Implementation of the New European Health Technology Assessment Regulation (HTAR)

The new European Health Technology Assessment Regulation (HTAR), introduced in 2021, mandates a Joint Clinical Assessment (JCA) for specific medicinal products and therapies, beginning with cancer treatments and Advanced Therapy Medicinal Products (ATMPs) in 2025. The regulation represents a significant shift in EU health technology assessment by harmonizing clinical assessments across member states, aiming to streamline market access for innovative therapies and ensure early patient access.

The JCA process includes several steps: after filing a Market Authorization Application (MAA) with the EMA, companies will prepare a JCA dossier within a 100-day timeframe, using specific frameworks (PICO) set by assessors from different EU states. Challenges exist due to the extensive data requirements, including clinical, safety, and epidemiological information, which may strain company resources and extend preparation time. ProPharma suggests a structured approach to tackle HTAR requirements, involving training, technology-specific scoping studies, PICO workshops, and comprehensive JCA dossier planning.

The regulation also introduces Joint Scientific Consultations (JSCs), allowing companies to gain feedback from HTA bodies and EMA on clinical development plans, ensuring alignment with JCA expectations. While the HTAR seeks to facilitate a faster and more consistent European market entry for health technologies, companies must begin preparations early to navigate the complex requirements and tight deadlines.