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Multistakeholder perspectives on Joint Clinical Assessment in Europe

By AmerisourceBergen

What are the opportunities and challenges for improving patient access to new treatments?

Article based on an interview published on The Evidence Base on June 19, 2023.

The Regulation (EU) 2021/2282EN on health technology assessment (HTAR) came into effect in January 2022 and, when fully applied from January 2025, is set to transform HTA in Europe. To be implemented under this regulation, the Joint Clinical Assessment (JCA) process aims to streamline the assessment process of new medical treatments and devices across Europe with the ultimate goal of improving patient access to novel therapies.

The JCA framework, though not yet finalized, has a clear implementation timeline. It will become mandatory for oncology drugs and advanced therapy medicinal products (ATMPs) in January 2025, followed by orphan drugs in January 2028. By January 2030, all drugs registered with the European Medicines Agency (EMA) will be required to undergo the JCA process. During the pilot phase until 2024, the Coordination Group, comprising one representative per EU member state, is working on establishing formal and methodological guidance.

In an interview with The Evidence Base, Herbert Altmann, Head of Commercialization and Access Solutions Europe, PharmaLex, Tommy Bramley, Senior Vice President, Global Consulting and Market Access, AmerisourceBergen, and Casper Paardekooper, partner at the strategic consultancy Vintura, discuss the JCA framework, its timeline for implementation, how it will streamline the HTA process and help address health inequalities in Europe, what are the risks and opportunities ahead, and the key requirements to meet the needs of the different EU member states.

Over the next 5-10 years, the JCA is expected to significantly impact HTA in Europe, but its success will depend on addressing existing complexities and gaining support from all stakeholders in the healthcare system. By reducing disparities and improving speed-to-market, the JCA has the potential to enhance patient access to essential medications across the EU. Click here to read the full interview and learn more.

Joint Clinical Assessment in Europe

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The EU JCA process: Opportunities and challenges in bringing innovative medicines to patients in Europe

During this panel discussion healthcare system  experts from AmerisourceBergen, the European Federation of Pharmaceutical Industries and Associations (EFPIA), MSD, PharmaLex, and Vintura, will explore the JCA process and efforts to ensure timely access to innovative healthcare products within this new framework. The discussion will consider the challenges and opportunities presented by the JCA and the potential next steps to best prepare Pharma & Biotech companies to manage the new process.