OBJECTIVES: To determine the unique US policy and market access nuances which must be addressed for ex-US biotech companies or startups to enter the US market. The aim of this study is to determine what ex-US biotech startups must understand and focus on within the US market access space to best position new drug launches, given the differences among landscapes. Additionally, this work provides a framework of required issues to explore during early decision-making process in a pre-launch setting.

METHODS: Qualitative research with key opinion leaders (KOLs) and subject matter experts in the US was performed to understand the unique challenges and key lessons learnt. Interviewed experts had experience working with product launches at ex-US companies

RESULTS: Our research identified specific nuances and differences in the US market access landscape that could be easily overlooked. Addressing these differences can be used to formulate a successful launch strategy for brining pharmaceutical innovation from other geographies into the US market. Additionally, we provided a list of specific recommendations for ex-US biotech startups and payers that pull best practices from other experiences to avoid critical blind-spots, inefficiencies, and missteps within the US market access environment.

CONCLUSIONS: New players and startups in the pharmaceutical industry outside the US have immense untapped potential to benefit patients in the US. The innovation and potential cost-effectiveness of these products can offer advantages for patients and payers in the US. As a result, any companies who are interesting in bring pharmaceutical innovation in the US should examine the differences in the US market access landscape and develop a framework that aims to expand product launches and improve access to innovative therapies within the United States.