and colleagues showed that ustekinumab was associated with superior effectiveness outcomes when compared to vedolizumab, while safety outcomes were comparable after 52 weeks of treatment in CD patients who have failed anti-TNF treatment. Alric and colleagues showed that ustekinumab is associated with a higher rate of clinical remission and treatment persistence than vedolizumab after 48 weeks of follow-up, in patients with CD refractory or intolerant to anti-TNF. 

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. Ustekinumab 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 mg [milligrams]) or intravenously (IV) (4 or 5 mg/kg [milligrams per kilogram]). The authors concluded that the ustekinumab response was more evident in patients who had previously received infliximab. 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, the requested health service/treatment of Stelara is medically necessary for this patient.