Q&A Interview: Navigating The Launch Of ATMPs In Europe

In the rapidly evolving landscape of Advanced Therapy Medicinal Products (ATMPs) in Europe, staying abreast of regulatory changes and market access dynamics is crucial for developers aiming to bring innovative therapies to patients in need.

Considering the imminent impact of the EU Health Technology Assessment (HTA) on ATMPs and oncology drugs, starting January 2025, Cencora experts Lung-I Cheng, Vice President and Head of Cell and Gene Therapy, and Herbert Altmann, Vice President of Market Access and Healthcare Consulting, shed light on the upcoming shifts in regulation and the strategies essential for successful navigation.

The EU HTA regulation and Joint Clinical Assessment (JCA) process aim to eradicate access disparities, streamline procedures, and foster innovation within the pharmaceutical sector. Given that ATMPs encounter distinct challenges in evidence generation and market access, understanding these changes is paramount.

Providing an overview of the European Union's new health technology assessment (HTA) regulation and Joint Clinical Assessment (JCA) process, Cheng and Altmann discuss the overarching objectives of EU HTA-R and delve into the key criteria used to assess pharmaceuticals in Europe, variations across member states, and the pivotal role of HTAs in determining reimbursement and market accessibility, in particular for ATMPs.

ATMPs pose a unique challenge due to their genetic-, tissue-, or cell-based nature. As treatments primarily aimed at rare diseases with European Medicine Agency (EMA) approval status, they face hurdles related to clinical trial design complexities leading to discrepancies in value compared to standard care options. The high cost associated with ATMPs further complicates pricing decisions and raises concerns about healthcare system affordability.

Watch the interview to gain a comprehensive overview of the evolving regulatory landscape and better understand the importance of proactive planning, collaboration, and expert guidance in navigating the dynamic ecosystem of ATMPs in Europe.