Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Ulcerating (chronic) Pancolitis. 
Treatment: Stelara SQ 90mg (every 6 weeks). 

The insurer denied the Stelara SQ 90mg (every 6 weeks). 
The denial is overturned. 

The patient is a female with moderate to severe ulcerative colitis status post colectomy. She has failed asacol, 6-MP(mercaptopurine) and Humira, and had some, but not a complete response to Stelara 90 mg (milligrams) every 8 weeks, with some ongoing symptoms as well as active disease on pouchoscopy. Her provider requesting to increase Stelara to 90 mg (milligrams) every 6 weeks. 

Yes, the requested Stelara every 6 weeks is medically necessary. 

Stelara was denied coverage by the health plan, as the dose of 90mg (milligrams) every 6 weeks is higher than the Food and Drug Administration Association (FDA) approved dose. However, 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 (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) (1). 

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 reinduction and dose escalation was required in 6.7% (7/104) of patients. The most common escalated maintenance dosing was 90mg (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 (3). 

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 90mg (milligrams) every eight weeks to every four weeks, 90mg (milligrams) 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 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 90mg (milligrams) every eight weeks. 

While the studies were all done in patients with Crohn's disease, as Stelara is FDA (United States Food and Drug Administration) 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 failed Stelara 90mg (milligrams) every eight weeks, with evidence of ongoing active diease on pouchoscopy. Therefore, an increase to the requested Stelara 90mg (milligrams) every 6 weeks is clinically appropriate, accepted standard of medical care, and is medically necessary.

No, as Stelara 90 mg (milligrams) every 6 weeks is medically necessary, the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient by denying it.