Cost-effectiveness projections of FOLFOX vs. IFL in first-line therapy of metastatic colorectal cancer in the context of the U.S. health care system

Abstract

3531 Background: A randomized comparison has shown FOLFOX to be superior to the previous U.S. standard of care, IFL for 1st-line therapy (Rx) of metastatic colon cancer. The tradeoffs between costs and survival for these two regimens have not been explored. Methods: A post-hoc incremental cost-effectiveness (ICE) projection using simulated cohorts of patients starting FOLFOX or IFL was tracked for major clinical events, toxicities and survival for 5 years using the perspective of Medicare as a 3rd party payer. Recurrence and survival risks were based on clinical trial data. Resource use was projected using observed dose intensity, duration of and delays in Rx, and grade >2 toxicities. Use of 2nd-line Rxs was estimated based on patterns observed for trial patients as well as contemporary estimates. Results: Initial Rx with FOLFOX v IFL had an average incremental cost of $29,523, a survival benefit of 4.4 months and an ICE of $80,410 per life yr (LY). The table compares component costs. Using the 95% confidence interval for the time to progression observed in N9741, the ICE associated with FOLFOX ranged from $121,220 to $59,250 per LY. In the clinical trial, dose delays and skipped doses were frequent. If progression-free pts were treated without delay for the first yr or lifetime, the ICE for FOLFOX increased to $117,910 and $222,200 per LY, respectively. Otherwise, the ICE changed minimally across a range of plausible parameters. The ICE increased to $84,780 per LY when the model used a revised IFL schedule with lower early toxicity and similar rates of Rx with 2nd-line regimens. Conclusions: Compared to IFL, FOLFOX provides substantial benefit at substantial increase in cost. The ICE falls in the upper range of commonly accepted oncology interventions in the U.S. This cost analysis supports FOLFOX as a standard for future comparisons to regimens that incorporate biologic agents. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Sanofi-Synthelabo Pfizer, sanofi-aventis, Sanofi- Synthelabo Pfizer, sanofi-aventis, Sanofi-Synthelabo Pfizer, Sanofi-Synthelabo