A quantitative evaluation of the regulatory assessment of the benefits and risks of rofecoxib relative to naproxen: an application of the incremental net-benefit framework†

摘要: Purpose To undertake a quantitative benefit–risk analysis of rofecoxib relative to naproxen using an incremental net-benefit (INB) from the societal perspective, same data evaluated by Health Canada and US FDA expert advisory panels. Methods We developed discrete event simulation model calculate INB in arthritis patients over 1-year time horizon. All outcomes were weighted utilities for each health state which facilitated use quality-adjusted life years (QALYs) as outcome. Probability distributions incorporated parameter facilitate probabilistic second-order Monte Carlo simulation. Results In base case analysis, mean (SD) was 0.0002 (0.415) QALYs per patient 12 months treatment, or 0.2 1000 treated. The sensitivity resulted 0.0022 (95%CI −0.0005, 0.0051). Overall, associated with ≥0 94% iterations model. Conclusions This illustrates application framework evaluation, suggests that potential benefits outweigh harms 1 year perspective under assumptions this model. Copyright © 2010 John Wiley & Sons, Ltd.