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HTA Quarterly Summer 2025

In this edition, our experts explore the health technology assessment (HTA) process and policies in Japan, describe early access program (EAP) pathways in France (in the first of a three-part series of articles on this topic), and consider potential impacts of the Joint Clinical Assessment (JCA) and Project Orbis on revenue generation for new medicinal products in oncology.

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Early Access Program in France: How much of an opportunity is it?

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HTA in Japan: The glass remains half full (for now)

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New opportunities for medicines in Europe? How JCA and Project Orbis may impact the revenue potential of innovative medicines

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Heard on the street

“If the JCA could help build a European market, accelerating the process and allowing developers to save one or two years after marketing approval, that is what would attract investment in clinical trials in Europe.”

- Stefano Benvenuti, Head of Public Affairs and Market Access, Fondazione Telethon, on the potential of the JCA to promote a competitive life sciences sector in Europe.

Source: Event Report--The First Joint Clinical Assessments for ATMPs: What's Next?

HTA by the numbers

2 of 25

The European Commission recently announced that the first two Joint Clinical Assessments (JCAs) are underway, evaluating a medicinal product for the treatment of pediatric low-grade glioma (led by health technology assessment [HTA] agencies from Ireland and Germany) and an advanced therapy medicinal product (ATMP) for the treatment of melanoma (led by HTA agencies from France and Poland). The Member State Coordination Group on HTA (HTACG) has previously estimated that 25 JCAs will be started in 2025.

Source: Health Technology Assessment: First Joint Clinical Assessments Begin

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