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
• ISSN: 1532-6535
• DOI: 10.1038/clpt.2011.224

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 ~€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.