Appeal type: Medical necessity
Decision: Overturned

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

This is a male patient who has severe ileocolonic Crohn's disease. He has previously tried and failed steroids. He was started on Stelara and initially did well on Stelara at standard dosing every 8 weeks but lost response recently as manifested with a flare of his Crohn' disease.
A computed tomography (CT) scan of the abdomen showed active inflammation in the proximal colon and distal ileum. A colonoscopy showed active inflammation on the ileocecal valve with stricture and rectal inflammation. Therefore, the attending provider is recommending an escalated dose of Stelara 90 milligrams (mg) subcutaneous (SC) every 4 weeks to treat this patient's severe Crohn's disease.
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 was not responding to standard dosing of Stelara, it is reasonable to increase the dose of Stelara to 90mg every 4 weeks. Dose escalation in biologic therapy used in inflammatory bowel disease can be done either based on clinical symptoms or laboratory markers or endoscopic or radiological features with or without therapeutic drug monitoring. Dose escalation is done either by increasing the dose of the medication or shortening the interval between doses or sometimes a combination of both. There are only a finite number of biological agents used to treat inflammatory bowel disease and the standard of care is to optimize the dose of the biological agent before switching to another agent.
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 tumor necrosis factor (TNF) antagonists, and up to 40% (percent) of patients who initially benefit subsequently lose response. Ustekinumab (Stelara), 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 or intravenously (IV). 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. 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.
Meserve and colleagues showed that in real world settings, ustekinumab dose escalation was effective in achieving response in patients with CD with inadequate response, or loss of response to standard dose induction and/or maintenance therapy. In addition, dose escalation in patients with inflammatory bowel disease (IBD) who are on biological therapy and who are not responding to the standard dose of the medication is a well-established practice based on current evidence and standard of care.
Therefore, the requested health service/treatment of Stelara is medically necessary.