The growing importance of incorporating US payers into biotechnology drug development decision-making

Abstract

There are numerous biotechnology agents in the research and development (R&D) pipeline. In part because of the approximately 20 per cent annual increase in biotechnology agents’ costs, US payers are already very concerned about their impact on health-care costs, and seeking to manage their utilization and total cost. Payer perspectives must be incorporated into the selection of development targets for biotechnology agents, as well as the development of payer-oriented outcomes data during the clinical trials process. Ideal times to do this are the conclusion of Phase I clinical trials, and before the commencement of Phase III clinical trials. A discussion of how the new focus on Comparative Effectiveness Research may impact biotechnology is also included. The article also discusses the very different review processes that US managed care payers employ for biotechnology agents that are in established therapeutic classes, versus truly innovative agents.