The EU’s Health Technology Assessment Regulation (HTAR), which kicked off in January 2025, has launched joint clinical assessments (JCAs) for oncology and advanced therapies; yet six months in, implementation remains rocky, communication is patchy, and the wider impact on access and innovation is still murky. Writing in DIA’s Global Forum magazine, Grammati Sarri, Lilia Leisle, Ben Rousseau, Wyatt Gotbetter, Holger Müller, and Ingrid Claverie Chau explore how, although up to 25 JCAs may roll out this year, only three oncology products are currently in process, while the Commission is hustling to support member states in adapting and integrating JCA findings at the national level.
The implementation of the EU Health Technology Assessment Regulation (HTAR) in January of 2025 marks a new era of joint scientific consultations (JSC) and joint clinical assessments (JCA) for products seeking market access in Europe. Six months in, the transition remains challenging. The broader implications across the healthcare ecosystem are still unclear regarding the impact of the HTAR on time to patient access, innovation, and the adoption of findings or related assessment mechanisms in other jurisdictions and regions.
The initial implementation of the regulation focuses on oncology and advanced medicinal therapies, such as cell and gene therapy and medical devices, with rare diseases to be added in 2028; the regulation will be expanded to include all therapies in 2030. The HTAR aims to harmonize clinical comparative assessments across EU Member States, seeking to reduce duplication of effort for both HTA bodies and manufacturers, improve efficiency in the process and, ultimately, accelerate access and improve equity to innovative therapies for citizens in the EU. How has our knowledge of this new era of JCA evolved as we entered the first year of real-life implementation?
Six Months In: What’s Happening on the Ground?
Three products—all in oncology indications—are officially moving through the JCA process (Table 1), although the EU stated that up to 25 JCAs may be initiated in the first year; official communication remains fragmented and, in some instances, an enigma. Operationally, the European Commission is intensively preparing to support EU Member States to adapt to this new regulation, not only in their responsibility to support bodies acting as assessors and co-assessors, but also to integrate the findings of JCAs into national healthcare decision-making.
Manufacturers and other stakeholders have been eagerly anticipating further announcements relating to JCA and local HTA alignment challenges and local methodological innovations to integrate the requirements; however, the recent EU HTAR workshop in July fell short of addressing these issues. The communication at the workshop was restricted to the ongoing operational and financial challenges of individual Member States to acclimatize to the new regulation, particularly for smaller countries with less-established HTA frameworks, as well as a description of the preparatory activities in terms of staff training and pilot assessments.
