Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Ulcerative colitis.
Treatment: Stelara 90mg/ml Every 4 Weeks, Pre-service.
The insurer denied the Stelara 90mg/ml Every 4 Weeks, Pre-service.
The denial is overturned.

The patient is a female with moderate to severe ulcerative colitis. She has failed mesalamine, Prednisone, Remicade and Entyvio. She had some, but not complete, response to Stelara 90 mg (milligrams) every 8 weeks. Her provider is requesting to increase Stelara to 90 mg (milligrams) every 4 weeks.

Yes, the health plan should cover the requested Stelara every four weeks.
Medical literature supports the use of Stelara as being safe and effective in children under the age of 18. This patient has failed anti-TNFs (tumor necrosis factors) and Entyvio, and has had some response to Stelara. 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 (milligrams) every 4 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 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 (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 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 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 [milligrams] SC [subcutaneous] every 8 weeks to every 4 weeks, 90 mg [milligrams] SC [subcutaneous] every 8 weeks to every 6 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 followup, dose escalation was required in 35% (7/20) of patients who received ustekinumab 90 mg (milligrams) SC (subcutaneous) every 8 weeks.

While the studies were all done in patients with Crohn's disease, as Stelara is FDA (United State 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 4 weeks, and as the patient had some, but not a complete response to Stelara 90 mg (milligrams) every 8 weeks, the requested Stelara 90 mg (milligrams) every 4 weeks is clinically appropriate and accepted standard of medical care and should be covered by the health plan.

Yes, the treatment with Stelera every four weeks is likely to be more beneficial.
The patient has failed anti-TNFs (tumor necrosis factor) and Entyvio. The only FDA (United Food and Drug Administration)-approved medication that she has not failed is Xeljanz, but that has not been shown to be safe in pediatric patients. As Stelara has been shown to be safe in patients under age 18, and as medical literature supports dose intensification prior to changing to another agent, the requested Stelara 90 mg (milligrams) every 4 weeks is more beneficial than any standard treatment for the insured's condition.