Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's disease. 
Treatment: Stelara 90mg (milligrams) Every 4 Weeks, Pre-service. 

The insurer denied the Stelara 90mg (milligrams) Every 4 Weeks, Pre-service.  The denial is overturned. 

The patient is a female with Crohn's disease. She has failed budesonide and Humira, and was started on Stelara 90 mg (milligrams) every eight weeks, with some but not a complete response. She started having symptom increase prior to her Stelara injection. She recently was hospitalized with an SBO (small bowel obstruction), felt to be related to active Crohn's. Her fecal calprotectin was elevated. Her provider is requesting an increase of Stelara dosing to 90 mg (milligrams) every four weeks. 

Yes, Stelara 90 mg (milligrams) every four 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 four 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 eight week maintenance dosing required dose intensification (frequency increased to every four weeks, every six weeks, or a combination of IV [intravenous] booster and frequency increase to every six weeks or every four weeks). 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 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) of 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 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 CD (Crohn's disease) receiving ustekinumab, demonstrated that, among 11 patients who required a dosing interval reduction (includes 90 mg [milligrams] SC [subcutaneous] every eight weeks to every four weeks, 90 mg [milligrams] SC [subcutaneous] every eight weeks to every six 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 eight weeks. 

Therefore, given the above, as the patient has lost response to Stelara 90 mg (milligrams) every eight weeks, the requested drug Stelara 90 mg (milligrams) every four weeks is medically necessary. 

As above, as the patient has failed Stelara 90 mg (milligrams) every eight weeks. and as medical literature supports the higher dose, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.