The European Commission has taken a significant step towards a unified European benefit assessment of new medicinal products. The first implementing act for the EU HTA Regulation has been officially adopted and published in various national languages. This “Implementing Regulation” outlines critical details for the joint clinical assessments set to commence in January 2025. Additional five implementing acts are expected in the second half of 2024.
The active substances to be assessed at the European level from next year include newly approved cancer drugs and advanced therapy medicinal products (ATMPs). Already approved cancer drugs with expanded indications are not included. The Federal Joint Committee (G-BA), along with the Federal Ministry of Health and the Institute for Quality and Efficiency in Health Care, is involved in developing and implementing HTA assessments from 2025.
The first implementing act provides detailed regulations for the European HTA assessment process. This includes the exchange of relevant documents and information with the European Medicines Agency (EMA), interaction with health technology manufacturers, and the involvement of patient representatives and clinical experts. Based on the requirements of this implementing act, further methodological guidelines and detailed process descriptions are being developed.
European Commission ImplementingÂ
The Commission Implementing Regulation (EU) 2024/1381 of May 23, 2024, sets the framework for the joint clinical assessments under the EU HTA Regulation. This regulation is crucial for ensuring that all member states follow a standardized process, facilitating smoother and more consistent assessments of new medicinal products across Europe. By establishing uniform procedures and criteria, it aims to reduce duplication of efforts, enhance collaboration among member states, and ensure that patients have timely access to high-quality, innovative treatments.
The regulation promotes transparency and efficiency in the evaluation process, which can lead to better decision-making and resource allocation. This comprehensive approach not only benefits patients but also supports the pharmaceutical industry’s efforts to bring new therapies to the market more effectively. The implementation of this regulation represents a significant step towards achieving a more integrated and cooperative healthcare system across the European Union, ultimately improving public health outcomes.
The G-BA is actively participating in shaping the structures and processes required for the new European HTA system. In collaboration with the Federal Ministry of Health and the Institute for Quality and Efficiency in Health Care, the G-BA is preparing for the upcoming changes. From 2025, the G-BA will be involved in conducting HTA assessments, ensuring that Germany aligns with the new European standards.
From January 2025, newly approved oncology drugs and ATMPs will be subject to joint clinical assessments at the European level. This change aims to streamline the evaluation process for these critical medicines, ensuring timely access for patients across Europe. However, oncology drugs that have already been approved and are undergoing indication expansion will not be part of this assessment.
Five more implementing acts are anticipated in the latter half of 2024. These acts will further refine the processes and methodologies for joint clinical assessments. The phased introduction of these regulations is designed to provide a comprehensive framework, ensuring all aspects of HTA are covered.
European Commission Consultations and G-BA’s Advisory Role
The G-BA continues to offer advisory services during the transition period leading up to the full implementation of the EU HTA Regulation. The European consultations provide a central contact point for parallel consultations by EMA and HTA agencies across Europe. These consultations aim to harmonize the evaluation processes and ensure a seamless transition to the new system.
The adoption of the first implementing act for the EU HTA Regulation marks a crucial milestone in harmonizing health technology assessments across Europe. By establishing a unified process, the regulation aims to enhance transparency, improve patient access to innovative treatments, and strengthen European competitiveness in the pharmaceutical sector.
Resource: Â Gemeinsame Bundesausschuss, May 27, 2024
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