EU HTA

On March 4, 2025, the Member State Coordination Group on Health Technology Assessment (HTACG) published submission (‘briefing’) templates for Joint Scientific Consultations (JSC) of medical devices and in-vitro diagnostics under the EU HTAR framework. Health Technology Developers submit completed briefing templates as part of the briefing package to be considered for JSC. The JSC Outcome Document template was published as well.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Gsteiger et al. explored the conceptual divergence between “technology assessment” and “technology appraisal” in the context of the new EU HTA Regulation. The authors advocated for a clearer distinction between scientific evaluation and value judgments to ensure effective implementation and avoid ambiguity. The study emphasized the importance of transitioning from centralized assessments to national-level appraisal processes that reflect local value judgments and uncertainties.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Gentilini et al. critically examined the European Commission’s 2024 Implementing Regulation on conflict-of-interest management in the EU Joint Clinical Assessment (JCA). A review of national HTA policies showed that the new conflict-of-interest management approach is largely modeled after French HTA guidelines. The authors identified concerns related to expert representativeness, disclosure clarity, and enforcement challenges. These findings highlighted the need for greater transparency and resource allocation to ensure an impartial assessment process.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Urbina et al. analyzed the EUnetHTA 21 project, a European initiative designed to support the implementation of Regulation (EU) 2021/2282 on Health Technology Assessment (HTA). Conducted by 13 European HTA bodies, the project resulted in 20 guidance documents, 13 templates, and pilot Joint Clinical Assessments (JCAs) aimed at refining evaluation methods. The study highlights the importance of structured collaboration and regulatory preparedness, providing a roadmap for the future integration of HTA at the EU level.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Schweitzer et al. explored the suitability of the current German HTA dossier templates for the impending EU joint clinical assessment (JCA). The study examined how extensively safety endpoint and subgroup analyses in German dossiers were actually considered by IQWiG and the G-BA. The authors found that the current German HTA templates significantly increased the workload of HTA developers while leaving many reported outcomes unconsidered by IQWiG and G-BA. To mitigate duplicative efforts and ensure prompt availability of medicinal products in line with the EU HTA Regulation framework, the authors recommend well-defined dossier requirements, early consultations, and proactive engagement with HTA developers.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Volker S. examined the 2022 EU HTA regulation and its activities, including Joint Clinical Assessment, Joint Scientific Consultations, and Horizon Scanning. While the regulation aims to harmonize clinical data assessments and reduce duplication, concerns persist about increased bureaucracy and delays in market access. The study highlighted the potential threats and opportunities for manufacturers and national affiliates, offering insights into the evolving European HTA landscape.

On January 24, 2025, the European Commission adopted an implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices under the EU HTAR framework.

Starting January 12, 2025, Norway joined the EU Health Technology Assessment Regulation (HTAR) framework, a collaborative European initiative for method assessments. In 2024, a national working group assessed how to integrate HTAR into the "New Methods" framework. The Norwegian Medical Products Agency (NOMA) will be the key organization representing Norway and contributing to the development of Joint Clinical Assessments (JCAs) of medicines and medical devices.

On December 3, 2024, the Member State Coordination Group on HTA released the 2025 Annual Work Programme for the new joint EU-level HTA framework (Regulation on Health Technology Assessment, HTAR). The framework will be fully operational from January 12, 2025.