Heading into the Unknown: How Will JCA Implementation Affect Global Launch Strategies?

OBJECTIVES: A key topic in market access over the past year has been the implementation of joint clinical assessments (JCA) across the European Union. While primarily affecting European launch strategy, this will also inevitably impact strategy on a global level and so it is key that manufacturers understand and evaluate the potential consequences of JCA as part of their early pipeline planning.

METHODS: A targeted literature search of relevant gray literature published between Jan and Dec 2023 was conducted to understand the potential implications of JCA implementation in terms of global launch strategies.

RESULTS: Four key potential impacts of JCA implementation were identified. First, since access to the JCA report will allow resource-constrained smaller European markets to accelerate their health technology assessment (HTA) processes, manufacturers will need to consider Europe as a single market requiring a single launch as opposed to staggering launches across Europe in waves. Second, manufacturers will need to be prepared to adapt launch strategies quickly given the shortened timeframe between regulatory and reimbursement processes. Third, JCA will likely reduce manufacturers' flexibility to define different market access goals in different European markets (e.g., targeting certain subpopulations in some markets to preserve value). This could affect price points both across the region and, due to international reference pricing, beyond Europe. Finally, potential delays in access in European countries with more established HTA processes due to the two-step process (JCA, followed by individual member state evaluation) could result in Europe being deprioritized as a launch market entirely, especially as markets like China and Brazil shift higher in the hierarchy.

CONCLUSIONS: JCA could result in an evolution in traditional global launch sequences, and so it will be even more important for manufacturers to follow a joined-up cross-functional approach, ensuring that the European perspective is included early on in clinical development.