Presentation (CTI)

OBJECTIVES: The EU Health Technology Assessment Regulation (HTAR) introduces parallel Joint Scientific Consultations (pJSCs) to streamline evidence generation for Joint Clinical Assessments (JCAs) and Marketing Authorisation Applications (MAAs) starting in 2025. This work outlines critical internal considerations for health technology developers (HTDs) to effectively engage in pJSCs, emphasizing the role of a structured internal decision framework.
METHODS: This conceptual analysis synthesizes essential considerations for HTDs based on the EU HTAR framework, published guidance, internal expert interviews and industry discussions. Considerations are categorised across organizational, strategic, and operational dimensions to identify best practices for pJSC preparedness including a framework to support the selection of health technologies for pJSC.
RESULTS: Successful pJSC engagement necessitates significant internal adaptations for HTDs. Organizational readiness involves clear frameworks for product selection, aligned with published pJSC eligibility and selection criteria, strategic considerations to support internal timelines and decision making for early evidence generation and briefing package preparation. This demands strong cross-functional collaboration during early product development by co-leadership from Access and Regulatory. Procedural and strategic aspects include internal processes for timeline management, coordination with parallel EMA scientific advice and other local early payer scientific advice. Early integration of market access insights is crucial for PICO refinement, informing diverse Member State evidence generation needs that serve regulatory and HTA assessments. HTDs should also develop a comprehensive implementation strategy that balances requirements from HTA and regulatory bodies, addresses potential divergent positions, and maintains a sustainable clinical development plan.
CONCLUSIONS: Internal capabilities, pre-defined processes and roles and responsibilities, with co-leadership from Access and Regulatory, are the basis for the organizational readiness and successful implementation of the pJSC. This internal readiness facilitates robust evidence generation, leading to more aligned and efficient HTA and regulatory submissions across EU member states, ultimately accelerating patient access to innovative therapies.