Session (CTI)

ISSUE Global pricing pressures, including Most Favored Nation (MFN) and intensified reference pricing (ERP), are reshaping pharmaceutical launch strategies. Companies are delaying or deprioritizing European launches to protect global pricing corridors. At the same time, the EU Joint Clinical Assessment (JCA), introduces a mandatory centralized clinical evaluation requiring early preparation on populations, comparators, endpoints, and evidence generation. This creates a strategic dilemma for manufacturers: How much should companies invest in JCA readiness when European launch is uncertain or delayed? The issue extends beyond operational readiness and raises broader questions around launch sequencing, portfolio prioritization, patient access, and interaction between global pricing policies and EU HTA requirements. OVERVIEW This panel will provide a practical framework to guide JCA investment decisions under MFN uncertainty and evolving global pricing dynamics. The discussion will focus on how different levels of JCA and payer evidence preparation may influence pricing lifecycle management, launch sequencing, evidence investment and HTA strategy, and time to patient access. The session will introduce a three-level readiness framework: Compliance Only – minimal JCA preparation with risk of delayed access or weaker positioning, Targeted Readiness – focused preparation balancing pricing protection and access readiness, and Full Readiness approach – comprehensive preparation to optimize future JCA and pricing outcomes Panelists will consider these approaches across three strategic scenarios: short-term MFN dominance, transitional/selective European launch strategies, and long-term rebalancing if MFN pressures decline. The panel will specifically debate: business risks of under-preparation, evidence investment across portfolios and geographies, whether “minimum viable JCA readiness” is sufficient, and how delayed launches affect patient access and equity. The session will be particularly relevant for global market access, HEOR, pricing, and HTA professionals navigating evolving EU and US policy dynamics.