The evaluation of drug regulation

This thesis studies the cost-effectiveness of the regulatory framework for medicines. Societal developments during the last decades have resulted in increasingly stringent safety regulations for medicines. Yet, the cost-effectiveness of these regulations has not been studied. This thesis assessed the cost-effectiveness of two parts of the regulatory framework for medicines: QT/QTc (TQT) studies and Periodic Safety Update Reports (PSURs) for biologicals. We found that both for QT/QTc studies and for PSURS, incremental cost-effectiveness ratios (ICERs) exceeded commonly applied willingness to pay thresholds for medical interventions. A second line of research in this thesis however found that the societal valuation of safety-related regulatory actions is high and the willingness to pay for safety regulations might be higher than the willingness to pay for medical interventions. Future research thus needs to determine an optimum between protecting and promoting public health through an efficient regulatory framework for medicines.

Results

• Bouvy JC, Koopmanschap MA, Shah RR, Schellekens H. The cost-effectiveness of medicine regulation: the example of thorough QT/QTc studies. In: Clin Pharmacol Ther, 2012; 91(2): 281-8. (journal publication)
• Bouvy JC, Ebbers HC, Schellekens H, Koopmanschap MA. The cost-effectiveness of Periodic Safety Update Reports (PSURs) for biologicals in Europe. In: Clinical Pharmacology & Therapeutics, 2013. (journal publication)
• The evaluation of drug regulation - Economic approaches into the valuation and evaluation of the drug regulatory framework (thesis)
• Bouvy JC, Koopmanschap MA, Schellekens H. Value for money of medicine regulation. In: Expert Rev Pharmacoecon Outcomes Res, 2012; 12(3): 247-9. (journal publication)
• Bouvy JC, Weemers J, Schellekens H, Koopmanschap MA. Willingness to pay for adverse medicine event regulatory actions. In: Pharmacoeconomics, 2011; 29(11): 963-75. (journal publication)