Publication Digest: An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and 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, 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.

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.

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.

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.

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.