Mechanism-based pharmacoeconomic modelling

Abstract: Standard health economic models of medicines may result in biased estimates of cost-effectiveness when extrapolations are made outside of the context of the clinical trial evidence upon which they are usually based. While some extrapolations are almost always necessary (e.g. modelling patient lifetimes) and accepted as standard practice, others, such as modelling different patient populations or different doses or dosing schedules, are much more difficult. The empirical nature of most health economic models essentially precludes such attempts to extrapolate outside the boundaries of the trial evidence, or at least considerably limits the confidence with which this can be done. Mechanism-based modelling refers to population pharmacokinetic-pharmacodynamic models that are used in quantitative pharmacology to predict the time course of drug action and the covariate effects on drug response. These have been used to inform licensing decisions for different patient subgroups and are accepted by regulatory authorities as evidence to support labelling recommendations. This presentation will reflect on recent research on developing mechanism-based health economic models for pharmaceuticals.