Clinical and Economic Impact of RBT-1 on Post-Operative Complications and Costs of Cardiac Surgery
Author(s)
Frans van Wagenberg, MD1, Lynn Cherry, PhD2, Bhupinder Singh, MD3, Stacey Ruiz, PhD3, Raf Magar, MBA4;
1Huntsville Heart Center, Cardiovascular Surgery, Huntsville, AL, USA, 2AHRM Inc., HEOR, Raleigh, NC, USA, 3Renibus Therapeutics, Medical Affairs, Southlake, TX, USA, 4AHRM Inc, President, Raleigh, NC, USA
1Huntsville Heart Center, Cardiovascular Surgery, Huntsville, AL, USA, 2AHRM Inc., HEOR, Raleigh, NC, USA, 3Renibus Therapeutics, Medical Affairs, Southlake, TX, USA, 4AHRM Inc, President, Raleigh, NC, USA
Presentation Documents
OBJECTIVES: Cardiac surgery post-operative complications are a major concern leading to adverse clinical outcomes and high-cost burden. A novel drug, RBT-1, has been shown to reduce post-operative complications when administered prior to surgery. We estimate potential cost savings for RBT-1 in CABG, Valve and Combined CABG and Valve surgery.
METHODS: Complication rates from the Phase 2 trial of RBT-1 (NCT04564833) were utilized in decision tree models to estimate the average expected cost of patients who were dosed with RBT-1 vs Placebo (Pbo) by surgery type (CABG, Valve, and Combined CABG/Valve). Complication rates were categorized as follows: 0 complications, 1 complication, 2 complications, and 3 or more complications for each treatment group. Costs for each category were estimated based on the literature. Complication rates for each surgery type were utilized to inform the decision tree models to estimate the magnitude of incremental cost savings for RBT-1 vs Pbo.
RESULTS: A total of 121 patients (80 RBT-1/41 Pbo) were evaluated for clinical outcomes in the Phase 2 trial. The most frequently reported post-operative complications were prolonged ICU stay, new-onset post-operative AF, and blood transfusion. Other complications assessed include AKI requiring dialysis, 30-day cardiopulmonary readmission, and death. The estimated cost of 1, 2, and 3 or more complications were $84K, $145K, and $254K, respectively. The cost of 0 complications ranged from $50-58K which is the estimated cost of each surgery type. Incremental cost savings ranged from $23K to $63.4K in favor RBT-1 and was influenced by the lower complication rates reported in the Phase 2 trial.
CONCLUSIONS: Cardiac surgery complications are common. Multiple complications increase costs exponentially. Phase 2 trial results support a protective effect of RBT-1 that lowers complication rates/expected costs across different surgery types. An ongoing Phase 3 trial will contribute additional data to evaluate the impact of RBT-1 on clinical, economic, and qualitative outcomes.
METHODS: Complication rates from the Phase 2 trial of RBT-1 (NCT04564833) were utilized in decision tree models to estimate the average expected cost of patients who were dosed with RBT-1 vs Placebo (Pbo) by surgery type (CABG, Valve, and Combined CABG/Valve). Complication rates were categorized as follows: 0 complications, 1 complication, 2 complications, and 3 or more complications for each treatment group. Costs for each category were estimated based on the literature. Complication rates for each surgery type were utilized to inform the decision tree models to estimate the magnitude of incremental cost savings for RBT-1 vs Pbo.
RESULTS: A total of 121 patients (80 RBT-1/41 Pbo) were evaluated for clinical outcomes in the Phase 2 trial. The most frequently reported post-operative complications were prolonged ICU stay, new-onset post-operative AF, and blood transfusion. Other complications assessed include AKI requiring dialysis, 30-day cardiopulmonary readmission, and death. The estimated cost of 1, 2, and 3 or more complications were $84K, $145K, and $254K, respectively. The cost of 0 complications ranged from $50-58K which is the estimated cost of each surgery type. Incremental cost savings ranged from $23K to $63.4K in favor RBT-1 and was influenced by the lower complication rates reported in the Phase 2 trial.
CONCLUSIONS: Cardiac surgery complications are common. Multiple complications increase costs exponentially. Phase 2 trial results support a protective effect of RBT-1 that lowers complication rates/expected costs across different surgery types. An ongoing Phase 3 trial will contribute additional data to evaluate the impact of RBT-1 on clinical, economic, and qualitative outcomes.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO118
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory), STA: Surgery