The U.S. market access landscape is complex, proving safety and efficacy is no longer a guarantee of commercial success. CLS’s three-part series, presented by Hogan Lovells, will provide the basics of government and commercial payer rules, offer hypotheticals that bring those rules to life, and help prepare you for the market’s evolving focus on value-delivery. At the end of the series, you will understand why your market access strategy can and should start before the initiation of your Phase IIIs, have identified early-stage steps to de-risk those variables with the potential to constrain market access later, and why you should be prepared for investors to ask you these same questions.

The Foundation: The Basics of Market Access and Why They Matter Before Phase IIIs
Part 1 provides foundation to the government and commercial payer landscape in relation to coverage, reimbursement, and pricing, and how those considerations can have a real-time impact on commercialization strategy. While there are a number of straightforward business considerations relevant to commercialization, the focus of this discussion will be legal and policy considerations, which typically are less readily known to biotechs at this earlier stage of drug development.

Bringing to Life: What Does an Early-Stage Market Access Strategy Look Like?
Using the foundations covered in Part 1, Part 2 walks through a series of hypotheticals that demonstrate why and how developers can create a market access strategy early in the clinical development process, including strategies for clinical trial design, likely investor inquiries, and competitive positioning.

Future-Proofing: How to Prepare a Value-Based Market Access Strategy
With an increasing focus on value delivery, Part 3 discusses the different ways to measure and demonstrate value, the interplay between FDA and CMS on such value propositions, and strategies for payer engagement.