EU HTA Publication Digest: EU HTA Regulation and Joint Clinical Assessment—Threat or Opportunity?

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Value-based Publications Digest. In a recent publication, Vogler et al. proposed fit-for-purpose policy recommendations based on the analysis of current funding and pricing structures for point-of-care tests (POCTs) for community-acquired acute respiratory tract infections across Europe. The authors aimed to improve antibiotic prescribing for respiratory infections by enhancing the uptake of POCTs. The study suggested several funding policy and pricing-related recommendations ‒ such as physician-focused remuneration models, public reimbursement coverage, and strategic procurement approaches ‒ which can substantially boost the implementation of rapid diagnostic tools in outpatient settings.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Sustainability Publications Digest. In a recent publication, Haluza et al. conducted an exploratory survey at the General Hospital in Vienna, Austria, to assess anesthesia team members’ perspectives on precycling and recycling of anesthetic gases. The study revealed a generally positive attitude toward adopting sustainable practices, suggesting a strong potential for reducing volatile anesthetic use through active staff engagement.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Health Economic Publications Digest. In a recent publication, Cocco et al. applied early economic modeling to establish target product profile specifications based on cost-effectiveness considerations, helping developers define key test performance criteria. The authors used the example of a novel rapid diagnostic for Clostridioides difficile infection in the UK setting. The study underscores how well-defined target product profiles can guide diagnostic test development to address pressing clinical needs.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Buccheri et al. explored the challenges of conducting randomized controlled trials (RCTs) for high-risk medical devices, emphasizing the added complexities of intervention costs, patient randomization, and blinding processes. Drawing on experience from the CORE-MD project and large-scale pharmaceutical trials during the COVID-19 pandemic, the authors highlighted the potential of large simple RCTs for high-risk medical devices. These trials leverage routine healthcare data to improve efficiency, reduce costs, and accelerate patient recruitment while maintaining robust clinical evidence.

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.