Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Ulcerative (chronic) pancolitis.
Treatment: Stelara SQ 90mg (every 4 weeks), Pre-service.
The insurer denied the Stelara SQ 90mg (every 4 weeks), Pre-service.

The denial is overturned.

The patient is a male. He has moderate to severe ulcerative colitis. He failed conventional therapy and biological agents including infliximab, Humira and Entyvio. He has been on Stelara 90 mg (milligrams) every 8 weeks. He has symptoms. His doctor requested Stelara 90 mg (milligrams) every 4 weeks. The reason for the health plan's prior denial was that the requested dosing exceeds the plan-approved quantity limit.

Yes, the requested Stelara every 4 weeks is medically necessary.
In a published 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 > (greater than) 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) (Daya).

A recent multicenter prospective study concluded that "Ustekinumab demonstrated efficacy in this paediatric cohort with otherwise treatment-refractory UC [ulcerative colitis]. Treatment failure was not due to inadequate drug exposure" ( Dhaliwal).

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

As documented, this patient has moderate to severe ulcerative colitis and has been on Stelara 90 mg (milligrams) every 8 weeks. The patient has had increased symptoms. The treatment option would be to increase Stelara dosing to 90 mg (milligrams) every 4 weeks, as supported by current medical literature and treatment guidelines. The requested Stelara 90 mg (milligrams) every 4 weeks is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
Current medical evidence shows that ustekinumab is reasonably safe and effective in children with severe IBD (inflammatory bowel disease) including ulcerative colitis. The standard maintenance dose for IBD is 90 mg (milligrams) every 8 weeks. For patients who responded to Stelara initially and then lost response due to low drug concentration and/or antibody formation, shortening the interval to every 4 weeks is recommended (1-4).

As documented, this patient has moderate to severe ulcerative colitis and has been on Stelara 90 mg (milligrams) every 8 weeks. The patient has had increased symptoms. The treatment option would be to increase Stelara dosing to 90 mg (milligrams) every 4 weeks, as supported by current medical literature and treatment guidelines.