Chapter 33 - Biotechnology Product Coverage, Coding, and Reimbursement Strategies

Abstract

The processes for successfully commercializing a new medical item or service in the United States are impacted by coverage, coding, and reimbursement determinations, each of which is a distinct process with different evidentiary standards. Biotechnology entrepreneurs and other stakeholders involved in bringing technologies to market should plan their strategy for obtaining coverage, coding, and reimbursement on a parallel path with clinical trials designed to support any application for approval or clearance by the Food and Drug Administration. The pricing and reimbursement system in European countries is different from that in the United States. In both settings, there are tremendous pricing pressures on medical products, particularly therapeutics. Each country determines its own pricing policy, but many have interdependencies based on international price referencing. In this chapter, we review the issues associated with biotechnology product pricing, coding, and reimbursement in the US and European countries. It is essential for the biotechnology entrepreneur to recognize that dealing with government and regulatory agencies takes time and therefore one should begin planning a reimbursement strategy early on during product development.