Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease
Treatment; Stelara
The insurer denied Stelara (90 mg every 6 weeks). The health plan's determination is upheld. 

The patient is a male with fistulizing Crohn's disease (CD). His disease course has been complicated by multiple fistulas and an intra-abdominal abscess. The patient was on anti- tumor necrosis factor (TNF) therapy; however, this failed because of the development of antibodies. He has been on Stelara. Right after starting, he needed multiple additional surgeries including repair of an entero-cutaneous fistula. On a recent colonoscopy, there was evidence of active disease. The patient is experiencing right sided abdominal pain, urgency and diarrhea. Recent MRE (magnetic resonance elastography) was unremarkable for active disease as was a limited flex sigmoidoscopy. A recent trough level of Stelara was 4.0 which is below the target threshold of 4.5.
The patient's provider has recommended treatment with Stelara at 90 milligrams (mg) Q (every) 6 weeks. 

Stelara (90 mg every 6 weeks) is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The best data for the relationship between Stelara drug levels comes from Adedokun, et al. In their analysis of data from Phase 3 studies of patients with moderate to severe CD, they found serum concentrations of ustekinumab to be proportional to dose and was associated with treatment efficacy. Trough concentrations of ustekinumab up to 1.4 or greater were associated with maintenance of clinical remission in a higher proportion of patients than patients with lower trough concentrations. In a more recent study by Battat et al, the investigators found that a higher level of ustekinumab was associated with efficacy. Patients received 90 milligrams (mg) of ustekinumab subcutaneously at weeks 0, 1, and 2 during induction and 90 mg every 4 or 8 weeks during maintenance. The authors found that the mean trough concentration of ustekinumab at week 26 was higher in patients with an endoscopic response than without. An optimal ustekinumab threshold trough concentration at week 26 or later was found to be 4.5 (area under the curve, 0.67). A greater proportion of patients with trough concentrations of ustekinumab above 4.5 at week 26 or later had an endoscopic response (75.9% [percent]) than did patients with trough concentrations below this level. Patients with trough concentrations of ustekinumab above 4.5 at week 26 or later also had a lower mean level of C-reactive protein (CRP) (12.6) than did patients with trough concentrations below this level.
In this specific patient, the level is very close to 4.5. In addition, there is evidence of minimally active luminal disease (2 small ulcerations in the neo-terminal ileum) and the most recent CRP was normal. It would be expected that the benefit of Q6 week dosing over Q 8 week dosing would be negligible. Therefore, Stelara (90 mg every 6 weeks) is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.