TY  - JOUR
PY  - 2012//
TI  - The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies
JO  - Clinical pharmacology and therapeutics
A1  - Bouvy, J. C.
A1  - Koopmanschap, M. A.
A1  - Shah, R. R.
A1  - Schellekens, H.
SP  - 281
EP  - 288
VL  - 91
IS  - 2
N2  - 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.<p /> <p>Language: en</p>
LA  - en
SN  - 0009-9236
UR  - http://dx.doi.org/10.1038/clpt.2011.224
ID  - ref1
ER  -