The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies

• Published in: Clinical pharmacology and therapeutics Vol. 91; no. 2; p. 281
• Main Authors: Bouvy, J C, Koopmanschap, M A, Shah, R R, Schellekens, H
• Format: Journal Article
• Language: English
• Published: United States 01.02.2012
• Subjects: Antipsychotic Agents - adverse effects; Antipsychotic Agents - economics; Cost-Benefit Analysis - statistics & numerical data; Drug and Narcotic Control - economics; Electrocardiography - economics; Humans; Models, Economic

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 ("reg...