Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ulcerative colitis.
Treatment: Stelara SQ 90mg every four weeks.
The insurer denied the Stelara SQ 90mg every four weeks.
The denial is upheld. 

The patient is a female with ulcerative colitis. She has failed Remicade. She was started on Stelara 90 milligrams (mg) every eight weeks 4 months ago, and had an initial response. She presented approximately 3 months later with increased blood, mucus, urgency, diarrhea and incontinence. The attending physician (MD) is requesting to increase Stelara to 90 milligrams every four weeks.

No, the proposed Stelara 90 milligrams (mg) every four weeks is not medically necessary.
Medical literature supports dose intensification of biologics in patients who lose response to Food and Drug Administration (FDA) approved dosing. Stelara has been found to be safe and effective at doses as high as 90 milligrams every four weeks. 

Results from a retrospective cohort study of patients with Chron's disease (CD) reported that among 122 patients on ustekinumab, 21 (17%) patients on every eight week maintenance dosing required dose intensification (frequency increased to every four weeks, every six weeks, or a combination of intravenous (IV) booster and frequency increase to every six weeks or every four weeks). A total of 11 patients (52%) had clinical response after dose escalation, two patients [18%] were primary nonresponders to induction while nine [82%] had poor initial clinical response). 

A multicenter, retrospective, open-label cohort study of adults with moderate to severe Chron's disease was conducted to evaluate the long-term maintenance efficacy of ustekinumab therapy. During the maintenance therapy, dose escalation was required in 16.3% (17/104) patients and a combination strategy of reinduction and dose escalation was required in 6.7% (7/104) of patients. The most common escalated maintenance dosing was 90 milligrams subcutaneous every four or six weeks. Clinical response was regained in 52.9% (9/17) of patients who had dose escalation, and 57.1% (4/7) of patients who had combined reinduction and dose escalation. 

Results from a retrospective, multicenter, open-label study of patients with refractory Chron's disease receiving ustekinumab, demonstrated that, among 11 patients who required a dosing interval reduction (includes 90 milligrams subcutaneous every eight weeks to every four weeks, 90 milligrams subcutaneous every eight weeks to every six weeks), clinical improvement was seen in 73% (8/11) of patients. 

Results from a retrospective, open-label, observational study of ustekinumab for the treatment of anti-tumor necrosis factor (anti-TNF) resistant Chron's disease patients, demonstrated that, among patients who achieved clinical response at the last follow-up, dose escalation was required in 35% (7/20) of patients who received ustekinumab 90 milligrams subcutaneous every eight weeks. Dose intensification of Stelara in patients with inflammatory bowel disease (IBD) has been found to be safe and effective at doses as high as 90 milligrams every four weeks.  

While the studies were all done in patients with Crohn's disease, as Stelara is Food and Drug Administration (FDA) approved for use in ulcerative colitis, the premise is the same, and such dose intensification of Stelara in ulcerative colitis is widely used and accepted by gastroenterologists. This patient had response to Stelara 90 milligrams every eight weeks, however, but has had a recurrence of symptoms. She has not tried and failed Stelara 90 milligrams every six weeks. As an increase in Stelara to 90 milligrams every six weeks may be beneficial for the patient, the requested Stelara 90 milligrams every four weeks is not clinically appropriate or accepted standard of care, and is not medically necessary at this time.

As the patient has not failed Stelara 90 milligrams every six weeks, the health plan acted reasonably, with sound medical judgment and in the best interest of the patient.