Economic and Clinical Impact of Serum-Derived Bovine Immunoglobulin / Protein Isolate (SBI) in the Management of Chronic Diarrhea in Inflammatory Bowel Disease (IBD)


      This study sought to evaluate the real-world economic and clinical impact of EnteraGam®—a medical food containing serum-derived bovine immunoglobulin/protein-isolate (SBI) for the management of chronic diarrhea.


      Medical records were reviewed across nine US gastroenterology practices for patients diagnosed with either ulcerative colitis (UC) or Crohn’s disease (CD). Patients included in the study had at least six months’ treatment for IBD prior to a minimum of six months’ continuous SBI use. Patients were excluded if they were involved with an interventional clinical trial during the study period, had a history of malignant disease of the gastrointestinal tract, or were suspected of therapy non-compliance. Information abstracted from medical records included all IBD-relevant prescription medications, tests, procedures, adverse events and healthcare contacts. Resource utilization was compared prior-to and during SBI use. Patients’ costs were fit to a log-normal distribution to calculate expected values (means). Medication classes were evaluated for utilization differences between periods. Budget impact was extrapolated to a hypothetical plan with 1M covered lives.


      32 of 170 potential subjects met eligibility criteria. Primary reason for exclusion was a lack of sufficient treatment time prior to SBI initiation and/or less than six months’ SBI use. Mean overall daily cost for IBD patients during SBI use was $110.46 versus $112.63 prior. Prescription medication costs were lower with SBI use ($98.55) compared to prior ($103.61). Medication class analysis showed reduced dosage ratios in several prominent classes. Budget impact analysis revealed annual net savings of $4,582,849 with SBI use for a plan with 1M lives.


      This retrospective real-world study suggests that inclusion of SBI for the management of chronic diarrhea in IBD can offer clinical benefits while also lowering the overall cost of treatment. Reduction in utilization of some notable medication classes can contribute to net savings.