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Publications Digest

23
Feb 2024

Publication Digest: Digital health applications from a government-regulated directory of reimbursable health apps in Germany – a systematic review for evidence and bias

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, Dittrich et al. conducted a systematic review to assess the evidence quality and manufacturers' approaches regarding digital health applications (DiGA) in Germany following the Digital Healthcare Act. The results revealed evidence-related gaps, such as the relatively low quality of most of the available studies for inclusion in the DiGA directory with high potential for bias and limited external generalizability. The authors highlighted the need for addressing found evidence gaps and further studies of higher quality to improve the evidence base concerning the benefits of prescribable apps.
19
Feb 2024

Publication Digest: Utilization of innovative medical technologies in German inpatient care: does evidence matter?

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, Eckhardt et al. investigated the evolution of clinical evidence and the utilization of 25 innovative technologies in German inpatient care. Through systematic searches and empirical analysis, the authors revealed that the body of clinical evidence per technology often consisted mainly of non-comparative studies, and its robustness increased over time for many but not all technologies. The results highlighted the need for strengthened market approval standards, HTA pathways, and approaches like coverage with evidence development to ensure informed reimbursement decisions.
16
Feb 2024

Publication Digest: Evolving Use of Health Technology Assessment in Medical Device Procurement-Global Systematic Review: An ISPOR Special Interest Group Report

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, Cangelosi et al. conducted a systematic review to assess how data from health technology assessments (HTAs) informs procurement decisions for medical devices. By synthesizing evidence from 11 relevant studies, the authors aimed to identify the criteria used in purchasing decisions, highlighting the minimal evidence of HTA influencing procurement. The authors emphasized the unmet need for enhanced transparency, incentivization for publishing procurement-related work, and further research to strengthen the connection between HTA and procurement, ultimately aiming to optimize resource allocation and expand access to innovative medical technologies within healthcare systems.
13
Feb 2024

Publication Digest: Covering digital health applications in the public insurance system: how to foster innovation in patient care while mitigating financial risks-evidence from Germany

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, Groene et al. conducted a comprehensive evaluation of Germany's pioneering policy to include digital health applications in the statutory health insurance system, aiming to assess its impact, highlight challenges, and propose prospective policy options. Through analysis of publicly available data from the Federal Institute for Drugs and Medical Devices and empirical findings published by academic institutions and sickness funds, the authors delineated areas for improvement, such as low prescription rates and temporary reimbursement of applications that lack proven benefit. The authors advocated for value-based pricing and increased budget authority for insurance organizations to foster innovation while ensuring optimal resource allocation in healthcare.
09
Feb 2024

Publication Digest: HB-HTA focus in a tertiary hospitals' network in Northern Italy: A three-years experience 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, Sharma et al. investigated the state and adoption of Hospital Based Health Technology Assessment (HB-HTA) in hospital management. By administering questionnaires to healthcare professionals, the authors aimed to assess HTA knowledge and analyze perspectives. The results revealed a notable interest in HB-HTA as a strategic tool for supporting clinical and organizational decision-making processes, particularly in the evolving healthcare landscape of Italy with increased funds from the National Recovery and Resilience Plan (NRRP).
05
Feb 2024

Publication Digest: Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium

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.
02
Feb 2024

Publication Digest: Looking at the fringes of MedTech innovation: a mapping review of horizon scanning and foresight methods

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.
30
Jan 2024

Publication Digest: Integration of real-world evidence from different data sources in health technology assessment

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.
29
Sep 2023

Publication Digest: Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions

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.
28
Sep 2023

Publication Digest: Health Technology Assessment-Informed Decision Making by the G-BA/IQWiG in Germany and NICE in England: The Role of Budget Impact

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.
25
Aug 2023

Publication Digest: Recommendations on the Selection, Development, and Modification of Performance Outcome Assessments: 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, 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.
21
Aug 2023

Publication Digest: Development and validation of Medical Device Key Evidence Tool ('MeDKET'): An evidence-based framework to explain success in selected European and US companies

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.