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Early value dossiers for medical technologies

The essential tool to understand the value proposition for your product and position it well with reimbursement/HTA stakeholders

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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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3D printed implants
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Ambulatory ECG monitoring
Aortic abdominal aneurysm
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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.

Access the full-text article here.

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Publications Digest

The latest related news

22
May 2024

Publication Digest: Real-world data: a comprehensive literature review on the barriers, challenges, and opportunities associated with their inclusion in the health technology assessment process

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, Zisis et al. conducted a systematic literature review to assess the current use and acceptance of real-world data (RWD) and real-world evidence (RWE) in health technology assessment (HTA) processes. The authors aimed to discern stakeholders' viewpoints on RWD and RWE, highlighting obstacles, difficulties, prospects, and consequences associated with their incorporation into HTA. The review emphasized the importance of recognizing regional nuances, addressing methodological challenges, and promoting collaboration for leveraging RWD and RWE effectively in healthcare decision-making.
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21
May 2024

Publication Digest: The end of an era? Activity-based funding based on diagnosis-related groups: A review of payment reforms in the inpatient sector in 10 high-income countries

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, Milstein et al. conducted a comprehensive review of reforms to Diagnosis-Related Group (DRG) payment systems across ten high-income countries. The authors aimed to provide an overview of the latest reforms and their evidence to date, highlighting a shift from volume-based to value-based payment mechanisms in hospital care. The findings revealed diverse reform trends, including reductions in DRG-based payments, episode-based payments, and incentives to promote care delivery in less costly settings, reflecting efforts to improve the quality of care while controlling healthcare expenditures.
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10
May 2024

Publication Digest: A Value Framework to Assess Patient-Facing Digital Health Technologies That Aim to Improve Chronic Disease Management: A Delphi Approach

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, Haig et al. developed a comprehensive framework for assessing the value of novel patient-facing Digital Health Technologies (DHTs) used in chronic disease management. The authors utilized a combination of literature review and primary data collection via a three-round web-Delphi exercise involving stakeholders from the USA, the UK, and Germany, resulting in a framework comprising 33 stable indicators across various domains. This framework elicits stakeholder value preferences to guide efficient and evidence-based decision-making in assessing these technologies.
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08
May 2024

Publication Digest: Evidence Synthesis and Linkage for Modelling the Cost-Effectiveness of Diagnostic Tests: Preliminary Good Practice Recommendations

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, Shinkins et al. developed preliminary good practice recommendations for the cost-effectiveness modeling of diagnostic tests. The authors conducted a targeted review of guidance from key Health Technology Assessment bodies and a specific cost-effectiveness study on troponin tests for diagnosing myocardial infarction. Recommendations aimed to improve the quality of cost-effectiveness evaluations of diagnostic tests by addressing the unique challenges in linking evidence on test accuracy to treatment effectiveness data, ultimately facilitating a better understanding of how diagnostic tests impact patient outcomes and costs.
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08
Mar 2024

Publication Digest: Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation

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, Brönneke et al. examined the implications of Germany's 2019 Digital Healthcare Act on the reimbursement pathway for patient-centered digital health applications (DiGA).  The authors outlined the challenges facing DiGA manufacturers in generating evidence required for ongoing price negotiations and reimbursement, proposing adaptations to current health technology assessment methods to accommodate the dynamic nature of DiGA assessment, and emphasizing the role of continuous evaluation using real-world evidence (RWE) in this process.
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