Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease
Treatment: Continued Stelara, subcutaneous (SQ), 90 milligrams (mg), Every Four Weeks
The insurer denied the Stelara SQ 90 mg every four weeks.
The denial is overturned.

The patient is a female with moderate to severe Crohn's. She has failed mesalamine, steroids, azathioprine, Remicade, Humira, Cimzia and Entyvio. Approximately four years ago, she started Stelara 90 milligrams (mg) every eight weeks and did well until a year later, when due to active disease, Stelara was increased to 90 mg every six weeks. She did well until a year ago, when due to increased pain and active disease on colonoscopy and computed tomography enterography (CTE), Stelara was increased to 90 mg every four weeks. She has done well since that time. The attending physician (AP) is requesting to continue Stelara at 90 mg every four weeks.

Yes, the proposed treatment with Stelara 90 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 90 mg every four weeks. 

Results from a retrospective cohort study of patients with Crohn's disease reported that among 122 patients on ustekinumab, 21 patients (17% [percent]) on every eight weeks maintenance dosing required dose intensification (frequency increased to every four weeks, every six weeks, or a combination of 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 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 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 subcutaneous (SQ) 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 receiving ustekinumab demonstrated that, among 11 patients who required a dosing interval reduction (includes 90 mg SQ every eight weeks to every four weeks, 90 mg SQ 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 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 SQ every eight weeks. 

Therefore, as this patient has failed Stelara 90 mg every eight weeks and 90 mg every six weeks, and is doing well on Stelara 90 mg every four weeks, the requested Stelara 90 mg every four weeks is clinically appropriate, accepted standard of care and is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient.

As above, as the patient has failed standard dosing, and is doing well on the current dose, the health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient by denying it.