Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Ulcerative Colitis
Treatment: Stelara (every 4 weeks), Pre-service
The insurer denied the Stelara (every 4 weeks), pre-service.
The denial is overturned.

The patient is a male with moderate to severe ulcerative colitis (UC). He has failed mesalamine, Remicade and Entyvio, and started Stelara 90 mg (milligrams) every 8 weeks. He had some, response, but recently was noted to have ongoing symptoms and elevated fecal calprotectin. His provider is requesting to increase Stelara to 90 mg every 4 weeks.

Yes, the health plan should cover the Stelara every 4 weeks.

Medical literature supports dose intensification of biologics in patients who lose response to FDA (United States Food and Drug Administration) approved dosing. Stelara has been found to be safe and effective at doses as high as 90 mg every 4 weeks.

Results from a retrospective cohort study of patients with CD (Crohn's disease) reported that among 122 patients on ustekinumab, 21 patients (17% [percent]) on every 8 week maintenance dosing required dose intensification (frequency increased to every 4 weeks, every 6 weeks, or a combination of IV [intravenous] booster and frequency increase to every 6 weeks or every 4 weeks). A total of 11 patients (52%) had clinical response after dose escalation (2 [18%] were primary non-responders to induction while 9 [82%] had poor initial clinical response).

A multicenter, retrospective, open-label cohort study of adults with moderate to severe CD 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 mg every 4 or 6 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 CD receiving ustekinumab demonstrated that, among 11 patients who required a dosing interval reduction (includes 90 mg every 8 weeks to every 4 weeks [n=8], 90 mg every 8 weeks to every 6 weeks [n=1]), 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-TNF (tumor necrosis factor) resistant CD 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 every 8 weeks.

While the studies were all done in patients with CD, as Stelara is FDA-approved for use in UC, the premise is the same, and such dose intensification of Stelara in UC is widely used and accepted by gastroenterologists. Therefore, as the patient has lost response to Stelara 90 mg every 8 weeks, the requested Stelara 90 mg every 4 weeks is clinically appropriate and accepted standard of medical care.

Yes, Stelara every 4 weeks is more beneficial.

As the patient has failed anti-TNFs (Remicade and Entyvio), and has had some response to Stelara, dose intensification to 90 mg every 4 weeks is more beneficial than any standard treatment for the insured's condition or disease.