Journal
CLINICAL PHARMACOLOGY & THERAPEUTICS
Volume 91, Issue 2, Pages 281-288Publisher
WILEY
DOI: 10.1038/clpt.2011.224
Keywords
-
Categories
Ask authors/readers for more resources
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 El 4 for a prototype QT-prolonging antipsychotic drug entering the US and European markets. The incremental cost-effectiveness ratios of regulation vs. no regulation were similar to is an element of 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.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available