The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs.
Rick A VremanLourens T BloemStijn van OirschotJarno HoekmanMenno E van der ElstHubert Gm LeufkensOlaf H KlungelWim G GoettschAukje K Mantel-TeeuwissePublished in: International journal of health policy and management (2020)
Results from regulator-imposed post-approval studies for conditionally approved drugs were not often used in REAs by HTA organizations, because they were often not yet available at the time of initial assessment and because reassessments were scarce. When available, results from post-approval studies were almost always used within HTA, and they have led to changes in conclusions about drugs' relative effectiveness. Post-approval studies can be relevant within HTA but the current lack of alignment between regulators and HTA organizations limits their potential.