EU HTA

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, Sciattella et al. shared the outcomes of the 2024 Italian Health Policy Forum, which explored how Italy is preparing for the implementation of the EU HTA Regulation 2021/2282.

On October 17, 2025, the European Commission adopted an implementing regulation that sets detailed procedural rules for Joint Clinical Assessments of medical devices and in vitro diagnostics under the HTA Regulation, which entered into force on 12 January 2025.

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, Boers et al. introduced the Common European Classification Grid (CEUGrid-DMD) and an Evidence Matrix to harmonize the evaluation of digital medical devices (DMDs) across the EU.

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, Eberle et al. explored whether the PICO elements (Population, Intervention, Comparator, Outcome) applied in EU Joint Clinical Assessments (JCAs) can be predicted across member states using publicly available data from national HTA bodies.

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, Pickaert analysed patient involvement practices in HTA across seven countries (Canada, England, Scotland, France, Germany, Spain, and Italy) to identify lessons for the EU Joint Clinical Assessment (JCA) framework.

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, Willemsen et al. analyzed the Dutch response to the EU Health Technology Assessment Regulation (HTAR), which took effect in January 2025.

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, Ivo et al. examined the evolution and future prospects of European-level cooperation in health technology assessment, focusing on the implementation of the EU HTA Regulation. The authors highlighted the critical role of harmonised methodologies and coordinated capacity building in overcoming national heterogeneity. The new regulation is expected to streamline assessments, improve efficiency, and accelerate equitable access to innovative health technologies across Europe.

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, Arcà et al. addressed the persistent challenge of integrating patient perspectives into PICO scoping for Health Technology Assessment (HTA) under the EU HTA Regulation. The authors proposed a structured framework based on the Delphi panel methodology to enhance the validity and transparency of patient contributions, facilitating structured engagement and consensus among patients and caregivers across Europe. This approach is designed to better align stakeholder expectations with HTA outcomes, and a study is currently underway to assess its practical feasibility.

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, Gupte et al. conducted a review of accelerated approval pathways for medical devices in the United States and the European Union. The authors found that while the US Breakthrough Devices Program granted marketing authorization to just 12.3% of 1,041 designated devices between 2015 and 2024, approval was achieved substantially faster than through standard routes. In the EU, where no specific accelerated pathway exists, newly introduced Medical Device and Health Technology Assessment Regulations aim to harmonize approvals, with joint clinical assessments set to begin in 2026. The authors highlight that aligning regulatory, funding, and coverage policies is essential for device accessibility, and call for global convergence of standards and post-market surveillance to balance innovation with patient safety.

On June 2, 2025, the submission period for Joint Scientific Consultations (JSCs) requests under the EU Health Technology Assessment Regulation (HTAR) framework opened. JSCs offer health technology developers the opportunity to seek scientific advice on the information and evidence required for a potential future Joint Clinical Assessment (JCA). Requests related to both medical devices and medicines can be submitted until June 30, 2025.

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, Fernandez et al. conducted a cross-European survey of Health Technology Assessment (HTA) bodies to map organizational diversity and assess progress toward harmonization. Their findings reveal substantial variation in agency structures and processes, but also a strong move toward collaboration, which is expected to accelerate with the implementation of the EU HTA Regulation in 2025. These developments are anticipated to drive mutual learning and more efficient technology adoption, ultimately benefiting patients across Europe.

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, Wang et al. conducted a survey and multi-stakeholder workshop to assess the readiness and strategic approaches of pharmaceutical companies regarding the Joint Clinical Assessment (JCA) under the new European HTA Regulation. Thirteen companies took part, reporting moderate preparedness for the JCA process (with readiness scores of 6–7 out of 10), but expressing concerns about uncertain timelines and challenges in integrating JCA outcomes into national processes. To support effective JCA implementation in national HTA decisions, the authors recommend creating a product-based scorecard for submission quality, increasing member state training, and promoting ongoing dialogue among key stakeholders.