Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Ulcerative Colitis. 
Treatment: Stelara 90mg/mL Syringe. 

The insurer denied the Stelara 90mg/mL Syringe. 
The denial is overturned. 

The patient is a male with severe ulcerative colitis. He has failed mercaptopurine (6-MP), Humira, Remicade and Entyvio. Earlier this year, the patient was started on Stelara 90 milligrams (mg) every eight weeks. One month later, the patient had increased diarrhea and bleeding. Serum Stelara level was low at 5.7 without antibodies. He continues to have ongoing evidence of active disease. The physician (MD) is requesting to increase Stelara to 90 milligrams (mg) every four weeks. 

Yes, the health plan should cover the proposed Stelara 90 milligrams every four weeks.
Medical literature supports dose intensification of biologics in patients who lose response to Food and Drug Administration (FDA) approved dosing. Stelara 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, every six weeks, or a combination of intravenous (IV) 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 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 [mg] subcutaneous (SC) every eight weeks to every four weeks, 90 milligrams 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) resistant Crohn's diease (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 (SC) every eight weeks. 

While the studies were all done in patients with Crohn's disease, as Stelara is Food and Drug Administration (FDA) approved for use in ulcerative colitis, the premise is the same, and such dose intensification of Stelara in ulcerative colitis is widely used and accepted by gastroenterologists. Therefore, as dose intensification of Stelara in patients with inflammaotry bowel disease (IBD) has been found to be safe and effective, and as the patient has had some response to Stelara 90 milligrams (mg) every eight weeks, and did not respond to two anti-tumor necrosis factors (TNFs) or Entyvio, increasing the patient's dose/frequency (beyond Food and Drug Administration labeling) is recommended by clinical practice guidelines over switching to other guideline-supported options, and the health plan should cover the proposed Stelara 90 milligrams every four weeks. 

Yes, the requested health service or treatment is more beneficial than any standard treatment for the patient's condition. 

Stelara 90 milligrams every four weeks is more beneficial than any standard treatment for this patient, as the patient has failed two anti-tumor necrosis facctors (TNFs), Entyvio and Stelara 90 milligrams every eight weeks.