Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Ulcerative Colitis
Treatment: Stelara 90 milligrams every four weeks
The insurer denied the Stelara 90 milligrams every four weeks.
The denial is overturned. 

The patient is a male with ulcerative colitis. He has failed 6-MP (mercaptopurine) and prednisone, and started Stelara. He had some response, but after a few weeks, he started having increased symptoms. His provider is requesting to increase Stelara to 90 mg (milligrams) every four weeks.

Yes, the treatment with Stelara every four weeks is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient by denying Stelara 90 mg (milligrams) every four weeks.

Medical literature supports dose intensification of biologics in patients who lose response to FDA (Food and Drug Administration)-approved dosing. Stelara has been found to be safe and effective at doses as high as 90 mg (milligrams) every four weeks.

Results from a retrospective cohort study of patients with CD (Crohn's disease) 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 [n=11], every six weeks, or a combination of IV (intravenous) booster and frequency increase to every six weeks or every four weeks). A total of 11 patients (52%) had clinical response after dose escalation (2 [18%] were primary non-responders to induction while nine [82%] had poor initial clinical response).

A multicenter, retrospective, open-label cohort study of adults with moderate to severe CD (Crohn'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 re-induction and dose escalation was required in 6.7% (7/104) of patients. The most common escalated maintenance dosing was 90 mg (milligrams) SC (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 re-induction and dose escalation.

Results from a retrospective, multicenter, open-label study of patients with refractory CD (Crohn's disease) receiving ustekinumab, demonstrated that, among 11 patients who required a dosing interval reduction (includes 90 mg SC [subcutaneous] every eight weeks to every four weeks, 90 mg (milligrams) SC [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 CD (Crohn'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 mg (milligrams) SC (subcutaneous) every eight weeks.

While the studies were all done in patients with Crohn's disease, as Stelara is FDA (Food and Drug Administration) 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. Therefore, as dose intensification of Stelara in patients with IBD (inflammatory bowel disease) has been found to be safe and effective at doses as high as 90 mg (milligrams) every four weeks, the requested Stelara 90 mg (milligrams) every four weeks is medically necessary.