Scientific Evidence Production and Specialty Drug Diffusion

Abstract

Specialty drugs treat complex, severe diseases and offer significant therapeutic advances. Despite their potential to transform patient care, little is known about the drivers of their diffusion. In this study, the authors develop a framework for the diffusion of specialty drugs that is motivated by the drugs’ novelty, complexity, and importance, with a focus on the role of scientific evidence production. They propose that the effects of scientific evidence on specialty drug diffusion are multifaceted and generated through the three stages of the scientific evidence production process: unpublished clinical studies, publications in medical journals not cited in clinical guidelines, and clinical guidelines. The findings from the empirical analysis of two specialty drugs validate the framework, supporting the idea of multistage scientific evidence effects. In contrast, marketing activities do not have a significant effect. Although this could be attributed to specialty drug prescribers discounting information from commercial sources, it may also be due to limited marketing support. An additional analysis on a nonspecialty drug further validates the proposed framework. Calculations of scientific evidence contributions to trial prescriptions indicate that scientific evidence production can generate returns beyond the publication stage, which should provide specialty drug manufacturers with strong incentives to commit to quality and innovation.