Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal/Ulcerative Colitis
Treatment: Pharmacy/Prescription Drugs
The health plan denied the requested prescription medication, Stelara. 
The health plan's determination is overturned.

This is a review for the use of Stelara (Ustekinumab) to treat severe Ulcerative Colitis (UC). This patient has severe universal ulcerative colitis. She has previously tried and failed a tumor necrosis factor (TNF) agent (Infliximab). She was started on Stelara and initially responded but recently lost response as manifested by a flare of her UC and elevated inflammatory markers. Hence, the attending provider would like to escalate the dose of Stelara to 90mg SC (subcutaneous) every 4 weeks to treat this patient's severe ulcerative colitis.
At issue is the medical necessity for the requested prescription medication, Stelara.

I overturn, in whole, the health plan's determination of medical necessity.

Yes, the requested health service/treatment of Stelara 90mg is medically necessary for this patient. Dose escalation is considered the standard of care in patients with inflammatory bowel disease who are on a biological agent and are not responding to a standard dose of the medication.
Since this patient was not responding to standard dosing of Stelara, it is reasonable to increase the dose of Stelara to 90mg every 28 days (4 weeks). Dose escalation in biologic therapy used in inflammatory bowel disease can be done based on clinical symptoms and signs or therapeutic drug monitoring by either increasing or shortening the interval infusions, or sometimes a combination of both.
Dose escalation in Stelara for Crohn's disease is well established in the medical literature. The medication was only approved for UC a little over two years ago. Ollech and colleagues showed that shortening the Ustekinumab 90 mg dose interval to 4 weeks for patients with Crohn's disease 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. Similarly, Kopylov and colleagues showed that intensification of Ustekinumab maintenance dosage was effective in over 50% of the patients with Crohn's disease who were not responding to standard dosing. This strategy should be considered in patients who are nonresponsive to every 8 weeks Ustekinumab maintenance dosing. Meserve and colleagues showed that in real world settings, Ustekinumab dose escalation was effective in achieving a response in patients with Crohn's disease with inadequate response, or loss of response to standard dose induction and/or maintenance therapy. A retrospective cohort study by Dalal and colleagues showed that Ustekinumab dose intensification seems to be safe and effective for patients with UC. This strategy may be more effective among patients with loss of response to dosing every 8 weeks rather than those with no response after induction.
The use of Stelara at the escalated dose of 90g mg SC every 4 weeks to treat this patient's severe Ulcerative Colitis is medically necessary.