Abstract
Background
Biologics are a mainstay in the treatment of moderate-severe IBD. Unlike other IBD medications, biologics typically require prior authorization from insurance providers. There is a paucity of information characterizing the length of the authorization process. Delays in the initiation of biologic therapy have the potential to impact clinical outcomes and quality of life. This study identified the time of biologic prescription and subsequent time for authorization and time of administration at a university medical center.
Methods
A chart review evaluating IBD patients seen in the GI clinic of a university medical center over a 5-year period was performed. Patient age, gender, race, IBD diagnosis, and biologic use were recorded in a confidential database generated using Microsoft Excel. Biologic agents evaluated included infliximab, adalimumab, vedolizumab and ustekinumab. The agreed upon date (AUD) of starting a biologic, length of time to approval (TTA), and length of time to first infusion (TFI) were recorded. TTA was set as the number of days between agreeing to start a biologic and prior authorization approval. TFI was set as the number of days between agreeing to start a biologic and their first infusion or injection. Patients were excluded if biologic was initiated at another institution or documentation of AUD or TFI was not apparent. Statistical analysis was performed using a t-test with significance set at p<0.05. The study was approved by the institutional IRB.
Results
458 total IBD patients were analyzed. 66 are currently being treated with a biologic (32 infliximab, 14 adalimumab, 13 vedolizumab, 7 ustekinumab). 37 patients had ulcerative colitis, 27 Crohn’s disease, and 2 indeterminate colitis. There were 38 men and 28 women (mean age 43.2 years; range 23–76). 32 patients were white, 26 African American, 1 Asian, 5 other/unknown, and 2 declined. Average TTA was 30.5 days (range 1–145) and average TFI was 45.3 days (range 2–166). There was no significant difference in TFI between a specific biologic compared to all others: infliximab (p=0.615), adalimumab (p=0.183), vedolizumab (p=0.804), ustekinumab (p=0.812). There were no significant differences in TFI with regard to gender (p=0.562), race (p=0.575), or IBD diagnosis (p=0.209).
Discussion
In IBD patients with an indication for biologic treatment, reducing the time to initiation of biologics can result in improved patient outcomes and quality of life. Average wait time for first infusion at our institution was 43.5 days with no difference based on the type of biologic or patient demographics. While a national benchmark does not exist for initiating patients on biologics, there is a need for continued evaluation of the authorization and treatment processes. As new biologic therapies for IBD become available, streamlining the approval process will be of increasing importance.
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