Publications Digest

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, Siontis et al. conducted a systematic review of the clinical evidence supporting 71 high-risk cardiovascular devices before and after market access in the European Union (CE-marking) between 2000 and 2021. The authors aimed to assess the quantity and quality of published studies, revealing a notable insufficiency in publicly available data and a lack of randomized clinical trial data published before CE-mark approval, with most studies being non-randomized and conducted in small populations without the provision of power calculations.

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, Garcia Gonzalez-Moral et al. conducted a mapping review to identify various methodologies employed in horizon scanning (HS) and foresight practices for medical technology (MedTech) innovation, with a specific focus on informing healthcare decision-making. The authors uncovered 25 distinct methods of HS, emphasizing the prevalence of combined approaches. Their findings underscored the necessity for greater transparency and consistency in methodologies to enhance the quality and timeliness of decision-making processes in the field of MedTech.

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, Graili et al. reviewed the comprehensive integration of real-world evidence (RWE) drawn from diverse sources of real-world data (RWD) within the health technology assessment (HTA) process. The authors examined the potential challenges and barriers that impede the widespread incorporation of RWE in routine HTA practices. The study sheds light on the effective utilization of RWE, offering insights into the strategic application of RWD at different stages of the HTA process, thus advocating for a more robust and inclusive approach to evidence-based decision-making in healthcare.

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, Hulstaert et al. investigated the level of evidence supporting innovative high-risk medical devices (class IIb-III) during their market entry phase. The authors reviewed assessment reports from the Belgian healthcare payer (RIZIV-INAMI) concerning novel implants and invasive medical devices (n=18) available between 2018 and mid-2019 and conducted a literature review on evidence gaps within the European legal and ethical frameworks. The findings highlighted issues with the evidence provided for CE marking, indicating that clinical effectiveness is not ensured by regulatory compliance alone. The study underscored the necessity for improved clinical evidence transparency and alignment with international ethical standards to ensure patient safety and efficacy in the realm of novel medical devices.

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, Schaefer et al. assessed the effect of official evaluation criteria, including the role of budget impact (BI), on health technology assessment (HTA) outcomes employed by the Federal Joint Committee (G-BA), Institute for Quality and Efficiency in Health Care (IQWiG) in Germany, and National Institute for Health and Care Excellence (NICE) in England. Analyzing data from 2011 to 2018, the authors underscored the consistent adherence of G-BA/IQWiG and NICE to official evaluation criteria while also revealing an independent influence of BI on HTA outcomes, potentially carrying implications for health policy decisions.

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, Edgar et al. introduced Performance Outcome assessments as a valuable tool that indirectly assesses the meaningful aspects of health for evaluating the clinical benefit of therapeutic interventions. These assessments involve standardized tasks actively undertaken by patients, reflecting their various important functional skills, especially when self-report is limited, or heterogeneity is a concern. However, the authors underscored the importance of adhering to established good practice recommendations for other clinical outcome assessment types, which remain directly applicable.

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, Manetti et al. developed a novel framework for assessing readiness in successful Medical Device (MD) development and deployment. Through a four-stage process, the authors developed and validated checklists for both small (21 items) and large (15 items) enterprises. The study identified three key drivers of MD success: R&D assessment strategy, device-outcome measures, and company profiling. Additional retrospective validation with 40 case studies on MDs highlighted the crucial role of early Health Technology Assessment in industry success, varying by enterprise size.

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, Solà-Morales et al. proposed recommendations for international standards in evaluating the acceptability of data governance practices for real-world data (RWD) and real-world evidence (RWE) in healthcare. Through a literature review and the following Delphi panel with 21 European experts, the authors identified key topics in RWD/RWE data governance, such as data privacy and security, data management and linkage, data access management, and the generation and use of RWE. The resulting refined checklist can assist RWD/RWE users in ensuring the quality and integrity of data governance while complementing data protection regulations.

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, Angelis et al. appraised the methodological changes proposed by the National Institute for Health and Care Excellence (NICE) in their recent review of HTA methods. The authors categorized proposed changes as critical, moderate, or limited updates and analyzed key decisions. The study found that most changes were appropriate and had a modest impact, although some decisions lacked justification. The authors emphasize the need for further research on certain topics and the importance of safeguarding NICE's role in resource allocation for valuable interventions while maintaining rigorous evidence standards.

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, Martin et al. calculated the marginal cost per quality-adjusted life year (QALY) for different categories of care (primary care, locally commissioned secondary care, specialised services) using the data from 2016 and analysed the mortality response to healthcare expenditure on the three categories of care. The results revealed that additional investments in primary care and locally commissioned services are likely the most productive, suggesting the potential benefits of directing resources towards these categories of care.

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, Tervonen et al. aimed to establish good practices for developing rigorous quantitative benefit-risk assessments (qBRAs) and provide a checklist for their reporting. The study outlines the five main steps of qBRA development, including formulating the research question, selecting appropriate analysis models, evaluating attribute sets, choosing preference elicitation methods, and effectively communicating the results. In addition, the authors provided recommendations on each step and discussed suitable methods for preference elicitation, such as discrete choice experiments, threshold technique, and swing weighting.

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, Albuquerque de Almeida et al. studied the regulatory framework differences between medical devices and drugs in the European Union and their impact on clinical and HTA research. The authors identified varying approval standards for devices and drugs as well as fewer manufacturer-sponsored clinical studies and HTA-supported recommendations for medical devices compared to drugs. The study concludes that policy changes, such as the consensual classification of medical devices from an HTA perspective and the adoption of conditional coverage practices, could promote an integrated evidence-based assessment system and improve resource allocation in healthcare.