Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease
Treatment: Stelara 90mg Every 4 Weeks
The insurer denied the Stelara 90mg Every 4 Weeks.
The denial is overturned.

The patient is a female with fistulizing Crohn's disease. She is status post an ileo-colonic resection.

The patient has failed treatment with methotrexate, Prednisone, metronidazole and Humira. She started Stelara 90 mg (milligrams) every 8 weeks. On that dose, and on 90 mg (milligrams) every six weeks, she never achieved response, with rectal pain, mucus, bleeding and active fistula. She was changed to Stelara 90 mg (milligrams) every 4 weeks and has done well. Her provider is requesting continuation of Stelara 90 mg (milligrams) every 4 weeks.

Yes, the treatment with Stelara 90 mg (milligrams) every 4 weeks is medically necessary.
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 reinduction 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 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] 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 [tumor necrosis factor])-resistant CD (Crohn's disease) 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 (milligrams) SC (subcutaneous) every 8 weeks.

Therefore, as the patient has lost response to Stelara 90 mg (milligrams) every 8 weeks, and every 6 weeks, and has been doing well on 90 mg (milligrams) every 4 weeks, the requested Stelara 90 mg (milligrams) every 4 weeks is clinically appropriate, accepted standard of medical care, and is medically necessary.