Purpose: The purpose of this analysis was to assess the potential cost-effectiveness of utilizing sulindac-difluoromethylornithine (DFMO) alone or in conjunction with endoscopic screening for the prevention of colorectal cancer.
Method: A Monte-Carlo Simulation was conducted on 100,000 hypothetical 50 year old adults without a history of colorectal cancer. Patients were assigned to one of the following four prevention strategies: 1. no screening, 2. colonoscopy only, 3. colonoscopy + sulindac-DFMO, or 4. sulindac-DFMO only. The model was conducted from the Medicare perspective. Historical costs were inflated to 2010 using the Consumer Price Index and future costs were discounted at an annual rate of 3%. One-way sensitivity analyses were conducted for all of the variables in the model. Additional analyses were conducted for high-risk patients and best case scenarios for sulindac-DFMO.
Result: Validation results showed that the model closely matched both the expected lifetime number of colorectal cancer cases and the expected stage at diagnosis when compared with the Surveillance Epidemiology and End Results data provided by the National Cancer Institute. Sulindac-DFMO prevented more cancers than colonoscopy.(Table 1) Screening with colonoscopy had the lowest mean cost ($10,040) and resulted in the highest number of quality adjusted life years (QALY) (17.81). (Table 2) Sulindac-DFMO was the most expensive strategy ($38,349) and produced the fewest QALYs (16.67). The dominance of colonoscopy persisted across the entire one-way sensitivity analyses and even persisted in the “best-case” scenarios for Sulindac-DFMO in high risk patients.
Conclusion: In this analysis, the use of Sulindac-DFMO did not decrease the cost per quality adjusted life-year (QALY) when used for the prevention of colorectal cancer. The results of this analysis are consistent with previous analyses and support the current joint screening guidelines published by the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology that recommend colonoscopy as the preferred prevention strategy. According to our current understanding, sulindac-DFMO does not appear to be a viable option for colorectal cancer prevention. The lack of benefit appears to be driven by the toxicity associated with sulindac. However, sulindac-DFMO may play a role for extremely high-risk patients with a hereditary predisposition for cancer (e.g. familial adenomatous polyposis), which was not considered in this analysis.
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