Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Stelara at a dose of 90mg every 4 weeks.
The insurer denied the Stelara at a dose of 90mg every 4 weeks.
The denial is upheld.

The patient is a male. He has the diagnosis of Crohn's disease. The provider has requested that the patient receive his Stelara maintenance dosing at an interval of every 4 weeks instead of every 8 weeks.

No, the health plan should not cover the treatment with Stelara at a dose of 90mg (milligrams) every 4 weeks.

No, the Stelara at a dose of 90mg every 4 weeks is not likely to be more beneficial.

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 other than anecdotal reports, e.g., as follows:

Per Greenup A. et al, in the absence of therapeutic drug monitoring, empirical dose escalation has been considered as a strategy to optimize response in patients with either primary or secondary non-response. Efficacy and safety of UST (ustekinumab) 90mg (milligrams) subcutaneous (SC) every 4 weeks is not known.

A retrospective, observational study of compassionate use of UST (ustekinumab) in CD (Crohn's disease) was conducted at a Canadian tertiary center.

Results indicate that real-life experience of UST (ustekinumab) use in patients with CD (Crohn's disease), maintenance dose escalation to 90mg (milligrams) every 4 weeks had a modest benefit in achieving a clinical response. This may be suggestive of the mechanism of loss of response to UST (ustekinumab) being driven by factors other than low bioavailability due to processes such as rapid clearance. Further assessment in larger cohorts as well as the use of therapeutic drug monitoring will be important to evaluate the usefulness of dose escalation for patients on UST (ustekinumab).

Reports such as the above are anecdotal and involve small numbers of patients. Therefore, 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.

The Ollech article provided noted that shortening the interval of dosing "might" improve patient outcomes. The Lleifferdich article did not make conclusions about dosing intervals. The Wils article also did not render conclusions regarding dosing intervals of Stelara for treatment of Crohn's disease. The Fumery article supports the use of stelara in certain clinical scenarios every 4 weeks.

Despite the patient's presentation and history, there is insufficient 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 clear 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.

Jauregui-Amezaga et. al., Danese, and Simon, et. al. all note the use of Stelara in the management of Crohn's; however, there is no notation or support of use every 4 weeks for maintenance dosing.