Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease
Treatment: Stelara 90mg/ml Syringe 1 For 28 Days
The insurer denied the Stelara 90mg/ml Syringe 1 For 28 Days.
The denial is overturned.

The patient is a male with ileo-colonic Crohn's diagnosed several years prior. He started Stelara 90 mg (milligrams) every 8 weeks. He did well for almost four years. Earlier this year, he started having increased symptoms of abdominal pain and diarrhea 1-2 weeks before his infusion. Colonoscopy revealed active ileitis and proctocolitis. His provider is requesting to increase Stelara to 90 mg (milligrams) 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 (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 nonresponders 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 reinduction and dose escalation was required in 6.7% (7/104) of patients. The most common escalated maintenance dosing was 90 mg (milligrams) 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 (Crohn's disease) receiving ustekinumab, demonstrated that, among 11 patients who required a dosing interval reduction (includes 90 mg [milligrams] every 8 weeks to every 4 weeks, 90 mg [milligrams] 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) every 8 weeks.

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 this patient had some, but not a complete response to Stelara 90 mg (milligrams) every 8 weeks, with breakthrough symptoms before his 8 week injection, and active disease on colonoscopy, the requested Stelara 90 mg (milligrams) every 4 weeks is clinically appropriate, accepted standard of medical care, and medically appropriate, and should be covered by the health plan.

Medical literature supports dose intensification of biologics prior to changing to another agent. As this patient has had a good response to Stelara, the requested increase to 90 mg (milligrams) every 4 weeks is more beneficial than any standard treatment for the insured's condition, such as changing to another biologic.