1. The Cost-Effectiveness of Drug Regulation: The Example of Thorough QT/QTc Studies
- Author
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Marc A. Koopmanschap, R.R. Shah, Huub Schellekens, Jacoline C. Bouvy, and Health Economics (HE)
- Subjects
Pharmacology ,medicine.medical_specialty ,Cost–utility analysis ,business.industry ,Cost effectiveness ,Cost-Benefit Analysis ,Poison control ,Cost-effectiveness analysis ,Guideline ,medicine.disease ,QT interval ,Sudden death ,Quality-adjusted life year ,Electrocardiography ,Models, Economic ,medicine ,Drug and Narcotic Control ,Humans ,Pharmacology (medical) ,cardiovascular diseases ,Medical emergency ,Intensive care medicine ,business ,health care economics and organizations ,Antipsychotic Agents - Abstract
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.
- Published
- 2012
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