Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal-Crohn's Disease
Treatment: Pharmacy/Prescription Drugs-Stelara 90mg every 6 weeks
The health plan denied the prescription for Stelara 90 milligrams (mg) every 6 weeks as not medically necessary.
The denial is overturned

This is a review for the use of Stelara (ustekinumab) to treat severe Crohn's disease (CD). This patient has severe ileocolonic Crohn's disease. She has previously tried and failed two anti-tumor necrosis factor (TNF) alpha agents (infliximab and adalimumab). She has also tried and failed an anti-integrin agent (vedolizumab) as well as steroids and an immunomodulator ((mercaptopurine) 6-MP). She was started on Stelara at standard dosing and was initially doing well but recently started losing response. She had symptoms suggestive of a flare of her Crohn's disease 6 weeks after her scheduled injection. Therefore, the attending provider would like to escalate the dose of Stelara to 90 milligrams (mg) every 6 weeks to treat her severe Crohn's disease. 
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 6 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. This patient has medically refractory Crohn's disease and has tried and failed every other Food and Drug Administration (FDA) approved biological agent used to treat Crohn's disease. There are only a finite number of biological agents used to treat inflammatory bowel disease and the standard of care is to optimize dose before switching to another agent. Therefore, it is medically necessary to use Stelara 90mg subcutaneous (SC) every 6 weeks to treat this patient's severe Crohn's disease.
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. The authors concluded that the ustekinumab response was more evident in patients who had previously received infliximab. 
Ollech and colleagues showed that shortening the ustekinumab 90 mg dose interval to 4 weeks for patients with CD who did not respond to doses every 8 weeks improved clinical and biological indices of disease activity. Patients who lose response to the standard dose of ustekinumab might benefit from dose interval shortening, which was effective and safe.