Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn' s Disease
Treatment: Stelara 90 milligrams/milliliter (mg/ml) Syringe, Preservice, one for 28 days
The insurer denied the request for Stelara 90 milligrams/milliliter (mg/ml) Syringe, Preservice, one for 28 days
The denial is overturned. 

The patient is an adult male with moderate to severe fistulizing Crohn's.  He has failed Remicade and Humira, and started Stelara 90 milligrams (mg) every eight weeks    He began having increased abdominal pain and diarrhea four weeks before his injection. His C-reactive protein (CRP) was elevated. Stelara was increased to 90 milligrams (mg) every four weeks.  His symptoms have improved since that time.  The attending physician is requesting to continue Stelara at 90 mg every four weeks.

Yes, Stelara (ustekinumab) 90 milligrams/milliliter (mg/ml) Syringe, one for 28 days is medically necessary.

Medical literature supports dose intensification of biologics in patients who lose response to Food and Drug Administration (FDA) approved dosing.  Stelara (ustekinumab) has been found to be safe and effective at doses as high as 90 milligrams every four weeks.

Results from a retrospective cohort study of patients with Crohn's disease (CD) reported that among 122 patients on ustekinumab, 21 (17%) patients on every eight week maintenance dosing required dose intensification (frequency increased to every four weeks [n=11], every six weeks [n=5], or a combination of intravenous booster and frequency increase to every six weeks or every four weeks [n=5]).  A total of 11 patients (52%) had clinical response after dose escalation (two [18%] were primary non-responders to induction while nine [82%] had poor initial clinical response).

A multicenter, retrospective, open-label cohort study of adults with moderate to severe Crohn's disease (CD) 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 milligrams subcutaneous (SC) every four or six 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 Crohn's disease (CD) receiving ustekinumab, demonstrated that, among 11 patients who required a dosing interval reduction (includes 90 milligrams subcutaneous every eight weeks to every four weeks [n=8], 90 milligrams subcutaneous every eight weeks to every six weeks [n=1]), 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 Crohn's disease (CD) 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 milligrams subcutaneous every eight weeks. 

Therefore, as dose intensification of Stelara in patients with inflammatory bowel disease (IBD) has been found to be safe and effective at doses as high as 90 milligrams (mg) every four weeks, and as this patient had some, but not a complete response to Stelara 90 milligrams every eight weeks with breakthrough symptoms four weeks before his next injection, the Stelara 90 milligrams/milliliter (mg/ml) Syringe, one for 28 days is clinically appropriate, accepted standard of medical care, and is medically necessary.