Presentation (CTI)

OBJECTIVES: With the implementation of the EU Health Technology Assessment (HTA) regulation, health technology developers face the complexity of managing parallel processes, internal restructuring, and ongoing uncertainties. Early learnings will be presented from initial EU HTA projects, focusing on organizational readiness and practical challenges during the early stages of implementation.
METHODS: Insights were derived from early EU HTA projects, including dossier preparation, PICO simulations, mock assessments, and strategic readiness initiatives.
RESULTS: Key learnings include: 1. Organizational Readiness and Cross-Departmental Coordination: Health technology developers must adopt a collaborative strategy ensuring alignment among global, regional, and local stakeholders. This often requires creating new structures, such as cross-functional teams, to proactively address national Market Access requirements. A unified strategy is crucial, particularly regarding data requirements for regulatory processes and EU HTA. Early alignment on necessary data and strategic coherence from the outset is key. 2. Early Market Access Planning: Market Access must be considered much earlier in the process, at a stage when the product label is not yet finalized. This introduces uncertainties, that can affect the PICO scoping and overall strategy. Companies should carefully consider initial label assumptions and allocate resources for updates as the label evolves. 3. National and Methodological Considerations: Diverse national requirements and methodological preferences, such as different approaches to indirect treatment comparisons, add complexity to the joint clinical assessment (JCA) dossier. Companies must navigate these variations and be ready for trade-off decisions.
CONCLUSIONS: Successfully navigating the EU HTA process requires early planning, strategic alignment, and cross-functional collaboration. Identifying challenges early and implementing solutions, such as aligning strategies and ensuring flexibility, is essential for successfully navigating the EU HTA process.