Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Ulcerative Colitis.
Treatment: Stelara 90mg/ml Syringe at A Dose of 1 Syringe Every 4 weeks.
The insurer denied the Stelara 90mg/ml Syringe at A Dose of 1 Syringe Every 4 weeks.
The denial is upheld.

The patient is a female patient. She has the diagnosis of ulcerative colitis. The patient has been maintained on Stelara 90 mg (milligrams) every 8 weeks as maintenance. As the patient began to evidence more symptoms, the provider has requested the provision of Stelara now at an interval of every 4 weeks.

No, the health plan should not cover the Stelara every 4 weeks.
The provider has requested Stelara at a dosing not approved by the FDA (United States Food and Drug Administration). A review of the literature indicates that there have been no significant studies to date demonstrating the safety and efficacy of Stelara dose escalation to every 4 weeks in Crohn's disease. The reports are anecdotal and involve small numbers of patients. As such, the usefulness, efficacy and safety of dose escalation of Stelara in patients with refractory Crohn's disease requires further study and would not be considered medically appropriate. Despite the patient's presentation and history, there is no cogent medical literature or society guidelines to recommend dosing Stelara at an interval of every 4 weeks for maintenance. There is no medical literature to show that this dosing frequency has a positive effect on healthcare outcomes. The formulary medications, including Stelara at a dosing of every 8 weeks for maintenance, is as effective and without more adverse side effects than the requested non-formulary medication.

Therefore, the request is denied and not medically appropriate for this patient.

"A subset of patients with Crohn's disease (CD) do not respond to ustekinumab at the standard dose of 90 mg every 8 weeks. Little is known about the efficacy of shortening the interval between doses." (Ollech, et al.).

"Crohn's disease is an immune-mediated disease that results in panenteric chronic inflammation in genetically predisposed individuals exposed to an appropriate environment. The past two decades have witnessed the emergence of an important class of drugs known as anti-tumour necrosis factor (TNF) agents in the treatment of Crohn's disease. Unfortunately, the utility of these agents have been hampered by primary and secondary nonresponse in a significant proportion of patients. Ustekinumab, a monoclonal antibody to the p40 subunit of interleukin (IL) 12 and 23, is a novel pharmacotherapy for this patient cohort that offers an out-of-class option. It is approved for use in psoriasis and psoriatic arthritis, and has now been evaluated in phase II trials for moderate-to-severe Crohn's disease." (Simon, et al.).

"Biological medicines have revolutionised the treatment of Crohn's disease [CD]. Yet, the management of patients not responding to tumour necrosis factor [TNF] antagonists remains a clinical challenge. Ustekinumab is a human monoclonal antibody blocking the biological activity of interleukins 12 and 23, which regulate the immune system and immune-mediated inflammatory disorders. Ustekinumab has recently been approved for the treatment of adult patients with moderately to severely active CD [Crohn's disease], who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF [tumor necrosis factor] antagonist, or have medical contraindications to such therapies. Herein, we review the new biological drug's efficacy and safety data reported from randomised controlled trials and real-world observational studies conducted in populations with CD [Crohn's disease], in order to identify the patient groups most likely to benefit, and to appropriately place ustekinumab into treatment algorithms for CD [Crohn's disease]." (Danese, et al.).

No, the Stelara every 4 weeks is not more beneficial.