@article{ref1,
title="The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies",
journal="Clinical pharmacology and therapeutics",
year="2012",
author="Bouvy, J. C. and Koopmanschap, M. A. and Shah, R. R. and Schellekens, H.",
volume="91",
number="2",
pages="281-288",
abstract="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 (&quot;regulation&quot; scenario) vs. not implementing ICH E14 (&quot;no regulation&quot; 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 ~€2.4 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.<p /><p>Language: en</p>",
language="en",
issn="0009-9236",
doi="10.1038/clpt.2011.224",
url="http://dx.doi.org/10.1038/clpt.2011.224"
}