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.

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doi.org/10.1038/clpt.2011.224, hdl.handle.net/1765/38273
Clinical Pharmacology and Therapeutics
Erasmus MC: University Medical Center Rotterdam

Bouvy, J., Koopmanschap, M., 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