Learnings from National HTA Reviews and Methodological Recommendations
Following the entry into force of the EU HTA Regulation, Advanced Therapy Medicinal Products (ATMPs) will undergo EU Joint Clinical Assessment (JCA) starting in 2025. Due to their unique and transformative nature, ATMPs require fit-for-purpose methodologies that are different from the review processes designed for traditional pharmaceuticals. If the EU HTA process does not modernize its approach, the reviews will fail to capture the clinical value of ATMPs and jeopardize patient access to transformative therapies in the coming years. Such an outcome would call into question the value of the JCA process.
