Economic Analysis: Randomized, Placebo-Controlled Clinical Trial of Dutasteride in Men at High Risk for Prostate Cancer

Abstract

Objective: Given the economic burden of prostate cancer (PCa), a PCa risk-reduction medication would be desirable. A within-trial economic analysis of the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) study was performed.Methods: REDUCE, a 4-year, randomized, double-blind, placebo-controlled, parallel-group clinical trial, compared efficacy and safety of dutasteride 0.5 mg daily and placebo to reduce the risk of PCa in men at increased risk. Resource use was prospectively collected; costs from standard costing sources were applied. Utilities were obtained from published literature. Relative risks and Wilcoxon rank sums were used to examine differences between treatments.Results: Placebo patients were at significantly higher risk (P < 0.05) for concomitant medication use; and health care visits related to surgical procedures, unscheduled biopsies, acute urinary retention, urinary tract infections, or macroscopic hematuria. Total costs were significantly lower (P < 0.001) in dutasteride patients ($1 300; 95% confidence interval: $806, $1 795). Incremental cost per quality-adjusted life-year (QALY) was $26 516; cost per PCa case avoided was $19. Conclusions:During the 4-year trial period, men at increased risk for PCa receiving dutasteride incurred fewer health care costs than men receiving placebo, which helped offset dutasteride costs. Dutasteride was good value for money.