Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease, unspecified without
complications
Treatment: Stelara SQ 90mg Every 4 Weeks, Pre-service
The insurer denied the Stelara SQ 90mg Every 4 Weeks, Pre-service
The denial is overturned.

The patient is a male with severe perianal and luminal Crohn's disease. He has failed Canasa, Asacol, Prednisone, 6-MP (mercaptopurine), Humira and Cimzia. He had some, but not a complete response to Stelara 90 mg (milligrams) every 8 weeks and 90 mg (milligrams) every 6 weeks. He has been on Stelara 90 mg (milligrams) every 4 weeks, with good results. His provider is requesting continuation of Stelara 90 mg (milligrams) every 4 weeks.

Yes, the treatment with Stelara 90mg (milligrams) every 4 weeks is medically necessary.
The patient has Crohn's disease, and he has lost response to Stelara 90 mg (milligrams) every 8 weeks, having symptoms 6 weeks after his injections.

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 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 [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) SC (subcutaneous) every 8 weeks.

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