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, 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.

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, Vandenberk et al. reviewed the topic of remote monitoring (RM) of cardiac implantable electronic devices (CIEDs). The publication discusses the clinical benefits of RM, which include improved survival, early detection of actionable events, and more efficient healthcare utilization. The authors emphasized the need for appropriate reimbursement for RM device clinics and the implementation of universal alert programming and data processing to optimize patient care and device clinic workflows. The study concluded that RM should be considered the standard of care for managing patients with CIEDs and implementing adapted healthcare policies to ensure its future manageability.

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, Farah et al. conducted a systematic literature review to investigate the acceptability of current studies assessing Artificial Intelligence-based Medical Devices (AI-based MDs) for health technology assessment (HTA) purposes. The authors found that AI-based MDs studies lack robust and complete evidence, with limited data on safety and economic issues. The study emphasizes the need for standardized evaluation models, reliable evidence generation, and adjustments in HTA processes for AI-based MDs. In addition, the study suggests a number of measures to improve the quality of evidence for AI-based MDs.

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, Everhart investigated the availability of cost-effectiveness analyses (CEAs) for medical devices in the United States. By analyzing data from the Tufts University Cost-Effectiveness Analysis Registry, the author identified 218 CEAs published between 2002 and 2020. On average, these CEAs were published 4 to 6 years after FDA approval or clearance of the studied devices. The findings suggest that decision-makers often lack timely evidence of cost-effectiveness when making initial reimbursement decisions regarding newly available 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, Lavaste investigated the relationship between primary care provision and the uptake of voluntary private health insurance (VPHI) in Finland. By analyzing the data obtained from the national registry and incorporating data on healthcare provider proximity and reimbursement fees, the study reveals that sociodemographic factors (employment, levels of income and education) and patients’ preference are key factors in VPHI uptake and not the (dis)satisfaction with the care provision in public settings. Furthermore, proximity to private (but not public) healthcare providers supports VPHI uptake.