R25 Cost-effectiveness of a Ceramide-infused Skin Barrier among Medicare Enrollees in the United States who have Recently Undergone Fecal Ostomy

Ariel Berger, MPH, Evidera, Waltham, MA, Gary Inglese, RN, MBA, Global Market Access, Hollister Incorporated, Libertyville, IL, George Skountrianos, MS, Hollister Incorporated, Libertyville, IL, Tonny Karlsmark, MD, DMSc, Department of Clinical Medicine, University of Copenhagen, Denmark, Copenhagen, Denmark and Mustafa Oguz, PhD, Evidera, London, United Kingdom
Objective: To estimate the cost-effectiveness of a ceramide-infused skin barrier (CIB) vs. other currently marketed skin barriers (standard of care [SoC]) among patients who recently underwent fecal ostomy, from the perspective of the United States Medicare system.

Methods: We used a cost-effectiveness model to estimate stoma-related outcomes and costs incurred in the one-year period following fecal ostomy. Parameter estimates for the model were taken from the ADVOCATE trial, which investigated stoma-related healthcare costs over 12 weeks among patients who had a fecal ostomy within the past three months randomized to CIB vs. SoC, and from other sources. Resources included skin barriers, ostomy accessories, pharmacotherapy, and visits to healthcare professionals. Incremental cost-effectiveness of CIB vs. SoC was estimated by dividing the expected difference (CIB vs. SoC) in total costs by the expected difference in quality-adjusted life-days (QALDs); we also calculated the net monetary benefit (NMB) of CIB (vs. SoC). We conducted probabilistic and deterministic sensitivity analyses.

Results: The use of CIB in a hypothetical cohort of 10,000 new stoma patients is expected to result in 1,643 fewer PSCs, an additional 3,471 QALDs, and cost savings of $2.1M (all over one year) when compared to SoC; this resulted in an estimated NMB of $256 per patient. The model was most sensitive to levels of use of higher cost accessories and annual probabilities of PSC; however, CIB was consistently dominant. In probabilistic sensitivity analyses, 97% of 2,000 runs resulted in fewer expected PSCs with CIB; while 98% of the runs resulted in lower expected costs.

Conclusions: CIB is expected to result in fewer PSCs, lower healthcare costs, and greater QALDs; findings were robust in sensitivity analyses. Accordingly, our analyses suggest that CIB is a cost-effective option for patients who have recently undergone fecal ostomy.