OBJECTIVES: Early awareness and alert activities (also known as horizon scanning) have been established in many countries but evidence on their ability to accurately prioritize new medicines is limited. The purpose of this study is to assess the accuracy of prioritization made by the Swedish Early Awareness and Alert (EAA) System between 2010 and 2015.

METHODS: We adapted a study design commonly used in the assessment of diagnostic test accuracy. The prioritization made by the Swedish EAA System prior to marketing authorization comprised the index test and national drug sales data in the second year post-authorization served as the reference standard. All new medicinal products processed by the European Medicines Agency (EMA) between 2010 and 2015 (study population) were classified using the index test and the reference standard. Outcome statistics were reported as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

RESULTS: Two hundred and fifty-three new medicinal products processed by EMA comprised the study population. Of these, 71 were prioritized by the Swedish EAA System and 21 were classified as having a substantial economic impact. The sensitivity, specificity, PPV, and NPV were 85.7%, 76.3%, 24.7%, and 98.3%, respectively. Subgroup analyses showed that the accuracy of prioritization, in terms of sensitivity, was highest for antineoplastic/immunomodulating agents (100%).

CONCLUSIONS: The Swedish EAA System accurately prioritized almost all new medicines that would have a substantial economic impact. Our findings provide reassurance to decision makers who rely on the outputs of the Swedish EAA System to keep informed about new medicines. Moreover, this study also provides valuable insights to stakeholders willing to establish and/or evaluate their own EAA activities.