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Publications Digest

12
Jul 2023

Publication Digest: Quantitative Benefit-Risk Assessment in Medical Product Decision Making: A Good Practices Report of an ISPOR Task Force

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.
10
Jul 2023

Publication Digest: Different regulatory framework for medical devices and drugs in the European Union: Impact on clinical research and health technology assessments

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.
07
Jul 2023

Publication Digest: Remote Patient Monitoring: What Have We Learned and Where Are We Going?

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.
05
Jul 2023

Publication Digest: Are current clinical studies on artificial intelligence-based medical devices comprehensive enough to support a full health technology assessment? A systematic review

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.
03
Jul 2023

Publication Digest: Time to publication of cost-effectiveness analyses for 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, 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.
07
Jun 2023

Publication Digest: Private health insurance in the universal public healthcare system: The role of healthcare provision in Finland

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.
05
Jun 2023

Publication Digest: High-energy devices in different surgical settings: lessons learnt from a full health technology assessment report developed by SICE (Società Italiana di Chirurgia Endoscopica)

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, Vettoretto et al. conducted a Health Technology Assessment in Italy to evaluate the potential benefits of high-energy devices (HEDs) compared to standard monopolar or bipolar devices in various surgical settings. By using various methods, such as literature review, questionnaires, and health-economic tools, the study found that HEDs could lead to reductions in operating time and length of stay, as well as generate significant organizational savings. The authors highlighted the strategic relevance, economic sustainability, and process improvement potential of HEDs in surgical practice.
02
Jun 2023

Publication Digest: Analytical Frameworks and Outcome Measures in Economic Evaluations of Digital Health Interventions: A Methodological Systematic Review

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, Benedetto et al. conducted a systematic review to evaluate the analytical frameworks and outcome measures used in economic evaluations of digital health interventions (DHIs). By synthesizing arguments from 15 studies, the authors identified limitations in using traditional health-related quality of life measures and proposed a set of methodological recommendations, including the use of impact matrices, cost-consequence analysis, and analyses of equity impacts. This review provides valuable insights for future economic evaluations of DHIs and advances the understanding of measuring their effects beyond health outcomes.
31
May 2023

Publication Digest: Suitability of Preference Methods Across the Medical Product Lifecycle: A Multicriteria Decision Analysis

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, Veldwijk et al. conducted a study to assess the importance of criteria describing methods for decision-makers in the medical product lifecycle (MPLC) and evaluate the suitability of various preference elicitation methods at each decision point. Using multicriteria decision analysis, an online survey was conducted among MPLC decision makers, who ranked and weighted 19 methods criteria. The results showed that criteria related to estimating trade-offs and weights for treatment characteristics were consistently important across all MPLC decision points. Additionally, swing weighting and probabilistic threshold techniques were found to be more suitable than other methods. The study highlights the need to consider other preference elicitation methods and suggests the development of evidence-based guidelines for their effective utilization.
29
May 2023

Publication Digest: The implementation of the 2017 national policy on patient-reported outcomes in Denmark: An overview of developments after six years

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, Egholm et al. investigated the implementation of a national patient-reported outcomes (PRO) policy in Denmark which aims to enhance patient-centered approaches in healthcare and realize benefits at the individual patient level. The paper outlines the three key elements: developing standardized PRO instruments within specific clinical areas, establishing a PRO instrument repository, and creating a national IT infrastructure for data sharing. Furthermore, the authors provided an overview of the progress made after six years of implementation, highlighting the promising value of PRO instruments for both patients and healthcare professionals, as well as challenges in operationalizing the IT infrastructure and implementation across healthcare sectors.
26
May 2023

Publication Digest: Best Practices: A Collection of Systematic Critical Reviews of Modeling Approaches in Specific Disease Areas

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, Caro noted the increasing use of models to forecast disease outcomes and intervention effects, particularly highlighted during the COVID-19 pandemic. To address the need for validation and systematic critical review of increasing numbers of models, the journal Pharmacoeconomics is launching a series of papers focusing on critical reviews of modeling approaches in specific disease areas, including pharmaceutical and non-pharmaceutical interventions, as well as diagnostic procedures. The short introduction outlines the scope and coverage of the review papers in the series.
24
May 2023

Publication Digest: Living Health Technology Assessment: Issues, Challenges and Opportunities

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, Thokala et al. introduced the concept of “Living Health Technology Assessment (HTA)”, which is considered to be an approach to address the issue of outdated reports by establishing a process for regular updates. The authors described the practical implementation of the “living HTA” approach including the challenges and considerations involved and highlighted scenarios where “living HTA” could be especially advantageous.