Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease
Treatment: Stelara 90MG/ML SC SOSY (dosed every four weeks), Pre-service
The denial is Stelara 90MG/ML SC SOSY (dosed every four weeks), Pre-service
The denial is overturned

The patient is a female with moderate to severe Crohn's. She has failed six-mercaptopurine (6-MP), steroids, Humira and Entyvio. She started Stelara 90 milligrams (mg) every eight weeks approximately two years ago, with some improvement, but still with evidence of active disease and ongoing symptoms. The attending physician (AP) is requesting to increase Stelara to 90 milligrams (mg) to every four weeks.

Yes, the proposed treatment with Stelara 90 milligrams (mg) every four weeks is medically necessary.
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 90mg 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, 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 nonresponders 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 (mg) 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 (SC) every eight weeks to every four weeks, 90 milligrams (mg) subcutaneous (SC) 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 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 (mg) subcutaneous (SC) every eight weeks. 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. 

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. Medical literature supports dose intensification prior to changing to another agent, when there has been some response. This patient has had some response to Stelara 90 milligrams (mg) every eight weeks, but still has evidence of active disease.  Therefore, the requested Stelara 90 milligrams (mg) every four weeks is clinically appropriate, accepted standard of care and medically necessary.

No, as Stelara 90 milligrams (mg) every four weeks is medically necessary, the health plan did not act reasonably, with sound medical judgment or in the best interest of the patient by denying it.