Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Ulcerative Colitis.
Treatment: Stelara 90mg/ml Syringe at A Dose of 1 Syringe Every 4 weeks.
The insurer denied the Stelara 90mg/ml Syringe at A Dose of 1 Syringe Every 4 weeks.
The denial is overturned.

The patient is a female with moderate to severe ulcerative colitis. She has failed mesalamine, methotrexate and steroids, and has had some, but not a complete response to Stelara 90 mg (milligrams) every 8 weeks, with low serum levels and evidence of ongoing active disease. Her provider is requesting to increase Stelara to 90 mg (milligrams) every 4 weeks. Stelara was denied, as the dose is higher than the FDA (United States Food and Drug Administration) approved dose of 90 mg (milligrams) every 8 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. c

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-tumor necrosis factor) 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.

While the studies have all been done in patients with Crohn's disease, as Stelara was only recently approved for use in ulcerative colitis, the findings are extrapolated to both conditions. 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.

This patient has improved, but still has failed Stelara 90 mg (milligrams) every 8 weeks, with low drug levels. Therefore, increasing the patient's dose/frequency (beyond FDA [United States Food and Drug Administration] labeling) is recommended by clinical practice guidelines over switching to another biologic, and the requested Stelara 90 mg (milligrams) every 4 weeks is clinically appropriate, accepted standard of care, and medically appropriate, and the health plan should cover it.

Yes, as per the rationale in question 1, the requested Stelara 90 mg (milligrams) every 4 weeks is more beneficial than any standard treatment for the insured's condition or disease.