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, Bloemen et al. analyzed the procedures and methods used by health technology assessment (HTA) agencies in evaluating medical devices, focusing on the normative commitments of HTA practitioners. The authors revealed that existing drug-focused frameworks and practical constraints limit innovation, underscoring the need for a re-evaluation of HTA roles and institutional changes to support methodological advancements tailored 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, Tarricone et al. analyzed assessment frameworks for digital medical devices (DMDs) across the EU to identify prevailing regulatory and reimbursement approaches. The study categorized these frameworks into the following five clusters: integrated national systems combining regulation and reimbursement, decentralized or non-reimbursement-linked frameworks, institutional certification processes lacking standardization, preparatory systems, and countries with underdeveloped infrastructures. The authors emphasized the cross-country learning effects, expediting the harmonization of approaches to foster innovation and improve access to DMDs across the EU.

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, Schramm et al. conducted a structured literature review to identify key success factors for the sustainability of digital health applications (DiGAs) under Germany’s Digital Supply Act. Their findings highlight the importance of patient-centered design, application effectiveness, user-friendliness, and robust data security measures in ensuring the long-term success of DiGAs and advancing digital transformation in European healthcare systems.

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, Di Bidino et al. conducted a Delphi survey among 46 experts to identify critical topics for developing a health technology assessment (HTA) framework tailored to AI-based health technologies (AIHTs). The study revealed 48 key topics, highlighting the most crucial: accuracy of the AI model, patient safety, ethical benefit-harm balance, and bias in data. The authors highlighted gaps in the EUnetHTA Core Model, proposing a comprehensive framework to guide the evaluation of AI tools like those being developed in the European AI-Mind project for early dementia diagnosis.

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.

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, Steigenberger et al. investigated barriers and facilitators in health technology assessment (HTA), pricing, and funding policies pertaining to the utilization of rapid point-of-care diagnostics for patients with community-acquired acute respiratory tract infections. The authors conducted expert interviews with representatives from five European countries and identified key challenges, such as the lack of evidence and limited transferability of methods from drug-based HTA to diagnostics, alongside pricing barriers due to the absence of price regulation and weak purchasing power. They underscored the importance of optimized peri-launch policies to enhance the adoption of point-of-care tests.

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, Pearson et al. proposed a novel value assessment framework for digital health technologies (DHTs). Given the diversity of DHT modalities and the lack of standard regulatory and payer pathways, the authors aimed to establish evidence standards tailored specifically for DHTs, guiding technology developers in generating robust evidence. This framework can help organizations in adopting high-impact DHTs with the strongest evidence for delivering improved clinical outcomes and cost savings.

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.