Mapping Biopharmaceutical Innovation and Diffusion: How the Second Translational Block (T2) Shapes Drug Diffusion

In the US, there is a vigorous public debate on the merits of biopharmaceutical innovations and their diffusion. There is virtual unanimity about the importance of maintaining a steady stream of biopharmaceutical innovations, to which patients should have timely access. However, the debate's participants are cognizant that the effects of innovation and diffusion on health outcomes, health care spending, and incentives for future innovation, must be weighed against one another. First, we performed a Medline literature review to map the innovation diffusion process, combining the search terms "in- novation," "diffusion," and "pharmaceutical." Second, we conducted a survey of 190 physicians to examine their valua- tion of the innovativeness and rate of diffusion of 20 new molecular entities (NMEs). Third, we collected data from the Centers for Medicare and Medicaid Services (CMS) Formulary Finder to assess payers' valuation of the innovativeness of the 20 NMEs in question. Based on our literature review, we identified the key stakeholders involved in the innovation diffusion process. Further- more, we highlighted the changing landscape of translational movers and shakers, tracing the emergence of T2 barriers, emanating largely from third party payer formulary management. Our empirical analysis suggests payers are exerting influence on physicians' prescribing decisions, while the role of pa- tients and pharmaceutical firms has diminished somewhat. Payers directly affect prescribing decisions through the use of formularies, and indirectly by funding evidence-based continuing medical education.