Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease
Treatment: Stelara (dosed every four weeks)
The insurer denied the Stelara (dosed every four weeks).
The denial is overturned.

The patient is a female with moderate to severe Crohn's. She was started on Stelara 90 milligrams (mg) every 8 weeks last year with good results, and five months later, she started experiencing breakthrough symptoms. Serum Stelara level was normal at 5.9. Colonoscopy revealed ongoing active disease. Stelara was increased to 90 mg every 4 weeks, and the patient has done well since that time. Her physician is requesting to continue Stelara at 90 mg every 4 weeks.

The proposed Stelara 90 mg every 4 weeks is medically necessary.
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 every 4 weeks. Results from a retrospective cohort study of patients with CD (Chrohn'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 (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 mg 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 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 SC (subcutaneous) every 8 weeks to every 4 weeks, 90 mg 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 SC (subcutaneous) every 8 weeks. Dose intensification of Stelara in patients with IBD (irritable bowel disease) has been found to be safe and effective at doses as high as 90 mg every 4 weeks. This patient had lost response to 90 mg every 8 weeks, with low serum drug levels and ongoing active disease on colonoscopy. She has improved on Stelara 90 mg every 4 weeks. Therefore the requested Stelara 90 mg every 4 weeks is clinically appropriate and accepted standard of medical care.

Dose intensification of Stelara in patients with IBD (irritable bowel disease) has been found to be safe and effective at doses as high as 90 mg every 4 weeks. This patient had lost response to 90 mg every 8 weeks, with low serum drug levels and ongoing active disease on colonoscopy. She has improved on Stelara 90 mg every 4 weeks. Therefore the requested Stelara 90 mg every 4 weeks is clinically appropriate and accepted standard of medical care, and the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient by denying it.