We analyzed the cost-effectiveness of the International Conference on Harmonisation (ICH) E14 guideline that requires a thorough QT/QTc (TQT) study for all drugs under development. We compared two pharmacoeconomic scenarios: the health effects and costs resulting from implementing ICH E14 (regulation scenario) vs. not implementing ICH E14 (no regulation scenario). We used a dynamic population model to calculate the cost-effectiveness of ICH E14 for a prototype QT-prolonging antipsychotic drug entering the US and European markets. The incremental cost-effectiveness ratios of regulation vs. no regulation were .4 million per sudden cardiac death prevented and 187,000 per quality-adjusted life year (QALY) gained in users of antipsychotic drugs. The main driver of cost was the requirement for electrocardiogram (ECG) monitoring of users of QTc-prolonging drugs. Even when several of the assumptions in the model were varied, there were no results in favor of regulation. Our study shows that cost-effectiveness analysis of drug regulatory measures is feasible and should be considered before developing such measures.

Europe, QT prolongation, QTc prolongation, United States, cost effectiveness analysis, cost utility analysis, drug research, electrocardiography monitoring, health care planning, heart ventricle fibrillation, human, intermethod comparison, international conference on harmonisation e14 guideline, population model, practice guideline, priority journal, quality adjusted life year, sensitivity analysis, sudden death, torsade des pointes, tqt study
dx.doi.org/10.1038/clpt.2011.224, hdl.handle.net/1765/38273
Clinical Pharmacology and Therapeutics
Erasmus MC: University Medical Center Rotterdam

Bouvy, J.C, Koopmanschap, M.A, Shah, R.R, & Schellekens, H. (2012). The cost-effectiveness of drug regulation: The example of thorough QT/QTc studies. Clinical Pharmacology and Therapeutics, 91(2), 281–288. doi:10.1038/clpt.2011.224