ABSTRACT

This chapter explains how each of the steps can be executed successfully leading to key answers with respect to market access and price approval potential and its impact on the business opportunity. The BEST PRICE Framework is used to provide structure to market access and pricing analysis. The framework systematically examines Benefits, Evidence, value STory and subsequent PRICE determination within each of the global payer segments. For each segment analyzed various country-specific examples to illustrate the relationship between demonstrated evidence of key benefits and the market access and price negotiation process. The chapter discusses how the framework fits into the drug development and commercialization process. A key moment during the drug development process is the decision making for the Phase III trial program. Phase III trial design should therefore be based on a thorough analysis of both regulatory and market access requirements. A customary approach to identify drug benefits is the bottom-up approach, starting with the drug's chemical attributes.