Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Ulcerative colitis.
Treatment: Stelara 90mg/ml Every 4 Weeks, Pre-service.
The insurer denied the Stelara 90mg/ml Every 4 Weeks, Pre-service,
The denial is overturned.

The patient is a female. She has been diagnosed with ulcerative colitis. She failed conventional therapy and two other biological agents, Remicade and vedolizumab. She has been on Stelara 90 mg (milligrams) every 8 weeks. She continues to have symptoms. Her doctor requested to increase Stelara dose to 90 mg (milligrams) every 4 weeks.

Yes, the health plan should cover the treatment with Stelara every four weeks.
Dayan et al published their real-world experience with ustekinumab at a tertiary care pediatric inflammatory bowel disease (IBD) center. Fifty-two children and young adults initiating ustekinumab were analyzed. Most patients (81%) failed >1 anti-TNF (tumor necrosis factor), and 37% failed anti-TNF (tumor necrosis factor) and vedolizumab; 10 patients were biologic-naive. At week 52, 75% were still on ustekinumab, and 50% (bio-exposed) and 90% (bio-naive) were in steroid-free remission. Their results suggested that ustekinumab is efficacious and safe in pediatric patients with IBD (inflammatory bowel disease). The dosage of ustekinumab in this study ranged from every 4 to every 8 weeks.

Recently, Dhaliwal et al published a multicenter study to prospectively monitor efficacy and serum concentrations of ustekinumab given to children with ulcerative colitis (UC) refractory to other biologics. They concluded that "Ustekinumab demonstrated efficacy in this paediatric cohort with otherwise treatment-refractory UC [ulcerative colitis]." The dosage of ustekinumab in this study ranged from every 4 to every 8 weeks.

In summary, current medical evidence shows that ustekinumab is reasonably safe and effective in children with moderate to severe ulcerative colitis (1-3). The standard maintenance dose for ulcerative colitis is 90 mg (milligrams) every 8 weeks. For patients who respond to Stelara initially and then lost response due to low drug concentration and/or antibody formation, shortening the interval up to every 4 weeks is recommended (1-4).

As documented in the clinical notes and appeal letter, this patient has had severe ulcerative colitis and did not respond to conventional therapy and two other biologicals, Remicade and vedolizumab. The patient has been on Stelara standard dose of 90 mg (milligrams) every 8 weeks but still has symptoms and active inflammation. Thus, the next treatment option would be to shorten the interval from every 8 weeks to every 4 weeks. The requested Stelara 90 mg (milligrams) every 4 weeks would be medically appropriate, as supported by current literature and treatment guidelines. The health plan should therefore cover the treatment with Stelara 90 mg (milligrams) every four weeks.

Yes, the treatment with Stelara every four weeks is likely to be more beneficial.
The patient failed standard conventional therapy, anti-TNF (tumor necrosis factor) drug, vedolizumab and then standard dose of Stelara. Current literature support that escalation of Stelara to every 4 weeks is more beneficial than standard treatment for this patient's condition.