Saturday, April 20, 2024

Navigating the Future of EU Health Technology Assessment: The Draft Joint Clinical Assessment Implementing Act Unveiled

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The unveiling of the draft Implementing Act (IA) for the Joint Clinical Assessment (JCA) of medicinal products marks a significant milestone in advancing the European Health Technology Assessment (HTA). This draft, eagerly awaited, aims to clarify the operational aspects of the EU HTA process under the Health Technology Assessment Regulation (HTAR), addressing critical questions about timelines, scoping, and stakeholder engagement that were previously left open by the EUnetHTA 21’s guidance. This examination sheds light on the modifications introduced in the IA, the areas that remain unexplored, and strategies for navigating the Health Technology Assessment landscape post-2025.

Delays by the European Commission’s Health Technology Assessment committee pushed the publication of this first IA to March 5th, 2024, despite initial expectations for a December 2023 release. Open for public feedback until April 2nd, 2024, this draft is the precursor to the remainder of the IAs, setting the stage for the regulation’s implementation from January 12th, 2025.

The draft IA elaborates on the JCA process’s initiation, stakeholder interaction, expert selection, and the mechanics of dossier submission and assessment creation, leaning on the foundation laid by previous EUnetHTA actions. While outlining procedural regulations, it leaves methodological details to future guidance from the Methodological and Procedural Guidance (MPG) Subgroup.

Key Updates and Unresolved Questions in the JCA Draft

Key updates in the draft include greater involvement of health technology developers (HTDs) in the assessment process, formalized expert and stakeholder consultation, and specified timelines for various stages of the JCA. The dossier submission requirements and the structure of the JCA report have been refined, with explicit expectations for incorporating patient registry searches and reporting potential data updates relevant to the assessment.

However, certain aspects, such as the exact commencement of the JCA process and the utilization of provided information for scoping, remain ambiguous. The provided dossier template and the approach to handling confidential information in the JCA report also raise questions, underlining the need for a nuanced strategy from HTDs.

Health Technology Assessment

The Road to a New Era of Health Technology Assessment in Europe

Looking ahead, this draft IA is just the beginning of a more transparent and structured Health Technology Assessment process in the EU. Despite its preliminary nature, it necessitates meticulous planning from HTDs, particularly in anticipating PICO requests and aligning with regulatory teams. The forthcoming guidance from the MPG subgroup is expected to further clarify methodological standards.

HTDs must now adapt to tighter timelines and more rigorous evidence requirements, emphasizing the importance of early and strategic stakeholder engagement. As the JCA process evolves, monitoring its impact on local submissions and the broader regulatory landscape will be crucial for ensuring seamless integration into the new Health Technology Assessment framework. This phase of preparation and adaptation is pivotal, laying the groundwork for successfully navigating the complexities of the JCA process and facilitating a smoother transition to this new era of HTA in Europe.

 

Resource: IQVIA, March 19, 2024

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