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, 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.

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, Merész et al. examined the implementation of the EU HTA Regulation from the perspective of public health decision-makers in Central European member states. Their study highlighted both opportunities for enhanced cooperation and challenges related to timelines and scope differences across member states. The authors concluded that while foundations for successful collaboration exist, policymakers and payers must share the responsibility of acting as drivers of change in health policy to reduce duplication of efforts by health technology 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, Pannelay et al. explored the evolving challenges of implementing the EU Health Technology Assessment Regulation, highlighting the burden of aligning national PICO requirements across Member States. The study showed that up to 720 evidence analyses per product may be required ‒ covering various permutations of population, comparator, and outcome ‒ raising serious concerns about feasibility and submission quality. The article also presented a user guide for applying generalized cost-effectiveness analysis to better capture societal value and examined the ongoing debate over NICE’s implementation of the severity modifier tool in the UK.

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, Sarri et al. investigated the methodological alignment between EU joint clinical assessments and national HTA requirements in France, Germany, The Netherlands, and Spain. While the study found strong consensus on the need for systematic evidence generation, national agencies diverged in their guidance on evidence derived from indirect treatment comparisons. These findings highlight the challenges health technology developers face in meeting both EU-wide and local evidentiary demands.

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, Julian et al. investigated how EU stakeholders perceive key challenges in implementing EU Regulation 2021/2282 on Health Technology Assessment. Drawing on survey data and structured discussions at the 2024 European Access Academy, the authors found that 65.5 % of respondents reported insufficient expert involvement in joint assessments, only 37.9 % anticipated faster national decision-making, and views on conflict-of-interest transparency were mixed. Stakeholders prioritized earlier and broader expert engagement, stronger EMA–EU HTA coordination, and increased national-level support.

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, Goetz et al. examined where EUnetHTA guidance documents require further methodological clarity in light of the upcoming EU HTA regulation. Through a systematic document review and structured stakeholder discussions conducted in Austria, the authors identified 32 key areas in need of refinement ‒ primarily related to evidence synthesis and eligibility criteria. Drawing on established HTA and evidence synthesis handbooks, the authors proposed concrete methodological options, offering actionable insights to support implementation across EU member states.

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, Tanner et al. examined key cross-functional challenges stemming from Joint Scientific Consultations (JSC) and Joint Clinical Assessments (JCA) and how manufacturers should address them in their EU HTAR readiness plans. Conducted through literature review, guidance analysis, and manufacturer insights, the study identified five key cross-functional areas: global asset strategy, non-EU regional readiness, launch sequence evolution, brand perception, and pricing impacts. Given the central role of market access in bringing innovation to patients, the EU HTAR will have far-reaching implications, with early Joint Clinical Assessment reports expected to significantly influence brand strategy, pricing dynamics, and global launch sequencing.