HEALTH-ECONOMIC VALUE OF A NOVEL ANASTOMOSIS PROTECTION DEVICE AFTER COLORECTAL RESECTION: AN ANALYSIS BASED ON THE SAFE-2025 STUDY AND U.S. CLAIMS DATA
Author(s)
Anne M. Ryschon, MA1, John H. Marks, MD, FACS, FASCRS2, Abigail M. Garner, MS1, Simon A. Weber, Dr.3, Jan B. Pietzsch, PhD1;
1Wing Tech Inc., Menlo Park, CA, USA, 2Lankenau Medical Center, Main Line Health, Colorectal Surgery Center, Wynnewood, PA, USA, 3Wingtec GmbH/Cellogic GmbH, Berlin, Germany
1Wing Tech Inc., Menlo Park, CA, USA, 2Lankenau Medical Center, Main Line Health, Colorectal Surgery Center, Wynnewood, PA, USA, 3Wingtec GmbH/Cellogic GmbH, Berlin, Germany
OBJECTIVES: Diverting ostomy after colorectal resection is associated with a substantial cost burden, including the index and subsequent procedures and hospitalizations related to stoma reversal, complications, as well as, when necessary, long-term stoma maintenance costs. This analysis explored the value implications of using Colovac, a temporary, intraluminal bypass device to avoid stoma creation compared to diverting ostomy (SoC) in a U.S. setting.
METHODS: A decision-analytic model was used to project strategy-specific lifetime costs from the payer perspective for patients receiving Colovac or SoC during a low anterior resection procedure. The base case, informed by SAFE-2025 study data (population mean age 61 years, 51% male), assumed 85.7% of patients would avoid an ileostomy at ten days. Further, 20% of stomas were assumed to not be reversed, hence incurring maintenance costs over lifetime. Survival was assumed to not differ between the two strategies, with long-term survival calibrated to U.S.-specific outcomes following rectal resection. Index procedure and ongoing stoma care, 30-day postoperative readmissions, and reversal costs were included and informed by contemporary Medicare claims data and published literature. Costs were discounted 3% per US guidelines. Extensive sensitivity analyses were performed.
RESULTS: Lifetime cost-savings with Colovac, compared to SoC and prior to consideration of a separate device add-on payment, were $23,583 (total cost $26,253 vs. $49,836). 67.3% of these savings materialized in the first year after index surgery. The magnitude of cost-savings was positively correlated with the percentage of patients avoiding stoma placement. These estimates are likely conservative as only 30-day complications of stomas were considered.
CONCLUSIONS: Model-based projections suggest colorectal anastomosis protection with Colovac might be associated with meaningful cost savings to U.S. payers, based on reduced need for stomas, subsequent reversal procedures, and related stoma management and complications cost. These data provide important perspective as U.S. payers consider add-on payments for this novel therapy.
METHODS: A decision-analytic model was used to project strategy-specific lifetime costs from the payer perspective for patients receiving Colovac or SoC during a low anterior resection procedure. The base case, informed by SAFE-2025 study data (population mean age 61 years, 51% male), assumed 85.7% of patients would avoid an ileostomy at ten days. Further, 20% of stomas were assumed to not be reversed, hence incurring maintenance costs over lifetime. Survival was assumed to not differ between the two strategies, with long-term survival calibrated to U.S.-specific outcomes following rectal resection. Index procedure and ongoing stoma care, 30-day postoperative readmissions, and reversal costs were included and informed by contemporary Medicare claims data and published literature. Costs were discounted 3% per US guidelines. Extensive sensitivity analyses were performed.
RESULTS: Lifetime cost-savings with Colovac, compared to SoC and prior to consideration of a separate device add-on payment, were $23,583 (total cost $26,253 vs. $49,836). 67.3% of these savings materialized in the first year after index surgery. The magnitude of cost-savings was positively correlated with the percentage of patients avoiding stoma placement. These estimates are likely conservative as only 30-day complications of stomas were considered.
CONCLUSIONS: Model-based projections suggest colorectal anastomosis protection with Colovac might be associated with meaningful cost savings to U.S. payers, based on reduced need for stomas, subsequent reversal procedures, and related stoma management and complications cost. These data provide important perspective as U.S. payers consider add-on payments for this novel therapy.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE396
Topic
Economic Evaluation
Topic Subcategory
Trial-Based Economic Evaluation
Disease
SDC: Gastrointestinal Disorders, SDC: Oncology, STA: Surgery